TriangleNCT00946647 · OUTCOME
Clinical Response Other Than Composite Clinical Response for Acute Myelogenous Leukemia (AML) 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), complete remission with incomplete blood count recovery (CRi) or partial remission 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 | 9 |
| 5-Azacytidine | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Panobinostat + 5-Azacytidine | 22.2 | Not reported | 2.8 | 60.0 | Not reported |
| 5-Azacytidine | 30.8 | Not reported | 9.1 | 61.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.8
- upper Limit
- 60.0
- value
- 22.2
- group Id
- OG001
- lower Limit
- 9.1
- upper Limit
- 61.4
- value
- 30.8
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 13
- units
- Participants
- description
- This is the best overall response as measured by Clinical response. Clinical response is defined as having complete remission (CR), complete remission with incomplete blood count recovery (CRi) or partial remission 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 Acute Myelogenous Leukemia (AML) 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