{"description":"Same event may appear as both non-serious adverse event and serious adverse event (SAE); however, are presented as distinct events. Event may be categorized as serious in 1 participant and non-serious in another or may have experienced both SAE and non-SAE. Safety analysis set: all participants who received any amount of study drug. All-cause mortality: No. of deaths were reported from Day 1 of study through End of Study for all participants.","eventGroups":[{"deathsNumAffected":9,"deathsNumAtRisk":11,"description":"Participants with cervical cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.","id":"EG000","otherNumAffected":10,"otherNumAtRisk":11,"seriousNumAffected":5,"seriousNumAtRisk":11,"title":"Tucatinib+Trastuzumab (Cohort 1)"},{"deathsNumAffected":22,"deathsNumAtRisk":31,"description":"Participants with uterine cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.","id":"EG001","otherNumAffected":30,"otherNumAtRisk":31,"seriousNumAffected":11,"seriousNumAtRisk":31,"title":"Tucatinib+Trastuzumab (Cohort 2)"},{"deathsNumAffected":22,"deathsNumAtRisk":30,"description":"Participants with biliary tract cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure","id":"EG002","otherNumAffected":29,"otherNumAtRisk":30,"seriousNumAffected":13,"seriousNumAtRisk":30,"title":"Tucatinib+Trastuzumab (Cohort 3)"},{"deathsNumAffected":17,"deathsNumAtRisk":25,"description":"Participants with urothelial cancer with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.","id":"EG003","otherNumAffected":23,"otherNumAtRisk":25,"seriousNumAffected":9,"seriousNumAtRisk":25,"title":"Tucatinib+Trastuzumab (Cohort 4)"},{"deathsNumAffected":6,"deathsNumAtRisk":12,"description":"Participants with NSCLC with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.","id":"EG004","otherNumAffected":12,"otherNumAtRisk":12,"seriousNumAffected":2,"seriousNumAtRisk":12,"title":"Tucatinib+Trastuzumab (Cohort 5)"},{"deathsNumAffected":21,"deathsNumAtRisk":31,"description":"Participants with solid tumor types (except breast, gastric or GEC, and CRC) with HER2 amplification/over expression, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.","id":"EG005","otherNumAffected":29,"otherNumAtRisk":31,"seriousNumAffected":9,"seriousNumAtRisk":31,"title":"Tucatinib+Trastuzumab (Cohort 6)"},{"deathsNumAffected":10,"deathsNumAtRisk":13,"description":"Participants with non-squamous NSCLC with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.","id":"EG006","otherNumAffected":13,"otherNumAtRisk":13,"seriousNumAffected":7,"seriousNumAtRisk":13,"title":"Tucatinib+Trastuzumab (Cohort 7)"},{"deathsNumAffected":11,"deathsNumAtRisk":31,"description":"Participants with breast cancer with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants with hormone-receptor positive breast cancer also received fulvestrant 500 mg IM once every 4 weeks starting from Day 1 of Cycle 1, and on Day 15 of Cycle 1. Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.","id":"EG007","otherNumAffected":31,"otherNumAtRisk":31,"seriousNumAffected":8,"seriousNumAtRisk":31,"title":"Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8)"},{"deathsNumAffected":25,"deathsNumAtRisk":33,"description":"Participants with all solid tumor cancers (except breast and non-squamous NSCLC) with HER2 mutations, received tucatinib 300 mg PO BID from Day 1 of Cycle 1 onwards and trastuzumab 8 mg/kg IV on Day 1 of Cycle 1 and then 6 mg/kg every 21 days starting on Day 1 of Cycle 2 (1 Cycle = 21 Days). Participants received treatment until unacceptable toxicity, occurrence of radiographic progression or clinical progression, withdrawal of consent, death, or study closure.","id":"EG008","otherNumAffected":30,"otherNumAtRisk":33,"seriousNumAffected":14,"seriousNumAtRisk":33,"title":"Tucatinib+Trastuzumab (Cohort 9)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11,"numEvents":3},{"groupId":"EG001","numAffected":6,"numAtRisk":31,"numEvents":8},{"groupId":"EG002","numAffected":4,"numAtRisk":30,"numEvents":4},{"groupId":"EG003","numAffected":7,"numAtRisk":25,"numEvents":13},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":5,"numAtRisk":31,"numEvents":5},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG007","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG008","numAffected":5,"numAtRisk":33,"numEvents":5}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":3},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Dry eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Eye irritation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Eyelid ptosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Lacrimation increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Abdominal discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":2},{"groupId":"EG004","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG005","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":31,"numEvents":5},{"groupId":"EG002","numAffected":5,"numAtRisk":30,"numEvents":5},{"groupId":"EG003","numAffected":2,"numAtRisk":25,"numEvents":2},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Abdominal pain lower"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":30,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Abnormal faeces"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":2,"numAtRisk":12,"numEvents":3},{"groupId":"EG005","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG007","numAffected":4,"numAtRisk":31,"numEvents":6},{"groupId":"EG008","numAffected":4,"numAtRisk":33,"numEvents":4}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":11,"numEvents":12},{"groupId":"EG001","numAffected":16,"numAtRisk":31,"numEvents":20},{"groupId":"EG002","numAffected":12,"numAtRisk":30,"numEvents":18},{"groupId":"EG003","numAffected":13,"numAtRisk":25,"numEvents":15},{"groupId":"EG004","numAffected":9,"numAtRisk":12,"numEvents":11},{"groupId":"EG005","numAffected":13,"numAtRisk":31,"numEvents":19},{"groupId":"EG006","numAffected":9,"numAtRisk":13,"numEvents":12},{"groupId":"EG007","numAffected":19,"numAtRisk":31,"numEvents":56},{"groupId":"EG008","numAffected":12,"numAtRisk":33,"numEvents":14}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Duodenal ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Flatulence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Impaired gastric emptying"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Large intestine polyp"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":11,"numEvents":10},{"groupId":"EG001","numAffected":13,"numAtRisk":31,"numEvents":16},{"groupId":"EG002","numAffected":6,"numAtRisk":30,"numEvents":6},{"groupId":"EG003","numAffected":6,"numAtRisk":25,"numEvents":7},{"groupId":"EG004","numAffected":3,"numAtRisk":12,"numEvents":4},{"groupId":"EG005","numAffected":7,"numAtRisk":31,"numEvents":7},{"groupId":"EG006","numAffected":4,"numAtRisk":13,"numEvents":4},{"groupId":"EG007","numAffected":11,"numAtRisk":31,"numEvents":12},{"groupId":"EG008","numAffected":9,"numAtRisk":33,"numEvents":10}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Oesophagitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Rectal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":31,"numEvents":4},{"groupId":"EG002","numAffected":4,"numAtRisk":30,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":11,"numEvents":10},{"groupId":"EG001","numAffected":12,"numAtRisk":31,"numEvents":14},{"groupId":"EG002","numAffected":4,"numAtRisk":30,"numEvents":6},{"groupId":"EG003","numAffected":2,"numAtRisk":25,"numEvents":3},{"groupId":"EG004","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG005","numAffected":7,"numAtRisk":31,"numEvents":10},{"groupId":"EG006","numAffected":4,"numAtRisk":13,"numEvents":6},{"groupId":"EG007","numAffected":9,"numAtRisk":31,"numEvents":12},{"groupId":"EG008","numAffected":10,"numAtRisk":33,"numEvents":13}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":11,"numEvents":5},{"groupId":"EG001","numAffected":5,"numAtRisk":31,"numEvents":5},{"groupId":"EG002","numAffected":7,"numAtRisk":30,"numEvents":7},{"groupId":"EG003","numAffected":7,"numAtRisk":25,"numEvents":7},{"groupId":"EG004","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG005","numAffected":11,"numAtRisk":31,"numEvents":12},{"groupId":"EG006","numAffected":4,"numAtRisk":13,"numEvents":5},{"groupId":"EG007","numAffected":6,"numAtRisk":31,"numEvents":6},{"groupId":"EG008","numAffected":13,"numAtRisk":33,"numEvents":13}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11,"numEvents":3},{"groupId":"EG001","numAffected":12,"numAtRisk":31,"numEvents":12},{"groupId":"EG002","numAffected":4,"numAtRisk":30,"numEvents":4},{"groupId":"EG003","numAffected":4,"numAtRisk":25,"numEvents":4},{"groupId":"EG004","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG005","numAffected":5,"numAtRisk":31,"numEvents":5},{"groupId":"EG006","numAffected":5,"numAtRisk":13,"numEvents":5},{"groupId":"EG007","numAffected":6,"numAtRisk":31,"numEvents":7},{"groupId":"EG008","numAffected":7,"numAtRisk":33,"numEvents":7}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Infusion site extravasation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Localised oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":5,"numAtRisk":30,"numEvents":5},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":4,"numAtRisk":31,"numEvents":4},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":11,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":25,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":3,"numAtRisk":13,"numEvents":4},{"groupId":"EG007","numAffected":7,"numAtRisk":31,"numEvents":7},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11,"numEvents":4},{"groupId":"EG001","numAffected":4,"numAtRisk":31,"numEvents":5},{"groupId":"EG002","numAffected":13,"numAtRisk":30,"numEvents":21},{"groupId":"EG003","numAffected":4,"numAtRisk":25,"numEvents":4},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":13,"numAtRisk":31,"numEvents":13},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":6,"numAtRisk":31,"numEvents":8},{"groupId":"EG008","numAffected":10,"numAtRisk":33,"numEvents":11}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":30,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Cholangitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":4,"numAtRisk":30,"numEvents":4},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG008","numAffected":2,"numAtRisk":33,"numEvents":2}],"term":"Hepatic function abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Hypertransaminasaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Contrast media allergy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":30,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Device related infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Herpes simplex"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":2,"numAtRisk":33,"numEvents":5}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Oral candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Oral herpes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Paronychia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Tooth abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":31,"numEvents":4},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":5,"numAtRisk":25,"numEvents":5},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":2},{"groupId":"EG005","numAffected":2,"numAtRisk":31,"numEvents":4},{"groupId":"EG006","numAffected":3,"numAtRisk":13,"numEvents":3},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":3},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Viral infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Clavicle fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":2},{"groupId":"EG005","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":2},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":11,"numEvents":4},{"groupId":"EG001","numAffected":6,"numAtRisk":31,"numEvents":7},{"groupId":"EG002","numAffected":8,"numAtRisk":30,"numEvents":8},{"groupId":"EG003","numAffected":8,"numAtRisk":25,"numEvents":8},{"groupId":"EG004","numAffected":4,"numAtRisk":12,"numEvents":4},{"groupId":"EG005","numAffected":12,"numAtRisk":31,"numEvents":13},{"groupId":"EG006","numAffected":3,"numAtRisk":13,"numEvents":3},{"groupId":"EG007","numAffected":8,"numAtRisk":31,"numEvents":8},{"groupId":"EG008","numAffected":12,"numAtRisk":33,"numEvents":12}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Skin laceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":11,"numEvents":4},{"groupId":"EG001","numAffected":4,"numAtRisk":31,"numEvents":5},{"groupId":"EG002","numAffected":8,"numAtRisk":30,"numEvents":13},{"groupId":"EG003","numAffected":5,"numAtRisk":25,"numEvents":6},{"groupId":"EG004","numAffected":3,"numAtRisk":12,"numEvents":3},{"groupId":"EG005","numAffected":7,"numAtRisk":31,"numEvents":9},{"groupId":"EG006","numAffected":3,"numAtRisk":13,"numEvents":5},{"groupId":"EG007","numAffected":4,"numAtRisk":31,"numEvents":4},{"groupId":"EG008","numAffected":8,"numAtRisk":33,"numEvents":9}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":6,"numAtRisk":30,"numEvents":7},{"groupId":"EG003","numAffected":4,"numAtRisk":25,"numEvents":4},{"groupId":"EG004","numAffected":3,"numAtRisk":12,"numEvents":5},{"groupId":"EG005","numAffected":6,"numAtRisk":31,"numEvents":7},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG007","numAffected":4,"numAtRisk":31,"numEvents":5},{"groupId":"EG008","numAffected":8,"numAtRisk":33,"numEvents":9}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":12,"numEvents":3},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":11,"numEvents":6},{"groupId":"EG001","numAffected":7,"numAtRisk":31,"numEvents":8},{"groupId":"EG002","numAffected":8,"numAtRisk":30,"numEvents":8},{"groupId":"EG003","numAffected":5,"numAtRisk":25,"numEvents":6},{"groupId":"EG004","numAffected":2,"numAtRisk":12,"numEvents":3},{"groupId":"EG005","numAffected":9,"numAtRisk":31,"numEvents":10},{"groupId":"EG006","numAffected":3,"numAtRisk":13,"numEvents":4},{"groupId":"EG007","numAffected":3,"numAtRisk":31,"numEvents":4},{"groupId":"EG008","numAffected":7,"numAtRisk":33,"numEvents":9}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Blood sodium decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Coronavirus test positive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":2,"numAtRisk":33,"numEvents":4}],"term":"Ejection fraction decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":11,"numEvents":4},{"groupId":"EG001","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":5,"numAtRisk":25,"numEvents":5},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":11,"numEvents":4},{"groupId":"EG001","numAffected":10,"numAtRisk":31,"numEvents":10},{"groupId":"EG002","numAffected":6,"numAtRisk":30,"numEvents":7},{"groupId":"EG003","numAffected":4,"numAtRisk":25,"numEvents":4},{"groupId":"EG004","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG005","numAffected":5,"numAtRisk":31,"numEvents":5},{"groupId":"EG006","numAffected":3,"numAtRisk":13,"numEvents":3},{"groupId":"EG007","numAffected":5,"numAtRisk":31,"numEvents":9},{"groupId":"EG008","numAffected":7,"numAtRisk":33,"numEvents":8}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":2},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Hyperphosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":2},{"groupId":"EG008","numAffected":2,"numAtRisk":33,"numEvents":2}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":30,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Vitamin D deficiency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG005","numAffected":4,"numAtRisk":31,"numEvents":4},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":5,"numAtRisk":31,"numEvents":8},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":2}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":31,"numEvents":5},{"groupId":"EG002","numAffected":3,"numAtRisk":30,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":7,"numAtRisk":31,"numEvents":7},{"groupId":"EG008","numAffected":3,"numAtRisk":33,"numEvents":4}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Cancer pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Monoclonal gammopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Tumour pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Cognitive disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":30,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG005","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":3},{"groupId":"EG007","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Extrapyramidal disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG002","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":3,"numAtRisk":12,"numEvents":3},{"groupId":"EG005","numAffected":4,"numAtRisk":31,"numEvents":5},{"groupId":"EG006","numAffected":3,"numAtRisk":13,"numEvents":4},{"groupId":"EG007","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":33,"numEvents":2}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Presyncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Vocal cord paralysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Agitation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":2},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":2,"numAtRisk":12,"numEvents":2},{"groupId":"EG005","numAffected":4,"numAtRisk":31,"numEvents":4},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":4,"numAtRisk":31,"numEvents":5},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Dysuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":33,"numEvents":2}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Hypertonic bladder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Micturition urgency"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Urinary retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Abnormal uterine bleeding"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Pelvic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Penile erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Vaginal discharge"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":31,"numEvents":4},{"groupId":"EG002","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG006","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG007","numAffected":7,"numAtRisk":31,"numEvents":7},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG003","numAffected":3,"numAtRisk":25,"numEvents":3},{"groupId":"EG004","numAffected":3,"numAtRisk":12,"numEvents":3},{"groupId":"EG005","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG006","numAffected":3,"numAtRisk":13,"numEvents":3},{"groupId":"EG007","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG008","numAffected":3,"numAtRisk":33,"numEvents":3}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Rhinitis allergic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Rhinorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Sputum discoloured"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":2,"numAtRisk":31,"numEvents":4},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Dermatitis acneiform"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":30,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":6,"numAtRisk":31,"numEvents":6},{"groupId":"EG008","numAffected":2,"numAtRisk":33,"numEvents":2}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":2},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Eczema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Hyperkeratosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Nail disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Nail toxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":3,"numAtRisk":31,"numEvents":3},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Onychoclasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Palmar-plantar erythrodysaesthesia syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG003","numAffected":3,"numAtRisk":25,"numEvents":3},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":9,"numAtRisk":31,"numEvents":10},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":3}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":2,"numAtRisk":31,"numEvents":3},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":31,"numEvents":6},{"groupId":"EG002","numAffected":2,"numAtRisk":30,"numEvents":3},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG008","numAffected":2,"numAtRisk":33,"numEvents":3}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Rash papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Hot flush"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":30,"numEvents":2},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":5,"numAtRisk":31,"numEvents":5},{"groupId":"EG008","numAffected":4,"numAtRisk":33,"numEvents":4}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Orthostatic hypotension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Immune thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Angina unstable"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Atrial flutter"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Myocardial ischaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Optic neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Retinal detachment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":33,"numEvents":2}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Duodenal perforation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Enteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Gastritis haemorrhagic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":33,"numEvents":2}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Obstruction gastric"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Bile duct stenosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Bile duct stone"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":30,"numEvents":6},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Cholangitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Haemobilia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Hepatotoxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Jaundice cholestatic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Liver disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Liver injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Anaphylactic reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Appendicitis perforated"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":3},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Biliary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Hepatic infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Liver abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Meningitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":2},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Pelvic abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Pyelonephritis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":25,"numEvents":2},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":2,"numAtRisk":33,"numEvents":2}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Lumbar vertebral fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Urostomy complication"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Amylase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Ejection fraction decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Hypophagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Malnutrition"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Osteoarthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Tumour pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Cerebral haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Cerebral infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":25,"numEvents":1},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Hepatic encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Product Issues","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Device occlusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Disorientation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":3,"numAtRisk":25,"numEvents":5},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":2,"numAtRisk":33,"numEvents":2}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Hydronephrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Urinary tract obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Female genital tract fistula"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":31,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Vaginal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":1,"numAtRisk":33,"numEvents":1}],"term":"Aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Bronchial artery aneurysm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":30,"numEvents":1},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Interstitial lung disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":11,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Laryngeal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Pulmonary oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Pulmonary toxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":31,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":0,"numAtRisk":12,"numEvents":0},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":11,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":30,"numEvents":0},{"groupId":"EG003","numAffected":0,"numAtRisk":25,"numEvents":0},{"groupId":"EG004","numAffected":1,"numAtRisk":12,"numEvents":1},{"groupId":"EG005","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG006","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG007","numAffected":0,"numAtRisk":31,"numEvents":0},{"groupId":"EG008","numAffected":0,"numAtRisk":33,"numEvents":0}],"term":"Hypotension"}],"timeFrame":"From first dose of the study treatment (Day 1) maximum up to 30 days after the last dose of study treatment death date, or data cut-off date, whichever was earlier (maximum up to 28.8 months)"}