NCT03201965 · 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
- All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
- Other-event reporting threshold
- 5%
All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Run-In: Daratumumab Plus CyBorD | 12 / 28 | 27 / 28 | 11 / 28 |
| CyBorD | 68 / 188 | 181 / 188 | 67 / 193 |
| Daratumumab Plus CyBorD | 91 / 193 | 184 / 193 | 47 / 195 |
Serious adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 193
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 193
- term
- Febrile Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 193
- term
- Haemorrhagic Diathesis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 193
- term
- Lymphopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 193
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 193
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 193
- term
- Acute Left Ventricular Failure
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 193
- term
- Acute Myocardial Infarction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 193
- term
- Angina Pectoris
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 193
- term
- Arrhythmia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 193
- term
- Arteriospasm Coronary
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 6
- num At Risk
- 193
- term
- Atrial Fibrillation
Other reported adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 13
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 44
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 49
- num At Risk
- 193
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 193
- term
- Eosinopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 193
- term
- Leukocytosis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 11
- num At Risk
- 193
- term
- Leukopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 28
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 37
- num At Risk
- 193
- term
- Lymphopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 12
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 21
- num At Risk
- 193
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 21
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 34
- num At Risk
- 193
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 12
- num At Risk
- 193
- term
- Palpitations
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 193
- term
- Tinnitus
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 193
- term
- Dry Eye
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 193
- term
- Ocular Hyperaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 13
- num At Risk
- 193
- term
- Vision Blurred
Complete source fields
- description
- All cause mortality: All participants randomized into the study. Serious and Other AEs: Safety analysis set was defined as participants who have received at least 1 administration of any study treatment (partial or complete).
- event Groups
- deaths Num Affected
- 11
- deaths Num At Risk
- 28
- description
- Participants received the combination therapy during Run-in phase starting with 20 milligrams (mg) dexamethasone as premedication followed by daratumumab 1800 mg on Day 1 Cycle 1, then cyclophosphamide 300 milligram per meter square (mg/m\^2) orally or intravenous (IV) maximum weekly dose 500 mg, followed by bortezomib 1.3 mg/m\^2 subcutaneous (SC) injection once every week and dexamethasone remaining 20 mg post daratumumab dosing for up to 1 cycle (28 Days) to assess the safety before randomizing participants in CyBorD or daratumumab plus CyBorD arms. However, participants also continued daratumumab plus CyBorD for up to 6 cycles and then daratumumab monotherapy for up to 24 months from the start of treatment. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
- id
- EG000
- other Num Affected
- 27
- other Num At Risk
- 28
- serious Num Affected
- 12
- serious Num At Risk
- 28
- title
- Run-In: Daratumumab Plus CyBorD
- deaths Num Affected
- 67
- deaths Num At Risk
- 193
- description
- Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
- id
- EG001
- other Num Affected
- 181
- other Num At Risk
- 188
- serious Num Affected
- 68
- serious Num At Risk
- 188
- title
- CyBorD
- deaths Num Affected
- 47
- deaths Num At Risk
- 195
- description
- Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).
- id
- EG002
- other Num Affected
- 184
- other Num At Risk
- 193
- serious Num Affected
- 91
- serious Num At Risk
- 193
- title
- Daratumumab Plus CyBorD
- frequency Threshold
- 5
- other Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 13
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 44
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 49
- num At Risk
- 193
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 193
- term
- Eosinopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 193
- term
- Leukocytosis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 7
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 11
- num At Risk
- 193
- term
- Leukopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 28
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 37
- num At Risk
- 193
- term
- Lymphopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 12
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 21
- num At Risk
- 193
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 21
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 34
- num At Risk
- 193
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 6
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 12
- num At Risk
- 193
- term
- Palpitations
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Ear and labyrinth disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 4
- num At Risk
- 193
- term
- Tinnitus
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 5
- num At Risk
- 193
- term
- Dry Eye
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 193
- term
- Ocular Hyperaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 8
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 13
- num At Risk
- 193
- term
- Vision Blurred
- serious Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 193
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 193
- term
- Febrile Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 193
- term
- Haemorrhagic Diathesis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 193
- term
- Lymphopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 193
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 193
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 193
- term
- Acute Left Ventricular Failure
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 193
- term
- Acute Myocardial Infarction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 2
- num At Risk
- 193
- term
- Angina Pectoris
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 0
- num At Risk
- 193
- term
- Arrhythmia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 1
- num At Risk
- 193
- term
- Arteriospasm Coronary
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 22.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 28
- group Id
- EG001
- num Affected
- 2
- num At Risk
- 188
- group Id
- EG002
- num Affected
- 6
- num At Risk
- 193
- term
- Atrial Fibrillation
- time Frame
- All cause mortality: From baseline (Day -28) up to 7.1 years; Serious and Other AEs: For CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 8.33 months). Daratumumab plus CyBorD: From start of treatment (Day 1) up to 30 days after last dose of study drug ( up to 27.7 months).
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle