TriangleNCT02064387 · OUTCOME
Number of Participants With Change From Baseline in Heart Rate and Temperature-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
The following criteria was used to flag vital signs of potential clinical importance: change from Baseline in heart rate (decrease to \<60 beats per minute \[bpm\] and increase to \>100 bpm) and change in temperature from Baseline (increase to \>=38 or decrease to \<=35 degrees celsius). 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
HR, decrease to <60
| 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 | 0 | 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 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.96 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 1.92 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 2.50 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 3.40 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 4.60 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
HR, change to normal or no change
| 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 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.12 mg/kg | 0 | 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 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.96 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 1.92 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 2.50 mg/kg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 3.40 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 4.60 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
HR, increase to >100
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK2857916 0.03 mg/kg | 1 | 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 | 3 | 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 | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 2.50 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 3.40 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 4.60 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
Temp, decrease to <=35
| 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 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.12 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.24 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.48 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.96 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 1.92 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 2.50 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 3.40 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 4.60 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
Temp, change to normal or no change
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: GSK2857916 0.03 mg/kg | 1 | 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 | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.24 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.48 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.96 mg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 1.92 mg/kg | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 2.50 mg/kg | 8 | 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 | 6 | Not reported | Not reported | Not reported | Not reported |
Temp, increase to >=38
| 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 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.12 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.24 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 0.48 mg/kg | 0 | 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 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 2.50 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 3.40 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: GSK2857916 4.60 mg/kg | 0 | 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
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 4
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 3
- title
- HR, decrease to <60
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 1
- title
- HR, change to normal or no change
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 2
- group Id
- OG007
- value
- 1
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 2
- title
- HR, increase to >100
- 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
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- title
- Temp, decrease to <=35
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 8
- group Id
- OG008
- value
- 2
- group Id
- OG009
- value
- 6
- title
- Temp, change to normal or no change
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- group Id
- OG009
- value
- 0
- title
- Temp, increase to >=38
- 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
- The following criteria was used to flag vital signs of potential clinical importance: change from Baseline in heart rate (decrease to \<60 beats per minute \[bpm\] and increase to \>100 bpm) and change in temperature from Baseline (increase to \>=38 or decrease to \<=35 degrees celsius). 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 Change From Baseline in Heart Rate and Temperature-Part 1
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice