TriangleNCT02580058 · OUTCOME
Area Under The Concentration Time Profile From Time Zero to The Last Quantifiable Concentration (AUClast) For Doxorubicin Following Cycle 2 Day 1 PLD Dose
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng*hr/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose
What was measured
AUClast was defined as area under the concentration time profile from time zero to the time of the last quantifiable concentration (Clast).
Analysis population: The PK parameter analysis set was defined as a subset of the safety analysis set and included patients who had at least one of the PK parameters of interest for doxorubicin.
Groups in this outcome
Pegylated Liposomal Doxorubicin (PLD)
PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
Avelumab + PLD
Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
| Group | Source count |
|---|---|
| Pegylated Liposomal Doxorubicin (PLD) | 15 |
| Avelumab + PLD | 15 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pegylated Liposomal Doxorubicin (PLD) | 2043000 | 119 | Not reported | Not reported | Not reported |
| Avelumab + PLD | 2052000 | 71 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 60
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 168
- group Description
- PLD was the Reference treatment and Avelumab + PLD was the Test treatment.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- Geometric Mean Ratio (Test/Reference, %)
- param Value
- 100
Complete source fields
- analyses
- ci Lower Limit
- 60
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 168
- group Description
- PLD was the Reference treatment and Avelumab + PLD was the Test treatment.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- param Type
- Geometric Mean Ratio (Test/Reference, %)
- param Value
- 100
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 119
- value
- 2043000
- group Id
- OG001
- spread
- 71
- value
- 2052000
- denoms
- counts
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 15
- units
- Participants
- description
- AUClast was defined as area under the concentration time profile from time zero to the time of the last quantifiable concentration (Clast).
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- PLD 40 mg/square meter given as a 1-hour IV infusion Q4W in 4-week cycles.
- id
- OG000
- title
- Pegylated Liposomal Doxorubicin (PLD)
- description
- Avelumab 10 mg/kg given as a 1-hour IV Q2W in 4-week cycles + pegylated liposomal doxorubicin (PLD) 40 mg/square meter given as a 1-hour IV infusion every 4 weeks (Q4W) in 4-week cycles.
- id
- OG001
- title
- Avelumab + PLD
- param Type
- GEOMETRIC_MEAN
- population Description
- The PK parameter analysis set was defined as a subset of the safety analysis set and included patients who had at least one of the PK parameters of interest for doxorubicin.
- reporting Status
- POSTED
- time Frame
- From predose (0 H) of Cycle 2 Day 1 through 336 hours postdose
- title
- Area Under The Concentration Time Profile From Time Zero to The Last Quantifiable Concentration (AUClast) For Doxorubicin Following Cycle 2 Day 1 PLD Dose
- type
- SECONDARY
- unit Of Measure
- ng*hr/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice