TriangleNCT01587703 · OUTCOME
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)-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
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. An SAE is 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; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment. All Treated Population comprised of all participants who received at least one dose of study treatment.
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 AE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 2 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 4 mg QD | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 8 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 16 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 30 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD | 9 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 31 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD | 9 | Not reported | Not reported | Not reported | Not reported |
Any SAE
| 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 | 2 | 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 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 21 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 9
- group Id
- OG006
- value
- 31
- group Id
- OG007
- value
- 9
- title
- Any AE
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 21
- group Id
- OG007
- value
- 3
- title
- Any SAE
- 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
- 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. An SAE is 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; important medical events that may require medical or surgical intervention to prevent one of the outcomes mentioned; events of possible study treatment-induced liver injury with hyperbilirubinemia; any new primary cancers; significant cardiac dysfunction; Grade 4 laboratory abnormalities; and drug related hepatobiliary event leading to permanent discontinuation of study treatment. All Treated Population comprised of all participants who received at least one dose of study treatment.
- 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 Adverse Events (AEs) and Serious Adverse Events (SAEs)-Part 1 QD
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice