TriangleNCT02064387 · OUTCOME
Number of Participants With Grade Change From Baseline in Vital Signs-DBP & SBP-Part 1
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 and Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)
What was measured
Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP), temperature (Temp) and heart rate (HR). SBP and DBP were graded using National Cancer Institute-Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. For SBP: Grade 0-\<120 millimeters of mercury\[mmHg\], 120-139 mmHg\[Grade 1\], 140-159 mmHg\[Grade 2\], \>=160 mmHg\[Grade 3\]); For DBP: \<80 mmHg \[Grade 0\], 80-89\[Grade 1\], 90-99\[Grade 2\], \>=100 mmHg\[Grade 3\]). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline was defined as the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented.
Analysis population: Part 1 Population
Groups in this outcome
Part 1: GSK2857916 0.03 mg/kg
Participants were administered a dose of 0.03 milligrams per kilogram (mg/kg) GSK2857916 as intravenous (IV) infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 0.06 mg/kg
Participants were administered a dose of 0.06 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 0.12 mg/kg
Participants were administered a dose of 0.12 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 0.24 mg/kg
Participants were administered a dose of 0.24 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 0.48 mg/kg
Participants were administered a dose of 0.48 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 0.96 mg/kg
Participants were administered a dose of 0.96 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 1.92 mg/kg
Participants were administered a dose of 1.92 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 2.50 mg/kg
Participants were administered a dose of 2.50 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 3.40 mg/kg
Participants were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
Part 1: GSK2857916 4.60 mg/kg
Participants were administered a dose of 4.60 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
| Group | Source count |
|---|---|
| Part 1: GSK2857916 0.03 mg/kg | 1 |
| Part 1: GSK2857916 0.06 mg/kg | 1 |
| Part 1: GSK2857916 0.12 mg/kg | 4 |
| Part 1: GSK2857916 0.24 mg/kg | 4 |
| Part 1: GSK2857916 0.48 mg/kg | 4 |
| Part 1: GSK2857916 0.96 mg/kg | 3 |
| Part 1: GSK2857916 1.92 mg/kg | 4 |
| Part 1: GSK2857916 2.50 mg/kg | 8 |
| Part 1: GSK2857916 3.40 mg/kg | 3 |
| Part 1: GSK2857916 4.60 mg/kg | 6 |
Reported measurements
DBP, any grade increase
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK2857916 0.03 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.06 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.12 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.24 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.48 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.96 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 1.92 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 2.50 mg/kg | 5 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 3.40 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 4.60 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
SBP, any grade increase
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK2857916 0.03 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.06 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.12 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.24 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.48 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.96 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 1.92 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 2.50 mg/kg | 7 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 3.40 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 4.60 mg/kg | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 4
- title
- DBP, any grade increase
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 7
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 5
- title
- SBP, any grade increase
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 8
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 6
- units
- Participants
- description
- Vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP), temperature (Temp) and heart rate (HR). SBP and DBP were graded using National Cancer Institute-Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0. For SBP: Grade 0-\<120 millimeters of mercury\[mmHg\], 120-139 mmHg\[Grade 1\], 140-159 mmHg\[Grade 2\], \>=160 mmHg\[Grade 3\]); For DBP: \<80 mmHg \[Grade 0\], 80-89\[Grade 1\], 90-99\[Grade 2\], \>=100 mmHg\[Grade 3\]). An increase is defined as an increase in CTCAE grade relative to Baseline grade. Baseline was defined as the latest pre-dose assessment with a non-missing value, including unscheduled visits. Data for worst-case post Baseline is presented.
- groups
- description
- Participants were administered a dose of 0.03 milligrams per kilogram (mg/kg) GSK2857916 as intravenous (IV) infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
- id
- OG000
- title
- Part 1: GSK2857916 0.03 mg/kg
- description
- Participants were administered a dose of 0.06 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
- id
- OG001
- title
- Part 1: GSK2857916 0.06 mg/kg
- description
- Participants were administered a dose of 0.12 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
- id
- OG002
- title
- Part 1: GSK2857916 0.12 mg/kg
- description
- Participants were administered a dose of 0.24 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
- id
- OG003
- title
- Part 1: GSK2857916 0.24 mg/kg
- description
- Participants were administered a dose of 0.48 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
- id
- OG004
- title
- Part 1: GSK2857916 0.48 mg/kg
- description
- Participants were administered a dose of 0.96 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
- id
- OG005
- title
- Part 1: GSK2857916 0.96 mg/kg
- description
- Participants were administered a dose of 1.92 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
- id
- OG006
- title
- Part 1: GSK2857916 1.92 mg/kg
- description
- Participants were administered a dose of 2.50 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
- id
- OG007
- title
- Part 1: GSK2857916 2.50 mg/kg
- description
- Participants were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
- id
- OG008
- title
- Part 1: GSK2857916 3.40 mg/kg
- description
- Participants were administered a dose of 4.60 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 16 cycles (1 cycle= 21 days).
- id
- OG009
- title
- Part 1: GSK2857916 4.60 mg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Part 1 Population
- reporting Status
- POSTED
- time Frame
- Baseline and Up to 21.6 months (maximum duration of follow-up from first dose to last contact or death)
- title
- Number of Participants With Grade Change From Baseline in Vital Signs-DBP & SBP-Part 1
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice