TriangleNCT02367456 · OUTCOME
Kaplan-Meier Estimate of Median Overall Survival (OS) 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
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- maximum of approximately 32 months in AML cohort and 32 months in MDS cohort
What was measured
Overall survival (OS) was defined as the time from date of first study treatment to date of death from any cause. Patients last known to be alive were to be censored at the date of last contact. OS was analyzed and displayed graphically for each expansion cohort separately using the Kaplan-Meier method. The median event time and corresponding two-sided 95%CI were provided for each cohort. OS was first analyzed when the primary endpoint of CR was analyzed in the respective expansion cohort.
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 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 | Source count |
|---|---|
| AML Cohort | 30 |
| MDS Cohort | 30 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AML Cohort | 9.2 | Not reported | 6.2 | 14.0 | Not reported |
| MDS Cohort | 17.8 | Not reported | 9.3 | NA | The upper limit was not estimable due to insufficient number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.2
- upper Limit
- 14.0
- value
- 9.2
- comment
- The upper limit was not estimable due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 9.3
- upper Limit
- NA
- value
- 17.8
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 30
- units
- Participants
- description
- Overall survival (OS) was defined as the time from date of first study treatment to date of death from any cause. Patients last known to be alive were to be censored at the date of last contact. OS was analyzed and displayed graphically for each expansion cohort separately using the Kaplan-Meier method. The median event time and corresponding two-sided 95%CI were provided for each cohort. OS was first analyzed when the primary endpoint of CR was analyzed in the respective expansion cohort.
- 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 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
- OG001
- title
- MDS Cohort
- param Type
- MEDIAN
- 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 approximately 32 months in AML cohort and 32 months in MDS cohort
- title
- Kaplan-Meier Estimate of Median Overall Survival (OS) in the AML and MDS Cohorts
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice