TriangleNCT03525678 · OUTCOME
Number of Participants With Abnormal Findings During Physical Examination
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Up to 186 weeks
What was measured
Physical examination included assessment of the head, eyes, ears, nose, throat, skin, thyroid, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes, and extremities. This analysis was planned, but data was not collected and captured in the database.
Analysis population: Full Safety Population. This analysis was planned, but data was not collected and captured in the database.
Groups in this outcome
Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)
Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
Main Study: GSK2857916 3.4 mg/kg (Lyophilized)
Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
| Group | Source count |
|---|---|
| Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid) | 0 |
| Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid) | 0 |
| Main Study: GSK2857916 3.4 mg/kg (Lyophilized) | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- units
- Participants
- description
- Physical examination included assessment of the head, eyes, ears, nose, throat, skin, thyroid, lungs, cardiovascular, abdomen (liver and spleen), lymph nodes, and extremities. This analysis was planned, but data was not collected and captured in the database.
- groups
- description
- Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 2.5 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 39 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
- id
- OG000
- title
- Main Study: GSK2857916 2.5 mg/kg (Frozen Liquid)
- description
- Participants were administered frozen liquid (30 mg/vial solution in a single use vial) at a dose of 3.4 mg/kg GSK2857916 as IV solution once every three weeks for a maximum of up to 32 cycles (1 cycle= 21 days). Frozen liquid was diluted with 0.9 percent saline.
- id
- OG001
- title
- Main Study: GSK2857916 3.4 mg/kg (Frozen Liquid)
- description
- Participants were administered lyophilized powder (100 mg/vial in a single use vial) at a dose of 3.4 mg/kg GSK2857916 given IV for a maximum of 35 cycles (1 cycle= 21 days). Lyophilized powder was reconstituted using water for injection.
- id
- OG002
- title
- Main Study: GSK2857916 3.4 mg/kg (Lyophilized)
- population Description
- Full Safety Population. This analysis was planned, but data was not collected and captured in the database.
- reporting Status
- POSTED
- time Frame
- Up to 186 weeks
- title
- Number of Participants With Abnormal Findings During Physical Examination
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice