TriangleNCT01587703 · OUTCOME
Number of Participants With Increase in Blood Pressure From Baseline-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
- Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure
What was measured
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Grading of SBP and DBP were done using NCI-CTCAE version 4.0 where, SBP (millimeters of mercury): Grade 0 (\<120), Grade 1 (120-139), Grade 2 (140-159), Grade 3/4 (\>=160) and DBP: Grade 0 (\<80), Grade 1 (80-89), Grade 2 (90-99), Grade 3/4 (\>=100). An increase is defined as an increase in CTCAE grade relative to baseline grade. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented
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
DBP; Increase to Grade 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 2 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 4 mg QD | 1 | 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 | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 9 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
DBP; 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 | 1 | 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 | 1 | 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 | 10 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
DBP; Increase to Grade 3/4
| 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 | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD | 2 | Not reported | Not reported | Not reported | Not reported |
SBP; Increase to Grade 1
| 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 | 1 | 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 | 1 | 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 | 11 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
SBP; Increase to Grade 2
| 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 | 3 | 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 | 9 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD | 3 | Not reported | Not reported | Not reported | Not reported |
SBP; Increase to Grade 3/4
| 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 | 1 | 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 | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 5 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD | 2 | 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
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 9
- group Id
- OG007
- value
- 0
- title
- DBP; Increase to Grade 1
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 10
- group Id
- OG007
- value
- 1
- title
- DBP; Increase to Grade 2
- 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
- 2
- group Id
- OG007
- value
- 2
- title
- DBP; Increase to Grade 3/4
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 11
- group Id
- OG007
- value
- 1
- title
- SBP; Increase to Grade 1
- 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
- 3
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 9
- group Id
- OG007
- value
- 3
- title
- SBP; Increase to Grade 2
- 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
- 0
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 2
- title
- SBP; Increase to Grade 3/4
- 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
- Systolic blood pressure (SBP) and diastolic blood pressure (DBP) was measured in a supine or semi-recumbent position after at least 5 minutes rest for the participant. Grading of SBP and DBP were done using NCI-CTCAE version 4.0 where, SBP (millimeters of mercury): Grade 0 (\<120), Grade 1 (120-139), Grade 2 (140-159), Grade 3/4 (\>=160) and DBP: Grade 0 (\<80), Grade 1 (80-89), Grade 2 (90-99), Grade 3/4 (\>=100). An increase is defined as an increase in CTCAE grade relative to baseline grade. Baseline is the most recent, non-missing value from a central laboratory prior to or on the first study treatment dose date. Data for worst case post-Baseline is presented
- 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
- Baseline (pre-dose Week1 Day1) and median of 1.38 months of drug exposure
- title
- Number of Participants With Increase in Blood Pressure From Baseline-Part 1 QD
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice