TriangleNCT04145700 · OUTCOME
PK: Minimum Serum Concentration of Ramucirumab (Cmin)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- microgram per milliliter (µg/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Prior to ramucirumab infusion on Day 8 of Cycle 1, Day 1 of Cycle 2 and Day 1 of Cycle 5
What was measured
Cmin was the concentration of study drug in the blood immediately before the next dose was administered. It was measured pre-dose at all visits and was summarized using descriptive statistics.
Analysis population: All randomized participants who received at least one dose of Ramucirumab and had evaluable PK data.
Groups in this outcome
Ramucirumab + Gemcitabine + Docetaxel
Participants received intravenous infusions of ramucirumab 9 mg/kg, gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.
| Group | Source count |
|---|---|
| Ramucirumab + Gemcitabine + Docetaxel | 10 |
Reported measurements
Day 8 of Cycle 1
| Group | Source count |
|---|---|
| Ramucirumab + Gemcitabine + Docetaxel | 9 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab + Gemcitabine + Docetaxel | 73.3 | 39 | Not reported | Not reported | Not reported |
Day 1 of Cycle 2
| Group | Source count |
|---|---|
| Ramucirumab + Gemcitabine + Docetaxel | 10 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab + Gemcitabine + Docetaxel | 55.4 | 24 | Not reported | Not reported | Not reported |
Day 1 of Cycle 5
| Group | Source count |
|---|---|
| Ramucirumab + Gemcitabine + Docetaxel | 2 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab + Gemcitabine + Docetaxel | NA | NA | Not reported | Not reported | Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as there were only two participants. Individual values reported: 32.4 µg/mL, 41.3 µg/mL |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 39
- value
- 73.3
- denoms
- counts
- group Id
- OG000
- value
- 9
- units
- Participants
- title
- Day 8 of Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 24
- value
- 55.4
- denoms
- counts
- group Id
- OG000
- value
- 10
- units
- Participants
- title
- Day 1 of Cycle 2
- categories
- measurements
- comment
- Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as there were only two participants. Individual values reported: 32.4 µg/mL, 41.3 µg/mL
- group Id
- OG000
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 2
- units
- Participants
- title
- Day 1 of Cycle 5
- denoms
- counts
- group Id
- OG000
- value
- 10
- units
- Participants
- description
- Cmin was the concentration of study drug in the blood immediately before the next dose was administered. It was measured pre-dose at all visits and was summarized using descriptive statistics.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received intravenous infusions of ramucirumab 9 mg/kg, gemcitabine 900 mg/m2 on days 1, 8, and docetaxel 75 mg/m2 on day 8 of a 21-day cycle until disease progression or a criterion for discontinuation were met.
- id
- OG000
- title
- Ramucirumab + Gemcitabine + Docetaxel
- param Type
- GEOMETRIC_MEAN
- population Description
- All randomized participants who received at least one dose of Ramucirumab and had evaluable PK data.
- reporting Status
- POSTED
- time Frame
- Prior to ramucirumab infusion on Day 8 of Cycle 1, Day 1 of Cycle 2 and Day 1 of Cycle 5
- title
- PK: Minimum Serum Concentration of Ramucirumab (Cmin)
- type
- SECONDARY
- unit Of Measure
- microgram per milliliter (µg/mL)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice