NCT04700176 · 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
- Adverse events are captured from time of consent through 30 days after the last dose of study drug, approximately 8 months
- Other-event reporting threshold
- 0%
Cohort B was not enrolled
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A) | 1 / 1 | 1 / 1 | 0 / 1 |
| Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B) | 0 / 0 | 0 / 0 | 0 / 0 |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- Fever
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- Febrile Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- RSV
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- Brain Fogginess
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- Constipation Intermittent
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- COVID-19
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- Dry Skin
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- Headache
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- Hyponatremia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- Nasal Congestion
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- Productive Cough
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- RSV
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- Thrombocytopenia
Complete source fields
- description
- Cohort B was not enrolled
- event Groups
- deaths Num Affected
- 0
- deaths Num At Risk
- 1
- description
- Patients with relapsed or refractory multiple myeloma who have progressed on the combination of Dara + Len + Dex (Cohort A) to be treated with a combination of Dara + Pom + Dex + ATRA (All-Transretinoic Acid) Daratumumab: During 28-day treatment cycles, patients will receive Dara 16 mg/kg intravenously (IV) at their current dose upon enrollment onto the study depending on their cycle. They will receive Dara depending on the cycle they are in. If they are on cycles 1-2 then they will receive Dara 16 mg/kg IV on days 1,8,15,22; if they are on cycles 3-6 they will receive Dara 16 mg/kg on days 1 and 15; and if they are on cycle 7 or beyond they will receive Dara 16 mg/kg on day 1. Pomalidomide: Pomalidomide will be administered at the patient's currently tolerated dose (4,3, or 2 mg po daily) on days 1-21 All-trans retinoic acid: ATRA will be administered in a divided dose of twice daily as an oral formulation at 45mg/m2/day for 3 days. The first administration of ATRA will be given in the morning, two days before the scheduled Dara infusion. The last administration of ATRA will be given in the evening of the day that Dara was administered Dexamethasone: Dexamethasone will be administered at 40 mg once weekly on days 1,8,15 for patients 75 years old and younger and at 20 mg once weekly on days 1,8,15 for patients older than 75.
- id
- EG000
- other Num Affected
- 1
- other Num At Risk
- 1
- serious Num Affected
- 1
- serious Num At Risk
- 1
- title
- Progressed on Daratumumab + Lenalidomide + Dexamethasone (Cohort A)
- deaths Num Affected
- 0
- deaths Num At Risk
- 0
- description
- Patients with relapsed or refractory multiple myeloma who have progressed on the combination of Dara + Pom + Dex (Cohort B) to be treated with a combination of Dara + Pom + Dex + ATRA (All-Transretinoic Acid) Daratumumab: During 28-day treatment cycles, patients will receive Dara 16 mg/kg intravenously (IV) at their current dose upon enrollment onto the study depending on their cycle. They will receive Dara depending on the cycle they are in. If they are on cycles 1-2 then they will receive Dara 16 mg/kg IV on days 1,8,15,22; if they are on cycles 3-6 they will receive Dara 16 mg/kg on days 1 and 15; and if they are on cycle 7 or beyond they will receive Dara 16 mg/kg on day 1. Pomalidomide: Pomalidomide will be administered at the patient's currently tolerated dose (4,3, or 2 mg po daily) on days 1-21 All-trans retinoic acid: ATRA will be administered in a divided dose of twice daily as an oral formulation at 45mg/m2/day for 3 days. The first administration of ATRA will be given in the morning, two days before the scheduled Dara infusion. The last administration of ATRA will be given in the evening of the day that Dara was administered Dexamethasone: Dexamethasone will be administered at 40 mg once weekly on days 1,8,15 for patients 75 years old and younger and at 20 mg once weekly on days 1,8,15 for patients older than 75.
- id
- EG001
- other Num Affected
- 0
- other Num At Risk
- 0
- serious Num Affected
- 0
- serious Num At Risk
- 0
- title
- Progressed on Daratumumab + Pomalidomide + Dexamethasone (Cohort B)
- frequency Threshold
- 0
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- Brain Fogginess
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- Constipation Intermittent
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- COVID-19
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Skin and subcutaneous tissue disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- Dry Skin
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Nervous system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- Headache
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Metabolism and nutrition disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 2
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- Hyponatremia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- Nasal Congestion
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 7
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Respiratory, thoracic and mediastinal disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- Productive Cough
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- RSV
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- Thrombocytopenia
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Investigations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- Fever
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- Febrile Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Infections and infestations
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 1
- num Events
- 1
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 0
- num Events
- 0
- term
- RSV
- time Frame
- Adverse events are captured from time of consent through 30 days after the last dose of study drug, approximately 8 months
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Preserved source evidence · Not medical advice
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