TriangleNCT02064387 · OUTCOME
Number of Participants With Grade Change From Baseline in Vital Signs-DBP & SBP-Part 2 (NHL)
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 7.2 months (maximum duration of follow-up from first dose to last contact or death)
What was measured
Vital signs included SBP, DBP, Temp and HR. SBP and DBP were graded using NCI CTCAE version 4.0. For SBP: Grade 0-\<120 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 2 NHL Population
Groups in this outcome
Part 2: GSK2857916 3.40 mg/kg (NHL)
Participants with non-hodgkin's lymphoma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 36 cycles (1 cycle=21 days)
| Group | Source count |
|---|---|
| Part 2: GSK2857916 3.40 mg/kg (NHL) | 6 |
Reported measurements
DBP, any grade increase
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: GSK2857916 3.40 mg/kg (NHL) | 5 | Not reported | Not reported | Not reported | Not reported |
SBP, any grade increase
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2: GSK2857916 3.40 mg/kg (NHL) | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 5
- title
- DBP, any grade increase
- categories
- measurements
- group Id
- OG000
- value
- 5
- title
- SBP, any grade increase
- denoms
- counts
- group Id
- OG000
- value
- 6
- units
- Participants
- description
- Vital signs included SBP, DBP, Temp and HR. SBP and DBP were graded using NCI CTCAE version 4.0. For SBP: Grade 0-\<120 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 with non-hodgkin's lymphoma were administered a dose of 3.40 mg/kg GSK2857916 as IV infusion once every three weeks for a maximum of 36 cycles (1 cycle=21 days)
- id
- OG000
- title
- Part 2: GSK2857916 3.40 mg/kg (NHL)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Part 2 NHL Population
- reporting Status
- POSTED
- time Frame
- Up to 7.2 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 2 (NHL)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice