TriangleNCT02367456 · OUTCOME
Number of Participants With SAEs 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
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- maximum of around 23 months in AML cohort and 40 months in MDS cohort
What was measured
An SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator.
Analysis population: The safety analysis population included all participants who received at least 1 dose of 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
All-causality SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AML Cohort | 24 | Not reported | Not reported | Not reported | Not reported |
| MDS Cohort | 19 | Not reported | Not reported | Not reported | Not reported |
Treatment-related SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| AML Cohort | 8 | Not reported | Not reported | Not reported | Not reported |
| MDS Cohort | 9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 19
- title
- All-causality SAEs
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 9
- title
- Treatment-related SAEs
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 30
- units
- Participants
- description
- An SAE was any untoward medical occurrence at any dose that resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect. Treatment-related SAEs were determined by the investigator.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- The safety analysis population included all participants who received at least 1 dose of study treatment
- reporting Status
- POSTED
- time Frame
- maximum of around 23 months in AML cohort and 40 months in MDS cohort
- title
- Number of Participants With SAEs in the AML and MDS Cohorts
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice