TriangleNCT00530816 · OUTCOME
Overall Survival (OS)
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 19 November 2012 for Part 1 and 07 January 2013 for Part 2. Median follow-up time was 19.1 months for Part 1 and 35.9 months in Part 2.
What was measured
Overall Survival is defined as the time from the start of study treatment to date of death due to any cause. Patients who were alive or lost to follow-up as of the data analysis cut-off date for the final OS analysis were censored at the date the patient was last known to be alive. Median OS was estimated using the Kaplan-Meier method.
Analysis population: Safety Population includes all patients enrolled on study and who received at least 1 dose of carfilzomib.
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 | 70 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Carfilzomib 20 mg/m² | 45.6 | Not reported | 28.4 | NA | Could not be estimated due to the low number of events |
| Part 2: Carfilzomib 20 mg/m² | NA | Not reported | 33.4 | NA | Could not be estimated due to the low number of events |
| Part 2: Carfilzomib 20/27 mg/m² | 37.3 | Not reported | 27.1 | NA | Could not be estimated due to the low number of events |
Complete source fields
- classes
- categories
- measurements
- comment
- Could not be estimated due to the low number of events
- group Id
- OG000
- lower Limit
- 28.4
- upper Limit
- NA
- value
- 45.6
- comment
- Could not be estimated due to the low number of events
- group Id
- OG001
- lower Limit
- 33.4
- upper Limit
- NA
- value
- NA
- comment
- Could not be estimated due to the low number of events
- group Id
- OG002
- lower Limit
- 27.1
- upper Limit
- NA
- value
- 37.3
- denoms
- counts
- group Id
- OG000
- value
- 35
- group Id
- OG001
- value
- 59
- group Id
- OG002
- value
- 70
- units
- Participants
- description
- Overall Survival is defined as the time from the start of study treatment to date of death due to any cause. Patients who were alive or lost to follow-up as of the data analysis cut-off date for the final OS analysis were censored at the date the patient was last known to be alive. Median OS 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
- Safety Population includes all patients enrolled on study and who received at least 1 dose of carfilzomib.
- reporting Status
- POSTED
- time Frame
- Patients were followed for up to 2 years after study discontinuation. The data cutoff for the analysis is 19 November 2012 for Part 1 and 07 January 2013 for Part 2. Median follow-up time was 19.1 months for Part 1 and 35.9 months in Part 2.
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice