{"description":"The SAS included all participants who had received at least 1 dose, even if incomplete, of any study drug.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":3,"description":"Participants received 80 milligrams (mg) modakafusp alfa, infusion intravenously (IV), once on Day 1, once every 4 weeks (Q4W), in combination with 10 mg lenalidomide capsules orally once daily continuously on Days 1 to 28, in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or to a maximum of 2 years for measurable/minimal residual disease-negative (MRD \\[-\\]) participants, whichever occurred first.","id":"EG000","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":0,"seriousNumAtRisk":3,"title":"Group 1 (NDMM): Modakafusp Alfa 80 mg + Lenalidomide 10 mg"},{"deathsNumAffected":0,"deathsNumAtRisk":4,"description":"Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 2 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.","id":"EG001","otherNumAffected":3,"otherNumAtRisk":4,"seriousNumAffected":1,"seriousNumAtRisk":4,"title":"Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 2 mg"},{"deathsNumAffected":2,"deathsNumAtRisk":4,"description":"Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 4 mg pomalidomide capsules orally once daily on Days 1 to 21 in a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.","id":"EG002","otherNumAffected":4,"otherNumAtRisk":4,"seriousNumAffected":1,"seriousNumAtRisk":4,"title":"Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Pomalidomide 4 mg"},{"deathsNumAffected":1,"deathsNumAtRisk":3,"description":"Participants received 80 mg modakafusp alfa, infusion IV, once on Day 1, Q4W in combination with 20/70 milligrams per meter square (mg/m\\^2) carfilzomib IV, on Day 1, 8 and 15 of a 28-day (4-week) treatment cycle until disease progression, unacceptable toxicity, or until any other discontinuation criterion was met, whichever occurred first.","id":"EG003","otherNumAffected":3,"otherNumAtRisk":3,"seriousNumAffected":3,"seriousNumAtRisk":3,"title":"Group 2 (RRMM Doublets): Modakafusp Alfa 80 mg + Carfilzomib 20/70 mg/m^2"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAffected":2,"numAtRisk":3}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":4},{"groupId":"EG002","numAffected":3,"numAtRisk":4},{"groupId":"EG003","numAffected":3,"numAtRisk":3}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Anal incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAffected":2,"numAtRisk":3}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":2,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Bundle branch block left"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Clostridium difficile colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Delirium"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Ear infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Electrocardiogram QT prolonged"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":2,"numAtRisk":4},{"groupId":"EG002","numAffected":2,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Gastroenteritis salmonella"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Groin pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Haematoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":2,"numAtRisk":3}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Hyperphosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Hyperuricaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Hypoaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":2,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Hypogammaglobulinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Hypoglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAffected":2,"numAtRisk":3}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":2,"numAtRisk":3}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":2,"numAtRisk":3}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Limb discomfort"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Mouth haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAffected":2,"numAtRisk":3}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":4},{"groupId":"EG002","numAffected":3,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Noninfective sialoadenitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Palpitations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Portal hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Post procedural haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Right ventricular dysfunction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Sacral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Salmonella bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Somnolence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Suprapubic pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":3},{"groupId":"EG001","numAffected":3,"numAtRisk":4},{"groupId":"EG002","numAffected":3,"numAtRisk":4},{"groupId":"EG003","numAffected":3,"numAtRisk":3}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Tinnitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Upper-airway cough syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Vomiting"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":1,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":1,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":0,"numAtRisk":3}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Haemolytic uraemic syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Palpitations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Pneumonia influenzal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":1,"numAtRisk":3}],"term":"Renal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":3},{"groupId":"EG001","numAffected":0,"numAtRisk":4},{"groupId":"EG002","numAffected":0,"numAtRisk":4},{"groupId":"EG003","numAffected":2,"numAtRisk":3}],"term":"Thrombotic microangiopathy"}],"timeFrame":"Up to 16.7 months"}