{"description":"Adverse events were assessed using the safety analysis set, which included all randomized patients who received at least 1 dose of any study drug (etoposide, carboplatin, atezolizumab, or trilaciclib). Analyses using the safety analysis set were conducted based on the actual treatment received.","eventGroups":[{"deathsNumAffected":42,"deathsNumAtRisk":54,"description":"Induction: Patients received trilaciclib 240 mg/m² administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.\n\nMaintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.","id":"EG000","otherNumAffected":49,"otherNumAtRisk":52,"seriousNumAffected":17,"seriousNumAtRisk":52,"title":"Trilaciclib+Etoposide/Carboplatin/Atezolizumab"},{"deathsNumAffected":44,"deathsNumAtRisk":53,"description":"Induction: Patients received placebo administered IV once daily prior to E/P/A on Days 1, 2 and 3 of each 21-day E/P/A therapy cycle (up to 4 cycles in total). Etoposide 100 mg/m² was administered IV daily on Days 1, 2, and 3 of each 21-day cycle. Carboplatin was administered on Day 1 of each 21-day cycle using the Calvert formula with a target AUC = 5 mg/mL/min to calculate the dose. Atezolizumab 1200 mg was administered as an IV infusion on Day 1 of each 21-day cycle.\n\nMaintenance: Following the induction phase, patients received maintenance atezolizumab at a dose of 1200 mg on Day 1 of every 21-day cycle until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator.","id":"EG001","otherNumAffected":52,"otherNumAtRisk":53,"seriousNumAffected":25,"seriousNumAtRisk":53,"title":"Placebo+Etoposide/Carboplatin/Atezolizumab"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":52,"numEvents":60},{"groupId":"EG001","numAffected":32,"numAtRisk":53,"numEvents":122}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":52,"numEvents":35},{"groupId":"EG001","numAffected":28,"numAtRisk":53,"numEvents":85}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":52,"numEvents":14},{"groupId":"EG001","numAffected":21,"numAtRisk":53,"numEvents":44}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52,"numEvents":5},{"groupId":"EG001","numAffected":14,"numAtRisk":53,"numEvents":38}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":52,"numEvents":24},{"groupId":"EG001","numAffected":20,"numAtRisk":53,"numEvents":32}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":52,"numEvents":17},{"groupId":"EG001","numAffected":9,"numAtRisk":53,"numEvents":21}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52,"numEvents":5},{"groupId":"EG001","numAffected":7,"numAtRisk":53,"numEvents":7}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":52,"numEvents":8},{"groupId":"EG001","numAffected":4,"numAtRisk":53,"numEvents":5}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52,"numEvents":4},{"groupId":"EG001","numAffected":4,"numAtRisk":53,"numEvents":4}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":53,"numEvents":5}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":53,"numEvents":3}],"term":"Gait disturbance"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":52,"numEvents":36},{"groupId":"EG001","numAffected":18,"numAtRisk":53,"numEvents":30}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52,"numEvents":6},{"groupId":"EG001","numAffected":12,"numAtRisk":53,"numEvents":15}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":52,"numEvents":13},{"groupId":"EG001","numAffected":6,"numAtRisk":53,"numEvents":10}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":52,"numEvents":10},{"groupId":"EG001","numAffected":5,"numAtRisk":53,"numEvents":6}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":53,"numEvents":5}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":53,"numEvents":5}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":53,"numEvents":0}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":52,"numEvents":8},{"groupId":"EG001","numAffected":18,"numAtRisk":53,"numEvents":21}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":52,"numEvents":9},{"groupId":"EG001","numAffected":3,"numAtRisk":53,"numEvents":3}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52,"numEvents":10},{"groupId":"EG001","numAffected":4,"numAtRisk":53,"numEvents":5}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":53,"numEvents":11}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52,"numEvents":10},{"groupId":"EG001","numAffected":13,"numAtRisk":53,"numEvents":63}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":11},{"groupId":"EG001","numAffected":11,"numAtRisk":53,"numEvents":50}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":52,"numEvents":20},{"groupId":"EG001","numAffected":6,"numAtRisk":53,"numEvents":25}],"term":"White blood cell count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":52,"numEvents":11},{"groupId":"EG001","numAffected":2,"numAtRisk":53,"numEvents":4}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52,"numEvents":10},{"groupId":"EG001","numAffected":2,"numAtRisk":53,"numEvents":4}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":53,"numEvents":6}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":4},{"groupId":"EG001","numAffected":4,"numAtRisk":53,"numEvents":5}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":5},{"groupId":"EG001","numAffected":4,"numAtRisk":53,"numEvents":8}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":53,"numEvents":3}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":2},{"groupId":"EG001","numAffected":5,"numAtRisk":53,"numEvents":10}],"term":"Lipase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":3},{"groupId":"EG001","numAffected":0,"numAtRisk":53,"numEvents":0}],"term":"Weight increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":52,"numEvents":13},{"groupId":"EG001","numAffected":13,"numAtRisk":53,"numEvents":20}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":52,"numEvents":8},{"groupId":"EG001","numAffected":8,"numAtRisk":53,"numEvents":12}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":3},{"groupId":"EG001","numAffected":5,"numAtRisk":53,"numEvents":7}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":53,"numEvents":4}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1},{"groupId":"EG001","numAffected":4,"numAtRisk":53,"numEvents":4}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":53,"numEvents":2}],"term":"Wheezing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":53,"numEvents":3}],"term":"Dysphonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":53,"numEvents":3}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52,"numEvents":7},{"groupId":"EG001","numAffected":3,"numAtRisk":53,"numEvents":4}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52,"numEvents":4},{"groupId":"EG001","numAffected":3,"numAtRisk":53,"numEvents":4}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":4},{"groupId":"EG001","numAffected":3,"numAtRisk":53,"numEvents":5}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":53,"numEvents":2}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52,"numEvents":6},{"groupId":"EG001","numAffected":9,"numAtRisk":53,"numEvents":11}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52,"numEvents":5},{"groupId":"EG001","numAffected":9,"numAtRisk":53,"numEvents":10}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52,"numEvents":11},{"groupId":"EG001","numAffected":3,"numAtRisk":53,"numEvents":3}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52,"numEvents":13},{"groupId":"EG001","numAffected":4,"numAtRisk":53,"numEvents":4}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52,"numEvents":6},{"groupId":"EG001","numAffected":2,"numAtRisk":53,"numEvents":2}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":7},{"groupId":"EG001","numAffected":1,"numAtRisk":53,"numEvents":1}],"term":"Hyperkalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":52,"numEvents":11},{"groupId":"EG001","numAffected":9,"numAtRisk":53,"numEvents":13}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":52,"numEvents":13},{"groupId":"EG001","numAffected":6,"numAtRisk":53,"numEvents":9}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":53,"numEvents":3}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":53,"numEvents":3}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52,"numEvents":10},{"groupId":"EG001","numAffected":3,"numAtRisk":53,"numEvents":3}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":53,"numEvents":2}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":53,"numEvents":3}],"term":"Muscular weakness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":53,"numEvents":4}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":53,"numEvents":3}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":6},{"groupId":"EG001","numAffected":3,"numAtRisk":53,"numEvents":4}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":53,"numEvents":2}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":53,"numEvents":4}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":4},{"groupId":"EG001","numAffected":0,"numAtRisk":53,"numEvents":0}],"term":"Phlebitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":3},{"groupId":"EG001","numAffected":7,"numAtRisk":53,"numEvents":7}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":3},{"groupId":"EG001","numAffected":6,"numAtRisk":53,"numEvents":6}],"term":"Hyperthyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":8},{"groupId":"EG001","numAffected":5,"numAtRisk":53,"numEvents":5}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":2},{"groupId":"EG001","numAffected":4,"numAtRisk":53,"numEvents":5}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":53,"numEvents":4}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":4},{"groupId":"EG001","numAffected":3,"numAtRisk":53,"numEvents":5}],"term":"Urinary incontinence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52,"numEvents":11},{"groupId":"EG001","numAffected":2,"numAtRisk":53,"numEvents":2}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":3},{"groupId":"EG001","numAffected":4,"numAtRisk":53,"numEvents":6}],"term":"Fall"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52,"numEvents":5},{"groupId":"EG001","numAffected":8,"numAtRisk":53,"numEvents":8}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":53,"numEvents":2}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":53,"numEvents":1}],"term":"Urinary Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":53,"numEvents":1}],"term":"Bronchiolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":53,"numEvents":1}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":53,"numEvents":1}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":53,"numEvents":2}],"term":"Empyema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":53,"numEvents":2}],"term":"Meningoencephalitis herpetic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":53,"numEvents":2}],"term":"Chronic obstructive pulmonary disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":53,"numEvents":2}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":53,"numEvents":1}],"term":"Pneumonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":53,"numEvents":0}],"term":"Haemoptysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":53,"numEvents":1}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":53,"numEvents":1}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":53,"numEvents":0}],"term":"Respiratory distress"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":53,"numEvents":4}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":3,"numAtRisk":53,"numEvents":3}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":53,"numEvents":1}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":53,"numEvents":1}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":53,"numEvents":1}],"term":"Cerebrovascular accident"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":53,"numEvents":1}],"term":"Balance disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":53,"numEvents":1}],"term":"Cognitive disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":53,"numEvents":1}],"term":"Generalised tonic-clonic seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":53,"numEvents":0}],"term":"Ischaemic stroke"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":53,"numEvents":1}],"term":"Paraneoplastic neurological syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":53,"numEvents":1}],"term":"Non-cardiac chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":53,"numEvents":2}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":53,"numEvents":1}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":53,"numEvents":1}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":53,"numEvents":2}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":53,"numEvents":1}],"term":"Failure to thrive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":5},{"groupId":"EG001","numAffected":2,"numAtRisk":53,"numEvents":2}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":53,"numEvents":0}],"term":"Acute coronary syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":53,"numEvents":0}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":53,"numEvents":1}],"term":"Fall"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":53,"numEvents":0}],"term":"Hip fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":53,"numEvents":0}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":53,"numEvents":0}],"term":"Thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":53,"numEvents":0}],"term":"Inappropriate antidiuretic hormone secretion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":53,"numEvents":0}],"term":"Retroperitoneal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":53,"numEvents":1}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":52,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":53,"numEvents":1}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA version 23.1.","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":53,"numEvents":0}],"term":"Angioedema"}],"timeFrame":"Treatment-emergent adverse events collected beginning with informed consent through 30 days after last dose of study drug. Treatment emergent serious adverse events collected through 90 days after last dose of study drug, assessed up to a maximum of 1192 days (maximum duration of exposure plus 30 days)."}