TriangleNCT01943851 · OUTCOME
Part 1: Number of Participants With Increase to Grade 3 From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
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
- Up to 86.9 weeks
What was measured
DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.0. For SBP: Grade 0 (\<=120 millimeter of mercury \[mmHg\]), Grade 1 (121-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg). For DBP: Grade 0 (\<=80 mmHg), Grade 1 (81-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg). Higher grade indicates greater severity. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. An increase is defined as an increase in grade relative to Baseline grade. Number of participants with increase to Grade 3 from Baseline is presented.
Analysis population: All Treated Population.
Groups in this outcome
Part 1: GSK525762 5 mg QD
Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
Part 1: GSK525762 10 mg QD
Participants were administered once daily oral dose of 10 mg GSK525762.
Part 1: GSK525762 20 mg QD
Participants were administered once daily oral dose of 20 mg GSK525762.
Part 1: GSK525762 30 mg QD MM
Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
Part 1: GSK525762 40 mg QD
Participants were administered once daily oral dose of 40 mg GSK525762.
Part 1: GSK525762 40 mg QD MM
Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
Part 1: GSK525762 60 mg QD AML
Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
Part 1: GSK525762 60 mg QD NHL
Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
Part 1: GSK525762 60 mg QD MM
Participants with MM were administered once daily oral dose of 60 mg GSK525762.
Part 1: GSK525762 75 mg QD AML
Participants with AML were administered once daily oral dose of 75 mg GSK525762.
Part 1: GSK525762 80 mg QD
Participants were administered once daily oral dose of 80 mg GSK525762.
Part 1: GSK525762 80 mg QD AML
Participants with AML were administered once daily oral dose of 80 mg GSK525762.
Part 1: GSK525762 80 mg QD NHL
Participants with NHL were administered once daily oral dose of 80 mg GSK525762.
Part 1: GSK525762 100 mg QD AML
Participants with AML were administered once daily oral dose of 100 mg GSK525762.
Part 1: GSK525762 120 mg QD AML
Participants with AML were administered once daily oral dose of 120 mg GSK525762.
| Group | Source count |
|---|---|
| Part 1: GSK525762 5 mg QD | 1 |
| Part 1: GSK525762 10 mg QD | 1 |
| Part 1: GSK525762 20 mg QD | 1 |
| Part 1: GSK525762 30 mg QD MM | 5 |
| Part 1: GSK525762 40 mg QD | 1 |
| Part 1: GSK525762 40 mg QD MM | 4 |
| Part 1: GSK525762 60 mg QD AML | 7 |
| Part 1: GSK525762 60 mg QD NHL | 18 |
| Part 1: GSK525762 60 mg QD MM | 3 |
| Part 1: GSK525762 75 mg QD AML | 8 |
| Part 1: GSK525762 80 mg QD | 1 |
| Part 1: GSK525762 80 mg QD AML | 7 |
| Part 1: GSK525762 80 mg QD NHL | 7 |
| Part 1: GSK525762 100 mg QD AML | 16 |
| Part 1: GSK525762 120 mg QD AML | 6 |
Reported measurements
DBP
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 5 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 10 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 20 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 30 mg QD MM | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 40 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 40 mg QD MM | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD AML | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD NHL | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD MM | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 75 mg QD AML | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD AML | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD NHL | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD AML | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 120 mg QD AML | 0 | Not reported | Not reported | Not reported | Not reported |
SBP
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK525762 5 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 10 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 20 mg QD | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 30 mg QD MM | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 40 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 40 mg QD MM | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD AML | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD NHL | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 60 mg QD MM | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 75 mg QD AML | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD AML | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 80 mg QD NHL | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 100 mg QD AML | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK525762 120 mg QD AML | 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
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- title
- DBP
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 4
- title
- SBP
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 7
- group Id
- OG007
- value
- 18
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 8
- group Id
- OG010
- value
- 1
- group Id
- OG011
- value
- 7
- units
- Participants
- description
- DBP and SBP were measured after resting for at least 5 minutes in a supine or semi-recumbent position. They were graded according to NCI-CTCAE version 4.0. For SBP: Grade 0 (\<=120 millimeter of mercury \[mmHg\]), Grade 1 (121-139 mmHg), Grade 2 (140-159 mmHg), Grade 3 (\>=160 mmHg). For DBP: Grade 0 (\<=80 mmHg), Grade 1 (81-89 mmHg), Grade 2 (90-99 mmHg), Grade 3 (\>=100 mmHg). Higher grade indicates greater severity. Baseline was the most recent, non-missing value prior to or on the first study treatment dose date. An increase is defined as an increase in grade relative to Baseline grade. Number of participants with increase to Grade 3 from Baseline is presented.
- groups
- description
- Participants were administered once daily oral dose of 5 milligrams (mg) GSK525762.
- id
- OG000
- title
- Part 1: GSK525762 5 mg QD
- description
- Participants were administered once daily oral dose of 10 mg GSK525762.
- id
- OG001
- title
- Part 1: GSK525762 10 mg QD
- description
- Participants were administered once daily oral dose of 20 mg GSK525762.
- id
- OG002
- title
- Part 1: GSK525762 20 mg QD
- description
- Participants with multiple myeloma (MM) were administered once daily oral dose of 30 mg GSK525762.
- id
- OG003
- title
- Part 1: GSK525762 30 mg QD MM
- description
- Participants were administered once daily oral dose of 40 mg GSK525762.
- id
- OG004
- title
- Part 1: GSK525762 40 mg QD
- description
- Participants with multiple myeloma were administered once daily oral dose of 40 mg GSK525762.
- id
- OG005
- title
- Part 1: GSK525762 40 mg QD MM
- description
- Participants with Acute Myeloid Leukemia (AML) were administered once daily oral dose of 60 mg GSK525762.
- id
- OG006
- title
- Part 1: GSK525762 60 mg QD AML
- description
- Participants with Non-Hodgkin's Lymphoma (NHL) were administered once daily oral dose of 60 mg GSK525762.
- id
- OG007
- title
- Part 1: GSK525762 60 mg QD NHL
- description
- Participants with MM were administered once daily oral dose of 60 mg GSK525762.
- id
- OG008
- title
- Part 1: GSK525762 60 mg QD MM
- description
- Participants with AML were administered once daily oral dose of 75 mg GSK525762.
- id
- OG009
- title
- Part 1: GSK525762 75 mg QD AML
- description
- Participants were administered once daily oral dose of 80 mg GSK525762.
- id
- OG010
- title
- Part 1: GSK525762 80 mg QD
- description
- Participants with AML were administered once daily oral dose of 80 mg GSK525762.
- id
- OG011
- title
- Part 1: GSK525762 80 mg QD AML
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All Treated Population.
- reporting Status
- POSTED
- time Frame
- Up to 86.9 weeks
- title
- Part 1: Number of Participants With Increase to Grade 3 From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice