TriangleNCT02367456 · OUTCOME
Number of Participants With Efficacy Measures Other Than CR in the LIC
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 approximately 16 months
What was measured
Number of participants with efficacy measures other than CR as defined by modified IWG criteria (2006) in LIC, including marrow CR(mCR), stable disease(SD), hematologic improvement(HI). CR: hemoglobin≥11 g/dL, neutrophils≥1 x 10\^9/L, platelets≥1 x 10\^11/L, percentage of blasts=0%, percentage of BMB≤5%, normal maturation of all cell lines (note if has persistent dysplasia), all responses last at least 4 weeks. mCR: BMB≤5% \& decreased by≥50%. SD: failure to achieve PR, no evidence of progression. 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 set was defined as all participants who received at least 1 dose of any study treatment.
Groups in this outcome
Lead-in Cohort
Participants received SC administration of azacitidine daily at a dose of 75 mg/m2/day on Days 1-7 of every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD. In Cycle 1 only, administration of glasdegib commenced on Day 2 of the cycle (C1D2) to permit DDI evaluation.
| Group | Source count |
|---|---|
| Lead-in Cohort | 12 |
Reported measurements
marrow CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-in Cohort | 2 | Not reported | Not reported | Not reported | Not reported |
stable disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-in Cohort | 4 | Not reported | Not reported | Not reported | Not reported |
hematologic improvement of at least 1 lineage
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-in Cohort | 6 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- title
- marrow CR
- categories
- measurements
- group Id
- OG000
- value
- 4
- title
- stable disease
- categories
- measurements
- group Id
- OG000
- value
- 6
- title
- hematologic improvement of at least 1 lineage
- denoms
- counts
- group Id
- OG000
- value
- 12
- units
- Participants
- description
- Number of participants with efficacy measures other than CR as defined by modified IWG criteria (2006) in LIC, including marrow CR(mCR), stable disease(SD), hematologic improvement(HI). CR: hemoglobin≥11 g/dL, neutrophils≥1 x 10\^9/L, platelets≥1 x 10\^11/L, percentage of blasts=0%, percentage of BMB≤5%, normal maturation of all cell lines (note if has persistent dysplasia), all responses last at least 4 weeks. mCR: BMB≤5% \& decreased by≥50%. SD: failure to achieve PR, no evidence of progression. 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 administration of azacitidine daily at a dose of 75 mg/m2/day on Days 1-7 of every 28 days, and received oral self-administration of glasdegib daily and continuously at home with a starting dose of 100 mg QD. In Cycle 1 only, administration of glasdegib commenced on Day 2 of the cycle (C1D2) to permit DDI evaluation.
- id
- OG000
- title
- Lead-in Cohort
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The full analysis set was defined as all participants who received at least 1 dose of any study treatment.
- reporting Status
- POSTED
- time Frame
- maximum of approximately 16 months
- title
- Number of Participants With Efficacy Measures Other Than CR in the LIC
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice