TriangleNCT02082977 · OUTCOME
Part 1: Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)
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
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. The analysis was performed on All Subjects Population which included all participants who received at least one dose of study treatment.
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
Any Non-SAE
| 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 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 200 mg Twice-weekly | 1 | 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 | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 1200 mg Twice-weekly | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 1800 mg Twice-weekly | 10 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 2400 mg Twice-weekly | 12 | Not reported | Not reported | Not reported | Not reported |
| Part 1:GSK2816126 3000 mg Twice-weekly | 7 | Not reported | Not reported | Not reported | Not reported |
Any SAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1:GSK2816126 50 mg Twice-weekly | 1 | 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 | 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 | 1 | 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 | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- 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
- title
- Any Non-SAE
- 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
- 1
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 3
- title
- Any SAE
- 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
- An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. The analysis was performed on All Subjects Population which included all participants who received at least one dose of study treatment.
- 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 Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice