TriangleNCT00511238 · OUTCOME
Time to Progression (A1 Only)
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
- Response assessments same as described in primary outcome measure
What was measured
Time to progression (TTP) is defined as the time from the study entry (first dose of carfilzomib) to disease progression.
Analysis population: Response-Evaluable Population: 1. had measurable disease at Baseline 2. received at least 1 dose of carfilzomib 3. underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib
Groups in this outcome
Carfilzomib (A1)
In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles. Assessed by Independent Review Committee
| Group | Source count |
|---|---|
| Carfilzomib (A1) | 257 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Carfilzomib (A1) | 3.9 | Not reported | 2.8 | 4.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.8
- upper Limit
- 4.8
- value
- 3.9
- denoms
- counts
- group Id
- OG000
- value
- 257
- units
- Participants
- description
- Time to progression (TTP) is defined as the time from the study entry (first dose of carfilzomib) to disease progression.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles. Assessed by Independent Review Committee
- id
- OG000
- title
- Carfilzomib (A1)
- param Type
- MEDIAN
- population Description
- Response-Evaluable Population: 1. had measurable disease at Baseline 2. received at least 1 dose of carfilzomib 3. underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib
- reporting Status
- POSTED
- time Frame
- Response assessments same as described in primary outcome measure
- title
- Time to Progression (A1 Only)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice