{"description":"Safety population included all participants who were enrolled and received at least 1 dose of study drug. AEs (serious and non-serious) and deaths occurred during TEAE period were reported. Data was only collected and reported by combined groups for the dose-escalation phase and not by individual doses.","eventGroups":[{"deathsNumAffected":2,"deathsNumAtRisk":2,"description":"Participants received mirvetuximab soravtansine 0.15 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.","id":"EG000","otherNumAffected":2,"otherNumAtRisk":2,"seriousNumAffected":2,"seriousNumAtRisk":2,"title":"Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.15 mg/kg Q3W)"},{"deathsNumAffected":0,"deathsNumAtRisk":1,"description":"Participants received mirvetuximab soravtansine 0.5 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.","id":"EG001","otherNumAffected":0,"otherNumAtRisk":1,"seriousNumAffected":0,"seriousNumAtRisk":1,"title":"Dose Escalation: Schedule A (Mirvetuximab Soravtansine 0.5 mg/kg Q3W)"},{"deathsNumAffected":0,"deathsNumAtRisk":1,"description":"Participants received mirvetuximab soravtansine 1.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.","id":"EG002","otherNumAffected":1,"otherNumAtRisk":1,"seriousNumAffected":1,"seriousNumAtRisk":1,"title":"Dose Escalation: Schedule A (Mirvetuximab Soravtansine 1.0 mg/kg Q3W)"},{"deathsNumAffected":0,"deathsNumAtRisk":1,"description":"Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.","id":"EG003","otherNumAffected":1,"otherNumAtRisk":1,"seriousNumAffected":0,"seriousNumAtRisk":1,"title":"Dose Escalation: Schedule A (Mirvetuximab Soravtansine 2.0 mg/kg Q3W)"},{"deathsNumAffected":0,"deathsNumAtRisk":9,"description":"Participants received mirvetuximab soravtansine 3.3 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.","id":"EG004","otherNumAffected":9,"otherNumAtRisk":9,"seriousNumAffected":0,"seriousNumAtRisk":9,"title":"Dose Escalation: Schedule A (Mirvetuximab Soravtansine 3.3 mg/kg Q3W)"},{"deathsNumAffected":1,"deathsNumAtRisk":18,"description":"Participants received mirvetuximab soravtansine 5.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.","id":"EG005","otherNumAffected":18,"otherNumAtRisk":18,"seriousNumAffected":5,"seriousNumAtRisk":18,"title":"Dose Escalation: Schedule A (Mirvetuximab Soravtansine 5.0 mg/kg Q3W)"},{"deathsNumAffected":0,"deathsNumAtRisk":7,"description":"Participants received mirvetuximab soravtansine 6.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.","id":"EG006","otherNumAffected":7,"otherNumAtRisk":7,"seriousNumAffected":1,"seriousNumAtRisk":7,"title":"Dose Escalation: Schedule A (Mirvetuximab Soravtansine 6.0 mg/kg Q3W)"},{"deathsNumAffected":0,"deathsNumAtRisk":5,"description":"Participants received mirvetuximab soravtansine 7.0 mg/kg IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.","id":"EG007","otherNumAffected":5,"otherNumAtRisk":5,"seriousNumAffected":2,"seriousNumAtRisk":5,"title":"Dose Escalation: Schedule A (Mirvetuximab Soravtansine 7.0 mg/kg Q3W)"},{"deathsNumAffected":0,"deathsNumAtRisk":5,"description":"Participants received mirvetuximab soravtansine 1.1 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.","id":"EG008","otherNumAffected":5,"otherNumAtRisk":5,"seriousNumAffected":2,"seriousNumAtRisk":5,"title":"Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.1 mg/kg Weekly)"},{"deathsNumAffected":0,"deathsNumAtRisk":4,"description":"Participants received mirvetuximab soravtansine 1.8 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.","id":"EG009","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":3,"seriousNumAtRisk":4,"title":"Dose Escalation: Schedule B (Mirvetuximab Soravtansine 1.8 mg/kg Weekly)"},{"deathsNumAffected":1,"deathsNumAtRisk":9,"description":"Participants received mirvetuximab soravtansine 2.0 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.","id":"EG010","otherNumAffected":9,"otherNumAtRisk":9,"seriousNumAffected":4,"seriousNumAtRisk":9,"title":"Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.0 mg/kg Weekly)"},{"deathsNumAffected":0,"deathsNumAtRisk":7,"description":"Participants received mirvetuximab soravtansine 2.5 mg/kg IV infusion on Days 1, 8, and 15 of every 28-day cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.","id":"EG011","otherNumAffected":7,"otherNumAtRisk":7,"seriousNumAffected":4,"seriousNumAtRisk":7,"title":"Dose Escalation: Schedule B (Mirvetuximab Soravtansine 2.5 mg/kg Weekly)"},{"deathsNumAffected":4,"deathsNumAtRisk":46,"description":"Participants with EOC, primary peritoneal cancer, or fallopian tube cancer resistant to platinum-based therapy received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.","id":"EG012","otherNumAffected":45,"otherNumAtRisk":46,"seriousNumAffected":18,"seriousNumAtRisk":46,"title":"Dose Expansion: Cohort 1 (Mirvetuximab Soravtansine Q3W)"},{"deathsNumAffected":4,"deathsNumAtRisk":24,"description":"Participants with FOLR1-positive uterine cancer (that was advanced or recurrent and had received at least 1 platinum-based regimen, and no more than 5 prior systemic treatment regimens for EC) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.","id":"EG013","otherNumAffected":24,"otherNumAtRisk":24,"seriousNumAffected":11,"seriousNumAtRisk":24,"title":"Dose Expansion: Cohort 2 (Mirvetuximab Soravtansine Q3W)"},{"deathsNumAffected":1,"deathsNumAtRisk":27,"description":"Participants with biopsy-accessible relapsed or refractory ovarian cancer, primary peritoneal cancer, or fallopian tube cancer received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.","id":"EG014","otherNumAffected":27,"otherNumAtRisk":27,"seriousNumAffected":9,"seriousNumAtRisk":27,"title":"Dose Expansion: Cohort 3 (Mirvetuximab Soravtansine Q3W)"},{"deathsNumAffected":4,"deathsNumAtRisk":40,"description":"Participants with EOC primary peritoneal cancer or fallopian tube cancer (that had relapsed following platinum-based therapy, excluding those participants with primary platinum refractory disease or low grade or clear cell ovarian cancer) received mirvetuximab soravtansine 6.0 mg/kg (MTD) IV infusion on Day 1 of every 21-day (Q3W) cycle. Participants continued to receive mirvetuximab soravtansine (for clinical benefit) until unacceptable toxicity or withdrawal of consent, whichever came first, or until the sponsor terminated the study.","id":"EG015","otherNumAffected":40,"otherNumAtRisk":40,"seriousNumAffected":17,"seriousNumAtRisk":40,"title":"Dose Expansion: Cohort 5 (Mirvetuximab Soravtansine Q3W)"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":3,"numAtRisk":9},{"groupId":"EG005","numAffected":7,"numAtRisk":18},{"groupId":"EG006","numAffected":2,"numAtRisk":7},{"groupId":"EG007","numAffected":2,"numAtRisk":5},{"groupId":"EG008","numAffected":2,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":5,"numAtRisk":9},{"groupId":"EG011","numAffected":3,"numAtRisk":7},{"groupId":"EG012","numAffected":24,"numAtRisk":46},{"groupId":"EG013","numAffected":8,"numAtRisk":24},{"groupId":"EG014","numAffected":10,"numAtRisk":27},{"groupId":"EG015","numAffected":23,"numAtRisk":40}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":4,"numAtRisk":9},{"groupId":"EG005","numAffected":4,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":2,"numAtRisk":5},{"groupId":"EG008","numAffected":3,"numAtRisk":5},{"groupId":"EG009","numAffected":2,"numAtRisk":4},{"groupId":"EG010","numAffected":6,"numAtRisk":9},{"groupId":"EG011","numAffected":3,"numAtRisk":7},{"groupId":"EG012","numAffected":19,"numAtRisk":46},{"groupId":"EG013","numAffected":10,"numAtRisk":24},{"groupId":"EG014","numAffected":9,"numAtRisk":27},{"groupId":"EG015","numAffected":19,"numAtRisk":40}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":1,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":5,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":3,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":4,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":4,"numAtRisk":27},{"groupId":"EG015","numAffected":7,"numAtRisk":40}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":3,"numAtRisk":9},{"groupId":"EG005","numAffected":2,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":2,"numAtRisk":5},{"groupId":"EG009","numAffected":2,"numAtRisk":4},{"groupId":"EG010","numAffected":3,"numAtRisk":9},{"groupId":"EG011","numAffected":2,"numAtRisk":7},{"groupId":"EG012","numAffected":15,"numAtRisk":46},{"groupId":"EG013","numAffected":5,"numAtRisk":24},{"groupId":"EG014","numAffected":6,"numAtRisk":27},{"groupId":"EG015","numAffected":10,"numAtRisk":40}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":2,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":2,"numAtRisk":4},{"groupId":"EG010","numAffected":2,"numAtRisk":9},{"groupId":"EG011","numAffected":2,"numAtRisk":7},{"groupId":"EG012","numAffected":9,"numAtRisk":46},{"groupId":"EG013","numAffected":7,"numAtRisk":24},{"groupId":"EG014","numAffected":8,"numAtRisk":27},{"groupId":"EG015","numAffected":10,"numAtRisk":40}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":2,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":2,"numAtRisk":40}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":4,"numAtRisk":40}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Gingival bleeding"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Mouth ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Oral dysaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":2,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Retching"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":3,"numAtRisk":18},{"groupId":"EG006","numAffected":2,"numAtRisk":7},{"groupId":"EG007","numAffected":5,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":3,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":2,"numAtRisk":7},{"groupId":"EG012","numAffected":23,"numAtRisk":46},{"groupId":"EG013","numAffected":7,"numAtRisk":24},{"groupId":"EG014","numAffected":11,"numAtRisk":27},{"groupId":"EG015","numAffected":16,"numAtRisk":40}],"term":"Vision blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":3,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":2,"numAtRisk":27},{"groupId":"EG015","numAffected":2,"numAtRisk":40}],"term":"Visual impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Diplopia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":8,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":2,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Punctate keratitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Corneal erosion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Corneal pigmentation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":3,"numAtRisk":40}],"term":"Eye disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":3,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Eye irritation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":3,"numAtRisk":40}],"term":"Eye pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Macular degeneration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":2,"numAtRisk":40}],"term":"Photophobia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Retinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Retinopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":2,"numAtRisk":40}],"term":"Vitreous floaters"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":3,"numAtRisk":5},{"groupId":"EG008","numAffected":2,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":2,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":3,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":3,"numAtRisk":27},{"groupId":"EG015","numAffected":3,"numAtRisk":40}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":3,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":2,"numAtRisk":27},{"groupId":"EG015","numAffected":7,"numAtRisk":40}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":2,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":2,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":2,"numAtRisk":27},{"groupId":"EG015","numAffected":2,"numAtRisk":40}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":2,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":2,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Flank pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":2,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":3,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":7,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":5,"numAtRisk":40}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":3,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":2,"numAtRisk":27},{"groupId":"EG015","numAffected":4,"numAtRisk":40}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Joint swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":4,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":2,"numAtRisk":40}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":2,"numAtRisk":9},{"groupId":"EG005","numAffected":4,"numAtRisk":18},{"groupId":"EG006","numAffected":4,"numAtRisk":7},{"groupId":"EG007","numAffected":3,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":4,"numAtRisk":9},{"groupId":"EG011","numAffected":3,"numAtRisk":7},{"groupId":"EG012","numAffected":19,"numAtRisk":46},{"groupId":"EG013","numAffected":12,"numAtRisk":24},{"groupId":"EG014","numAffected":12,"numAtRisk":27},{"groupId":"EG015","numAffected":23,"numAtRisk":40}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":3,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":6,"numAtRisk":46},{"groupId":"EG013","numAffected":3,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":4,"numAtRisk":40}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":4,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":2,"numAtRisk":40}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":2,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":4,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":4,"numAtRisk":40}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":2,"numAtRisk":40}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":5,"numAtRisk":40}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":4,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":3,"numAtRisk":46},{"groupId":"EG013","numAffected":4,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":4,"numAtRisk":40}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":2,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":2,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":9,"numAtRisk":46},{"groupId":"EG013","numAffected":8,"numAtRisk":24},{"groupId":"EG014","numAffected":5,"numAtRisk":27},{"groupId":"EG015","numAffected":15,"numAtRisk":40}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":7,"numAtRisk":46},{"groupId":"EG013","numAffected":8,"numAtRisk":24},{"groupId":"EG014","numAffected":3,"numAtRisk":27},{"groupId":"EG015","numAffected":7,"numAtRisk":40}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":1,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":10,"numAtRisk":46},{"groupId":"EG013","numAffected":6,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":8,"numAtRisk":40}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":2,"numAtRisk":9},{"groupId":"EG005","numAffected":4,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":2,"numAtRisk":5},{"groupId":"EG008","numAffected":3,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":5,"numAtRisk":9},{"groupId":"EG011","numAffected":6,"numAtRisk":7},{"groupId":"EG012","numAffected":9,"numAtRisk":46},{"groupId":"EG013","numAffected":6,"numAtRisk":24},{"groupId":"EG014","numAffected":6,"numAtRisk":27},{"groupId":"EG015","numAffected":12,"numAtRisk":40}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":2,"numAtRisk":9},{"groupId":"EG005","numAffected":3,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":5,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":3,"numAtRisk":27},{"groupId":"EG015","numAffected":3,"numAtRisk":40}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":2,"numAtRisk":4},{"groupId":"EG010","numAffected":2,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":9,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":2,"numAtRisk":27},{"groupId":"EG015","numAffected":7,"numAtRisk":40}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":4,"numAtRisk":46},{"groupId":"EG013","numAffected":6,"numAtRisk":24},{"groupId":"EG014","numAffected":3,"numAtRisk":27},{"groupId":"EG015","numAffected":3,"numAtRisk":40}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":2,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Hypoaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Aphasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Balance disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":4,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":2,"numAtRisk":40}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Facial neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hypogeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":2,"numAtRisk":27},{"groupId":"EG015","numAffected":4,"numAtRisk":40}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":3,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Sciatica"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":5,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":2,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":2,"numAtRisk":7},{"groupId":"EG012","numAffected":7,"numAtRisk":46},{"groupId":"EG013","numAffected":3,"numAtRisk":24},{"groupId":"EG014","numAffected":7,"numAtRisk":27},{"groupId":"EG015","numAffected":5,"numAtRisk":40}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":2,"numAtRisk":9},{"groupId":"EG005","numAffected":3,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":2,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":2,"numAtRisk":7},{"groupId":"EG012","numAffected":9,"numAtRisk":46},{"groupId":"EG013","numAffected":5,"numAtRisk":24},{"groupId":"EG014","numAffected":8,"numAtRisk":27},{"groupId":"EG015","numAffected":11,"numAtRisk":40}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":3,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":4,"numAtRisk":40}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":2,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":4,"numAtRisk":46},{"groupId":"EG013","numAffected":5,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":5,"numAtRisk":40}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Breath sounds abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Electrocardiogram QT prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":2,"numAtRisk":18},{"groupId":"EG006","numAffected":2,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":2,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":3,"numAtRisk":7},{"groupId":"EG012","numAffected":8,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":4,"numAtRisk":27},{"groupId":"EG015","numAffected":6,"numAtRisk":40}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":3,"numAtRisk":7},{"groupId":"EG012","numAffected":5,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":5,"numAtRisk":27},{"groupId":"EG015","numAffected":7,"numAtRisk":40}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":2,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":2,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":3,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Dysphonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":5,"numAtRisk":40}],"term":"Nasal congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":5,"numAtRisk":40}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Paranasal sinus hypersecretion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Pulmonary oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Sinus disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Upper respiratory tract congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":2,"numAtRisk":9},{"groupId":"EG005","numAffected":2,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":3,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":6,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":4,"numAtRisk":40}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":2,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":7,"numAtRisk":46},{"groupId":"EG013","numAffected":3,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":2,"numAtRisk":40}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":2,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":3,"numAtRisk":40}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":2,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Eye infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Eye infection bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":2,"numAtRisk":40}],"term":"Hordeolum"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Sweating fever"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":9,"numAtRisk":46},{"groupId":"EG013","numAffected":3,"numAtRisk":24},{"groupId":"EG014","numAffected":2,"numAtRisk":27},{"groupId":"EG015","numAffected":5,"numAtRisk":40}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":2,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":2,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":3,"numAtRisk":40}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Mental status changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Restlessness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":2,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":3,"numAtRisk":40}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":2,"numAtRisk":40}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Dermatitis acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Dermatitis contact"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Night sweats"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Psoriasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Urticaria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":4,"numAtRisk":46},{"groupId":"EG013","numAffected":3,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":4,"numAtRisk":40}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Arthropod bite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Eye contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hip fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":2,"numAtRisk":40}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Skin abrasion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Wound complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":3,"numAtRisk":40}],"term":"Vaginal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Pelvic discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Pelvic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Vulvovaginal erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":1,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":4,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":4,"numAtRisk":40}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hot flush"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Phlebitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":3,"numAtRisk":40}],"term":"Pollakiuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":3,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":2,"numAtRisk":40}],"term":"Proteinuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Urinary incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":3,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":2,"numAtRisk":40}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Inner ear disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":3,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":2,"numAtRisk":7},{"groupId":"EG012","numAffected":3,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":8,"numAtRisk":40}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":2,"numAtRisk":40}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Abdominal hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":4,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":2,"numAtRisk":40}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Disturbance in attention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Lethargy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Catheter site pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Joint range of motion decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Osteopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":2,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":3,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Dyspnoea exertional"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":2,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Upper-airway cough syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":2,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Rhinitis allergic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Throat irritation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Wheezing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":3,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Blood urea increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Oxygen saturation decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Vitamin D decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Weight increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":2,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":7,"numAtRisk":46},{"groupId":"EG013","numAffected":4,"numAtRisk":24},{"groupId":"EG014","numAffected":5,"numAtRisk":27},{"groupId":"EG015","numAffected":9,"numAtRisk":40}],"term":"Dry eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":4,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":3,"numAtRisk":27},{"groupId":"EG015","numAffected":6,"numAtRisk":40}],"term":"Cataract"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Conjunctival haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":3,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Corneal deposits"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Eye pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":4,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":6,"numAtRisk":27},{"groupId":"EG015","numAffected":6,"numAtRisk":40}],"term":"Keratopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Ocular discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Photopsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":2,"numAtRisk":7},{"groupId":"EG012","numAffected":4,"numAtRisk":46},{"groupId":"EG013","numAffected":6,"numAtRisk":24},{"groupId":"EG014","numAffected":2,"numAtRisk":27},{"groupId":"EG015","numAffected":5,"numAtRisk":40}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":4,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hyperuricaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Metabolic alkalosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Polydipsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":2,"numAtRisk":27},{"groupId":"EG015","numAffected":2,"numAtRisk":40}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Chronic pigmented purpura"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":3,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Hyperhidrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Nail disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Palmar-plantar erythrodysaesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Skin lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Candida infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Fungal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Pneumonia staphylococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":2,"numAtRisk":40}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":3,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Tinnitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Ear pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"External ear inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":3,"numAtRisk":24},{"groupId":"EG014","numAffected":2,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Muscle strain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":3,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":3,"numAtRisk":40}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":2,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":3,"numAtRisk":40}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Dysuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":3,"numAtRisk":40}],"term":"Hydronephrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Micturition urgency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":2,"numAtRisk":40}],"term":"Palpitations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Supraventricular tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Thyroid pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Breast mass"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":3,"numAtRisk":27},{"groupId":"EG015","numAffected":5,"numAtRisk":40}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":3,"numAtRisk":40}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Rectal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Abdominal discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Abdominal pain lower"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Abdominal rigidity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Anorectal discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Enteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Haematochezia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hypoaesthesia oral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Large intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Lip haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Lip pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Mouth swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Oesophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Oral disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Proctalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Rectal discharge"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Tooth discolouration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Early satiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":2,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Infusion site extravasation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Catheter site inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Catheter site rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Chest discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Infusion site discolouration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Localised oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Necrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Nodule"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Performance status decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":5,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":3,"numAtRisk":27},{"groupId":"EG015","numAffected":5,"numAtRisk":40}],"term":"Keratitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":3,"numAtRisk":27},{"groupId":"EG015","numAffected":2,"numAtRisk":40}],"term":"Corneal epithelial microcysts"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":3,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Corneal cyst"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Corneal disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Lacrimation increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Vitreous degeneration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Abnormal sensation in eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Asthenopia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Blepharitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Chalazion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Corneal lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Corneal oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Glaucoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Iritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Lacrimation decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Lagophthalmos"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Macular fibrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Ocular hyperaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Posterior capsule opacification"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Retinal vein occlusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Visual acuity reduced"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Vitreous adhesions"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Vitreous detachment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Memory impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Brain oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Burning sensation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Depressed level of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Dysarthria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hemiparesis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Hyperreflexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Ischaemic stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Migraine"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Nystagmus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Restless legs syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":4,"numAtRisk":40}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Glucose tolerance impaired"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hypercholesterolaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hypermagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hypoglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":3,"numAtRisk":27},{"groupId":"EG015","numAffected":3,"numAtRisk":40}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Blood magnesium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":2,"numAtRisk":40}],"term":"Blood potassium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":2,"numAtRisk":40}],"term":"Eastern Cooperative Oncology Group performance status worsened"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Activated partial thromboplastin time prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Carbon monoxide diffusing capacity decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Gastrointestinal stoma output decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Intraocular pressure increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Lymph node palpable"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Protein total decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Waist circumference increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":2,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Diaphragmalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Respiratory distress"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Respiratory tract congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Rhinorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Sinus congestion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Sinus pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Coccydynia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Limb discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Musculoskeletal stiffness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Oral candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Angular cheilitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Clostridium difficile infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Eye infection fungal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Fungal skin infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Oral herpes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Paronychia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Vulvitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Vulvovaginal mycotic infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":2,"numAtRisk":40}],"term":"Corneal abrasion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Wound"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Anastomotic ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Excoriation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Joint injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Laceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Post procedural diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Procedural pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Spinal compression fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Stomal hernia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Tooth fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Upper limb fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Vascular access complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Wound dehiscence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":3,"numAtRisk":40}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Ligament sprain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Leukocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Increased tendency to bruise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Rash macular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Ecchymosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Pain of skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Rash papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Swelling face"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Telangiectasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Bladder spasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Nocturia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Urinary hesitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Urinary tract pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Arterial intramural haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Lymphoedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Agitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Vaginal discharge"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":2,"numAtRisk":40}],"term":"Breast pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Vulvovaginal dryness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Perineal rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Vaginal lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Vulvovaginal discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Vulvovaginal pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Right ventricular hypertrophy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Sinus bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hypoacusis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Ear discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Otorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Hyperbilirubinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hepatic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Portal hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Metastatic neoplasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Adenoma benign"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Congenital, familial and genetic disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Corneal dystrophy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Drug hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Limbal stem cell deficiency"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":1,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":7,"numAtRisk":40}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Corneal opacity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Punctate keratitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":1,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hip fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Humerus fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Pulmonary oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":1,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":1,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Metastatic neoplasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":3,"numAtRisk":40}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Organising pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":3,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":4,"numAtRisk":27},{"groupId":"EG015","numAffected":7,"numAtRisk":40}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Electrocardiogram QT prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":1,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hypoglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Metastases to central nervous system"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":1,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":1,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":1,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Superior vena cava syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":3,"numAtRisk":40}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":2,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Large intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Enteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Enterocutaneous fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Intestinal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Oesophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Gallbladder obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hyperbilirubinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Abdominal wall abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Haemophilus infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":3,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":2,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Metastases to meninges"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Spinal fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":1,"numAtRisk":40}],"term":"Arthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":1,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":0,"numAtRisk":46},{"groupId":"EG013","numAffected":1,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Pulmonary fibrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 17.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":2},{"groupId":"EG001","numAffected":0,"numAtRisk":1},{"groupId":"EG002","numAffected":0,"numAtRisk":1},{"groupId":"EG003","numAffected":0,"numAtRisk":1},{"groupId":"EG004","numAffected":0,"numAtRisk":9},{"groupId":"EG005","numAffected":0,"numAtRisk":18},{"groupId":"EG006","numAffected":0,"numAtRisk":7},{"groupId":"EG007","numAffected":0,"numAtRisk":5},{"groupId":"EG008","numAffected":0,"numAtRisk":5},{"groupId":"EG009","numAffected":0,"numAtRisk":4},{"groupId":"EG010","numAffected":0,"numAtRisk":9},{"groupId":"EG011","numAffected":0,"numAtRisk":7},{"groupId":"EG012","numAffected":1,"numAtRisk":46},{"groupId":"EG013","numAffected":0,"numAtRisk":24},{"groupId":"EG014","numAffected":0,"numAtRisk":27},{"groupId":"EG015","numAffected":0,"numAtRisk":40}],"term":"Hypotension"}],"timeFrame":"From first dose of study drug up to 28 days after last dose of study drug (maximum exposure: 36 weeks for dose-escalation Schedule A, 101.3 weeks for dose-escalation Schedule B, 124 weeks for dose-expansion EOC, 33.3 weeks for dose-expansion EC)"}