TriangleNCT02718417 · OUTCOME
Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Carboplatin (Total and Free)
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
- Pre-dose and at 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2
What was measured
AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Analysis population: Carboplatin PK parameter analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK parameters of interest for carboplatin. 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.
PK: Chemotherapy + Avelumab Followed by Avelumab
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab 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).
PK: Chemotherapy Followed by Observation
In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles.
| Group | Source count |
|---|---|
| PK: Chemotherapy Followed by Avelumab | 11 |
| PK: Chemotherapy + Avelumab Followed by Avelumab | 6 |
| PK: Chemotherapy Followed by Observation | 13 |
Reported measurements
Total Carboplatin
| Group | Source count |
|---|---|
| PK: Chemotherapy Followed by Avelumab | 1 |
| PK: Chemotherapy + Avelumab Followed by Avelumab | 5 |
| PK: Chemotherapy Followed by Observation | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PK: Chemotherapy Followed by Avelumab | 87600 | Not reported | Not reported | Not reported | Not reported |
| PK: Chemotherapy + Avelumab Followed by Avelumab | 100500 | 13 | Not reported | Not reported | Not reported |
| PK: Chemotherapy Followed by Observation | 90430 | 18 | Not reported | Not reported | Not reported |
Free Carboplatin
| Group | Source count |
|---|---|
| PK: Chemotherapy Followed by Avelumab | 11 |
| PK: Chemotherapy + Avelumab Followed by Avelumab | 6 |
| PK: Chemotherapy Followed by Observation | 13 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| PK: Chemotherapy Followed by Avelumab | 55840 | 25 | Not reported | Not reported | Not reported |
| PK: Chemotherapy + Avelumab Followed by Avelumab | 52000 | 29 | Not reported | Not reported | Not reported |
| PK: Chemotherapy Followed by Observation | 52300 | 25 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 87600
- group Id
- OG001
- spread
- 13
- value
- 100500
- group Id
- OG002
- spread
- 18
- value
- 90430
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 5
- units
- Participants
- title
- Total Carboplatin
- categories
- measurements
- group Id
- OG000
- spread
- 25
- value
- 55840
- group Id
- OG001
- spread
- 29
- value
- 52000
- group Id
- OG002
- spread
- 25
- value
- 52300
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 13
- units
- Participants
- title
- Free Carboplatin
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 13
- units
- Participants
- description
- AUCinf is the area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
- 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
- description
- In chemotherapy phase, participants received paclitaxel Q3W (or QW on Days 1, 8 and 15), followed by carboplatin Q3W along with avelumab 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
- OG001
- title
- PK: Chemotherapy + Avelumab Followed by Avelumab
- description
- In chemotherapy phase, participants received paclitaxel Q3W (or QW on Day 1, 8 and 15), followed by carboplatin Q3W on Day 1 of each 21 day cycle for 6 cycles.
- id
- OG002
- title
- PK: Chemotherapy Followed by Observation
- param Type
- GEOMETRIC_MEAN
- population Description
- Carboplatin PK parameter analysis set included all participants who had received at least one dose of study drug and who had at least one of the PK parameters of interest for carboplatin. Here "Overall number of participants analyzed" signifies participants who had data available for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Pre-dose and at 0.5, 1, 5, 6, 10, and 24 hours post carboplatin infusion on Day 1 of Cycle 2
- title
- Chemotherapy Phase: Area Under the Plasma Concentration Time Curve From Time Zero to Infinite Time (AUCinf) of Carboplatin (Total and Free)
- type
- SECONDARY
- unit Of Measure
- ng*hr/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice