{"description":"AE documentation included onset/resolution dates, severity using the NCI CTCAE (version 4.03), seriousness, relationship to study drug, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a \"possible\", \"probable\", or \"definite\" relationship to the indicated study drug; preferred terms were counted only once per subject at the maximum reported grade.","eventGroups":[{"deathsNumAffected":0,"deathsNumAtRisk":6,"description":"\"Late\" post-ASCT treatment (tremelimumab alone in Cycles 1-2, durvalumab alone in Cycles 3+)","id":"EG000","otherNumAffected":6,"otherNumAtRisk":6,"seriousNumAffected":1,"seriousNumAtRisk":6,"title":"Cohort 1"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":6}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Blood blister"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Influenza like illness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Peripheral swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Amylase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Blood creatinine increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Thyroxine decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Jugular vein occlusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Memory impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Neuropathy peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Dyspnoea exertional"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Throat irritation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":6}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":6}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Diverticulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Pain in jaw"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Nocturia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Hepatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Restlessness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Hypertension"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (19.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":6}],"term":"Hypercalcaemia"}],"timeFrame":"All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 14 months."}