{"description":"The FAS consisted of all enrolled participants.","eventGroups":[{"deathsNumAffected":3,"deathsNumAtRisk":52,"description":"Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\\^2 and doxorubicin 50 mg/m\\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.","id":"EG000","otherNumAffected":52,"otherNumAtRisk":52,"seriousNumAffected":18,"seriousNumAtRisk":52,"title":"Brentuximab Vedotin + CHP"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":52}],"term":"Alanine aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":52}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":52}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Blood alkaline phosphatase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52}],"term":"Blood bilirubin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":52}],"term":"Blood lactate dehydrogenase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":52}],"term":"C-reactive protein increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":52}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":52}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52}],"term":"Faecal occult blood positive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":52}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Hepatic function abnormal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Hypercholesterolaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":52}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":52}],"term":"Hyperlipidaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Hyperphosphataemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52}],"term":"Hypertriglyceridaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":52}],"term":"Hyperuricaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":52}],"term":"Hypoaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":52}],"term":"Hypoalbuminaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52}],"term":"Hypochloraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Hypoglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":52}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":52}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":52}],"term":"Hypoproteinaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Infusion related reaction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":52}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":52}],"term":"Lymphocyte count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":52}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":52}],"term":"Malaise"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Mouth ulceration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":52}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":52}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":35,"numAtRisk":52}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":52}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":52}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":52}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52}],"term":"Procalcitonin increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":52}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":52}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":52}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":52}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":52}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":52}],"term":"Weight increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":52}],"term":"White blood cell count decreased"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Gastrointestinal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Haemophagocytic lymphohistiocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":52}],"term":"Neutrophil count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Platelet count decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":52}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Soft tissue infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":52}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 28.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":52}],"term":"White blood cell count decreased"}],"timeFrame":"AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months)."}