TriangleNCT01677858 · OUTCOME
Number of Participants With Adverse Events
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 the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
What was measured
Adverse events were graded using National Cancer Institute-Common Terminology Criteria for Adverse Events (version 4.03).
Analysis population: Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).
Groups in this outcome
Phase 1: Carfilzomib 45 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². 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.
Phase 1: Carfilzomib 56 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². 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.
Phase 1: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². 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.
Phase 1: Carfilzomib 88 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². 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.
Phase 2: Carfilzomib 70 mg/m²
Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². 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 | Source count |
|---|---|
| Phase 1: Carfilzomib 45 mg/m² | 3 |
| Phase 1: Carfilzomib 56 mg/m² | 3 |
| Phase 1: Carfilzomib 70 mg/m² | 15 |
| Phase 1: Carfilzomib 88 mg/m² | 6 |
| Phase 2: Carfilzomib 70 mg/m² | 89 |
Reported measurements
All adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Carfilzomib 45 mg/m² | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Carfilzomib 56 mg/m² | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Carfilzomib 70 mg/m² | 15 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Carfilzomib 88 mg/m² | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Carfilzomib 70 mg/m² | 89 | Not reported | Not reported | Not reported | Not reported |
Adverse events ≥ grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Carfilzomib 45 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Carfilzomib 56 mg/m² | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Carfilzomib 70 mg/m² | 9 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Carfilzomib 88 mg/m² | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Carfilzomib 70 mg/m² | 60 | Not reported | Not reported | Not reported | Not reported |
Serious adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Carfilzomib 45 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Carfilzomib 56 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Carfilzomib 70 mg/m² | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Carfilzomib 88 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Carfilzomib 70 mg/m² | 35 | Not reported | Not reported | Not reported | Not reported |
AE leading to discontinuation of carfilzomib & dex
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Carfilzomib 45 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Carfilzomib 56 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Carfilzomib 70 mg/m² | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Carfilzomib 88 mg/m² | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Carfilzomib 70 mg/m² | 14 | Not reported | Not reported | Not reported | Not reported |
AE leading to discontinuation of carfilzomib
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Carfilzomib 45 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Carfilzomib 56 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Carfilzomib 70 mg/m² | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Carfilzomib 88 mg/m² | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Carfilzomib 70 mg/m² | 14 | Not reported | Not reported | Not reported | Not reported |
Fatal adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Carfilzomib 45 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Carfilzomib 56 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Carfilzomib 70 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: Carfilzomib 88 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2: Carfilzomib 70 mg/m² | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 89
- title
- All adverse events
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 60
- title
- Adverse events ≥ grade 3
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 35
- title
- Serious adverse events
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 14
- title
- AE leading to discontinuation of carfilzomib & dex
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 14
- title
- AE leading to discontinuation of carfilzomib
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 5
- title
- Fatal adverse events
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 89
- units
- Participants
- description
- Adverse events were graded using National Cancer Institute-Common Terminology Criteria for Adverse Events (version 4.03).
- groups
- description
- Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 45 mg/m². 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
- Phase 1: Carfilzomib 45 mg/m²
- description
- Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 56 mg/m². 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
- Phase 1: Carfilzomib 56 mg/m²
- description
- Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². 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
- OG002
- title
- Phase 1: Carfilzomib 70 mg/m²
- description
- Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 88 mg/m². 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
- OG003
- title
- Phase 1: Carfilzomib 88 mg/m²
- description
- Participants received carfilzomib administered by intravenous (IV) infusion on days 1, 8 and 15 of each 28-day cycle. The carfilzomib dose was 20 mg/m² on day 1 of cycle 1; thereafter, subsequent carfilzomib dosing was 70 mg/m². 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
- OG004
- title
- Phase 2: Carfilzomib 70 mg/m²
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants who received at least 1 dose of any investigational product (carfilzomib or dexamethasone).
- reporting Status
- POSTED
- time Frame
- From the first day of study treatment and within 30 days of the last day of study treatment; median duration of treatment was 33.6 weeks.
- title
- Number of Participants With Adverse Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice