TriangleNCT02718417 · OUTCOME
Maintenance Phase: Maximum Plasma Concentration (Cmax) of Avelumab
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- mcg/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- End of avelumab infusion on Day 1 of Cycle 2
What was measured
Cmax is the concentration at the end of a 1 hour infusion, corresponding to the maximum plasma concentration of avelumab. The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy + Avelumab followed by Avelumab"(since data was not planned to be collected 1 cycle after the initiation of avelumab dosing ) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned).
Analysis population: Avelumab PK concentration analysis set included all participants who had received at least one dose of study drug and who had at least one post-dose concentration measurement above the LLQ for avelumab. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure.
Groups in this outcome
PK: Chemotherapy Followed by Avelumab
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W on Days 1, 15 and 29 of each 42 day cycle.
| Group | Source count |
|---|---|
| PK: Chemotherapy Followed by Avelumab | 174 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PK: Chemotherapy Followed by Avelumab | 205.6 | 50 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 50
- value
- 205.6
- denoms
- counts
- group Id
- OG000
- value
- 174
- units
- Participants
- description
- Cmax is the concentration at the end of a 1 hour infusion, corresponding to the maximum plasma concentration of avelumab. The LLQ of avelumab was 0.20 mcg/mL. Data for this outcome measure was not reported for reporting arms "PK: Chemotherapy + Avelumab followed by Avelumab"(since data was not planned to be collected 1 cycle after the initiation of avelumab dosing ) and "PK: Chemotherapy followed by Observation" (since avelumab was not administered in this arm and therefore data collection was not planned).
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles. During the maintenance phase, participants received avelumab Q2W on Days 1, 15 and 29 of each 42 day cycle.
- id
- OG000
- title
- PK: Chemotherapy Followed by Avelumab
- param Type
- GEOMETRIC_MEAN
- population Description
- Avelumab PK concentration analysis set included all participants who had received at least one dose of study drug and who had at least one post-dose concentration measurement above the LLQ for avelumab. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure.
- reporting Status
- POSTED
- time Frame
- End of avelumab infusion on Day 1 of Cycle 2
- title
- Maintenance Phase: Maximum Plasma Concentration (Cmax) of Avelumab
- type
- SECONDARY
- unit Of Measure
- mcg/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice