TriangleNCT02367456 · OUTCOME
Number of Participants Meeting Categorical Criteria of QTcF Values in LIC, 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 approximately 15 months in the LIC cohort, 23 months in AML cohort, and 40 months in MDS cohort
What was measured
Number of participants that met categorical criteria of QTcF values in LIC, AML and MDS cohorts
Analysis population: The safety analysis population included 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.
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 |
|---|---|
| Lead-in Cohort | 12 |
| AML Cohort | 30 |
| MDS Cohort | 30 |
Reported measurements
Maximum QTcF interval <450 ms
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-in Cohort | 5 | Not reported | Not reported | Not reported | Not reported |
| AML Cohort | 16 | Not reported | Not reported | Not reported | Not reported |
| MDS Cohort | 17 | Not reported | Not reported | Not reported | Not reported |
450 ms <=Maximum QTcF interval <480 ms
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-in Cohort | 2 | Not reported | Not reported | Not reported | Not reported |
| AML Cohort | 6 | Not reported | Not reported | Not reported | Not reported |
| MDS Cohort | 7 | Not reported | Not reported | Not reported | Not reported |
480 ms <=Maximum QTcF interval <500 ms
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-in Cohort | 4 | Not reported | Not reported | Not reported | Not reported |
| AML Cohort | 5 | Not reported | Not reported | Not reported | Not reported |
| MDS Cohort | 4 | Not reported | Not reported | Not reported | Not reported |
Maximum QTcF interval ≥500 ms
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-in Cohort | 1 | Not reported | Not reported | Not reported | Not reported |
| AML Cohort | 3 | Not reported | Not reported | Not reported | Not reported |
| MDS Cohort | 2 | Not reported | Not reported | Not reported | Not reported |
QTcF maximum increase from baseline <30 ms
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-in Cohort | 3 | Not reported | Not reported | Not reported | Not reported |
| AML Cohort | 18 | Not reported | Not reported | Not reported | Not reported |
| MDS Cohort | 21 | Not reported | Not reported | Not reported | Not reported |
30 ms <= QTcF maximum increase from baseline <60 ms
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-in Cohort | 7 | Not reported | Not reported | Not reported | Not reported |
| AML Cohort | 10 | Not reported | Not reported | Not reported | Not reported |
| MDS Cohort | 7 | Not reported | Not reported | Not reported | Not reported |
QTcF maximum increase from baseline >=60 ms
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lead-in Cohort | 2 | Not reported | Not reported | Not reported | Not reported |
| AML Cohort | 2 | Not reported | Not reported | Not reported | Not reported |
| MDS Cohort | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 17
- title
- Maximum QTcF interval <450 ms
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 7
- title
- 450 ms <=Maximum QTcF interval <480 ms
- categories
- measurements
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 4
- title
- 480 ms <=Maximum QTcF interval <500 ms
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- title
- Maximum QTcF interval ≥500 ms
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 18
- group Id
- OG002
- value
- 21
- title
- QTcF maximum increase from baseline <30 ms
- categories
- measurements
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 7
- title
- 30 ms <= QTcF maximum increase from baseline <60 ms
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- title
- QTcF maximum increase from baseline >=60 ms
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 30
- group Id
- OG002
- value
- 30
- units
- Participants
- description
- Number of participants that met categorical criteria of QTcF values in LIC, AML and MDS cohorts
- 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
- 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
- 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
- OG002
- title
- MDS Cohort
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The safety analysis population included all participants who received at least 1 dose of any study treatment.
- reporting Status
- POSTED
- time Frame
- maximum of approximately 15 months in the LIC cohort, 23 months in AML cohort, and 40 months in MDS cohort
- title
- Number of Participants Meeting Categorical Criteria of QTcF Values in LIC, AML and MDS Cohorts
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice