TriangleNCT01587703 · OUTCOME
Number of Participants With Increase in QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF)-Part 1 QD
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
- Median of 1.38 months of drug exposure
What was measured
Electrocardiogram (ECG) measurements were done using an automated 12-lead ECG machine. QTc parameters were graded according to NCI-CTCAE version 4.0. Grade 0 (\<450 milliseconds \[msec\]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), Grade 3 (\>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Number of participants with increase in QTcF at worst-case post Baseline is reported.
Analysis population: All Treated Population
Groups in this outcome
Part 1: GSK525762 2 mg QD
Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.
Part 1: GSK525762 4 mg QD
Participants were administered once daily oral dose of 4 mg GSK525762.
Part 1: GSK525762 8 mg QD
Participants were administered once daily oral dose of 8 mg GSK525762
Part 1: GSK525762 16 mg QD
Participants were administered once daily oral dose of 16 mg GSK525762
Part 1: GSK525762 30 mg QD
Participants were administered once daily oral dose of 30 mg GSK525762.
Part 1: GSK525762 60 mg QD
Participants were administered once daily oral dose of 60 mg GSK525762.
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
Part 1: GSK525762 100 mg QD
Participants were administered once daily oral dose of 100 mg GSK525762.
| Group | Source count |
|---|---|
| Part 1: GSK525762 2 mg QD | 3 |
| Part 1: GSK525762 4 mg QD | 4 |
| Part 1: GSK525762 8 mg QD | 1 |
| Part 1: GSK525762 16 mg QD | 3 |
| Part 1: GSK525762 30 mg QD | 4 |
| Part 1: GSK525762 60 mg QD | 9 |
| Part 1: GSK525762 80 mg QD | 32 |
| Part 1: GSK525762 100 mg QD | 9 |
Reported measurements
Any Grade increase
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 2 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 4 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 8 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 16 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 30 mg QD | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 13 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD | 4 | Not reported | Not reported | Not reported | Not reported |
Increase to Grade 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 2 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 4 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 8 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 16 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 30 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
Increase to Grade 3
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 2 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 4 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 8 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 16 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 30 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 13
- group Id
- OG007
- value
- 4
- title
- Any Grade increase
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- title
- Increase to Grade 2
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- title
- Increase to Grade 3
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 32
- group Id
- OG007
- value
- 9
- units
- Participants
- description
- Electrocardiogram (ECG) measurements were done using an automated 12-lead ECG machine. QTc parameters were graded according to NCI-CTCAE version 4.0. Grade 0 (\<450 milliseconds \[msec\]), Grade 1 (450-480 msec), Grade 2 (481-500 msec), Grade 3 (\>=501 msec). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline is the most recent, non-missing value prior to or on the first study treatment dose date. Number of participants with increase in QTcF at worst-case post Baseline is reported.
- groups
- description
- Participants were administered once daily (QD) oral dose of 2 milligrams (mg) GSK525762.
- id
- OG000
- title
- Part 1: GSK525762 2 mg QD
- description
- Participants were administered once daily oral dose of 4 mg GSK525762.
- id
- OG001
- title
- Part 1: GSK525762 4 mg QD
- description
- Participants were administered once daily oral dose of 8 mg GSK525762
- id
- OG002
- title
- Part 1: GSK525762 8 mg QD
- description
- Participants were administered once daily oral dose of 16 mg GSK525762
- id
- OG003
- title
- Part 1: GSK525762 16 mg QD
- description
- Participants were administered once daily oral dose of 30 mg GSK525762.
- id
- OG004
- title
- Part 1: GSK525762 30 mg QD
- description
- Participants were administered once daily oral dose of 60 mg GSK525762.
- id
- OG005
- title
- Part 1: GSK525762 60 mg QD
- description
- Participants were administered once daily oral dose of 80 mg GSK525762.
- id
- OG006
- title
- Part 1: GSK525762 80 mg QD
- description
- Participants were administered once daily oral dose of 100 mg GSK525762.
- id
- OG007
- title
- Part 1: GSK525762 100 mg QD
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All Treated Population
- reporting Status
- POSTED
- time Frame
- Median of 1.38 months of drug exposure
- title
- Number of Participants With Increase in QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF)-Part 1 QD
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice