NCT02412878 · OUTCOME
Number of Participants With Adverse Events (AEs)
Once-weekly Versus Twice-weekly Carfilzomib in Combination With Dexamethasone in Adults With Relapsed and Refractory Multiple Myeloma · Source last updated 2022-09-23
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose of study drug up to 30 days after last dose, up to the end of study; median (minimum, maximum) duration of treatment was 29.1 (0.1, 156.3) weeks and 38.0 (0.1, 158.3) weeks in each treatment group respectively.
What was measured
The severity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03, where where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening; Grade 5 = Fatal.
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: All participants who received at least 1 dose of study drug
Groups in this outcome
Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter).
Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone
Participants received carfilzomib administered by IV infusion on days 1, 8, and 15 of each 28-day cycle (20 mg/m² on day 1 of cycle 1 and 70 mg/m² thereafter).
Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
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 |
|---|
| Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone | 235 |
|---|
| Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone | 238 |
|---|
Reported measurements
Adverse events (AEs)
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone | 230 | Not reported | Not reported | Not reported | Not reported |
|---|
| Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone | 233 | Not reported | Not reported | Not reported | Not reported |
|---|
Adverse events Grade ≥ 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone | 152 | Not reported | Not reported | Not reported | Not reported |
|---|
| Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone | 181 | Not reported | Not reported | Not reported | Not reported |
|---|
Serious adverse events
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone | 102 | Not reported | Not reported | Not reported | Not reported |
|---|
| Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone | 118 | Not reported | Not reported | Not reported | Not reported |
|---|
AEs leading to discontinuation of carfilzomib
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone | 29 | Not reported | Not reported | Not reported | Not reported |
|---|
| Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone | 35 | Not reported | Not reported | Not reported | Not reported |
|---|
AEs leading to discontinuation of dexamethasone
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone | 31 | Not reported | Not reported | Not reported | Not reported |
|---|
| Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone | 40 | Not reported | Not reported | Not reported | Not reported |
|---|
Fatal adverse events
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
| Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone | 21 | 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 |
|---|
| Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone | 176 | Not reported | Not reported | Not reported | Not reported |
|---|
| Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone | 180 | Not reported | Not reported | Not reported | Not reported |
|---|
Treatment-related adverse events Grade ≥ 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone | 82 | Not reported | Not reported | Not reported | Not reported |
|---|
| Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone | 108 | Not reported | Not reported | Not reported | Not reported |
|---|
Serious treatment-related adverse events
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone | 31 | Not reported | Not reported | Not reported | Not reported |
|---|
| Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone | 57 | Not reported | Not reported | Not reported | Not reported |
|---|
TRAE leading to discontinuation of carfilzomib
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
TRAEs leading to discontinuation of dexamethasone
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
| Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone | 29 | Not reported | Not reported | Not reported | Not reported |
|---|
Fatal treatment-related adverse events
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 230
- group Id
- OG001
- value
- 233
- title
- Adverse events (AEs)
- categories
- measurements
- group Id
- OG000
- value
- 152
- group Id
- OG001
- value
- 181
- title
- Adverse events Grade ≥ 3
- categories
- measurements
- group Id
- OG000
- value
- 102
- group Id
- OG001
- value
- 118
- title
- Serious adverse events
- categories
- measurements
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 35
- title
- AEs leading to discontinuation of carfilzomib
- categories
- measurements
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 40
- title
- AEs leading to discontinuation of dexamethasone
- categories
- measurements
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 21
- title
- Fatal adverse events
- categories
- measurements
- group Id
- OG000
- value
- 176
- group Id
- OG001
- value
- 180
- title
- Treatment-related adverse events (TRAEs)
- categories
- measurements
- group Id
- OG000
- value
- 82
- group Id
- OG001
- value
- 108
- title
- Treatment-related adverse events Grade ≥ 3
- categories
- measurements
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 57
- title
- Serious treatment-related adverse events
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 23
- title
- TRAE leading to discontinuation of carfilzomib
- categories
- measurements
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 29
- title
- TRAEs leading to discontinuation of dexamethasone
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- title
- Fatal treatment-related adverse events
- denoms
- counts
- group Id
- OG000
- value
- 235
- group Id
- OG001
- value
- 238
- units
- Participants
- description
- The severity of adverse events was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03, where where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening; Grade 5 = Fatal.
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 carfilzomib administered by intravenous (IV) infusion on days 1, 2, 8, 9, 15, and 16 of each 28-day cycle (20 mg/m² on days 1 and 2 of cycle 1 and 27 mg/m² thereafter).
Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
- id
- OG000
- title
- Twice-weekly Carfilzomib 20/27 mg/m² + Dexamethasone
- description
- Participants received carfilzomib administered by IV infusion on days 1, 8, and 15 of each 28-day cycle (20 mg/m² on day 1 of cycle 1 and 70 mg/m² thereafter).
Participants also received 40 mg dexamethasone IV or orally on days 1, 8, 15 and 22 for the first 8 cycles; starting with cycle 9, dexamethasone was administered only on days 1, 8, and 15.
- id
- OG001
- title
- Once-weekly Carfilzomib 20/70 mg/m² + Dexamethasone
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants who received at least 1 dose of study drug
- reporting Status
- POSTED
- time Frame
- From first dose of study drug up to 30 days after last dose, up to the end of study; median (minimum, maximum) duration of treatment was 29.1 (0.1, 156.3) weeks and 38.0 (0.1, 158.3) weeks in each treatment group respectively.
- title
- Number of Participants With Adverse Events (AEs)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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