{"description":"Safety analyses were performed in the safety set, including all participants who received at least one dose of study treatment. Deaths in the post treatment survival follow-up period are not considered Adverse Events. The total number at risk in the post-treatment survival includes patients that entered the post-treatment survival follow-up period.","eventGroups":[{"deathsNumAffected":5,"deathsNumAtRisk":335,"description":"AEs collected during on-treatment period (up to 30 days post-treatment)","id":"EG000","otherNumAffected":326,"otherNumAtRisk":335,"seriousNumAffected":81,"seriousNumAtRisk":335,"title":"Ribociclib + NSAI/Tamoxifen + Goserelin (On-treatment)"},{"deathsNumAffected":6,"deathsNumAtRisk":337,"description":"AEs collected during on-treatment period (up to 30 days post-treatment or start of crossover treatment)","id":"EG001","otherNumAffected":312,"otherNumAtRisk":337,"seriousNumAffected":49,"seriousNumAtRisk":337,"title":"Placebo + NSAI/Tamoxifen+ Goserelin (On-treatment)"},{"deathsNumAffected":0,"deathsNumAtRisk":17,"description":"AEs collected during crossover on-treatment period with ribociclib for participants randomized to placebo arm who crossed-over to ribociclib (up to 30 days post- crossover treatment)","id":"EG002","otherNumAffected":14,"otherNumAtRisk":17,"seriousNumAffected":1,"seriousNumAtRisk":17,"title":"Placebo Crossover to Ribociclib (On-Treatment)"},{"deathsNumAffected":168,"deathsNumAtRisk":251,"description":"Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment to end of study). No AEs were collected during this period","id":"EG003","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Ribociclib + NSAI/Tamoxifen + Goserelin (Post-treatment Survival Follow-up)"},{"deathsNumAffected":202,"deathsNumAtRisk":293,"description":"Deaths collected in the post- treatment survival follow-up period (starting from day 31 post- treatment to end of study or start of crossover treatment). No AEs were collected during this period","id":"EG004","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Placebo + NSAI/Tamoxifen+ Goserelin (Post-treatment Survival Follow-up)"},{"deathsNumAffected":1,"deathsNumAtRisk":17,"description":"Deaths collected in the crossover post- treatment survival follow-up period (starting from day 31 post-crossover treatment to end of study). No AEs were collected during this period","id":"EG005","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Placebo Crossover to Ribociclib (Post-treatment Survival Follow-up)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":73,"numAtRisk":335},{"groupId":"EG001","numAffected":37,"numAtRisk":337},{"groupId":"EG002","numAffected":2,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":66,"numAtRisk":335},{"groupId":"EG001","numAffected":13,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":335},{"groupId":"EG001","numAffected":5,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":194,"numAtRisk":335},{"groupId":"EG001","numAffected":22,"numAtRisk":337},{"groupId":"EG002","numAffected":5,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":335},{"groupId":"EG001","numAffected":6,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":335},{"groupId":"EG001","numAffected":2,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Lacrimation increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":335},{"groupId":"EG001","numAffected":27,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":335},{"groupId":"EG001","numAffected":24,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":62,"numAtRisk":335},{"groupId":"EG001","numAffected":48,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":82,"numAtRisk":335},{"groupId":"EG001","numAffected":67,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":335},{"groupId":"EG001","numAffected":18,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Dry mouth"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":335},{"groupId":"EG001","numAffected":14,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Gingival swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Mouth haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":113,"numAtRisk":335},{"groupId":"EG001","numAffected":78,"numAtRisk":337},{"groupId":"EG002","numAffected":4,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":48,"numAtRisk":335},{"groupId":"EG001","numAffected":30,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":335},{"groupId":"EG001","numAffected":11,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Toothache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":76,"numAtRisk":335},{"groupId":"EG001","numAffected":61,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":54,"numAtRisk":335},{"groupId":"EG001","numAffected":43,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":335},{"groupId":"EG001","numAffected":4,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":89,"numAtRisk":335},{"groupId":"EG001","numAffected":86,"numAtRisk":337},{"groupId":"EG002","numAffected":2,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":335},{"groupId":"EG001","numAffected":13,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":5,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Localised oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Mucosal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":335},{"groupId":"EG001","numAffected":15,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":335},{"groupId":"EG001","numAffected":18,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":60,"numAtRisk":335},{"groupId":"EG001","numAffected":29,"numAtRisk":337},{"groupId":"EG002","numAffected":3,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hepatic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Contrast media reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":2,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":335},{"groupId":"EG001","numAffected":6,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":335},{"groupId":"EG001","numAffected":24,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":335},{"groupId":"EG001","numAffected":23,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Suspected COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":53,"numAtRisk":335},{"groupId":"EG001","numAffected":40,"numAtRisk":337},{"groupId":"EG002","numAffected":2,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":38,"numAtRisk":335},{"groupId":"EG001","numAffected":31,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Post procedural erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Wound"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":58,"numAtRisk":335},{"groupId":"EG001","numAffected":34,"numAtRisk":337},{"groupId":"EG002","numAffected":2,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":55,"numAtRisk":335},{"groupId":"EG001","numAffected":36,"numAtRisk":337},{"groupId":"EG002","numAffected":4,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":335},{"groupId":"EG001","numAffected":9,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Blood cholesterol increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":335},{"groupId":"EG001","numAffected":16,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Electrocardiogram QT prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":335},{"groupId":"EG001","numAffected":32,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":119,"numAtRisk":335},{"groupId":"EG001","numAffected":5,"numAtRisk":337},{"groupId":"EG002","numAffected":4,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"SARS-CoV-2 test negative"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"SARS-CoV-2 test positive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":335},{"groupId":"EG001","numAffected":10,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Weight increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":55,"numAtRisk":335},{"groupId":"EG001","numAffected":4,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":335},{"groupId":"EG001","numAffected":27,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":335},{"groupId":"EG001","numAffected":13,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hypercholesterolaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":335},{"groupId":"EG001","numAffected":18,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hypermagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":335},{"groupId":"EG001","numAffected":17,"numAtRisk":337},{"groupId":"EG002","numAffected":2,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hypertriglyceridaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":130,"numAtRisk":335},{"groupId":"EG001","numAffected":122,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":76,"numAtRisk":335},{"groupId":"EG001","numAffected":72,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":34,"numAtRisk":335},{"groupId":"EG001","numAffected":32,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":335},{"groupId":"EG001","numAffected":12,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Joint stiffness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":335},{"groupId":"EG001","numAffected":10,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":335},{"groupId":"EG001","numAffected":20,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":335},{"groupId":"EG001","numAffected":17,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":47,"numAtRisk":335},{"groupId":"EG001","numAffected":42,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":335},{"groupId":"EG001","numAffected":19,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":53,"numAtRisk":335},{"groupId":"EG001","numAffected":44,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Ageusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":335},{"groupId":"EG001","numAffected":25,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":96,"numAtRisk":335},{"groupId":"EG001","numAffected":89,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":2,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Loss of consciousness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":335},{"groupId":"EG001","numAffected":18,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335},{"groupId":"EG001","numAffected":4,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":335},{"groupId":"EG001","numAffected":17,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":335},{"groupId":"EG001","numAffected":23,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":51,"numAtRisk":335},{"groupId":"EG001","numAffected":55,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":335},{"groupId":"EG001","numAffected":23,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Breast pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":73,"numAtRisk":335},{"groupId":"EG001","numAffected":42,"numAtRisk":337},{"groupId":"EG002","numAffected":3,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":335},{"groupId":"EG001","numAffected":21,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":335},{"groupId":"EG001","numAffected":18,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":335},{"groupId":"EG001","numAffected":13,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":64,"numAtRisk":335},{"groupId":"EG001","numAffected":41,"numAtRisk":337},{"groupId":"EG002","numAffected":2,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":335},{"groupId":"EG001","numAffected":8,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":335},{"groupId":"EG001","numAffected":18,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":53,"numAtRisk":335},{"groupId":"EG001","numAffected":32,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":118,"numAtRisk":335},{"groupId":"EG001","numAffected":117,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hot flush"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":42,"numAtRisk":335},{"groupId":"EG001","numAffected":28,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":335},{"groupId":"EG001","numAffected":11,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Lymphoedema"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Arrhythmia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pericardial effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335},{"groupId":"EG001","numAffected":2,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Dysphagia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Epigastric discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Ileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335},{"groupId":"EG001","numAffected":2,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Subileus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":335},{"groupId":"EG001","numAffected":2,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Axillary pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":335},{"groupId":"EG001","numAffected":4,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Cholecystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Cholelithiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Drug-induced liver injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hepatic haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hepatotoxicity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hyperbilirubinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Liver disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Abdominal wall abscess"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Acute sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Atypical pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":2,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Gastroenteritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Gastroenteritis viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Influenza"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Otitis media"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Postoperative wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pyelonephritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pyelonephritis acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Vascular device infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Viral infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Wound infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Alcohol poisoning"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":335},{"groupId":"EG001","numAffected":2,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Femur fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hand fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":2,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Humerus fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Meniscus injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Post lumbar puncture syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Spinal fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Wound haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":2,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":2,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hepatic enzyme increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"SARS-CoV-2 antibody test positive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Electrolyte imbalance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":2,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Lactic acidosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":335},{"groupId":"EG001","numAffected":2,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Intervertebral disc protrusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Myositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Osteoarthritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Osteonecrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Osteonecrosis of jaw"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pathological fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Rhabdomyolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Spinal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Benign soft tissue neoplasm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Cancer pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Chronic myeloid leukaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"HER2 positive breast cancer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Intracranial tumour haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":1,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Leiomyoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Lipoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Malignant pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Metastases to central nervous system"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":2,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Metastases to meninges"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Renal cell carcinoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Cerebral infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Haemorrhage intracranial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hydrocephalus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hypoaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Superior sagittal sinus thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Alcohol abuse"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Obsessive-compulsive disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":2,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pelvic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Vaginal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Acute respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":335},{"groupId":"EG001","numAffected":2,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hydrothorax"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Nasal polyps"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Paranasal sinus inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":335},{"groupId":"EG001","numAffected":5,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pleural effusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":335},{"groupId":"EG001","numAffected":1,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Skin ulcer"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Aortic thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Hypovolaemic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (26.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":335},{"groupId":"EG001","numAffected":0,"numAtRisk":337},{"groupId":"EG002","numAffected":0,"numAtRisk":17},{"groupId":"EG003","numAtRisk":0},{"groupId":"EG004","numAtRisk":0},{"groupId":"EG005","numAtRisk":0}],"term":"Superior vena cava syndrome"}],"timeFrame":"On-treatment: from 1st dose to 30 days post-treatment or start of crossover treatment, up to 90 months Crossover on-treatment: from 1st dose of crossover treatment to 30 days post-crossover treatment, up to approximately 33 months. Post-treatment survival follow-up: from day 31 post-treatment to end of study or start of crossover treatment, up to 90 months. Crossover post-treatment survival follow-up period from day 31 post-crossover treatment to end of study, up to approximately 33 months."}