TriangleNCT00946647 · OUTCOME
Hematologic Improvement (HI) 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
Hematologic response consists of Erythroid response (HI-E), Platelet response (HI-P) and Neutrophil response (HI-N). HI-E: Hgb increase by ≥ 1.5 g/dL over pretreatment \& relevant reduction of units of RBC transfusions by an absolute number of at least 4 units of PRBCs/8 weeks compared with the pretreatment transfusion number in the previous 8 weeks. Only RBC transfusions given for a Hgb of ≤ 9.0 g/dL pretreatment will count in the RBC transfusion response evaluation. HI-P: Absolute increase of ≥ 30 x 109/L over pretreatment or patients starting with ≥ 20 x 109/L platelets OR increase from \<20 x 109/L at pretreatment to \> 20 x 109/L and by at least 100%. HI-N: At least 100% increase and an absolute increase \> 0.5 x 109/L over pretreatment value.
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
Erythroid response (HI-E)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Panobinostat + 5-Azacytidine | 25.8 | Not reported | 11.9 | 44.6 | Not reported |
| 5-Azacytidine | 31.0 | Not reported | 15.3 | 50.8 | Not reported |
Platelet response (HI-P)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Panobinostat + 5-Azacytidine | 35.5 | Not reported | 19.2 | 54.6 | Not reported |
| 5-Azacytidine | 24.1 | Not reported | 10.3 | 43.5 | Not reported |
Neutrophil response (HI-N)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Panobinostat + 5-Azacytidine | 19.4 | Not reported | 7.5 | 37.5 | Not reported |
| 5-Azacytidine | 13.8 | Not reported | 3.9 | 31.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.9
- upper Limit
- 44.6
- value
- 25.8
- group Id
- OG001
- lower Limit
- 15.3
- upper Limit
- 50.8
- value
- 31.0
- title
- Erythroid response (HI-E)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19.2
- upper Limit
- 54.6
- value
- 35.5
- group Id
- OG001
- lower Limit
- 10.3
- upper Limit
- 43.5
- value
- 24.1
- title
- Platelet response (HI-P)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.5
- upper Limit
- 37.5
- value
- 19.4
- group Id
- OG001
- lower Limit
- 3.9
- upper Limit
- 31.7
- value
- 13.8
- title
- Neutrophil response (HI-N)
- denoms
- counts
- group Id
- OG000
- value
- 31
- group Id
- OG001
- value
- 29
- units
- Participants
- description
- Hematologic response consists of Erythroid response (HI-E), Platelet response (HI-P) and Neutrophil response (HI-N). HI-E: Hgb increase by ≥ 1.5 g/dL over pretreatment \& relevant reduction of units of RBC transfusions by an absolute number of at least 4 units of PRBCs/8 weeks compared with the pretreatment transfusion number in the previous 8 weeks. Only RBC transfusions given for a Hgb of ≤ 9.0 g/dL pretreatment will count in the RBC transfusion response evaluation. HI-P: Absolute increase of ≥ 30 x 109/L over pretreatment or patients starting with ≥ 20 x 109/L platelets OR increase from \<20 x 109/L at pretreatment to \> 20 x 109/L and by at least 100%. HI-N: At least 100% increase and an absolute increase \> 0.5 x 109/L over pretreatment value.
- 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
- Hematologic Improvement (HI) for Myeloid Dysplastic Syndromes(MDS)/Chronic Myelomonocytic Leukemia (CMML) Patients Per Investigator (Phase Llb)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice