{"description":"An AE was defined as any untoward, undesired, or unplanned medical occurrence in a subject administered SRA737. All AEs and SAEs were assessed for seriousness, causality, and expectedness.\n\nAs specified in the Statistical Analysis Plan, the frequency of each AE was evaluated in the overall Safety Evaluable Population (all enrolled subjects who receive at least 1 dose of SRA737) of patients with advanced solid tumors, irrespective of tumor type. All AEs collected are included in the summary.","eventGroups":[{"deathsNumAffected":18,"deathsNumAtRisk":107,"description":"Due to the small numbers of patients in some tumor type subgroups and with the intention of displaying the overall safety profile of SRA737 in advanced solid tumors, the frequency of each AE was evaluated in the overall Safety Evaluable Population rather than by tumor type subgroups. The Safety Evaluable Population includes all enrolled subjects who receive at least 1 dose of SRA737.","id":"EG000","otherNumAffected":106,"otherNumAtRisk":107,"seriousNumAffected":48,"seriousNumAtRisk":107,"title":"Safety Evaluable Population"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":74,"numAtRisk":107,"numEvents":131}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":72,"numAtRisk":107,"numEvents":125}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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(19.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":107,"numEvents":11}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":107,"numEvents":7}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":107,"numEvents":7}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":107,"numEvents":6}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":54,"numAtRisk":107,"numEvents":85}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":107,"numEvents":13}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":107,"numEvents":36}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":107,"numEvents":9}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":107,"numEvents":9}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":107,"numEvents":21}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":107,"numEvents":13}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":107,"numEvents":14}],"term":"Lethargy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":107,"numEvents":9}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":107,"numEvents":7}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":107,"numEvents":15}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":107,"numEvents":7}],"term":"Oral candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":107,"numEvents":8}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":107,"numEvents":6}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":107,"numEvents":8}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":107,"numEvents":22}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":107,"numEvents":21}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":107,"numEvents":19}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":107,"numEvents":32}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":107,"numEvents":9}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 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(19.1)","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":107,"numEvents":48}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":107,"numEvents":34}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":107,"numEvents":16}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":107,"numEvents":23}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":107,"numEvents":11}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":107,"numEvents":18}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":107,"numEvents":9}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":107,"numEvents":8}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":107,"numEvents":7}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":107,"numEvents":9}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":107,"numEvents":7}],"term":"Tachycardia"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":107,"numEvents":10}],"term":"Disease progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 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pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":107,"numEvents":3}],"term":"Ascites"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":107,"numEvents":2}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":107,"numEvents":3}],"term":"Small intestinal obstruction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":107,"numEvents":2}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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(19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":107,"numEvents":1}],"term":"Haematuria"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.1)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":107,"numEvents":1}],"term":"Jugular vein thrombosis"}],"timeFrame":"Treatment-emergent adverse events (TEAEs) were reported until the safety Follow up (SFU) visit, 30 days after the last dose of SRA737 or prior to the initiation of a new anticancer treatment, whichever came first. Long term Follow up (LTFU) visits were conducted every 16 weeks for subjects who had not progressed and had not initiated new anticancer therapy."}