TriangleNCT00833833 · OUTCOME
Phase 2: Time to Response as of the 01 April 2011 Cut-off
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- weeks
- Interval / dispersion
- Full Range
- Time frame
- up to 70 weeks
What was measured
Time to myeloma response is defined as the time from randomization to the time the response criteria for complete response (CR) or partial response (PR) are first met. Response was assessed by the Independent Response Adjudication Committee (IRAC) using European Group for Blood and Bone Marrow Transplant (EBMT) criteria as described previously. Data collection is ongoing and future data results will be included as available.
Analysis population: Responders (participants achieving CR or PR) from ITT population. Data collection is ongoing and future data results will be included as available.
Groups in this outcome
Phase 2: Pomalidomide + Dexamethasone
Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
Phase 2: Pomalidomide
4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
| Group | Source count |
|---|---|
| Phase 2: Pomalidomide + Dexamethasone | 34 |
| Phase 2: Pomalidomide | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: Pomalidomide + Dexamethasone | 8.1 | Not reported | 3.7 | 45.1 | Not reported |
| Phase 2: Pomalidomide | 8.9 | Not reported | 4.1 | 49.6 | Not reported |
Source statistical analyses
- ci Pct Value
- 95
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.070
- statistical Method
- Wilcoxon (Mann-Whitney)
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Pct Value
- 95
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.070
- statistical Method
- Wilcoxon (Mann-Whitney)
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.7
- upper Limit
- 45.1
- value
- 8.1
- group Id
- OG001
- lower Limit
- 4.1
- upper Limit
- 49.6
- value
- 8.9
- denoms
- counts
- group Id
- OG000
- value
- 34
- group Id
- OG001
- value
- 10
- units
- Participants
- description
- Time to myeloma response is defined as the time from randomization to the time the response criteria for complete response (CR) or partial response (PR) are first met. Response was assessed by the Independent Response Adjudication Committee (IRAC) using European Group for Blood and Bone Marrow Transplant (EBMT) criteria as described previously. Data collection is ongoing and future data results will be included as available.
- dispersion Type
- Full Range
- groups
- description
- Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
- id
- OG000
- title
- Phase 2: Pomalidomide + Dexamethasone
- description
- 4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
- id
- OG001
- title
- Phase 2: Pomalidomide
- param Type
- MEDIAN
- population Description
- Responders (participants achieving CR or PR) from ITT population. Data collection is ongoing and future data results will be included as available.
- reporting Status
- POSTED
- time Frame
- up to 70 weeks
- title
- Phase 2: Time to Response as of the 01 April 2011 Cut-off
- type
- SECONDARY
- unit Of Measure
- weeks
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice