TriangleNCT02082977 · OUTCOME
Part 1: Number of Participants With Abnormal Findings for Electrocardiogram (ECG) Parameters
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 3.2 years
What was measured
Single measurements of 12-lead ECGs were obtained a semi-recumbent or semi-supine position after at least a 5 minutes rest using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and corrected QT (QTc) intervals. The number of participants with abnormal, abnormal-not clinically significant (NCS), and abnormal-clinically significant (CS) worst case Post Baseline findings have been presented.
Analysis population: All Subjects Population
Groups in this outcome
Part 1:GSK2816126 50 mg Twice-weekly
Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1:GSK2816126 100 mg Twice-weekly
Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1:GSK2816126 200 mg Twice-weekly
Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1:GSK2816126 400 mg Twice-weekly
Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1:GSK2816126 800 mg Twice-weekly
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1:GSK2816126 1200 mg Twice-weekly
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1:GSK2816126 1800 mg Twice-weekly
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1:GSK2816126 2400 mg Twice-weekly
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Part 1:GSK2816126 3000 mg Twice-weekly
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
| Group | Source count |
|---|---|
| Part 1:GSK2816126 50 mg Twice-weekly | 2 |
| Part 1:GSK2816126 100 mg Twice-weekly | 1 |
| Part 1:GSK2816126 200 mg Twice-weekly | 1 |
| Part 1:GSK2816126 400 mg Twice-weekly | 1 |
| Part 1:GSK2816126 800 mg Twice-weekly | 3 |
| Part 1:GSK2816126 1200 mg Twice-weekly | 4 |
| Part 1:GSK2816126 1800 mg Twice-weekly | 10 |
| Part 1:GSK2816126 2400 mg Twice-weekly | 12 |
| Part 1:GSK2816126 3000 mg Twice-weekly | 7 |
Reported measurements
Abnormal; NCS
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1:GSK2816126 50 mg Twice-weekly | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 100 mg Twice-weekly | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 200 mg Twice-weekly | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 400 mg Twice-weekly | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 800 mg Twice-weekly | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 1200 mg Twice-weekly | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 1800 mg Twice-weekly | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 2400 mg Twice-weekly | 6 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 3000 mg Twice-weekly | 2 | Not reported | Not reported | Not reported | Not reported |
Abnormal; CS
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1:GSK2816126 50 mg Twice-weekly | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 100 mg Twice-weekly | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 200 mg Twice-weekly | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 400 mg Twice-weekly | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 800 mg Twice-weekly | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 1200 mg Twice-weekly | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 1800 mg Twice-weekly | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 2400 mg Twice-weekly | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 3000 mg Twice-weekly | 0 | Not reported | Not reported | Not reported | Not reported |
Abnormal
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1:GSK2816126 50 mg Twice-weekly | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 100 mg Twice-weekly | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 200 mg Twice-weekly | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 400 mg Twice-weekly | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 800 mg Twice-weekly | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 1200 mg Twice-weekly | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 1800 mg Twice-weekly | 5 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 2400 mg Twice-weekly | 5 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 3000 mg Twice-weekly | 4 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- 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
- 3
- group Id
- OG007
- value
- 6
- group Id
- OG008
- value
- 2
- title
- Abnormal; NCS
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- title
- Abnormal; CS
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 4
- title
- Abnormal
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 12
- group Id
- OG008
- value
- 7
- units
- Participants
- description
- Single measurements of 12-lead ECGs were obtained a semi-recumbent or semi-supine position after at least a 5 minutes rest using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and corrected QT (QTc) intervals. The number of participants with abnormal, abnormal-not clinically significant (NCS), and abnormal-clinically significant (CS) worst case Post Baseline findings have been presented.
- groups
- description
- Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG000
- title
- Part 1:GSK2816126 50 mg Twice-weekly
- description
- Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG001
- title
- Part 1:GSK2816126 100 mg Twice-weekly
- description
- Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG002
- title
- Part 1:GSK2816126 200 mg Twice-weekly
- description
- Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG003
- title
- Part 1:GSK2816126 400 mg Twice-weekly
- description
- Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG004
- title
- Part 1:GSK2816126 800 mg Twice-weekly
- description
- Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG005
- title
- Part 1:GSK2816126 1200 mg Twice-weekly
- description
- Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG006
- title
- Part 1:GSK2816126 1800 mg Twice-weekly
- description
- Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG007
- title
- Part 1:GSK2816126 2400 mg Twice-weekly
- description
- Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
- id
- OG008
- title
- Part 1:GSK2816126 3000 mg Twice-weekly
- param Type
- NUMBER
- population Description
- All Subjects Population
- reporting Status
- POSTED
- time Frame
- Up to 3.2 years
- title
- Part 1: Number of Participants With Abnormal Findings for Electrocardiogram (ECG) Parameters
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice