TriangleNCT01980589 · 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
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose of study drug until 30 days after last dose; median duration of treatment was 31 weeks.
What was measured
Adverse events (AEs) were graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 and using the following scale: Grade 1 = Mild, Grade 3 = Moderate; Grade 3 = Severe, Grade 4 = Life-threatening; Grade 5 = Fatal.
Analysis population: Safety population
Groups in this outcome
Carfilzomib 36 mg/m²
Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
Carfilzomib 45 mg/m²
Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
Carfilzomib 56 mg/m²
Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
| Group | Source count |
|---|---|
| Carfilzomib 36 mg/m² | 3 |
| Carfilzomib 45 mg/m² | 3 |
| Carfilzomib 56 mg/m² | 16 |
Reported measurements
Any adverse event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib 36 mg/m² | 3 | Not reported | Not reported | Not reported | Not reported |
| Carfilzomib 45 mg/m² | 3 | Not reported | Not reported | Not reported | Not reported |
| Carfilzomib 56 mg/m² | 16 | Not reported | Not reported | Not reported | Not reported |
Adverse event ≥ Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib 36 mg/m² | 3 | Not reported | Not reported | Not reported | Not reported |
| Carfilzomib 45 mg/m² | 3 | Not reported | Not reported | Not reported | Not reported |
| Carfilzomib 56 mg/m² | 10 | Not reported | Not reported | Not reported | Not reported |
Serious adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib 36 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| Carfilzomib 45 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| Carfilzomib 56 mg/m² | 5 | Not reported | Not reported | Not reported | Not reported |
AE leading to discontinuation of study drug
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib 36 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| Carfilzomib 45 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| Carfilzomib 56 mg/m² | 4 | Not reported | Not reported | Not reported | Not reported |
Fatal adverse events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib 36 mg/m² | 0 | Not reported | Not reported | Not reported | Not reported |
| Carfilzomib 45 mg/m² | 1 | Not reported | Not reported | Not reported | Not reported |
| Carfilzomib 56 mg/m² | 0 | 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
- 16
- title
- Any adverse event
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 10
- title
- Adverse event ≥ Grade 3
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 5
- title
- Serious adverse events
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 4
- title
- AE leading to discontinuation of study drug
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- title
- Fatal adverse events
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 16
- units
- Participants
- description
- Adverse events (AEs) were graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 and using the following scale: Grade 1 = Mild, Grade 3 = Moderate; Grade 3 = Severe, Grade 4 = Life-threatening; Grade 5 = Fatal.
- groups
- description
- Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
- id
- OG000
- title
- Carfilzomib 36 mg/m²
- description
- Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
- id
- OG001
- title
- Carfilzomib 45 mg/m²
- description
- Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
- id
- OG002
- title
- Carfilzomib 56 mg/m²
- param Type
- NUMBER
- population Description
- Safety population
- reporting Status
- POSTED
- time Frame
- From first dose of study drug until 30 days after last dose; median duration of treatment was 31 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