NCT02426125 · OUTCOME
PK: Minimum Concentration (Cmin) of Ramucirumab
A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer · Source last updated 2023-08-21
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- μg/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Day 1 of Cycle 2, 3, 5 and 9 (Predose and Postdose)
What was measured
Cmin of Ramucirumab following administration every 3 weeks.
Analysis population: All randomized participants who had evaluable PK data.
Groups in this outcome
Ramucirumab + Docetaxel
Ramucirumab (10 mg/kg) IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Ramucirumab + Docetaxel | 188 |
|---|
Reported measurements
Cycle 2
Analysis denominator · Participants
| Group | Source count |
|---|
| Ramucirumab + Docetaxel | 188 |
|---|
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ramucirumab + Docetaxel | 14.9 | 64 | Not reported | Not reported | Not reported |
|---|
Cycle 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Ramucirumab + Docetaxel | 146 |
|---|
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ramucirumab + Docetaxel | 23.5 | 63 | Not reported | Not reported | Not reported |
|---|
Cycle 5
Analysis denominator · Participants
| Group | Source count |
|---|
| Ramucirumab + Docetaxel | 94 |
|---|
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ramucirumab + Docetaxel | 32.5 | 70 | Not reported | Not reported | Not reported |
|---|
Cycle 9
Analysis denominator · Participants
| Group | Source count |
|---|
| Ramucirumab + Docetaxel | 25 |
|---|
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Ramucirumab + Docetaxel | 48.9 | 56 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 64
- value
- 14.9
- title
- Cycle 2
- categories
- measurements
- group Id
- OG000
- spread
- 63
- value
- 23.5
- title
- Cycle 3
- categories
- measurements
- group Id
- OG000
- spread
- 70
- value
- 32.5
- title
- Cycle 5
- categories
- measurements
- group Id
- OG000
- spread
- 56
- value
- 48.9
- title
- Cycle 9
- description
- Cmin of Ramucirumab following administration every 3 weeks.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Ramucirumab (10 mg/kg) IV plus docetaxel (75 mg/m²) IV on day 1 of each 21-day cycle. Participants may continue to receive treatment until discontinuation criteria are met.
- id
- OG000
- title
- Ramucirumab + Docetaxel
- param Type
- GEOMETRIC_MEAN
- population Description
- All randomized participants who had evaluable PK data.
- reporting Status
- POSTED
- time Frame
- Day 1 of Cycle 2, 3, 5 and 9 (Predose and Postdose)
- title
- PK: Minimum Concentration (Cmin) of Ramucirumab
- type
- SECONDARY
- unit Of Measure
- μg/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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