TriangleNCT03112603 · OUTCOME
Cmax of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- nanograms per milliliter (ng/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose
What was measured
Cmax was defined as the maximum observed plasma concentration of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule.
Analysis population: Pharmacokinetic Analysis Set (PAS): all participants who provided at least one evaluable pharmacokinetic (PK) concentration. Only participants with available data were analyzed.
Groups in this outcome
Ruxolitinib
Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).
| Group | Source count |
|---|---|
| Ruxolitinib | 20 |
Reported measurements
Day 1
| Group | Source count |
|---|---|
| Ruxolitinib | 20 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ruxolitinib | 167 | 39.3 | Not reported | Not reported | Not reported |
Day 15
| Group | Source count |
|---|---|
| Ruxolitinib | 16 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ruxolitinib | 215 | 48.8 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 39.3
- value
- 167
- denoms
- counts
- group Id
- OG000
- value
- 20
- units
- Participants
- title
- Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 48.8
- value
- 215
- denoms
- counts
- group Id
- OG000
- value
- 16
- units
- Participants
- title
- Day 15
- denoms
- counts
- group Id
- OG000
- value
- 20
- units
- Participants
- description
- Cmax was defined as the maximum observed plasma concentration of ruxolitinib. Early enrolling participants (approximately the first 8 adult and first 4 adolescent participants) randomized to ruxolitinib arm followed an "extensive PK" sampling schedule. Subsequent participants randomized to ruxolitinib, any randomized participants receiving ruxolitinib after Cycle 6, and any randomized participants receiving BAT that cross over to ruxolitinib followed the "sparse PK" sampling schedule.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Ruxolitinib was administered orally twice per day at a dose of 10 milligrams (mg).
- id
- OG000
- title
- Ruxolitinib
- param Type
- GEOMETRIC_MEAN
- population Description
- Pharmacokinetic Analysis Set (PAS): all participants who provided at least one evaluable pharmacokinetic (PK) concentration. Only participants with available data were analyzed.
- reporting Status
- POSTED
- time Frame
- Extensive Sampling Schedule: Cycle 1 Days 1 and 15: predose; 0.5, 1, 1.5, 4, 6, and 9 hours post-dose. Sparse Sampling Schedule: Cycle 1 Days 1 and 15: predose; 1.5 hours post-dose
- title
- Cmax of Ruxolitinib After Single (Cycle 1 Day 1) and Multiple (Cycle 1 Day 15) Doses
- type
- SECONDARY
- unit Of Measure
- nanograms per milliliter (ng/mL)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice