{"eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":4,"description":"40 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.","id":"EG000","otherNumAffected":3,"otherNumAtRisk":4,"seriousNumAffected":2,"seriousNumAtRisk":4,"title":"BT062 40 mg/m²"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"50 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.","id":"EG001","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"title":"BT062 50 mg/m²"},{"deathsNumAffected":0,"deathsNumAtRisk":4,"description":"65 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.","id":"EG002","otherNumAffected":3,"otherNumAtRisk":4,"seriousNumAffected":0,"seriousNumAtRisk":4,"title":"BT062 65 mg/m²"},{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"80 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.","id":"EG003","otherNumAffected":2,"otherNumAtRisk":3,"seriousNumAffected":2,"seriousNumAtRisk":3,"title":"BT062 80 mg/m²"},{"deathsNumAffected":1,"deathsNumAtRisk":4,"description":"100 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.","id":"EG004","otherNumAffected":3,"otherNumAtRisk":4,"seriousNumAffected":2,"seriousNumAtRisk":4,"title":"BT062 100 mg/m²"},{"deathsNumAffected":1,"deathsNumAtRisk":3,"description":"120 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.","id":"EG005","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":1,"seriousNumAtRisk":3,"title":"BT062 120 mg/m²"},{"deathsNumAffected":1,"deathsNumAtRisk":10,"description":"140 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.","id":"EG006","otherNumAffected":8,"otherNumAtRisk":10,"seriousNumAffected":5,"seriousNumAtRisk":10,"title":"BT062 140 mg/m²"},{"deathsNumAffected":1,"deathsNumAtRisk":4,"description":"160 mg/m² BT062 was administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.","id":"EG007","otherNumAffected":3,"otherNumAtRisk":4,"seriousNumAffected":2,"seriousNumAtRisk":4,"title":"BT062 160 mg/m²"},{"deathsNumAffected":4,"deathsNumAtRisk":35,"description":"BT062 administration (all dose levels)","id":"EG008","otherNumAffected":28,"otherNumAtRisk":35,"seriousNumAffected":14,"seriousNumAtRisk":35,"title":"Total"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":2},{"groupId":"EG004","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":2},{"groupId":"EG006","numAffected":3,"numAtRisk":10,"numEvents":4},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG008","numAffected":11,"numAtRisk":35,"numEvents":14}],"term":"ANAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":2},{"groupId":"EG008","numAffected":3,"numAtRisk":35,"numEvents":4}],"term":"LEUKOPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":5,"numAtRisk":35,"numEvents":5}],"term":"LYMPHOPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":2},{"groupId":"EG008","numAffected":4,"numAtRisk":35,"numEvents":5}],"term":"NEUTROPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG005","numAffected":2,"numAtRisk":3,"numEvents":3},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":4,"numAtRisk":35,"numEvents":5}],"term":"THROMBOCYTOPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"ABDOMINAL DISTENSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG008","numAffected":3,"numAtRisk":35,"numEvents":3}],"term":"ABDOMINAL PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG008","numAffected":5,"numAtRisk":35,"numEvents":5}],"term":"CONSTIPATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":3,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":3,"numEvents":7},{"groupId":"EG006","numAffected":3,"numAtRisk":10,"numEvents":3},{"groupId":"EG007","numAffected":3,"numAtRisk":4,"numEvents":4},{"groupId":"EG008","numAffected":13,"numAtRisk":35,"numEvents":21}],"term":"DIARRHOEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"DYSPEPSIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"HAEMATOCHEZIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":3,"numAtRisk":10,"numEvents":4},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":8,"numAtRisk":35,"numEvents":9}],"term":"NAUSEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":4,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG005","numAffected":3,"numAtRisk":3,"numEvents":5},{"groupId":"EG006","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":2},{"groupId":"EG008","numAffected":12,"numAtRisk":35,"numEvents":17}],"term":"FATIGUE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":3}],"term":"INFLUENZA LIKE ILLNESS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"INFUSION SITE ERYTHEMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"NON-CARDIAC CHEST PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":7,"numAtRisk":35,"numEvents":7}],"term":"OEDEMA PERIPHERAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"PYREXIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"PNEUMONIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":4,"numAtRisk":35,"numEvents":4}],"term":"UPPER RESPIRATORY TRACT INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"FALL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"INFUSION RELATED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"SKIN ABRASION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":3,"numEvents":4},{"groupId":"EG006","numAffected":3,"numAtRisk":10,"numEvents":4},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":2},{"groupId":"EG008","numAffected":6,"numAtRisk":35,"numEvents":10}],"term":"ALANINE AMINOTRANSFERASE INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":10,"numEvents":3},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":3,"numAtRisk":35,"numEvents":5}],"term":"AMYLASE INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":4,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG006","numAffected":3,"numAtRisk":10,"numEvents":4},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG008","numAffected":9,"numAtRisk":35,"numEvents":11}],"term":"ASPARTATE AMINOTRANSFERASE INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"BLOOD CREATINE PHOSPHOKINASE INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"BLOOD CREATININE INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG008","numAffected":4,"numAtRisk":35,"numEvents":4}],"term":"BLOOD LACTATE DEHYDROGENASE INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"BLOOD URIC ACID INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":4,"numAtRisk":35,"numEvents":4}],"term":"GAMMA-GLUTAMYLTRANSFERASE INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"LIPASE INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":3,"numEvents":6},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":3,"numAtRisk":35,"numEvents":7}],"term":"LYMPHOCYTE COUNT DECREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":3,"numEvents":5},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":5}],"term":"NEUTROPHIL COUNT DECREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":4,"numAtRisk":35,"numEvents":4}],"term":"OCCULT BLOOD POSITIVE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":3,"numAtRisk":35,"numEvents":3}],"term":"DECREASED APPETITE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":3,"numAtRisk":35,"numEvents":3}],"term":"HYPERCALCAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":3,"numEvents":6},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":3,"numAtRisk":10,"numEvents":4},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":6,"numAtRisk":35,"numEvents":11}],"term":"HYPERGLYCAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"HYPERKALAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":4,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":4},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG008","numAffected":7,"numAtRisk":35,"numEvents":11}],"term":"HYPOKALAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":3}],"term":"HYPONATRAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":3,"numAtRisk":35,"numEvents":4}],"term":"ARTHRALGIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG008","numAffected":4,"numAtRisk":35,"numEvents":4}],"term":"BACK PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":5,"numAtRisk":35,"numEvents":5}],"term":"BONE PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"FLANK PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"MUSCULOSKELETAL CHEST PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":3,"numAtRisk":35,"numEvents":3}],"term":"MUSCULOSKELETAL PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"MYALGIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":3,"numAtRisk":35,"numEvents":3}],"term":"PAIN IN EXTREMITY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"HYPOAESTHESIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":4,"numEvents":3},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":3,"numAtRisk":35,"numEvents":3}],"term":"NEURALGIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":3,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG008","numAffected":4,"numAtRisk":35,"numEvents":4}],"term":"NEUROPATHY PERIPHERAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"ANXIETY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"INSOMNIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"DYSURIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG008","numAffected":3,"numAtRisk":35,"numEvents":3}],"term":"COUGH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"DYSPNOEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG008","numAffected":3,"numAtRisk":35,"numEvents":3}],"term":"DYSPNOEA EXERTIONAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":3,"numAtRisk":35,"numEvents":3}],"term":"PRODUCTIVE COUGH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"UPPER-AIRWAY COUGH SYNDROME"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"BLISTER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":4,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":4,"numEvents":3},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":2},{"groupId":"EG008","numAffected":5,"numAtRisk":35,"numEvents":7}],"term":"DRY SKIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":3,"numEvents":5},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG008","numAffected":3,"numAtRisk":35,"numEvents":6}],"term":"ERYTHEMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"PRURITUS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":3},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG008","numAffected":5,"numAtRisk":35,"numEvents":7}],"term":"RASH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"RASH ERYTHEMATOUS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"HOT FLUSH"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG008","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"NEUTROPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"ATRIAL FIBRILLATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"EXTRAOCULAR MUSCLE PARESIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"PYREXIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":10,"numEvents":2},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG008","numAffected":3,"numAtRisk":35,"numEvents":3}],"term":"PNEUMONIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"HEAD INJURY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG008","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"HIP FRACTURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"PELVIC FRACTURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"TRANSAMINASES INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"BONE PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"BRAIN MASS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG008","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"HAEMORRHAGE INTRACRANIAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":35,"numEvents":2}],"term":"RENAL FAILURE ACUTE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":3,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"ALVEOLITIS ALLERGIC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"PULMONARY EMBOLISM"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":10,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"PALMAR-PLANTAR / ERYTHRODYSAESTHESIA SYNDROME"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"STEVENS-JOHNSON SYNDROME"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (17.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":4,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":3,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":10,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":4,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":35,"numEvents":1}],"term":"DEEP VEIN THROMBOSIS"}],"timeFrame":"Adverse events (AEs) were to be documented during the entire study period including the 30 day follow up (average 4.99 months)."}