{"description":"AE definition: An AE is any untoward medical occurrence in a patient or clinical study patient, temporally associated with the use of study treatment, whether or not considered related to the study treatment.\n\nAEs are grouped by MedDRA system organ class (SOC) and preferred term (PT).","eventGroups":[{"deathsNumAffected":2,"deathsNumAtRisk":22,"description":"Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n* Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle\n* Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years)\n* Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7","id":"EG000","otherNumAffected":21,"otherNumAtRisk":22,"seriousNumAffected":6,"seriousNumAtRisk":22,"title":"Arm A (Melflufen+Dexamethasone+Daratumumab)"},{"deathsNumAffected":3,"deathsNumAtRisk":26,"description":"Treatment was given in 28-day cycles in an outpatient treatment setting.\n\n• Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7","id":"EG001","otherNumAffected":22,"otherNumAtRisk":26,"seriousNumAffected":12,"seriousNumAtRisk":26,"title":"Arm B (Daratumumab)"},{"deathsNumAffected":1,"deathsNumAtRisk":2,"description":"Patients in Arm B were allowed to crossover and receive the same treatment as Arm A after a confirmed disease progression (2 patients crossed over).","id":"EG002","otherNumAffected":2,"otherNumAtRisk":2,"seriousNumAffected":1,"seriousNumAtRisk":2,"title":"Crossover (From Arm B to the Same Treatment as Arm A)"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22},{"groupId":"EG001","numAffected":3,"numAtRisk":26},{"groupId":"EG002","numAffected":1,"numAtRisk":2}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22},{"groupId":"EG001","numAffected":2,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Upper respiratory tract infection"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":13,"numAtRisk":22},{"groupId":"EG001","numAffected":8,"numAtRisk":26},{"groupId":"EG002","numAffected":1,"numAtRisk":2}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":22},{"groupId":"EG001","numAffected":7,"numAtRisk":26},{"groupId":"EG002","numAffected":1,"numAtRisk":2}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":22},{"groupId":"EG001","numAffected":4,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":22},{"groupId":"EG001","numAffected":2,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Lymphopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Diarrhea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAffected":1,"numAtRisk":2}],"term":"Nausea"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22},{"groupId":"EG001","numAffected":3,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Pyrexia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Fatigue"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":22},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Neutrophil count decrease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Platelet count decrease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22},{"groupId":"EG001","numAffected":2,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"SARS-CoV-2 test positive"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22},{"groupId":"EG001","numAffected":2,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Femur fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Decreased appetite"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAffected":1,"numAtRisk":2}],"term":"Musculoskeletal chest pain"}],"seriousEvents":[{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22},{"groupId":"EG001","numAffected":3,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":22},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Pancytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":22},{"groupId":"EG001","numAffected":2,"numAtRisk":26},{"groupId":"EG002","numAffected":1,"numAtRisk":2}],"term":"Pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Asymptomatic COVID-19"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"COVID-19 pneumonia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":22},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Enterocolitis"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Gingival bleeding"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":22},{"groupId":"EG001","numAffected":0,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Rectal haemorrhage"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Death"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Disease progression"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22},{"groupId":"EG001","numAffected":2,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Femur fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Upper limb fracture"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Hypercalcaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Confusional state"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Acute kidney injury"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":22},{"groupId":"EG001","numAffected":1,"numAtRisk":26},{"groupId":"EG002","numAffected":0,"numAtRisk":2}],"term":"Hypotension"}],"timeFrame":"Adverse events (AEs) were collected from the start of study treatment until 30 days after the last dose of study drug or initiation of subsequent therapy whichever occurred first. Serious AEs (SAEs) were collected from signing of the informed consent form (ICF) until 30 days after the last dose of study treatment or initiation of subsequent therapy whichever occurred first. The maximum duration of treatment was 48 weeks, and the maximum duration of AEs/SAEs collection was 48 weeks + 30 days."}