TriangleNCT02580058 · OUTCOME
Serum Trough Concentration (Ctrough) For Avelumab Following Cycle 2 Day 1 Pegylated Liposomal Doxorubicin (PLD) Dose
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- microgram per milliliter (mcg/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- At predose (0 H) on Cycle 2 Day 1
What was measured
Ctrough was defined as predose concentration during multiple dosing, and can be observed directly from data.
Analysis population: The PK parameter analysis set was defined as participants in the safety analysis set who had at least 1 post-dose concentration measurement above the lower limit of quantitation (LLQ) for avelumab.
Groups in this outcome
Avelumab
Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) 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 |
|---|---|
| Avelumab | 136 |
| Avelumab + PLD | 139 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Avelumab | 21.1 | 89 | Not reported | Not reported | Not reported |
| Avelumab + PLD | 23.19 | 74 | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 95.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 126.7
- group Description
- Avelumab 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
- 110
Complete source fields
- analyses
- ci Lower Limit
- 95.4
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 90
- ci Upper Limit
- 126.7
- group Description
- Avelumab 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
- 110
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 89
- value
- 21.1
- group Id
- OG001
- spread
- 74
- value
- 23.19
- denoms
- counts
- group Id
- OG000
- value
- 136
- group Id
- OG001
- value
- 139
- units
- Participants
- description
- Ctrough was defined as predose concentration during multiple dosing, and can be observed directly from data.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Avelumab 10 milligram (mg)/kilogram (kg) given as a 1-hour intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles.
- id
- OG000
- title
- Avelumab
- 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 participants in the safety analysis set who had at least 1 post-dose concentration measurement above the lower limit of quantitation (LLQ) for avelumab.
- reporting Status
- POSTED
- time Frame
- At predose (0 H) on Cycle 2 Day 1
- title
- Serum Trough Concentration (Ctrough) For Avelumab Following Cycle 2 Day 1 Pegylated Liposomal Doxorubicin (PLD) Dose
- type
- SECONDARY
- unit Of Measure
- microgram per milliliter (mcg/mL)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice