TriangleNCT00946647 · OUTCOME
Time to Progression (TTP) (Phase Llb)
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
- 48 months
What was measured
Time to progression (TTP) was defined as the time from the date of randomization to the date of the first documented PD per investigator's assessment or death due to study indication. Time to progression was analyzed by the Kaplan Meier method. Based on the Guidelines for Implementation of international working group (IWG) response criteria in AML, MDS and CMML according to Cheson 2003 and 2006.
Analysis population: Full analysis set: Consisted of all patients who were randomized to one of the two treatment arms
Groups in this outcome
Panobinostat + 5-Azacytidine
In phase II: Panobinostat : Rapid Phase II doses at 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15. In both phases, dose of 5-Azacytidine was 75 mg/m\^2, subcutaneously Daily for Day 1 to Day 7.
5-Azacytidine
The dose of 5-Aza was fixed at 75 mg/m2/day for 7 days in Week 1 of each cycle. 5-Aza was sourced locally, except in 4 countries (Hungary, Switzerland, UK, and Spain, for which a central purchase was used by Novartis. Dose of 5-Azacytidine : 75 mg/m\^2 subcutaneously daily from Day 1 to Day 7.
| Group | Source count |
|---|---|
| Panobinostat + 5-Azacytidine | 40 |
| 5-Azacytidine | 42 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Panobinostat + 5-Azacytidine | NA | Not reported | 11.1 | NA | NA - The follow-up was too short that the quantiles of the survival distribution could not be estimated. |
| 5-Azacytidine | 15.2 | Not reported | 11.0 | NA | NA - The follow-up was too short that the quantiles of the survival distribution could not be estimated. |
Complete source fields
- classes
- categories
- measurements
- comment
- NA - The follow-up was too short that the quantiles of the survival distribution could not be estimated.
- group Id
- OG000
- lower Limit
- 11.1
- upper Limit
- NA
- value
- NA
- comment
- NA - The follow-up was too short that the quantiles of the survival distribution could not be estimated.
- group Id
- OG001
- lower Limit
- 11.0
- upper Limit
- NA
- value
- 15.2
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 42
- units
- Participants
- description
- Time to progression (TTP) was defined as the time from the date of randomization to the date of the first documented PD per investigator's assessment or death due to study indication. Time to progression was analyzed by the Kaplan Meier method. Based on the Guidelines for Implementation of international working group (IWG) response criteria in AML, MDS and CMML according to Cheson 2003 and 2006.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- In phase II: Panobinostat : Rapid Phase II doses at 30 mg delivered orally at Day 3, Day 5, Day 8, Day 10, Day 12, Day 15. In both phases, dose of 5-Azacytidine was 75 mg/m\^2, subcutaneously Daily for Day 1 to Day 7.
- id
- OG000
- title
- Panobinostat + 5-Azacytidine
- description
- The dose of 5-Aza was fixed at 75 mg/m2/day for 7 days in Week 1 of each cycle. 5-Aza was sourced locally, except in 4 countries (Hungary, Switzerland, UK, and Spain, for which a central purchase was used by Novartis. Dose of 5-Azacytidine : 75 mg/m\^2 subcutaneously daily from Day 1 to Day 7.
- id
- OG001
- title
- 5-Azacytidine
- param Type
- MEDIAN
- population Description
- Full analysis set: Consisted of all patients who were randomized to one of the two treatment arms
- reporting Status
- POSTED
- time Frame
- 48 months
- title
- Time to Progression (TTP) (Phase Llb)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice