TriangleNCT01578499 · OUTCOME
Ctrough: Observed Concentration at the End of a Dosing Interval for MMAE for Brentuximab Vedotin
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Day 1 pre-dose of Cycles 2 and 4
Analysis population: The PK population included participants with sufficient dose and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.
Groups in this outcome
pcALCL: Brentuximab Vedotin
Participants with pcALCL received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
MF: Brentuximab Vedotin 1.8 mg/kg
Participants with MF received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
| Group | Source count |
|---|---|
| pcALCL: Brentuximab Vedotin | 16 |
| MF: Brentuximab Vedotin 1.8 mg/kg | 50 |
Reported measurements
Cycle 2 Day 1
| Group | Source count |
|---|---|
| pcALCL: Brentuximab Vedotin | 11 |
| MF: Brentuximab Vedotin 1.8 mg/kg | 33 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| pcALCL: Brentuximab Vedotin | 0.11 | 0.095 | Not reported | Not reported | Not reported |
| MF: Brentuximab Vedotin 1.8 mg/kg | 0.09 | 0.060 | Not reported | Not reported | Not reported |
Cycle 4 Day 1
| Group | Source count |
|---|---|
| pcALCL: Brentuximab Vedotin | 10 |
| MF: Brentuximab Vedotin 1.8 mg/kg | 34 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| pcALCL: Brentuximab Vedotin | 0.14 | 0.113 | Not reported | Not reported | Not reported |
| MF: Brentuximab Vedotin 1.8 mg/kg | 0.11 | 0.091 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.095
- value
- 0.11
- group Id
- OG001
- spread
- 0.060
- value
- 0.09
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 33
- units
- Participants
- title
- Cycle 2 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 0.113
- value
- 0.14
- group Id
- OG001
- spread
- 0.091
- value
- 0.11
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 34
- units
- Participants
- title
- Cycle 4 Day 1
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 50
- units
- Participants
- dispersion Type
- Standard Deviation
- groups
- description
- Participants with pcALCL received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
- id
- OG000
- title
- pcALCL: Brentuximab Vedotin
- description
- Participants with MF received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
- id
- OG001
- title
- MF: Brentuximab Vedotin 1.8 mg/kg
- param Type
- MEAN
- population Description
- The PK population included participants with sufficient dose and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.
- reporting Status
- POSTED
- time Frame
- Day 1 pre-dose of Cycles 2 and 4
- title
- Ctrough: Observed Concentration at the End of a Dosing Interval for MMAE for Brentuximab Vedotin
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice