TriangleNCT04607421 · OUTCOME
SLI: PFS as Assessed by Investigator According to Line of Therapy - 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 randomization to earliest documentation of PD or death or censoring date, whichever occurred first (maximum up to 33.9 months)
What was measured
PFS: time from date of randomization to earliest documented PD per RECIST version 1.1 or death due to any cause as assessed by response reported by investigator on eCRF. 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. Censoring details: no adequate baseline assessment, including no disease at baseline: participants were censored to randomization date; no PD, lost to follow-up, withdrawal of consent, PD or death \>12 (or 16) weeks after the last adequate tumor assessment, and start of new anticancer treatment: participants were censored to last adequate tumor assessment documenting no PD prior to new anticancer therapy, or missed assessments. Participants with PFS for first line and second line were presented. Analysis performed using Kaplan Meier method.
Analysis population: The FAS for SLI included all participants who were randomized in the SLI portion of the study. Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for each row.
Groups in this outcome
SLI: Cohort 1 [EC + FOLFIRI]
Participants received encorafenib 300 milligrams (mg) once daily (QD) orally (received after Cycle 1 Day 3) and cetuximab 500 mg per square meters (mg/m\^2) intravenous (IV) infusion for 120 minutes once every 2 weeks (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.
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 1 [EC + FOLFIRI] | 30 |
| SLI: Cohort 2 [EC + mFOLFOX6] | 27 |
Reported measurements
First Line Treatment
| Group | Source count |
|---|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 12 |
| SLI: Cohort 2 [EC + mFOLFOX6] | 19 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SLI: Cohort 1 [EC + FOLFIRI] | NA | Not reported | 15.3 | NA | Median and upper limit of 95% confidence interval (CI) could not be estimated due to insufficient number of participants with events. |
| SLI: Cohort 2 [EC + mFOLFOX6] | 9.9 | Not reported | 6.4 | 21.9 | Not reported |
Second Line Treatment
| Group | Source count |
|---|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 18 |
| SLI: Cohort 2 [EC + mFOLFOX6] | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| SLI: Cohort 1 [EC + FOLFIRI] | 13.8 | Not reported | 4.9 | 15.9 | Not reported |
| SLI: Cohort 2 [EC + mFOLFOX6] | 9.0 | Not reported | 6.9 | 12.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and upper limit of 95% confidence interval (CI) could not be estimated due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 15.3
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 6.4
- upper Limit
- 21.9
- value
- 9.9
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 19
- units
- Participants
- title
- First Line Treatment
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.9
- upper Limit
- 15.9
- value
- 13.8
- group Id
- OG001
- lower Limit
- 6.9
- upper Limit
- 12.4
- value
- 9.0
- denoms
- counts
- group Id
- OG000
- value
- 18
- group Id
- OG001
- value
- 8
- units
- Participants
- title
- Second Line Treatment
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 27
- units
- Participants
- description
- PFS: time from date of randomization to earliest documented PD per RECIST version 1.1 or death due to any cause as assessed by response reported by investigator on eCRF. 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. Censoring details: no adequate baseline assessment, including no disease at baseline: participants were censored to randomization date; no PD, lost to follow-up, withdrawal of consent, PD or death \>12 (or 16) weeks after the last adequate tumor assessment, and start of new anticancer treatment: participants were censored to last adequate tumor assessment documenting no PD prior to new anticancer therapy, or missed assessments. Participants with PFS for first line and second line were presented. Analysis performed using Kaplan Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received encorafenib 300 milligrams (mg) once daily (QD) orally (received after Cycle 1 Day 3) and cetuximab 500 mg per square meters (mg/m\^2) intravenous (IV) infusion for 120 minutes once every 2 weeks (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
- SLI: Cohort 1 [EC + FOLFIRI]
- 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
- OG001
- title
- SLI: Cohort 2 [EC + mFOLFOX6]
- param Type
- MEDIAN
- population Description
- The FAS for SLI included all participants who were randomized in the SLI portion of the study. Here, "Number Analyzed" signifies participants evaluable for specified rows. All participants under "Overall Number of Participants Analyzed" contributed data to the table but may not have data evaluable for each row.
- reporting Status
- POSTED
- time Frame
- From date of randomization to earliest documentation of PD or death or censoring date, whichever occurred first (maximum up to 33.9 months)
- title
- SLI: PFS as Assessed by Investigator According to Line of Therapy - FAS
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice