{"description":"Safety population: All participants who received at least 1 dose of study treatment in monotherapy or combination therapy periods. Mortality data for the combination therapy evaluated all participants who received treatment, including those who moved to combination therapy during the study.","eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":11,"description":"Participants with normal hepatic function received Tablet A (selinexor 5 × 20 mg tablets) orally on Day 1 or Day 8, until PD, intolerability, or Investigator decision.","id":"EG000","otherNumAffected":9,"otherNumAtRisk":11,"seriousNumAffected":4,"seriousNumAtRisk":11,"title":"Monotherapy: Tablet A (Selinexor 5 x 20 mg Tablet): Normal Hepatic Function"},{"deathsNumAffected":1,"deathsNumAtRisk":11,"description":"Participants with normal hepatic function received Tablet B (selinexor 1 × 100 mg tablet) orally on Day 1 or Day 8, until PD, intolerability, or Investigator decision.","id":"EG001","otherNumAffected":11,"otherNumAtRisk":11,"seriousNumAffected":1,"seriousNumAtRisk":11,"title":"Monotherapy: Tablet B (Selinexor 1 x 100 mg Tablet): Normal Hepatic Function"},{"deathsNumAffected":3,"deathsNumAtRisk":7,"description":"Participants with moderate hepatic function received Tablet A (selinexor 2 × 20 mg tablets) orally once weekly on Day 1 up to 4 months.","id":"EG002","otherNumAffected":7,"otherNumAtRisk":7,"seriousNumAffected":5,"seriousNumAtRisk":7,"title":"Monotherapy: Moderate Hepatic Function (Tablet A Only)"},{"deathsNumAffected":5,"deathsNumAtRisk":6,"description":"Participants with severe hepatic function received Tablet A (selinexor 2 X 20 mg tablets) orally once weekly on Day 1 up to 4 months.","id":"EG003","otherNumAffected":4,"otherNumAtRisk":6,"seriousNumAffected":1,"seriousNumAtRisk":6,"title":"Monotherapy: Severe Hepatic Function (Tablet A Only)"},{"deathsNumAffected":11,"deathsNumAtRisk":17,"description":"Participants with non-small cell lung cancer received selinexor 60 mg orally QW and docetaxel 75 mg/m\\^2 IV for every 3 weeks up to 25 months.","id":"EG004","otherNumAffected":17,"otherNumAtRisk":17,"seriousNumAffected":11,"seriousNumAtRisk":17,"title":"Combination Therapy: NSCLC Arm A: Selinexor + Docetaxel"},{"deathsNumAffected":30,"deathsNumAtRisk":38,"description":"Participants with colorectal cancer received selinexor 80 mg orally QW and pembrolizumab 200 mg IV every 3 weeks up to 25 months.","id":"EG005","otherNumAffected":37,"otherNumAtRisk":38,"seriousNumAffected":10,"seriousNumAtRisk":38,"title":"Combination Therapy: CRC Arm B: Selinexor + Pembrolizumab"},{"deathsNumAffected":5,"deathsNumAtRisk":6,"description":"Participants with colorectal cancer received selinexor 40 mg orally on Days 1, 3, 15 and 18 in a 28-day cycle and FOLFIRI (irinotecan 180 mg/m\\^2; leucovorin 400 mg/m\\^2; 5- fluorouracil (5-FU) 400 mg/m\\^2 bolus then 5-FU 2400 mg/m\\^2 continuous over 46-48 hours; IV on Day 1 and 15 in a 28-day cycle) until PD or intolerable toxicity up to 25 months.","id":"EG006","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":2,"seriousNumAtRisk":6,"title":"Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 1)"},{"deathsNumAffected":2,"deathsNumAtRisk":2,"description":"Participants with colorectal cancer received selinexor 80 mg orally on Days 1 and 15 in a 28-day cycle and FOLFIRI (irinotecan 180 mg/m\\^2; leucovorin 400 mg/m\\^2; 5-FU 400 mg/m\\^2 bolus then 5-FU 2400 mg/m\\^2 continuous over 46-48 hours; IV on Day 1 and 15 in a 28-day cycle) until PD or intolerable toxicity up to 25 months.","id":"EG007","otherNumAffected":2,"otherNumAtRisk":2,"seriousNumAffected":1,"seriousNumAtRisk":2,"title":"Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 2)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":3,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":9,"numAtRisk":17},{"groupId":"EG005","numAffected":7,"numAtRisk":38},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":5,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":2,"numAtRisk":38},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Thrombocytopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":2,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":2,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Leukopenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":2}],"term":"Leukocytosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":2}],"term":"Neutrophilia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":2,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Sinus tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Arrhythmia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Myocardial infarction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Deafness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Hypoacusis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Vestibular disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Hypothyroidism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":2,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Vision blurred"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":2,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Eye oedema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Blepharitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Cataract"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Visual impairment"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":11},{"groupId":"EG001","numAffected":7,"numAtRisk":11},{"groupId":"EG002","numAffected":3,"numAtRisk":7},{"groupId":"EG003","numAffected":2,"numAtRisk":6},{"groupId":"EG004","numAffected":8,"numAtRisk":17},{"groupId":"EG005","numAffected":21,"numAtRisk":38},{"groupId":"EG006","numAffected":4,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":2}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":8,"numAtRisk":17},{"groupId":"EG005","numAffected":9,"numAtRisk":38},{"groupId":"EG006","numAffected":2,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Diarrhoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11},{"groupId":"EG001","numAffected":8,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":6},{"groupId":"EG004","numAffected":4,"numAtRisk":17},{"groupId":"EG005","numAffected":11,"numAtRisk":38},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":2}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":6},{"groupId":"EG004","numAffected":2,"numAtRisk":17},{"groupId":"EG005","numAffected":8,"numAtRisk":38},{"groupId":"EG006","numAffected":2,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":3,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":4,"numAtRisk":38},{"groupId":"EG006","numAffected":2,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":2}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":2}],"term":"Ascites"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":2,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":2}],"term":"Dyspepsia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":2,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Small intestinal obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Anal haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Hypoaesthesia oral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Odynophagia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Proctalgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":7,"numAtRisk":17},{"groupId":"EG005","numAffected":17,"numAtRisk":38},{"groupId":"EG006","numAffected":3,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":7,"numAtRisk":17},{"groupId":"EG005","numAffected":5,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":2}],"term":"Asthenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":3,"numAtRisk":17},{"groupId":"EG005","numAffected":4,"numAtRisk":38},{"groupId":"EG006","numAffected":3,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Pyrexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":3,"numAtRisk":6},{"groupId":"EG004","numAffected":6,"numAtRisk":17},{"groupId":"EG005","numAffected":3,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Oedema peripheral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":2,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Gait disturbance"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":2,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Chest discomfort"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Mucosal inflammation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Non-cardiac chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Swelling face"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Cholangitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Cholecystitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":4,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":2,"numAtRisk":17},{"groupId":"EG005","numAffected":2,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Bacteraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Urinary tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Bacterial vaginosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"COVID-19"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":2}],"term":"Candida infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Fungal infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Necrotising fasciitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":2,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Septic shock"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Sinusitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Upper respiratory tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Fall"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Overdose"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Spinal fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Wound"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":3,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":7,"numAtRisk":17},{"groupId":"EG005","numAffected":9,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":2}],"term":"Weight decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":2,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Blood creatinine increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Breath sounds abnormal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Eastern Cooperative Oncology Group performance status worsened"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11},{"groupId":"EG001","numAffected":3,"numAtRisk":11},{"groupId":"EG002","numAffected":3,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":6},{"groupId":"EG004","numAffected":9,"numAtRisk":17},{"groupId":"EG005","numAffected":17,"numAtRisk":38},{"groupId":"EG006","numAffected":3,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":2}],"term":"Decreased appetite"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":3,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":3,"numAtRisk":17},{"groupId":"EG005","numAffected":4,"numAtRisk":38},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":2}],"term":"Hyponatraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":3,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Hypoalbuminaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":2,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Hypokalaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Hyperglycaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Hyperkalaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Hypernatraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Hypoglycaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Hypomagnesaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Hypophosphataemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Iron deficiency"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":4,"numAtRisk":17},{"groupId":"EG005","numAffected":4,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":2,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Myalgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Bone pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Musculoskeletal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Osteoporosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":6},{"groupId":"EG004","numAffected":2,"numAtRisk":17},{"groupId":"EG005","numAffected":5,"numAtRisk":38},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":2}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":4,"numAtRisk":38},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":2}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":2,"numAtRisk":17},{"groupId":"EG005","numAffected":2,"numAtRisk":38},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Dysgeusia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":2}],"term":"Neuropathy peripheral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Syncope"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Ageusia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Cerebral infarction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Encephalopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Hypoaesthesia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Paraesthesia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Sensory disturbance"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":2,"numAtRisk":17},{"groupId":"EG005","numAffected":2,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Insomnia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":3,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Confusional state"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Delirium"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Mood altered"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Panic attack"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Agitation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Dysuria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Haematuria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Incontinence"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Breast discharge"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":5,"numAtRisk":17},{"groupId":"EG005","numAffected":2,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":2}],"term":"Dyspnoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":4,"numAtRisk":17},{"groupId":"EG005","numAffected":2,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":2}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":2,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Haemoptysis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Oropharyngeal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Pulmonary embolism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Dysphonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Epistaxis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Lung opacity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Wheezing"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":6,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":2,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Alopecia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":2,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Rash"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Dry skin"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Hyperhidrosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Pruritus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Blister"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Decubitus ulcer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Erythema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Nail discolouration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Night sweats"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Onychomadesis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Urticaria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":2,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":2}],"term":"Deep vein thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Orthostatic hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Intestinal perforation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Stomatitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Device related infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Infected fistula"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Femur fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Liver function test"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Oxygen saturation decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Malnutrition"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Disturbance in attention"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Product Issues","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Device occlusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"General physical health deterioration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Pain in extremity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Balance disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Anxiety"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":2}],"term":"Medical device site pain"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Intestinal perforation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Upper gastrointestinal haemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":2,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Pyrexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Cholangitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Cholecystitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Device related infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":1,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Respiratory tract infection viral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Femur fracture"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Oxygen saturation decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Hyponatraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Product Issues","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":1,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Device occlusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":2,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Anaemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Myocardial infarction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Hypothyroidism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Visual impairment"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":2,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Small intestinal obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Intestinal obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Gait disturbance"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Incarcerated hernia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":2,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Bacteraemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Escherichia sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Necrotising fasciitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Septic shock"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Hypophosphataemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Encephalopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":1,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Ischaemic stroke"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Syncope"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Delirium"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Dyspnoea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":1,"numAtRisk":2}],"term":"Deep vein thrombosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":1,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":1,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Orthostatic hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 25.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":7},{"groupId":"EG003","numAffected":0,"numAtRisk":6},{"groupId":"EG004","numAffected":0,"numAtRisk":17},{"groupId":"EG005","numAffected":0,"numAtRisk":38},{"groupId":"EG006","numAffected":0,"numAtRisk":6},{"groupId":"EG007","numAffected":0,"numAtRisk":2}],"term":"Overdose"}],"timeFrame":"Monotherapy: From start of study drug administration (Day 1) up to survival follow-up (up to 4 months); Combination therapy: From start of study drug administration (Day 1) up to survival follow-up (up to 25 months)"}