{"description":"Serious Adverse Events and Other Adverse Events: Safety Population included all participants who received at least one dose of sacituzumab govitecan or TPC.\n\nAll-Cause Mortality: The ITT Population included all randomized participants.","eventGroups":[{"deathsNumAffected":201,"deathsNumAtRisk":267,"description":"Participants received sacituzumab govitecan 10 mg/kg of body weight, administered as a slow IV infusion either by gravity or with an infusion pump on Days 1 and 8 of a 21-day treatment cycle for up to 29.6 months. Infusion rate for the first 15 minutes started with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.","id":"EG000","otherNumAffected":256,"otherNumAtRisk":258,"seriousNumAffected":69,"seriousNumAtRisk":258,"title":"Sacituzumab Govitecan"},{"deathsNumAffected":222,"deathsNumAtRisk":262,"description":"Participants received TPC (ie, eribulin, capecitabine, gemcitabine, or vinorelbine), administered as a single-agent regimen that was selected by the investigator before participant randomization. Participants continued treatment until progression of disease requiring treatment discontinuation or occurrence of unacceptable AEs.\n\nEribulin was administered IV over 2 to 5 minutes at a dose 1.4 mg/m\\^2 at North American sites and 1.23 mg/m\\^2 at European sites on Days 1 and 8 of a 21-day cycle for up to 15.3 months. Lower doses were administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m\\^2 and 0.67 mg/m\\^2 for North American and European sites, respectively).\n\nCapecitabine 1000 to 1250 mg/m\\^2 was administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period for up to 10.6 months.\n\nGemcitabine 800 to 1200 mg/m\\^2 was administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle for up to 8.1 months.\n\nVinorelbine 25 mg/m\\^2 was administered as a weekly IV injection over 6-10 minutes for up to 11.5 months. Vinorelbine was not allowed as TPC for any participant with Grade 2 neuropathy.","id":"EG001","otherNumAffected":213,"otherNumAtRisk":224,"seriousNumAffected":64,"seriousNumAtRisk":224,"title":"Treatment of Physician's Choice (TPC)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":102,"numAtRisk":258},{"groupId":"EG001","numAffected":61,"numAtRisk":224}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":108,"numAtRisk":258},{"groupId":"EG001","numAffected":56,"numAtRisk":224}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":258},{"groupId":"EG001","numAffected":14,"numAtRisk":224}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":54,"numAtRisk":258},{"groupId":"EG001","numAffected":16,"numAtRisk":224}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":258},{"groupId":"EG001","numAffected":8,"numAtRisk":224}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":96,"numAtRisk":258},{"groupId":"EG001","numAffected":52,"numAtRisk":224}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":168,"numAtRisk":258},{"groupId":"EG001","numAffected":38,"numAtRisk":224}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":258},{"groupId":"EG001","numAffected":7,"numAtRisk":224}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":160,"numAtRisk":258},{"groupId":"EG001","numAffected":68,"numAtRisk":224}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":258},{"groupId":"EG001","numAffected":14,"numAtRisk":224}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":85,"numAtRisk":258},{"groupId":"EG001","numAffected":36,"numAtRisk":224}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":39,"numAtRisk":258},{"groupId":"EG001","numAffected":28,"numAtRisk":224}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":258},{"groupId":"EG001","numAffected":6,"numAtRisk":224}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":133,"numAtRisk":258},{"groupId":"EG001","numAffected":89,"numAtRisk":224}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":258},{"groupId":"EG001","numAffected":14,"numAtRisk":224}],"term":"Mucosal inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":258},{"groupId":"EG001","numAffected":24,"numAtRisk":224}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":258},{"groupId":"EG001","numAffected":11,"numAtRisk":224}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":258},{"groupId":"EG001","numAffected":27,"numAtRisk":224}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":258},{"groupId":"EG001","numAffected":5,"numAtRisk":224}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":258},{"groupId":"EG001","numAffected":7,"numAtRisk":224}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":258},{"groupId":"EG001","numAffected":17,"numAtRisk":224}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":258},{"groupId":"EG001","numAffected":22,"numAtRisk":224}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":258},{"groupId":"EG001","numAffected":27,"numAtRisk":224}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":258},{"groupId":"EG001","numAffected":12,"numAtRisk":224}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":258},{"groupId":"EG001","numAffected":13,"numAtRisk":224}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":71,"numAtRisk":258},{"groupId":"EG001","numAffected":45,"numAtRisk":224}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":258},{"groupId":"EG001","numAffected":15,"numAtRisk":224}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 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22.1","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":258},{"groupId":"EG001","numAffected":12,"numAtRisk":224}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":258},{"groupId":"EG001","numAffected":5,"numAtRisk":224}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":46,"numAtRisk":258},{"groupId":"EG001","numAffected":29,"numAtRisk":224}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":32,"numAtRisk":258},{"groupId":"EG001","numAffected":13,"numAtRisk":224}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":258},{"groupId":"EG001","numAffected":9,"numAtRisk":224}],"term":"Hypophosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":33,"numAtRisk":258},{"groupId":"EG001","numAffected":16,"numAtRisk":224}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":44,"numAtRisk":258},{"groupId":"EG001","numAffected":30,"numAtRisk":224}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":258},{"groupId":"EG001","numAffected":14,"numAtRisk":224}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":258},{"groupId":"EG001","numAffected":6,"numAtRisk":224}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":258},{"groupId":"EG001","numAffected":19,"numAtRisk":224}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 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pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":61,"numAtRisk":258},{"groupId":"EG001","numAffected":40,"numAtRisk":224}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":45,"numAtRisk":258},{"groupId":"EG001","numAffected":41,"numAtRisk":224}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 22.1","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":258},{"groupId":"EG001","numAffected":3,"numAtRisk":224}],"term":"Dyspnoea exertional"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 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