NCT04181827 · 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 randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
- Other-event reporting threshold
- 5%
All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Arm A: Standard Therapy: PVd or DPd | 98 / 208 | 207 / 208 | 83 / 211 |
| Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel]) | 98 / 208 | 208 / 208 | 50 / 208 |
Serious adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 208
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 208
- term
- Cytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 208
- term
- Febrile Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 208
- term
- Hyperviscosity Syndrome
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 208
- term
- Immune Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 208
- term
- Lymphocytosis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 208
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 208
- term
- Pancytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 208
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 208
- term
- Acute Coronary Syndrome
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 208
- term
- Acute Myocardial Infarction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 208
- term
- Angina Pectoris
Other reported adverse events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 57
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 110
- num At Risk
- 208
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 27
- num At Risk
- 208
- term
- Leukopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 29
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 47
- num At Risk
- 208
- term
- Lymphopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 178
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 187
- num At Risk
- 208
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 67
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 113
- num At Risk
- 208
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 15
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 208
- term
- Cataract
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 208
- term
- Vision Blurred
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 208
- term
- Abdominal Pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 47
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 49
- num At Risk
- 208
- term
- Constipation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 65
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 69
- num At Risk
- 208
- term
- Diarrhoea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 43
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 101
- num At Risk
- 208
- term
- Nausea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 18
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 29
- num At Risk
- 208
- term
- Vomiting
Complete source fields
- description
- All-cause mortality was analyzed on all randomized participants. Serious and other AEs were analyzed in safety analysis set that included all participants who received any part of study treatment.
- event Groups
- deaths Num Affected
- 83
- deaths Num At Risk
- 211
- description
- Participants received either PVd or DPd as standard therapy. In pomalidomide, bortezomib and dexamethasone (PVd) treatment, participants received pomalidomide 4 milligrams (mg) orally (PO) on Days 1 to 14 in each treatment cycle; bortezomib 1.3 mg/meter square (m\^2) subcutaneous (SC) injection on Days 1, 4, 8 and 11 (Cycles 1 to 8) and on Days 1 and 8 (Cycle 9 onwards); and dexamethasone 20 mg (or 10 mg for participants aged greater than \[\>\] 75 years) PO on Days 1, 2, 4, 5, 8, 9, 11 and 12 (Cycles 1 to 8) and Days 1, 2, 8 and 9 (Cycle 9 onwards). Each treatment cycle of 21 days. In daratumumab, pomalidomide and dexamethasone (DPd) treatment, participants received daratumumab 1800 mg SC injection weekly on Days 1, 8, 15 and 22 (Cycle 1 and 2), every 2 weeks on Days 1 and 15 (Cycle 3 to 6) and every 4 weeks on Day 1 (Cycle 7 onwards); pomalidomide 4 mg PO on Days 1 to 21 (Cycle 1 onwards); dexamethasone 40 mg (or 20 mg for participants aged \>75 years) PO or intravenous(IV) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Participants continued to receive PVd or DPd until confirmed progressive disease (PD), death, intolerable toxicity, withdrawal of consent, or end of study, whichever occurred earlier.
- id
- EG000
- other Num Affected
- 207
- other Num At Risk
- 208
- serious Num Affected
- 98
- serious Num At Risk
- 208
- title
- Arm A: Standard Therapy: PVd or DPd
- deaths Num Affected
- 50
- deaths Num At Risk
- 208
- description
- Participants received at least one cycle of bridging therapy, that is PVd: pomalidomide 4 mg PO on Days 1 to 14, bortezomib 1.3 mg/m\^2 SC injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg (or 10 mg for participants aged \>75 years) PO on Days 1, 2, 4, 5, 8, 9, 11, and 12; each treatment cycle of 21 days. DPd: daratumumab SC 1800 mg (co-formulated with rHuPH20) weekly on Days 1, 8, 15, and 22, pomalidomide 4 mg PO on Days 1 to 21, and dexamethasone PO or IV 40 mg (or 20 mg for participants aged \>75 years) weekly during Cycle 1-2 on Days 1, 8, 15, and 22 or split with 20 mg on Days 1, 2, 8, 9, 15, 16, 22, and 23. Each treatment cycle of 28 days. Additional cycles of bridging therapy was considered based on participant's clinical status and timing of availability of JNJ-68284528 (cilta-cel). Followed by bridging therapy, participants received conditioning regimen: cyclophosphamide 300 mg/m\^2 IV and fludarabine 30 mg/m\^2 IV daily, for 3 days on chimeric antigen receptor T cells (CAR-T) Day -5, -4, -3 (prior to JNJ-68284528 infusion), followed by JNJ-68284528 (cilta-cel) infusion 0.75\*10\^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (kg) 5 to 7 days after the start of conditioning regimen.
- id
- EG001
- other Num Affected
- 208
- other Num At Risk
- 208
- serious Num Affected
- 98
- serious Num At Risk
- 208
- title
- Arm B: JNJ-68284528 (Ciltacabtagene Autoleucel [Cilta-cel])
- frequency Threshold
- 5
- other Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 57
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 110
- num At Risk
- 208
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 27
- num At Risk
- 208
- term
- Leukopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 29
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 47
- num At Risk
- 208
- term
- Lymphopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 178
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 187
- num At Risk
- 208
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 67
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 113
- num At Risk
- 208
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 15
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 208
- term
- Cataract
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 208
- term
- Vision Blurred
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 10
- num At Risk
- 208
- term
- Abdominal Pain
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 47
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 49
- num At Risk
- 208
- term
- Constipation
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 65
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 69
- num At Risk
- 208
- term
- Diarrhoea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 43
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 101
- num At Risk
- 208
- term
- Nausea
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 18
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 29
- num At Risk
- 208
- term
- Vomiting
- serious Events
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 208
- term
- Anaemia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 208
- term
- Cytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 5
- num At Risk
- 208
- term
- Febrile Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 208
- term
- Hyperviscosity Syndrome
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 208
- term
- Immune Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 208
- term
- Lymphocytosis
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 4
- num At Risk
- 208
- term
- Neutropenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 208
- term
- Pancytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 208
- term
- Thrombocytopenia
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 0
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 1
- num At Risk
- 208
- term
- Acute Coronary Syndrome
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 208
- term
- Acute Myocardial Infarction
- assessment Type
- NON_SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA Version 26.1
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 208
- group Id
- EG001
- num Affected
- 0
- num At Risk
- 208
- term
- Angina Pectoris
- time Frame
- All-cause mortality: From randomization (Day 1) up to 3.9 years; SAEs/Other AEs: Arm A: From Cycle 1 Day 1 up to 45 months; Arm B: From Cycle 1 Day 1 up to 8 months
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Preserved source evidence · Not medical advice
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