TriangleNCT04607421 · OUTCOME
Cohort 3: DOR by Derived Investigator Assessment - FAS
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From date of first radiographic evidence of response (CR or PR) to earliest documented PD or death due to any cause, whichever occurred first (maximum up to 14.1 months)
What was measured
DOR was defined as the time from the date of first radiographic evidence of response (CR or PR) to the earliest documented PD per RECIST v1.1 by derived investigator assessment, or death due to any cause. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. PD: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, with minimum absolute increase of 5 mm for target disease or unequivocal progression of pre-existing lesions for non-target disease or any new lesion. Analysis was performed using Kaplan Meier method.
Analysis population: The FAS for Cohort 3 included all participants who were randomized in the Cohort 3 portion of the study, respectively. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure with a confirmed objective response by derived investigator assessment.
Groups in this outcome
Cohort 3: Arm D [EC + FOLFIRI]
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 irinotecan 180 mg/m\^2 as IV infusion for 90 minutes Q2W. Participants received treatment in 28-day cycles.
Cohort 3: Arm E [FOLFIRI With or Without Bevacizumab]
Participants received 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 irinotecan 180 mg/m\^2 as IV infusion for 90 minutes Q2W with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. Participants received treatment in 28-day cycles.
| Group | Source count |
|---|---|
| Cohort 3: Arm D [EC + FOLFIRI] | 44 |
| Cohort 3: Arm E [FOLFIRI With or Without Bevacizumab] | 30 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 3: Arm D [EC + FOLFIRI] | NA | Not reported | 9.5 | NA | The Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events. |
| Cohort 3: Arm E [FOLFIRI With or Without Bevacizumab] | NA | Not reported | 6.9 | NA | The Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- The Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 9.5
- upper Limit
- NA
- value
- NA
- comment
- The Median and upper limit of 95% CI could not be estimated due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 6.9
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 44
- group Id
- OG001
- value
- 30
- units
- Participants
- description
- DOR was defined as the time from the date of first radiographic evidence of response (CR or PR) to the earliest documented PD per RECIST v1.1 by derived investigator assessment, or death due to any cause. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. PD: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, with minimum absolute increase of 5 mm for target disease or unequivocal progression of pre-existing lesions for non-target disease or any new lesion. Analysis was performed using Kaplan Meier method.
- dispersion Type
- 95% 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 irinotecan 180 mg/m\^2 as IV infusion for 90 minutes Q2W. Participants received treatment in 28-day cycles.
- id
- OG000
- title
- Cohort 3: Arm D [EC + FOLFIRI]
- description
- Participants received 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 irinotecan 180 mg/m\^2 as IV infusion for 90 minutes Q2W with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. Participants received treatment in 28-day cycles.
- id
- OG001
- title
- Cohort 3: Arm E [FOLFIRI With or Without Bevacizumab]
- param Type
- MEDIAN
- population Description
- The FAS for Cohort 3 included all participants who were randomized in the Cohort 3 portion of the study, respectively. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure with a confirmed objective response by derived investigator assessment.
- reporting Status
- POSTED
- time Frame
- From date of first radiographic evidence of response (CR or PR) to earliest documented PD or death due to any cause, whichever occurred first (maximum up to 14.1 months)
- title
- Cohort 3: DOR by Derived Investigator Assessment - FAS
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice