TriangleNCT02367456 · OUTCOME
Percentage of Participants Achieving Complete Remission (CR) in the AML and MDS Cohorts
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
- maximum of 23 months in AML cohort and 34 months in MDS cohort
What was measured
Percentage of participants achieving CR as defined by the 2017 European Leukemia Net (ELN) Response Criteria for all participants with AML and modified International Working Group (IWG) criteria (2006) for all participants with MDS in the expansion cohorts. For AML cohort, CR was defined as neutrophils ≥ 1 x 10\^9/L, platelets ≥ 1 x 10\^11/L, percentage of bone marrow blasts (BMB) \<5% with no peripheral blasts and no blasts with Auer rods, no extramedullary disease (EMD), and transfusion independent. For MDS cohort, CR was defined as having responses of hemoglobin ≥11 g/dL, neutrophils ≥1 x 10\^9/L, platelets ≥1 x 10\^11/L, percentage of blasts = 0%, percentage of BMB≤5%, and normal maturation of all cell lines (note if has persistent dysplasia), and all responses must last at least 4 weeks.
Analysis population: The full analysis population included all participants who received at least 1 dose of any study treatment.
Groups in this outcome
AML Cohort
Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.
MDS Cohort
Participants received SC or IV administration of azacitidine with a starting dose of 75 mg/m2/day for 7 days every 28 days, and received daily oral administration of glasdegib at home with a starting dose of 100 mg QD.
| Group | Source count |
|---|---|
| AML Cohort | 30 |
| MDS Cohort | 30 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AML Cohort | 20.0 | Not reported | 7.7 | 38.6 | Not reported |
| MDS Cohort | 13.3 | Not reported | 3.8 | 30.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.7
- upper Limit
- 38.6
- value
- 20.0
- group Id
- OG001
- lower Limit
- 3.8
- upper Limit
- 30.7
- value
- 13.3
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 30
- units
- Participants
- description
- Percentage of participants achieving CR as defined by the 2017 European Leukemia Net (ELN) Response Criteria for all participants with AML and modified International Working Group (IWG) criteria (2006) for all participants with MDS in the expansion cohorts. For AML cohort, CR was defined as neutrophils ≥ 1 x 10\^9/L, platelets ≥ 1 x 10\^11/L, percentage of bone marrow blasts (BMB) \<5% with no peripheral blasts and no blasts with Auer rods, no extramedullary disease (EMD), and transfusion independent. For MDS cohort, CR was defined as having responses of hemoglobin ≥11 g/dL, neutrophils ≥1 x 10\^9/L, platelets ≥1 x 10\^11/L, percentage of blasts = 0%, percentage of BMB≤5%, and normal maturation of all cell lines (note if has persistent dysplasia), and all responses must last at least 4 weeks.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received SC or IV administration of azacitidine at the starting dose of 75 mg/m2/day for 7 days every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD.
- id
- OG000
- title
- AML Cohort
- description
- Participants received SC or IV administration of azacitidine with a starting dose of 75 mg/m2/day for 7 days every 28 days, and received daily oral administration of glasdegib at home with a starting dose of 100 mg QD.
- id
- OG001
- title
- MDS Cohort
- param Type
- NUMBER
- population Description
- The full analysis population included all participants who received at least 1 dose of any study treatment.
- reporting Status
- POSTED
- time Frame
- maximum of 23 months in AML cohort and 34 months in MDS cohort
- title
- Percentage of Participants Achieving Complete Remission (CR) in the AML and MDS Cohorts
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice