TriangleNCT00530816 · OUTCOME
Progression-free Survival (PFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Patients were followed for up to 2 years after study discontinuation. The data cutoff for the analysis is 30 November 2010 for Part 1 and 22 April 2011 for Part 2. Median follow-up time was 13.4 months for Part 1 and 11.5 months in Part 2.
What was measured
Progression-free Survival (PFS) is defined as the time from start of treatment to IRC determined disease progression or death due to any cause. Patients who were lost to follow-up prior to documentation of disease progression and patients who were alive without disease progression before a data analysis cut-off date were censored at the last disease assessment. Median PFS was estimated using the Kaplan-Meier method.
Analysis population: Response Evaluable Population
Groups in this outcome
Part 1: Carfilzomib 20 mg/m²
Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
Part 2: Carfilzomib 20 mg/m²
Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
Part 2: Carfilzomib 20/27 mg/m²
Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
| Group | Source count |
|---|---|
| Part 1: Carfilzomib 20 mg/m² | 35 |
| Part 2: Carfilzomib 20 mg/m² | 59 |
| Part 2: Carfilzomib 20/27 mg/m² | 67 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Carfilzomib 20 mg/m² | 4.6 | Not reported | 2.1 | 11.1 | Not reported |
| Part 2: Carfilzomib 20 mg/m² | 8.2 | Not reported | 6.0 | 12.3 | Not reported |
| Part 2: Carfilzomib 20/27 mg/m² | NA | Not reported | 11.3 | NA | Could not be estimated due to the low number of events |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.1
- upper Limit
- 11.1
- value
- 4.6
- group Id
- OG001
- lower Limit
- 6.0
- upper Limit
- 12.3
- value
- 8.2
- comment
- Could not be estimated due to the low number of events
- group Id
- OG002
- lower Limit
- 11.3
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 35
- group Id
- OG001
- value
- 59
- group Id
- OG002
- value
- 67
- units
- Participants
- description
- Progression-free Survival (PFS) is defined as the time from start of treatment to IRC determined disease progression or death due to any cause. Patients who were lost to follow-up prior to documentation of disease progression and patients who were alive without disease progression before a data analysis cut-off date were censored at the last disease assessment. Median PFS was estimated using the Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
- id
- OG000
- title
- Part 1: Carfilzomib 20 mg/m²
- description
- Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
- id
- OG001
- title
- Part 2: Carfilzomib 20 mg/m²
- description
- Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
- id
- OG002
- title
- Part 2: Carfilzomib 20/27 mg/m²
- param Type
- MEDIAN
- population Description
- Response Evaluable Population
- reporting Status
- POSTED
- time Frame
- Patients were followed for up to 2 years after study discontinuation. The data cutoff for the analysis is 30 November 2010 for Part 1 and 22 April 2011 for Part 2. Median follow-up time was 13.4 months for Part 1 and 11.5 months in Part 2.
- title
- Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice