NCT02367456 · OUTCOME
Number of Participants With Disease-Specific Efficacy Measures in the MDS Cohort
A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients · Source last updated 2024-01-19
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- maximum of 34 months
What was measured
Number of participants with PR, mCR, SD, complete or partial cytogenetic response, and HI. PR: BMB \>5% and decreased by ≥50% (at least 4 weeks), meeting all CR criteria if abnormal before treatment except BMB. mCR: BMB ≤5% and decreased by ≥50%. SD: failure to achieve PR, no evidence of progression. Complete or partial cytogenic response: disappearance of chromosomal abnormality without new ones, or ≥ 50% reduction of chromosomal abnormality. HI: erythroid response (pretreatment \<11g/dL): hemoglobin increase by≥1.5 g/dL, relevant reduction of units of red blood cell transfusions by at least 4 transfusions/8 weeks compared to pretreatment transfusion number in previous 8 weeks; platelet response (pretreatment \<1x10\^11/L): increase of ≥30x10\^9/L if starting with \>20x10\^9/L, and increase from \<20x10\^9/L to \>20x10\^9/L and by at least 100%; neutrophil response (pretreatment \<1x10\^9/L): at least a 100% increase, absolute increase \>0.5x10\^9/L.
Analysis population: The full analysis population included all participants who received at least 1 dose of any study treatment.
Groups in this outcome
MDS 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.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| MDS Cohort | 30 |
|---|
Reported measurements
PR
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MDS Cohort | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
mCR
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MDS Cohort | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
SD
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MDS Cohort | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete cytogenetic response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MDS Cohort | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Partial cytogenetic response
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MDS Cohort | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
HI of at least 1 lineage
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MDS Cohort | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
HI of at least 1 lineage without CR or PR
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| MDS Cohort | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- title
- PR
- title
- mCR
- title
- SD
- title
- Complete cytogenetic response
- title
- Partial cytogenetic response
- title
- HI of at least 1 lineage
- title
- HI of at least 1 lineage without CR or PR
- description
- Number of participants with PR, mCR, SD, complete or partial cytogenetic response, and HI. PR: BMB \>5% and decreased by ≥50% (at least 4 weeks), meeting all CR criteria if abnormal before treatment except BMB. mCR: BMB ≤5% and decreased by ≥50%. SD: failure to achieve PR, no evidence of progression. Complete or partial cytogenic response: disappearance of chromosomal abnormality without new ones, or ≥ 50% reduction of chromosomal abnormality. HI: erythroid response (pretreatment \<11g/dL): hemoglobin increase by≥1.5 g/dL, relevant reduction of units of red blood cell transfusions by at least 4 transfusions/8 weeks compared to pretreatment transfusion number in previous 8 weeks; platelet response (pretreatment \<1x10\^11/L): increase of ≥30x10\^9/L if starting with \>20x10\^9/L, and increase from \<20x10\^9/L to \>20x10\^9/L and by at least 100%; neutrophil response (pretreatment \<1x10\^9/L): at least a 100% increase, absolute increase \>0.5x10\^9/L.
- 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
- MDS Cohort
- param Type
- COUNT_OF_PARTICIPANTS
- 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 34 months
- title
- Number of Participants With Disease-Specific Efficacy Measures in the MDS Cohort
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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