TriangleNCT04607421 · OUTCOME
SLI, Cohort 2: Ratio of AUClast on Cycle 1 Day 15 as Compared to Cycle 1 Day 1 for Oxaliplatin
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Ratio
- Interval / dispersion
- 90% Confidence Interval
- Time frame
- Cohort 2: Pre-dose (0 hr), 1, 2, 3, 4, 6, 8, and 48 hrs post-dose on Days 1 and 15 of Cycle 1
What was measured
AUClast was defined as area under the plasma concentration time curve from time zero to the last measurable concentration. AUClast was calculated using linear/log trapezoidal method. Oxaliplatin was evaluated as total platinum in plasma and platinum in plasma ultrafiltrate. The ratio between geometric LS mean (within Cohort 2) for AUClast on Cycle 1 Day 15 and geometric LS mean (within Cohort 2) for AUClast on Cycle 1 Day 1 for Oxaliplatin has been presented in this outcome measure, which explains the data reported for this outcome measure using measure type as "Number".
Analysis population: The PK parameter analysis set was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Participants received oxaliplatin in Cohort 2 of SLI, hence data is reported only for Cohort 2 and not for Cohort 1.
Groups in this outcome
SLI: Cohort 2 [EC + mFOLFOX6]
Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
| Group | Source count |
|---|---|
| SLI: Cohort 2 [EC + mFOLFOX6] | 15 |
Reported measurements
Platinum in plasma
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SLI: Cohort 2 [EC + mFOLFOX6] | 1.12 | Not reported | 1.04 | 1.2 | Not reported |
Platinum in ultrafiltrate
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SLI: Cohort 2 [EC + mFOLFOX6] | 1.04 | Not reported | 0.985 | 1.11 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.04
- upper Limit
- 1.2
- value
- 1.12
- title
- Platinum in plasma
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.985
- upper Limit
- 1.11
- value
- 1.04
- title
- Platinum in ultrafiltrate
- denoms
- counts
- group Id
- OG000
- value
- 15
- units
- Participants
- description
- AUClast was defined as area under the plasma concentration time curve from time zero to the last measurable concentration. AUClast was calculated using linear/log trapezoidal method. Oxaliplatin was evaluated as total platinum in plasma and platinum in plasma ultrafiltrate. The ratio between geometric LS mean (within Cohort 2) for AUClast on Cycle 1 Day 15 and geometric LS mean (within Cohort 2) for AUClast on Cycle 1 Day 1 for Oxaliplatin has been presented in this outcome measure, which explains the data reported for this outcome measure using measure type as "Number".
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and oxaliplatin 85 mg/m\^2 IV infusion for 120 minutes Q2W. Participants received treatment in 28-day cycles.
- id
- OG000
- title
- SLI: Cohort 2 [EC + mFOLFOX6]
- param Type
- NUMBER
- population Description
- The PK parameter analysis set was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Participants received oxaliplatin in Cohort 2 of SLI, hence data is reported only for Cohort 2 and not for Cohort 1.
- reporting Status
- POSTED
- time Frame
- Cohort 2: Pre-dose (0 hr), 1, 2, 3, 4, 6, 8, and 48 hrs post-dose on Days 1 and 15 of Cycle 1
- title
- SLI, Cohort 2: Ratio of AUClast on Cycle 1 Day 15 as Compared to Cycle 1 Day 1 for Oxaliplatin
- type
- SECONDARY
- unit Of Measure
- Ratio
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice