{"description":"Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.","eventGroups":[{"description":"Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.","id":"EG000","otherNumAffected":9,"otherNumAtRisk":10,"seriousNumAffected":4,"seriousNumAtRisk":10,"title":"Brentuximab Vedotin"},{"description":"Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.","id":"EG001","otherNumAffected":9,"otherNumAtRisk":10,"seriousNumAffected":0,"seriousNumAtRisk":10,"title":"Brentuximab Vedotin + Rifampicin"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":10},{"groupId":"EG001","numAffected":3,"numAtRisk":10}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":10},{"groupId":"EG001","numAffected":2,"numAtRisk":10}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10},{"groupId":"EG001","numAffected":2,"numAtRisk":10}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":2,"numAtRisk":10}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":2,"numAtRisk":10}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":2,"numAtRisk":10}],"term":"Eosinophilia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":2,"numAtRisk":10}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":2,"numAtRisk":10}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":2,"numAtRisk":10}],"term":"Sinus tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":2,"numAtRisk":10}],"term":"Herpes zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Hyponatraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":2,"numAtRisk":10}],"term":"Toxic skin eruption"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Abdominal pain upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Anal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Blood urea increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Body temperature increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Cystitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Diabetes mellitus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Dry eye"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Glaucoma"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Hypocalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Hypochloraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Injection site pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Joint stiffness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Local swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Localised oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Lung infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Musculoskeletal chest pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Oral herpes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Psoriasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Rash maculo-papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Scratch"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Skin lesion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Sneezing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Viral infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Weight increased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":10},{"groupId":"EG001","numAffected":1,"numAtRisk":10}],"term":"Wound"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Thrombosis in device"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Staphylococcal infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Pulmonary tuberculosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Pneumocystis jirovecii pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 18.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":10},{"groupId":"EG001","numAffected":0,"numAtRisk":10}],"term":"Neuralgia"}],"timeFrame":"Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16)."}