NCT04649359 · 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
- From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
- Other-event reporting threshold
- 5%
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Cohort A | 84 / 123 | 123 / 123 | 43 / 123 |
| Cohort B | 44 / 64 | 63 / 64 | 30 / 64 |
Serious adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 64
- term
- Anemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 64
- term
- Aplasia pure red cell
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 64
- term
- Febrile neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 64
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 64
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 64
- term
- Angina pectoris
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 64
- term
- Atrial fibrillation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 64
- term
- Cardiac failure acute
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 64
- term
- Cardio-respiratory arrest
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 64
- term
- Cardiogenic shock
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 64
- term
- Cardiopulmonary failure
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 64
- term
- Sinus bradycardia
Other reported adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 58
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 39
- num At Risk
- 64
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 17
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 12
- num At Risk
- 64
- term
- Leukopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 32
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 22
- num At Risk
- 64
- term
- Lymphopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 59
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 24
- num At Risk
- 64
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 36
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 27
- num At Risk
- 64
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 64
- term
- Sinus tachycardia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 64
- term
- Tachycardia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 64
- term
- Abdominal pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 11
- num At Risk
- 64
- term
- Constipation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 47
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 18
- num At Risk
- 64
- term
- Diarrhoea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 64
- term
- Dry mouth
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 32
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 64
- term
- Nausea
Complete source fields
- description
- Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Safety analysis set evaluated. All-Cause Mortality:total number of deaths during study,from first dose of study drug and up to end of study are reported for all treated participants and included deaths which occurred after 90 days post last dose of study drug.
- event Groups
- deaths Num Affected
- 43
- deaths Num At Risk
- 123
- description
- BCMA-naïve participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
- id
- EG000
- other Num Affected
- 123
- other Num At Risk
- 123
- serious Num Affected
- 84
- serious Num At Risk
- 123
- title
- Cohort A
- deaths Num Affected
- 30
- deaths Num At Risk
- 64
- description
- BCMA-exposed participants received subcutaneous elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 and 32 mg on Cycle 1 Day 4 followed by 76 mg weekly thereafter starting from Cycle 1 Day 8.
- id
- EG001
- other Num Affected
- 63
- other Num At Risk
- 64
- serious Num Affected
- 44
- serious Num At Risk
- 64
- title
- Cohort B
- frequency Threshold
- 5
- other Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 58
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 39
- num At Risk
- 64
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 17
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 12
- num At Risk
- 64
- term
- Leukopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 32
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 22
- num At Risk
- 64
- term
- Lymphopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 59
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 24
- num At Risk
- 64
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 36
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 27
- num At Risk
- 64
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 64
- term
- Sinus tachycardia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 64
- term
- Tachycardia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 64
- term
- Abdominal pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 11
- num At Risk
- 64
- term
- Constipation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 47
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 18
- num At Risk
- 64
- term
- Diarrhoea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 64
- term
- Dry mouth
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 32
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 9
- num At Risk
- 64
- term
- Nausea
- serious Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 5
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 3
- num At Risk
- 64
- term
- Anemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 64
- term
- Aplasia pure red cell
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 64
- term
- Febrile neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 64
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 64
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 64
- term
- Angina pectoris
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 64
- term
- Atrial fibrillation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 64
- term
- Cardiac failure acute
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 64
- term
- Cardio-respiratory arrest
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 64
- term
- Cardiogenic shock
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 64
- term
- Cardiopulmonary failure
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA v25.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 123
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 64
- term
- Sinus bradycardia
- time Frame
- From the date of first dose up to 90 days after last dose or start of new anticancer therapy whichever occurred first (up to approximately 20.14 months)
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