TriangleNCT00530816 · OUTCOME
Time to Progression (TTP)
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
Time to Progression is defined as the time from the start of treatment to IRC-determined disease progression. Patients who were lost to follow-up prior to documentation of disease progression, or who died before documentation of disease progression or who were alive and did not have documentation of disease progression before the data analysis cut-off date were censored at the last disease assessment. Median TTP 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 | 1.9 | 11.1 | Not reported |
| Part 2: Carfilzomib 20 mg/m² | 8.3 | 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
- 1.9
- upper Limit
- 11.1
- value
- 4.6
- group Id
- OG001
- lower Limit
- 6.0
- upper Limit
- 12.3
- value
- 8.3
- 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
- Time to Progression is defined as the time from the start of treatment to IRC-determined disease progression. Patients who were lost to follow-up prior to documentation of disease progression, or who died before documentation of disease progression or who were alive and did not have documentation of disease progression before the data analysis cut-off date were censored at the last disease assessment. Median TTP 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
- Time to Progression (TTP)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice