TriangleNCT00946647 · OUTCOME
Clinical Response Other Than Composite Clinical Response for Myeloid Dysplastic Syndromes(MDS)/Chronic Myelomonocytic Leukemia (CMML) Patients Per Investigator (Phase Llb)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 48 months
What was measured
This is the best overall response as measured by Clinical response. Clinical response is defined as having complete remission (CR), bone marrow complete remission (BM-CR), partial remission or hematologic improvement (HI) as defined by the International Working Group (IWG) response criteria.
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 | 31 |
| 5-Azacytidine | 29 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Panobinostat + 5-Azacytidine | 41.9 | Not reported | 24.5 | 60.9 | Not reported |
| 5-Azacytidine | 41.4 | Not reported | 23.5 | 61.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 24.5
- upper Limit
- 60.9
- value
- 41.9
- group Id
- OG001
- lower Limit
- 23.5
- upper Limit
- 61.1
- value
- 41.4
- denoms
- counts
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 29
- units
- Participants
- description
- This is the best overall response as measured by Clinical response. Clinical response is defined as having complete remission (CR), bone marrow complete remission (BM-CR), partial remission or hematologic improvement (HI) as defined by the International Working Group (IWG) response criteria.
- 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
- NUMBER
- 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
- Clinical Response Other Than Composite Clinical Response for Myeloid Dysplastic Syndromes(MDS)/Chronic Myelomonocytic Leukemia (CMML) Patients Per Investigator (Phase Llb)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice