{"eventGroups":[{"description":"Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion","id":"EG000","otherNumAffected":58,"otherNumAtRisk":58,"seriousNumAffected":25,"seriousNumAtRisk":58,"title":"Brentuximab Vedotin"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":58}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":58}],"term":"Lymphadenopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":58}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":58}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58}],"term":"Abdominal distension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":58}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":58}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":58}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":58}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":58}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":58}],"term":"Oral pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":58}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":58}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":58}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":58}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":58}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":58}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":58}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":58}],"term":"Folliculitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":58}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58}],"term":"Excoriation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":58}],"term":"Weight decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":58}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58}],"term":"Dehydration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":58}],"term":"Hypokalaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":58}],"term":"Arthralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":58}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":58}],"term":"Groin pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":58}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":58}],"term":"Musculoskeletal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":58}],"term":"Myalgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":58}],"term":"Neck pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":58}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":58}],"term":"Tumour flare"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":58}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":58}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":58}],"term":"Paraesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":58}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":58}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":58}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":58}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":58}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":58}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":58}],"term":"Oropharyngeal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58}],"term":"Productive cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":58}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":58}],"term":"Dermatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":58}],"term":"Dry skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":58}],"term":"Night sweats"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":58}],"term":"Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":58}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":58}],"term":"Rash pruritic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58}],"term":"Hot flush"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58}],"term":"Anaplastic large cell lymphoma t- and null-cell types recurrent"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58}],"term":"Hypomagnesaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58}],"term":"Nasopharyngitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":58}],"term":"Sinusitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58}],"term":"Gastrooesophageal reflux disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58}],"term":"Haemorrhoids"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58}],"term":"Memory impairment"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58}],"term":"Neuralgia"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":58}],"term":"Arrhythmia supraventricular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Atrial fibrillation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Atrioventricular block complete"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Bradycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Retinal vein occlusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Abdominal pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Gastrointestinal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Generalised oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Sudden death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Endocarditis staphylococcal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Gastroenteritis viral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Klebsiella bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":58}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Superinfection bacterial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":58}],"term":"Urinary tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Lower limb fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Fluid overload"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Tumour lysis syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Myositis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":58}],"term":"Pain in extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":58}],"term":"Anaplastic large cell lymphoma t- and null-cell types recurrent"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Mycosis fungoides"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Neoplasms benign, malignant and unspecified (incl cysts and polyps)","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Tumour flare"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Encephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Haemorrhage intracranial"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Neuralgia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Peripheral motor neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Spinal cord compression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Mental status changes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Hydronephrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Renal failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Renal failure acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Pulmonary embolism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Pulmonary oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Tracheal disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Rash papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Deep vein thrombosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA (13.0)","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":58}],"term":"Demyelinating polyneuropathy"}],"timeFrame":"Adverse events through 30 days after last dose (up to 12 months)"}