TriangleNCT02435433 · OUTCOME
Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) Before 2nd, 4th, 7th, and 10th Infusion
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- nanogram/milliliter (ng/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Predose, Weeks 2, 6, 12 and 18, Day 1; Up to 3 Days Before Infusion (14-Day Cycles)
What was measured
PK Cmin of Ramucirumab Blood samples were collected at specified time points, and in the event of an infusion-related reaction, for assessment of ramucirumab serum concentrations.
Analysis population: All randomized participants who received at least one dose of study drug.
Groups in this outcome
Ramucirumab + BSC
8 mg/kg ramucirumab administered as an IV injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
| Group | Source count |
|---|---|
| Ramucirumab + BSC | 195 |
Reported measurements
Week 0
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab + BSC | NA | NA | Not reported | Not reported | 1 trough concentrations that was reported below the limit of quantitation were treated as missing for the concentration summaries. |
Week 2
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab + BSC | 23.5 | 57 | Not reported | Not reported | Not reported |
Week 6
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab + BSC | 44.1 | 60 | Not reported | Not reported | Not reported |
Week 12
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab + BSC | 60.2 | 46 | Not reported | Not reported | Not reported |
Week 18
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab + BSC | 63.2 | 40 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- 1 trough concentrations that was reported below the limit of quantitation were treated as missing for the concentration summaries.
- group Id
- OG000
- spread
- NA
- value
- NA
- title
- Week 0
- categories
- measurements
- group Id
- OG000
- spread
- 57
- value
- 23.5
- title
- Week 2
- categories
- measurements
- group Id
- OG000
- spread
- 60
- value
- 44.1
- title
- Week 6
- categories
- measurements
- group Id
- OG000
- spread
- 46
- value
- 60.2
- title
- Week 12
- categories
- measurements
- group Id
- OG000
- spread
- 40
- value
- 63.2
- title
- Week 18
- denoms
- counts
- group Id
- OG000
- value
- 195
- units
- Participants
- description
- PK Cmin of Ramucirumab Blood samples were collected at specified time points, and in the event of an infusion-related reaction, for assessment of ramucirumab serum concentrations.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- 8 mg/kg ramucirumab administered as an IV injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
- id
- OG000
- title
- Ramucirumab + BSC
- param Type
- GEOMETRIC_MEAN
- population Description
- All randomized participants who received at least one dose of study drug.
- reporting Status
- POSTED
- time Frame
- Predose, Weeks 2, 6, 12 and 18, Day 1; Up to 3 Days Before Infusion (14-Day Cycles)
- title
- Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) Before 2nd, 4th, 7th, and 10th Infusion
- type
- SECONDARY
- unit Of Measure
- nanogram/milliliter (ng/mL)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice