NCT01818752 · OUTCOME
Number of Participants With Adverse Events
Phase 3 Study of Carfilzomib, Melphalan, Prednisone vs Bortezomib, Melphalan, Prednisone in Newly Diagnosed Multiple Myeloma · Source last updated 2019-08-26
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups.
What was measured
Adverse events (AEs)were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.03, where GRADE 1 = Mild; GRADE 2 = Moderate; GRADE 3 = Severe; GRADE 4 = Life-threatening; GRADE 5 = Fatal.
A serious adverse event is an adverse event that met 1 or more of the following criteria:
* Death
* Life-threatening
* Required inpatient hospitalization or prolongation of an existing hospitalization
* Resulted in persistent or significant disability/incapacity
* Congenital anomaly/birth defect
* Important medical event that jeopardized the participant and may have required medical or surgical intervention to prevent 1 of the outcomes listed above.
Treatment-related adverse events are adverse events considered related to at least 1 investigational product by the investigator, including those with unknown relationship.
Analysis population: Safety population
Groups in this outcome
Bortezomib, Melphalan, Prednisone
Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
Carfilzomib, Melphalan, Prednisone
Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Bortezomib, Melphalan, Prednisone | 470 |
|---|
| Carfilzomib, Melphalan, Prednisone | 474 |
|---|
Reported measurements
All adverse events
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bortezomib, Melphalan, Prednisone | 454 | Not reported | Not reported | Not reported | Not reported |
|---|
| Carfilzomib, Melphalan, Prednisone | 460 | Not reported | Not reported | Not reported | Not reported |
|---|
AEs ≥ grade 3
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bortezomib, Melphalan, Prednisone | 358 | Not reported | Not reported | Not reported | Not reported |
|---|
| Carfilzomib, Melphalan, Prednisone | 354 | Not reported | Not reported | Not reported | Not reported |
|---|
Serious adverse events
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bortezomib, Melphalan, Prednisone | 198 | Not reported | Not reported | Not reported | Not reported |
|---|
| Carfilzomib, Melphalan, Prednisone | 235 | Not reported | Not reported | Not reported | Not reported |
|---|
Leading to discontinuation of study drug
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bortezomib, Melphalan, Prednisone | 73 | Not reported | Not reported | Not reported | Not reported |
|---|
| Carfilzomib, Melphalan, Prednisone | 83 | Not reported | Not reported | Not reported | Not reported |
|---|
Fatal adverse events
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bortezomib, Melphalan, Prednisone | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
| Carfilzomib, Melphalan, Prednisone | 31 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment-related adverse events (TRAEs)
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bortezomib, Melphalan, Prednisone | 431 | Not reported | Not reported | Not reported | Not reported |
|---|
| Carfilzomib, Melphalan, Prednisone | 408 | Not reported | Not reported | Not reported | Not reported |
|---|
TRAEs ≥ grade 3
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bortezomib, Melphalan, Prednisone | 285 | Not reported | Not reported | Not reported | Not reported |
|---|
| Carfilzomib, Melphalan, Prednisone | 268 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment-related serious adverse events
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bortezomib, Melphalan, Prednisone | 102 | Not reported | Not reported | Not reported | Not reported |
|---|
| Carfilzomib, Melphalan, Prednisone | 136 | Not reported | Not reported | Not reported | Not reported |
|---|
TRAE leading to discontinuation of study drug
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bortezomib, Melphalan, Prednisone | 51 | Not reported | Not reported | Not reported | Not reported |
|---|
| Carfilzomib, Melphalan, Prednisone | 54 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment-related fatal adverse events
Values in participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Bortezomib, Melphalan, Prednisone | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Carfilzomib, Melphalan, Prednisone | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 454
- group Id
- OG001
- value
- 460
- title
- All adverse events
- categories
- measurements
- group Id
- OG000
- value
- 358
- group Id
- OG001
- value
- 354
- title
- AEs ≥ grade 3
- categories
- measurements
- group Id
- OG000
- value
- 198
- group Id
- OG001
- value
- 235
- title
- Serious adverse events
- categories
- measurements
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 83
- title
- Leading to discontinuation of study drug
- categories
- measurements
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 31
- title
- Fatal adverse events
- categories
- measurements
- group Id
- OG000
- value
- 431
- group Id
- OG001
- value
- 408
- title
- Treatment-related adverse events (TRAEs)
- categories
- measurements
- group Id
- OG000
- value
- 285
- group Id
- OG001
- value
- 268
- title
- TRAEs ≥ grade 3
- categories
- measurements
- group Id
- OG000
- value
- 102
- group Id
- OG001
- value
- 136
- title
- Treatment-related serious adverse events
- categories
- measurements
- group Id
- OG000
- value
- 51
- group Id
- OG001
- value
- 54
- title
- TRAE leading to discontinuation of study drug
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 10
- title
- Treatment-related fatal adverse events
- denoms
- counts
- group Id
- OG000
- value
- 470
- group Id
- OG001
- value
- 474
- units
- Participants
- description
- Adverse events (AEs)were graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.03, where GRADE 1 = Mild; GRADE 2 = Moderate; GRADE 3 = Severe; GRADE 4 = Life-threatening; GRADE 5 = Fatal.
A serious adverse event is an adverse event that met 1 or more of the following criteria:
* Death
* Life-threatening
* Required inpatient hospitalization or prolongation of an existing hospitalization
* Resulted in persistent or significant disability/incapacity
* Congenital anomaly/birth defect
* Important medical event that jeopardized the participant and may have required medical or surgical intervention to prevent 1 of the outcomes listed above.
Treatment-related adverse events are adverse events considered related to at least 1 investigational product by the investigator, including those with unknown relationship.
- groups
- description
- Participants received bortezomib in combination with melphalan and prednisone for nine 42-day cycles. Bortezomib was administered either IV or subcutaneously at 1.3 mg/m² during cycles 1 to 4 on days 1, 4, 8, 11, 22, 25, 29, and 32 followed by 1.3 mg/m² during cycles 5 to 9 on days 1, 8, 22, and 29. On days 1 to 4 of each cycle, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
- id
- OG000
- title
- Bortezomib, Melphalan, Prednisone
- description
- Participants received carfilzomib administered in combination with melphalan and prednisone for nine 42-day cycles. Carfilzomib was administered as an intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29, and 30 of each 42-day cycle. The carfilzomib dose was at 20 mg/m² on cycle 1, days 1 and 2 followed by 36 mg/m² thereafter. On days 1 to 4, melphalan was administered at 9 mg/m² and prednisone was administered at 60 mg/m².
- id
- OG001
- title
- Carfilzomib, Melphalan, Prednisone
- param Type
- NUMBER
- population Description
- Safety population
- reporting Status
- POSTED
- time Frame
- From the first dose of any study drug up to 30 days after the last dose of any study drug as of the data cut-off date of 15 July 2016; median duration of treatment was 52 weeks in both treatment groups.
- title
- Number of Participants With Adverse Events
- type
- SECONDARY
- unit Of Measure
- participants
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Preserved source evidence · Not medical advice
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