TriangleNCT02082977 · OUTCOME
Part 1: Number of Participants Withdrawn Due to AEs
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
A participant was considered to have completed the study if they have completed their end of study visit or if the participant died or was still in follow-up at the time the study was closed or terminated. Participants were monitored from start of the study till the development of toxicity. The data for number of participants withdrawn due to AEs have been presented.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
Source class 1
| 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 | 0 | 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 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 3000 mg Twice-weekly | 0 | 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
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- 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
- A participant was considered to have completed the study if they have completed their end of study visit or if the participant died or was still in follow-up at the time the study was closed or terminated. Participants were monitored from start of the study till the development of toxicity. The data for number of participants withdrawn due to AEs 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 Withdrawn Due to AEs
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice