TriangleNCT00056160 · OUTCOME
Time to Tumor Progression (TTP)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Weeks
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 60 weeks (median Time To Progression of CC-5013/Dex treatment group)
What was measured
Time to progression (TTP) was calculated as the time from randomization to the first documentation of progressive disease based on the myeloma response determination criteria developed by Bladé et. al., Br J Haematol 1998; 102:1115-1123.
Analysis population: Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.
Groups in this outcome
CC-5013/Dex
CC-5013 (lenalidomide) plus oral high-dose dexamethasone
Placebo/Dex
Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
| Group | Source count |
|---|---|
| CC-5013/Dex | 177 |
| Placebo/Dex | 176 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CC-5013/Dex | 60.1 | Not reported | 41.1 | 80.0 | Not reported |
| Placebo/Dex | 20.1 | Not reported | 16.1 | 21.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 41.1
- upper Limit
- 80.0
- value
- 60.1
- group Id
- OG001
- lower Limit
- 16.1
- upper Limit
- 21.1
- value
- 20.1
- denoms
- counts
- group Id
- OG000
- value
- 177
- group Id
- OG001
- value
- 176
- units
- Participants
- description
- Time to progression (TTP) was calculated as the time from randomization to the first documentation of progressive disease based on the myeloma response determination criteria developed by Bladé et. al., Br J Haematol 1998; 102:1115-1123.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- CC-5013 (lenalidomide) plus oral high-dose dexamethasone
- id
- OG000
- title
- CC-5013/Dex
- description
- Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
- id
- OG001
- title
- Placebo/Dex
- param Type
- MEDIAN
- population Description
- Analysis conducted on the Intent-To-Treat (ITT) Population. The ITT Population was defined as all subjects randomized.
- reporting Status
- POSTED
- time Frame
- 60 weeks (median Time To Progression of CC-5013/Dex treatment group)
- title
- Time to Tumor Progression (TTP)
- type
- PRIMARY
- unit Of Measure
- Weeks
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice