{"description":"Analysis was performed on the AT population.","eventGroups":[{"deathsNumAffected":17,"deathsNumAtRisk":27,"description":"Participants with B-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first.","id":"EG000","otherNumAffected":26,"otherNumAtRisk":27,"seriousNumAffected":19,"seriousNumAtRisk":27,"title":"B-cell Acute Lymphoblastic Leukemia (B-ALL)"},{"deathsNumAffected":8,"deathsNumAtRisk":13,"description":"Participants with T-ALL received isatuximab 20 mg/kg IV infusion QW for 4 weeks during the induction period (i.e., on Days 1, 8, 15, and 22) and Q2W during the consolidation period (i.e., on Days 29, 43, and 57. Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first.","id":"EG001","otherNumAffected":12,"otherNumAtRisk":13,"seriousNumAffected":12,"seriousNumAtRisk":13,"title":"T-cell Acute Lymphoblastic Leukemia (T-ALL)"},{"deathsNumAffected":18,"deathsNumAtRisk":27,"description":"Participants with AML received isatuximab 20 mg/kg IV infusion on Days 1, 8, and 15 of each Cycle (up to 2 treatment cycles, each cycle 28 days). Participants received recommended isatuximab premedication as per protocol. Starting on Day 8, combination chemotherapies were added. Participants without documented disease progression at EOT visit who had not started treatment with another anticancer therapy received follow-up visits every 2 months until initiation of another anticancer therapy, disease progression, death, or final analysis cut-off date, whichever occurred first. Participants with documented disease progression/initiation of new anticancer treatment were followed for survival every 4 months until death or final analysis cut-off date, whichever occurred first.","id":"EG002","otherNumAffected":24,"otherNumAtRisk":27,"seriousNumAffected":17,"seriousNumAtRisk":27,"title":"Acute Myeloid Leukemia (AML)"},{"deathsNumAffected":43,"deathsNumAtRisk":67,"description":"All participants in the study were included in this cohort.","id":"EG003","otherNumAffected":62,"otherNumAtRisk":67,"seriousNumAffected":48,"seriousNumAtRisk":67,"title":"All Participants"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG003","numAffected":4,"numAtRisk":67,"numEvents":4}],"term":"Conjunctivitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG003","numAffected":3,"numAtRisk":67,"numEvents":3}],"term":"Device Related Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Lip Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Oral Candidiasis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":67,"numEvents":2}],"term":"Oral Herpes"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":67,"numEvents":2}],"term":"Respiratory Syncytial Virus Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Skin Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":67,"numEvents":2}],"term":"Upper Respiratory Tract Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Viral Rhinitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":27,"numEvents":5},{"groupId":"EG003","numAffected":3,"numAtRisk":67,"numEvents":6}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":27,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":5,"numAtRisk":27,"numEvents":5},{"groupId":"EG003","numAffected":10,"numAtRisk":67,"numEvents":12}],"term":"Febrile Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Haemolysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Drug Hypersensitivity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Food Allergy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG002","numAffected":8,"numAtRisk":27,"numEvents":8},{"groupId":"EG003","numAffected":11,"numAtRisk":67,"numEvents":11}],"term":"Decreased Appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Increased Appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG003","numAffected":4,"numAtRisk":67,"numEvents":4}],"term":"Anxiety"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Depression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":67,"numEvents":2}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Irritability"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG003","numAffected":3,"numAtRisk":67,"numEvents":3}],"term":"Dizziness"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":67,"numEvents":2}],"term":"Dysaesthesia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":67,"numEvents":2}],"term":"Dysgeusia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Facial Paralysis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG001","numAffected":3,"numAtRisk":13,"numEvents":4},{"groupId":"EG002","numAffected":9,"numAtRisk":27,"numEvents":14},{"groupId":"EG003","numAffected":15,"numAtRisk":67,"numEvents":21}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Peripheral Sensory Neuropathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG003","numAffected":4,"numAtRisk":67,"numEvents":5}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":2},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":2}],"term":"Eyelid Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":67,"numEvents":2}],"term":"Periorbital Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG003","numAffected":5,"numAtRisk":67,"numEvents":5}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG003","numAffected":3,"numAtRisk":67,"numEvents":3}],"term":"Flushing"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":5,"numAtRisk":13,"numEvents":7},{"groupId":"EG002","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG003","numAffected":8,"numAtRisk":67,"numEvents":10}],"term":"Hypertension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG003","numAffected":3,"numAtRisk":67,"numEvents":3}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":27,"numEvents":8},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG003","numAffected":8,"numAtRisk":67,"numEvents":10}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":67,"numEvents":2}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":27,"numEvents":5},{"groupId":"EG003","numAffected":3,"numAtRisk":67,"numEvents":5}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":27,"numEvents":3},{"groupId":"EG003","numAffected":2,"numAtRisk":67,"numEvents":3}],"term":"Hypoxia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG003","numAffected":5,"numAtRisk":67,"numEvents":5}],"term":"Oropharyngeal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":67,"numEvents":2}],"term":"Rhinorrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":27,"numEvents":6},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":3},{"groupId":"EG002","numAffected":5,"numAtRisk":27,"numEvents":8},{"groupId":"EG003","numAffected":12,"numAtRisk":67,"numEvents":17}],"term":"Abdominal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG003","numAffected":4,"numAtRisk":67,"numEvents":4}],"term":"Abdominal Pain Upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":27,"numEvents":5},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG003","numAffected":5,"numAtRisk":67,"numEvents":7}],"term":"Anal Fissure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":13,"numEvents":3},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":67,"numEvents":4}],"term":"Anal Inflammation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG003","numAffected":5,"numAtRisk":67,"numEvents":5}],"term":"Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":13,"numEvents":3},{"groupId":"EG002","numAffected":7,"numAtRisk":27,"numEvents":7},{"groupId":"EG003","numAffected":12,"numAtRisk":67,"numEvents":13}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":27,"numEvents":5},{"groupId":"EG001","numAffected":3,"numAtRisk":13,"numEvents":3},{"groupId":"EG002","numAffected":8,"numAtRisk":27,"numEvents":9},{"groupId":"EG003","numAffected":15,"numAtRisk":67,"numEvents":17}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":4,"numAtRisk":27,"numEvents":6},{"groupId":"EG003","numAffected":5,"numAtRisk":67,"numEvents":7}],"term":"Dyspepsia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":27,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":67,"numEvents":3}],"term":"Gastritis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":27,"numEvents":17},{"groupId":"EG001","numAffected":3,"numAtRisk":13,"numEvents":5},{"groupId":"EG002","numAffected":6,"numAtRisk":27,"numEvents":9},{"groupId":"EG003","numAffected":18,"numAtRisk":67,"numEvents":31}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":67,"numEvents":2}],"term":"Oral Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":67,"numEvents":2}],"term":"Pancreatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":27,"numEvents":10},{"groupId":"EG001","numAffected":4,"numAtRisk":13,"numEvents":5},{"groupId":"EG002","numAffected":8,"numAtRisk":27,"numEvents":8},{"groupId":"EG003","numAffected":22,"numAtRisk":67,"numEvents":23}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":27,"numEvents":7},{"groupId":"EG001","numAffected":3,"numAtRisk":13,"numEvents":3},{"groupId":"EG002","numAffected":10,"numAtRisk":27,"numEvents":15},{"groupId":"EG003","numAffected":19,"numAtRisk":67,"numEvents":25}],"term":"Vomiting"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Hepatic Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Hepatic Steatosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":67,"numEvents":3}],"term":"Alopecia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":67,"numEvents":2}],"term":"Dry Skin"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":27,"numEvents":3},{"groupId":"EG003","numAffected":3,"numAtRisk":67,"numEvents":4}],"term":"Erythema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":6,"numAtRisk":27,"numEvents":7},{"groupId":"EG003","numAffected":6,"numAtRisk":67,"numEvents":7}],"term":"Rash"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":27,"numEvents":6},{"groupId":"EG003","numAffected":3,"numAtRisk":67,"numEvents":7}],"term":"Rash Maculo-Papular"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG003","numAffected":4,"numAtRisk":67,"numEvents":4}],"term":"Back Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG003","numAffected":3,"numAtRisk":67,"numEvents":3}],"term":"Bone Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG003","numAffected":3,"numAtRisk":67,"numEvents":3}],"term":"Neck Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":27,"numEvents":6},{"groupId":"EG001","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG002","numAffected":2,"numAtRisk":27,"numEvents":5},{"groupId":"EG003","numAffected":8,"numAtRisk":67,"numEvents":13}],"term":"Pain In Extremity"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Nephropathy Toxic"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Renal Tubular Necrosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":3,"numAtRisk":13,"numEvents":4},{"groupId":"EG002","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG003","numAffected":6,"numAtRisk":67,"numEvents":7}],"term":"Urinary Retention"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":27,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":67,"numEvents":3}],"term":"Catheter Site Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":67,"numEvents":2}],"term":"Chills"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":3,"numAtRisk":67,"numEvents":3}],"term":"Face Oedema"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":3,"numAtRisk":27,"numEvents":5},{"groupId":"EG003","numAffected":6,"numAtRisk":67,"numEvents":8}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":67,"numEvents":2}],"term":"Oedema Peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":27,"numEvents":14},{"groupId":"EG001","numAffected":4,"numAtRisk":13,"numEvents":6},{"groupId":"EG002","numAffected":12,"numAtRisk":27,"numEvents":23},{"groupId":"EG003","numAffected":26,"numAtRisk":67,"numEvents":43}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG003","numAffected":4,"numAtRisk":67,"numEvents":4}],"term":"Weight Decreased"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Contusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":27,"numEvents":12},{"groupId":"EG001","numAffected":4,"numAtRisk":13,"numEvents":5},{"groupId":"EG002","numAffected":14,"numAtRisk":27,"numEvents":16},{"groupId":"EG003","numAffected":26,"numAtRisk":67,"numEvents":33}],"term":"Infusion Related Reaction"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Appendicitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Bacterial Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Catheter Site Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Cellulitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Device Related Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Disseminated Aspergillosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Encephalitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Escherichia Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Fournier's Gangrene"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":67,"numEvents":2}],"term":"Fungal Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Fungal Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Genital Herpes Zoster"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Neutropenic Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Otitis Externa"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Peritonitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Pneumocystis Jirovecii Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG003","numAffected":3,"numAtRisk":67,"numEvents":3}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Pseudomonal Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Rhinovirus Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG002","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG003","numAffected":4,"numAtRisk":67,"numEvents":4}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG001","numAffected":2,"numAtRisk":13,"numEvents":2},{"groupId":"EG002","numAffected":3,"numAtRisk":27,"numEvents":3},{"groupId":"EG003","numAffected":8,"numAtRisk":67,"numEvents":8}],"term":"Septic Shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Sinusitis Fungal"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":67,"numEvents":2}],"term":"Staphylococcal Bacteraemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Staphylococcal Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Febrile Bone Marrow Aplasia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":27,"numEvents":12},{"groupId":"EG001","numAffected":5,"numAtRisk":13,"numEvents":6},{"groupId":"EG002","numAffected":7,"numAtRisk":27,"numEvents":11},{"groupId":"EG003","numAffected":22,"numAtRisk":67,"numEvents":29}],"term":"Febrile Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Anaphylactic Shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG003","numAffected":2,"numAtRisk":67,"numEvents":2}],"term":"Cytokine Release Syndrome"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Haemophagocytic Lymphohistiocytosis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Generalised Tonic-Clonic Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Headache"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Leukoencephalopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Seizure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Cardiac Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Aortic Aneurysm"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG003","numAffected":2,"numAtRisk":67,"numEvents":2}],"term":"Hypotension"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Epistaxis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Anal Fissure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Mouth Haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":67,"numEvents":2}],"term":"Neutropenic Colitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Pancreatitis Acute"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":0,"numAtRisk":13,"numEvents":0},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":2,"numAtRisk":67,"numEvents":2}],"term":"Stomatitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Hepatic Failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":0,"numAtRisk":27,"numEvents":0},{"groupId":"EG003","numAffected":1,"numAtRisk":67,"numEvents":1}],"term":"Bone Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":27,"numEvents":2},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG003","numAffected":4,"numAtRisk":67,"numEvents":4}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"MedDra 26.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG001","numAffected":1,"numAtRisk":13,"numEvents":1},{"groupId":"EG002","numAffected":1,"numAtRisk":27,"numEvents":1},{"groupId":"EG003","numAffected":3,"numAtRisk":67,"numEvents":3}],"term":"Infusion Related Reaction"}],"timeFrame":"TEAEs were collected from the time of the first treatment administration (Day 1) up to 30 days after the last treatment (maximum duration of exposure of 13.1 weeks for B-ALL cohort, 10.7 weeks for T-ALL cohort and 7.1 weeks for AML cohort). All-cause mortality (Deaths) was collected for the entire study duration, a maximum of 45 months"}