{"description":"Safety results are summarized for 299 patients (Pd arm: 150; DPd arm: 149).\n\nAlmost all patients in the DPd arm (142/149) received daratumumab SC, per Amendment 1. Of the remaining 7 patients, 4 were switched to daratumumab SC and 3 discontinued treatment before the study was amended to SC administration. The safety information for the DPd arm is presented for all patients who received daratumumab IV and/or SC (n=149) and for patients who received daratumumab SC only (n=142).","eventGroups":[{"deathsNumAffected":88,"deathsNumAtRisk":150,"description":"Patients (n=150) received pomalidomide 4 mg orally on Days 1 through 21 of each 28-day treatment cycle and dexamethasone 40 mg (or 20 mg for patients ≥75 years of age) orally on Days 1, 8, 15, and 22 of each 28-day treatment cycle.","id":"EG000","otherNumAffected":144,"otherNumAtRisk":150,"seriousNumAffected":60,"seriousNumAtRisk":150,"title":"Pomalidomide+Dexamethasone"},{"deathsNumAffected":82,"deathsNumAtRisk":149,"description":"Patients (n=149) received: daratumumab SC (fixed dose of 1800 mg) or IV (16 mg/kg) at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, and every 4 weeks (Q4W) thereafter; pomalidomide at a dose of 4 mg orally on Days 1 through 21 of each 28-day treatment cycle; and dexamethasone at a dose of 40 mg (or 20 mg for patients ≥75 years of age) orally on Days 1, 8, 15, and 22 of each 28-day treatment cycle.Only 7 patients received Dara IV and are included in the overall reporting category(DaraPomDex) and the DaraSC subcategory is presented separately to define the safety of the SC dosing regimen.","id":"EG001","otherNumAffected":144,"otherNumAtRisk":149,"seriousNumAffected":80,"seriousNumAtRisk":149,"title":"Daratumumab+Pomalidomide+Dexamethasone"},{"deathsNumAffected":77,"deathsNumAtRisk":142,"description":"Patients (n=142) received: daratumumab SC (fixed dose of 1800 mg) at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, and every 4 weeks (Q4W) thereafter; pomalidomide at a dose of 4 mg orally on Days 1 through 21 of each 28-day treatment cycle; and dexamethasone at a dose of 40 mg (or 20 mg for patients ≥75 years of age) orally on Days 1, 8, 15, and 22 of each 28-day treatment cycle.","id":"EG002","otherNumAffected":137,"otherNumAtRisk":142,"seriousNumAffected":77,"seriousNumAtRisk":142,"title":"Daratumumab (SC)+Pomalidomide+Dexamethasone"},{"deathsNumAffected":5,"deathsNumAtRisk":7,"description":"Patients (n=7) received: daratumumab IV (fixed dose of 1800 mg) at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, and every 4 weeks (Q4W) thereafter; pomalidomide at a dose of 4 mg orally on Days 1 through 21 of each 28-day treatment cycle; and dexamethasone at a dose of 40 mg (or 20 mg for patients ≥75 years of age) orally on Days 1, 8, 15, and 22 of each 28-day treatment cycle.","id":"EG003","otherNumAffected":7,"otherNumAtRisk":7,"seriousNumAffected":3,"seriousNumAtRisk":7,"title":"Daratumumab (IV)+Pomalidomide+Dexamethasone"}],"frequencyThreshold":"5.0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":80,"numAtRisk":150},{"groupId":"EG001","numAffected":107,"numAtRisk":149},{"groupId":"EG002","numAffected":103,"numAtRisk":142},{"groupId":"EG003","numAffected":4,"numAtRisk":7}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":67,"numAtRisk":150},{"groupId":"EG001","numAffected":57,"numAtRisk":149},{"groupId":"EG002","numAffected":55,"numAtRisk":142},{"groupId":"EG003","numAffected":2,"numAtRisk":7}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":51,"numAtRisk":150},{"groupId":"EG001","numAffected":49,"numAtRisk":149},{"groupId":"EG002","numAffected":48,"numAtRisk":142},{"groupId":"EG003","numAffected":1,"numAtRisk":7}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":150},{"groupId":"EG001","numAffected":39,"numAtRisk":149},{"groupId":"EG002","numAffected":38,"numAtRisk":142},{"groupId":"EG003","numAffected":1,"numAtRisk":7}],"term":"Leukopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":150},{"groupId":"EG001","numAffected":22,"numAtRisk":149},{"groupId":"EG002","numAffected":19,"numAtRisk":142},{"groupId":"EG003","numAffected":3,"numAtRisk":7}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":150},{"groupId":"EG001","numAffected":34,"numAtRisk":149},{"groupId":"EG002","numAffected":31,"numAtRisk":142},{"groupId":"EG003","numAffected":3,"numAtRisk":7}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":150},{"groupId":"EG001","numAffected":11,"numAtRisk":149},{"groupId":"EG002","numAffected":11,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":150},{"groupId":"EG001","numAffected":20,"numAtRisk":149},{"groupId":"EG002","numAffected":19,"numAtRisk":142},{"groupId":"EG003","numAffected":1,"numAtRisk":7}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":150},{"groupId":"EG001","numAffected":21,"numAtRisk":149},{"groupId":"EG002","numAffected":21,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":37,"numAtRisk":150},{"groupId":"EG001","numAffected":43,"numAtRisk":149},{"groupId":"EG002","numAffected":39,"numAtRisk":142},{"groupId":"EG003","numAffected":4,"numAtRisk":7}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":150},{"groupId":"EG001","numAffected":33,"numAtRisk":149},{"groupId":"EG002","numAffected":33,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Asthenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":150},{"groupId":"EG001","numAffected":28,"numAtRisk":149},{"groupId":"EG002","numAffected":27,"numAtRisk":142},{"groupId":"EG003","numAffected":1,"numAtRisk":7}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":150},{"groupId":"EG001","numAffected":25,"numAtRisk":149},{"groupId":"EG002","numAffected":24,"numAtRisk":142},{"groupId":"EG003","numAffected":1,"numAtRisk":7}],"term":"Oedema peripheral"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":150},{"groupId":"EG001","numAffected":36,"numAtRisk":149},{"groupId":"EG002","numAffected":35,"numAtRisk":142},{"groupId":"EG003","numAffected":1,"numAtRisk":7}],"term":"Diarrhoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":150},{"groupId":"EG001","numAffected":21,"numAtRisk":149},{"groupId":"EG002","numAffected":21,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Constipation"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":150},{"groupId":"EG001","numAffected":18,"numAtRisk":149},{"groupId":"EG002","numAffected":18,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Back pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":150},{"groupId":"EG001","numAffected":17,"numAtRisk":149},{"groupId":"EG002","numAffected":17,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Bone pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":150},{"groupId":"EG001","numAffected":15,"numAtRisk":149},{"groupId":"EG002","numAffected":14,"numAtRisk":142},{"groupId":"EG003","numAffected":1,"numAtRisk":7}],"term":"Tremor"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":150},{"groupId":"EG001","numAffected":17,"numAtRisk":149},{"groupId":"EG002","numAffected":15,"numAtRisk":142},{"groupId":"EG003","numAffected":2,"numAtRisk":7}],"term":"Hyperglycaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":150},{"groupId":"EG001","numAffected":18,"numAtRisk":149},{"groupId":"EG002","numAffected":18,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Cough"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":150},{"groupId":"EG001","numAffected":16,"numAtRisk":149},{"groupId":"EG002","numAffected":16,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":150},{"groupId":"EG001","numAffected":13,"numAtRisk":149},{"groupId":"EG002","numAffected":12,"numAtRisk":142},{"groupId":"EG003","numAffected":1,"numAtRisk":7}],"term":"Insomnia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":150},{"groupId":"EG001","numAffected":9,"numAtRisk":149},{"groupId":"EG002","numAffected":8,"numAtRisk":142},{"groupId":"EG003","numAffected":1,"numAtRisk":7}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":150},{"groupId":"EG001","numAffected":15,"numAtRisk":149},{"groupId":"EG002","numAffected":14,"numAtRisk":142},{"groupId":"EG003","numAffected":1,"numAtRisk":7}],"term":"Muscle spasms"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":150},{"groupId":"EG001","numAffected":19,"numAtRisk":149},{"groupId":"EG002","numAffected":17,"numAtRisk":142},{"groupId":"EG003","numAffected":2,"numAtRisk":7}],"term":"Peripheral sensory neuropathy"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pd: 2 deaths DPd: 3 deaths DPd (SC): 3 deaths","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":150},{"groupId":"EG001","numAffected":23,"numAtRisk":149},{"groupId":"EG002","numAffected":23,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pd: 1 death DPd: 1 death DPd (SC): 1 death","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":150},{"groupId":"EG001","numAffected":18,"numAtRisk":149},{"groupId":"EG002","numAffected":18,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Lower respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":150},{"groupId":"EG001","numAffected":3,"numAtRisk":149},{"groupId":"EG002","numAffected":3,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":149},{"groupId":"EG002","numAffected":1,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Bronchitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":150},{"groupId":"EG001","numAffected":5,"numAtRisk":149},{"groupId":"EG002","numAffected":5,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Febrile neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":4,"numAtRisk":149},{"groupId":"EG002","numAffected":4,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pd: 0 deaths DPd: 1 death DPd (SC): 0 deaths","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":3,"numAtRisk":149},{"groupId":"EG002","numAffected":2,"numAtRisk":142},{"groupId":"EG003","numAffected":1,"numAtRisk":7}],"term":"Dyspnoea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":150},{"groupId":"EG001","numAffected":3,"numAtRisk":149},{"groupId":"EG002","numAffected":3,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":149},{"groupId":"EG002","numAffected":1,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":4,"numAtRisk":149},{"groupId":"EG002","numAffected":4,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Syncope"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":3,"numAtRisk":149},{"groupId":"EG002","numAffected":3,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"All deaths are reported as footnotes. The table only refers to the most common SAEs reported with ≥2% higher frequency in the DPd group compared to the Pd group.\n\nPd: 0 deaths DPd: 1 death DPd (SC): 1 death","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":149},{"groupId":"EG002","numAffected":1,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Campylobacter infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pd: 1 death DPd: 2 deaths DPd (SC): 2 deaths","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":7,"numAtRisk":149},{"groupId":"EG002","numAffected":7,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pd: 0 deaths DPd: 1 death DPd (SC): 1 death","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":149},{"groupId":"EG002","numAffected":1,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Sepsis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pd: 2 deaths DPd: 1 death DPd (SC): 0 deaths","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":149},{"groupId":"EG002","numAffected":0,"numAtRisk":142},{"groupId":"EG003","numAffected":1,"numAtRisk":7}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pd: 0 deaths DPd: 1 death DPd (SC): 1 death","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":149},{"groupId":"EG002","numAffected":1,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Systemic candida"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pd: 0 deaths DPd: 1 death DPd (SC): 1 death","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":149},{"groupId":"EG002","numAffected":1,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Bone marrow failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pd: 0 deaths DPd: 1 death DPd (SC): 1 death","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":2,"numAtRisk":149},{"groupId":"EG002","numAffected":2,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Respiratory failure"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pd: 1 death DPd: 1 death DPd (SC): 1 death","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":149},{"groupId":"EG002","numAffected":1,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Pneumonia aspiration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pd: 0 deaths DPd: 1 death DPd (SC): 1 death","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":149},{"groupId":"EG002","numAffected":1,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Sudden death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pd: 1 death DPd: 0 deaths DPd (SC): 0 deaths","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":0,"numAtRisk":149},{"groupId":"EG002","numAffected":0,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Cerebral haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pd: 1 death DPd: 0 deaths DPd (SC): 0 deaths","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":0,"numAtRisk":149},{"groupId":"EG002","numAffected":0,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Hypertensive hydrocephalus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pd: 1 death DPd: 0 deaths DPd (SC): 0 deaths","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":149},{"groupId":"EG002","numAffected":1,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Acute myocardial infarction"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pd: 1 death DPd: 0 deaths DPd (SC): 0 deaths","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":0,"numAtRisk":149},{"groupId":"EG002","numAffected":0,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Cardiac arrest"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pd: 0 deaths DPd: 1 death DPd (SC): 1 death","organSystem":"Hepatobiliary disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":0,"numAtRisk":149},{"groupId":"EG002","numAffected":0,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Liver disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Pd: 2 deaths DPd: 0 deaths DPd (SC): 0 deaths","organSystem":"General disorders","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":0,"numAtRisk":149},{"groupId":"EG002","numAffected":0,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"General physical health deterioration"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":149},{"groupId":"EG002","numAffected":1,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Atypical pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":149},{"groupId":"EG002","numAffected":1,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Campylobacter infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":150},{"groupId":"EG001","numAffected":1,"numAtRisk":149},{"groupId":"EG002","numAffected":0,"numAtRisk":142},{"groupId":"EG003","numAffected":1,"numAtRisk":7}],"term":"Septic shock"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA 24.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":150},{"groupId":"EG001","numAffected":0,"numAtRisk":149},{"groupId":"EG002","numAffected":0,"numAtRisk":142},{"groupId":"EG003","numAffected":0,"numAtRisk":7}],"term":"Viral infection"}],"timeFrame":"Over a median follow-up of 39.6 months (clinical cutoff date: 31 May 2022; approximately an additional 23 months since the primary analysis)."}