NCT02951819 · ADVERSE EVENTS
Adverse events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.
- Collection time frame
- Up to 36 months
- Other-event reporting threshold
- 0%
Safety analysis set is defined as enrolled participants who received at least 1 dose (partial or complete) of study treatment (Dara-CyBorD).
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Newly Diagnosed Multiple Myeloma (NDMM) | 28 / 86 | 86 / 86 | 9 / 86 |
| Relapsed Multiple Myeloma (RMM) | 5 / 14 | 14 / 14 | 7 / 14 |
Serious adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Febrile Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Atrial Fibrillation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Atrial Flutter
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 14
- term
- Haemorrhoidal Haemorrhage
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Vomiting
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Fatigue
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Non-Cardiac Chest Pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Pyrexia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Hepatobiliary disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Cholecystitis Acute
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Bacteraemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Bacterial Sepsis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Bronchitis
Other reported adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 14
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 14
- term
- Hyperleukocytosis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Increased Tendency to Bruise
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Iron Deficiency Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 14
- term
- Leukopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Lymphopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 14
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 14
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Atrial Fibrillation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Atrial Flutter
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Bradycardia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Cardiac Failure Congestive
Complete source fields
- description
- Safety analysis set is defined as enrolled participants who received at least 1 dose (partial or complete) of study treatment (Dara-CyBorD).
- event Groups
- deaths Num Affected
- 9
- deaths Num At Risk
- 86
- description
- Induction therapy:Participants received daratumumab, cyclophosphamide, bortezomib, and dexamethasone (Dara-CyBorD) as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22), Cycle 2 (Days 1,8,15,22), Cycles 3-6 (Days 1,15), Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m\^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m\^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2 (Days 1,8,15,22), Cycle 3-8 (\[if with CyBorD\] Days 1,8,15,22). Consolidation therapy (CT): Participants who were considered eligible for transplant underwent autologous stem cell transplantation \[ASCT\] at investigator discretion. Maintenance therapy: Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
- id
- EG000
- other Num Affected
- 86
- other Num At Risk
- 86
- serious Num Affected
- 28
- serious Num At Risk
- 86
- title
- Newly Diagnosed Multiple Myeloma (NDMM)
- deaths Num Affected
- 7
- deaths Num At Risk
- 14
- description
- Participants with RMM (defined as having achieved at least a PR with first-line therapy before progression) received treatment as-Induction therapy:Participants received Dara-CyBorD as: daratumumab 8 mg/kg IV on Cycle 1(Day 1,2) and 16 mg/kg IV on Cycle 1(Days 8,15,22),Cycle 2 (Days 1,8,15,22),Cycles 3-6(Days 1,15),Cycles 7-8(Day 1); Cyclophosphamide 300 mg/m\^2 orally on Days 1,8,15,22 of each cycle (28 days); Bortezomib 1.5 mg/m\^2 SC on Days 1,8,15 of each cycle; Dexamethasone 20 mg IV on Cycle 1(Day1,2,8,15,22) and orally on Cycle 1(Day 9,16,23), 40 mg IV or oral on Cycle 2(Days 1,8,15,22),Cycle 3-8 (\[if with CyBorD\] Days 1,8,15,22). CT: Participants who were considered eligible for transplant underwent ASCT at investigator discretion. Maintenance therapy: Daratumumab 16 mg/kg IV on Day 1 for 12 cycles or until PD, whichever occurred first; Dexamethasone 12 mg IV or oral on Day 1 of each cycle(for ASCT participants, maintenance therapy was to begin approximately 90 days after ASCT).
- id
- EG001
- other Num Affected
- 14
- other Num At Risk
- 14
- serious Num Affected
- 5
- serious Num At Risk
- 14
- title
- Relapsed Multiple Myeloma (RMM)
- frequency Threshold
- 0
- other Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 14
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 14
- term
- Hyperleukocytosis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Increased Tendency to Bruise
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Iron Deficiency Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 8
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 14
- term
- Leukopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Lymphopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 14
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 14
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Atrial Fibrillation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Atrial Flutter
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Bradycardia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Cardiac Failure Congestive
- serious Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Febrile Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Atrial Fibrillation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Atrial Flutter
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 14
- term
- Haemorrhoidal Haemorrhage
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Vomiting
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Fatigue
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Non-Cardiac Chest Pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- General disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Pyrexia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Hepatobiliary disorders
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Cholecystitis Acute
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Bacteraemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Bacterial Sepsis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- source Vocabulary
- MedDRA Version 23.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 86
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 14
- term
- Bronchitis
- time Frame
- Up to 36 months
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Preserved source evidence · Not medical advice
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