NCT01712490 · OUTCOME
A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin ADC and TAb
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- day*microgram per milliliter (day*ug/mL)
- Interval / dispersion
- Standard Deviation
- Time frame
- Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
Analysis population: The PK population included enrolled participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. The iPK population was the subset of PK population. The iPK population where data at specified timepoints was available.
Groups in this outcome
A+AVD
Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m\^2), vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.
| Group | Source count |
|---|---|
| A+AVD | 59 |
Reported measurements
Cycle 1 Day 1: ADC
| Group | Source count |
|---|---|
| A+AVD | 53 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| A+AVD | 47.4 | 12.0 | Not reported | Not reported | Not reported |
Cycle 1 Day 1: TAb
| Group | Source count |
|---|---|
| A+AVD | 51 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| A+AVD | 93.0 | 25.7 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 12.0
- value
- 47.4
- denoms
- counts
- group Id
- OG000
- value
- 53
- units
- Participants
- title
- Cycle 1 Day 1: ADC
- categories
- measurements
- group Id
- OG000
- spread
- 25.7
- value
- 93.0
- denoms
- counts
- group Id
- OG000
- value
- 51
- units
- Participants
- title
- Cycle 1 Day 1: TAb
- denoms
- counts
- group Id
- OG000
- value
- 59
- units
- Participants
- dispersion Type
- Standard Deviation
- groups
- description
- Brentuximab vedotin 1.2 milligram per kilogram (mg/kg), infusion, intravenously over 30-minutes plus doxorubicin 25 milligram per square meter (mg/m\^2), vinblastine 6 mg/m\^2, and dacarbazine 375 mg/m\^2, infusion, intravenously, once on Days 1 and 15 of each 28-day treatment cycle for up to a maximum of 6 cycles. Brentuximab vedotin was administered within approximately 1 hour after completion of AVD.
- id
- OG000
- title
- A+AVD
- param Type
- MEAN
- population Description
- The PK population included enrolled participants with sufficient dosing and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. The iPK population was the subset of PK population. The iPK population where data at specified timepoints was available.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 48 hours) post-dose
- title
- A+AVD: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Brentuximab Vedotin ADC and TAb
- type
- SECONDARY
- unit Of Measure
- day*microgram per milliliter (day*ug/mL)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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