TriangleNCT01949532 · OUTCOME
Time to Maximum Observed Plasma Concentration (Tmax) for Metabolite PR-519/M16
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hours
- Interval / dispersion
- Full Range
- Time frame
- Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.
Analysis population: PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.
Groups in this outcome
Normal Renal Function
Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
End Stage Renal Disease
Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
| Group | Source count |
|---|---|
| Normal Renal Function | 13 |
| End Stage Renal Disease | 9 |
Reported measurements
Cycle 1, Day 16 (n = 13, 9)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Normal Renal Function | 0.617 | Not reported | 0.467 | 1.00 | Not reported |
| End Stage Renal Disease | 0.600 | Not reported | 0.467 | 0.917 | Not reported |
Cycle 2, Day 1 (n = 10, 8)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Normal Renal Function | 0.525 | Not reported | 0.250 | 0.617 | Not reported |
| End Stage Renal Disease | 0.533 | Not reported | 0.467 | 0.750 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.467
- upper Limit
- 1.00
- value
- 0.617
- group Id
- OG001
- lower Limit
- 0.467
- upper Limit
- 0.917
- value
- 0.600
- title
- Cycle 1, Day 16 (n = 13, 9)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.250
- upper Limit
- 0.617
- value
- 0.525
- group Id
- OG001
- lower Limit
- 0.467
- upper Limit
- 0.750
- value
- 0.533
- title
- Cycle 2, Day 1 (n = 10, 8)
- denoms
- counts
- group Id
- OG000
- value
- 13
- group Id
- OG001
- value
- 9
- units
- Participants
- dispersion Type
- Full Range
- groups
- description
- Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
- id
- OG000
- title
- Normal Renal Function
- description
- Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
- id
- OG001
- title
- End Stage Renal Disease
- param Type
- MEDIAN
- population Description
- PK evaluable population; one participant was excluded due to samples taken from the infusion arm, distal to the infusion site.
- reporting Status
- POSTED
- time Frame
- Cycle 1, day 16 and cycle 2, day 1 at predose, 15 minutes post start of infusion, immediately before the end of infusion, and at 5, 15, and 30 minutes, and 1, 2, and 4 hours after the end of the infusion.
- title
- Time to Maximum Observed Plasma Concentration (Tmax) for Metabolite PR-519/M16
- type
- SECONDARY
- unit Of Measure
- hours
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice