{"description":"The safety population was defined as all participants who have received any amount of study medication.","eventGroups":[{"deathsNumAffected":1,"deathsNumAtRisk":64,"description":"Participants received obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose was up titrated to a target dose of 2.0 - 2.5 grams per day (g/day) (or equivalent). Investigators, at their discretion, could use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants could receive 1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants received 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.","id":"EG000","otherNumAffected":51,"otherNumAtRisk":64,"seriousNumAffected":17,"seriousNumAtRisk":64,"title":"OBINUTUZUMAB 1000MG + MMF"},{"deathsNumAffected":4,"deathsNumAtRisk":61,"description":"Participants received placebo matching to obinutuzumab IV infusion on Days 1, 15, 168, and 182 along with MMF/MPA at a starting dose of 1500 mg/day (or equivalent) administered orally in 2 or 3 divided doses. MMF/MPA dose was up titrated to a target dose of 2.0 - 2.5 g/day (or equivalent). Investigators, at their discretion, could use MPA as a substitute for MMF, with a 360 mg dose being equivalent to a 500 mg dose of MMF. During screening or at randomization, if clinically indicated, participants could receive 1000 mg methylprednisolone IV once daily for up to 3 days to treat underlying LN clinical activity. Participants received 0.5 mg/kg oral prednisone, tapering this prednisone dose, per protocol, starting on Day 16 and reducing the prednisone dosage to 7.5 mg/day by Week 12.","id":"EG001","otherNumAffected":39,"otherNumAtRisk":61,"seriousNumAffected":18,"seriousNumAtRisk":61,"title":"PLACEBO + MMF"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":64,"numEvents":5},{"groupId":"EG001","numAffected":4,"numAtRisk":61,"numEvents":6}],"term":"ANAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":64,"numEvents":7},{"groupId":"EG001","numAffected":3,"numAtRisk":61,"numEvents":3}],"term":"ABDOMINAL PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":64,"numEvents":3},{"groupId":"EG001","numAffected":5,"numAtRisk":61,"numEvents":5}],"term":"DIARRHOEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":64,"numEvents":7},{"groupId":"EG001","numAffected":3,"numAtRisk":61,"numEvents":3}],"term":"NAUSEA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":61,"numEvents":4}],"term":"CHEST PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":64,"numEvents":15},{"groupId":"EG001","numAffected":5,"numAtRisk":61,"numEvents":8}],"term":"BRONCHITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":64,"numEvents":6},{"groupId":"EG001","numAffected":2,"numAtRisk":61,"numEvents":2}],"term":"CONJUNCTIVITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":64,"numEvents":4},{"groupId":"EG001","numAffected":6,"numAtRisk":61,"numEvents":9}],"term":"GASTROENTERITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":64,"numEvents":6},{"groupId":"EG001","numAffected":6,"numAtRisk":61,"numEvents":7}],"term":"HERPES ZOSTER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":64,"numEvents":4},{"groupId":"EG001","numAffected":2,"numAtRisk":61,"numEvents":3}],"term":"INFLUENZA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":64,"numEvents":5},{"groupId":"EG001","numAffected":6,"numAtRisk":61,"numEvents":8}],"term":"NASOPHARYNGITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":64,"numEvents":8},{"groupId":"EG001","numAffected":4,"numAtRisk":61,"numEvents":4}],"term":"PHARYNGITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":64,"numEvents":8},{"groupId":"EG001","numAffected":5,"numAtRisk":61,"numEvents":6}],"term":"UPPER RESPIRATORY TRACT INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":64,"numEvents":19},{"groupId":"EG001","numAffected":12,"numAtRisk":61,"numEvents":20}],"term":"URINARY TRACT INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":64,"numEvents":7},{"groupId":"EG001","numAffected":6,"numAtRisk":61,"numEvents":7}],"term":"INFUSION RELATED REACTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":64,"numEvents":7},{"groupId":"EG001","numAffected":3,"numAtRisk":61,"numEvents":3}],"term":"HEADACHE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":4,"numAtRisk":61,"numEvents":4}],"term":"ANXIETY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":64,"numEvents":6},{"groupId":"EG001","numAffected":2,"numAtRisk":61,"numEvents":2}],"term":"HYPERTENSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":64,"numEvents":6},{"groupId":"EG001","numAffected":4,"numAtRisk":61,"numEvents":5}],"term":"ARTHRALGIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":64,"numEvents":3},{"groupId":"EG001","numAffected":4,"numAtRisk":61,"numEvents":4}],"term":"INSOMNIA"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"NEUTROPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"THROMBOCYTOPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"CARDIAC FAILURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"INTESTINAL PERFORATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"GENERAL PHYSICAL HEALTH DETERIORATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":64,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":2}],"term":"PYREXIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"BRONCHIOLITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"CYTOMEGALOVIRUS CHORIORETINITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"CYTOMEGALOVIRUS MYOCARDITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"DISSEMINATED CYTOMEGALOVIRAL INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"ENDOMETRITIS BACTERIAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64,"numEvents":1},{"groupId":"EG001","numAffected":3,"numAtRisk":61,"numEvents":3}],"term":"HERPES ZOSTER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"KLEBSIELLA BACTERAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"MENINGITIS CRYPTOCOCCAL"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":61,"numEvents":0}],"term":"ORAL CANDIDIASIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"PNEUMONIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"PYELONEPHRITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"URINARY TRACT INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"UROSEPSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"LUMBAR VERTEBRAL FRACTURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"ROAD TRAFFIC ACCIDENT"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":61,"numEvents":0}],"term":"INFLUENZA A VIRUS TEST POSITIVE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"WEIGHT INCREASED"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"HYPONATRAEMIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":61,"numEvents":0}],"term":"ARTHRALGIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"ARTHRITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":64,"numEvents":2},{"groupId":"EG001","numAffected":2,"numAtRisk":61,"numEvents":2}],"term":"SYSTEMIC LUPUS ERYTHEMATOSUS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":61,"numEvents":0}],"term":"EPILEPSY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"HEADACHE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"IDIOPATHIC INTRACRANIAL HYPERTENSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":61,"numEvents":0}],"term":"PSYCHOTIC DISORDER"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"LUPUS NEPHRITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":2,"numAtRisk":61,"numEvents":2}],"term":"RENAL FAILURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":61,"numEvents":0}],"term":"ASTHMA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":61,"numEvents":0}],"term":"PULMONARY EMBOLISM"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"HYPERTENSION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":61,"numEvents":0}],"term":"SHOCK HAEMORRHAGIC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"LEUKOPENIA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":64,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":61,"numEvents":0}],"term":"ABDOMINAL PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"INTUSSUSCEPTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":61,"numEvents":0}],"term":"OESOPHAGEAL FISTULA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"UPPER GASTROINTESTINAL HAEMORRHAGE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":61,"numEvents":0}],"term":"CHOLELITHIASIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"HEPATITIS ACUTE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"APPENDICITIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":61,"numEvents":0}],"term":"RESPIRATORY TRACT INFECTION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":2}],"term":"SEPSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":61,"numEvents":0}],"term":"TUBERCULOSIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"VARICELLA"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"HEMIPARESIS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":61,"numEvents":0}],"term":"MYELITIS TRANSVERSE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"SEIZURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Pregnancy, puerperium and perinatal conditions","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":61,"numEvents":0}],"term":"ABORTION SPONTANEOUS"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"NEPHROPATHY TOXIC"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"RENAL IMPAIRMENT"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"ACUTE RESPIRATORY FAILURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"PLEURITIC PAIN"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":61,"numEvents":0}],"term":"PULMONARY ALVEOLAR HAEMORRHAGE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":61,"numEvents":0}],"term":"RESPIRATORY FAILURE"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":61,"numEvents":0}],"term":"RASH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":61,"numEvents":0}],"term":"DEATH"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":64,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":61,"numEvents":0}],"term":"PNEUMONIA ASPIRATION"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDRA, v26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":64,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":61,"numEvents":1}],"term":"SUPERFICIAL VEIN THROMBOSIS"}],"timeFrame":"From baseline to approximately 7 years and 8 months"}