TriangleNCT02928224 · OUTCOME
(Phase 3) Comparison of Duration of Response (DOR) in Triplet Arm vs Doublet Arm by BICR
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 time of response to PD or death due to underlying disease (maximum treatment exposure of 277.4 weeks for triplet arm and 268 weeks for doublet arm)
What was measured
DOR was defined as the time from first radiographic evidence of response to the earliest documented PD or death due to underlying disease. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated.
Analysis population: The Phase 3 Response Efficacy Set consisted of the first 330 participants randomized into the Phase 3 portion of the study and any additional participants randomized on the same day as the 330th randomized participant. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
Groups in this outcome
Phase 3: Triplet Arm
Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.
Phase 3:Doublet Arm
Encorafenib + cetuximab. Encorafenib: Orally, once daily. Cetuximab: Standard of care.
| Group | Source count |
|---|---|
| Phase 3: Triplet Arm | 111 |
| Phase 3:Doublet Arm | 113 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 3: Triplet Arm | 4.80 | Not reported | 2.96 | 9.69 | Not reported |
| Phase 3:Doublet Arm | 6.06 | Not reported | 4.07 | 8.28 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.96
- upper Limit
- 9.69
- value
- 4.80
- group Id
- OG001
- lower Limit
- 4.07
- upper Limit
- 8.28
- value
- 6.06
- denoms
- counts
- group Id
- OG000
- value
- 111
- group Id
- OG001
- value
- 113
- units
- Participants
- description
- DOR was defined as the time from first radiographic evidence of response to the earliest documented PD or death due to underlying disease. PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Encorafenib + binimetinib + cetuximab. Encorafenib: Orally, once daily. Binimetinib: Orally, twice daily. Cetuximab: Standard of care.
- id
- OG000
- title
- Phase 3: Triplet Arm
- description
- Encorafenib + cetuximab. Encorafenib: Orally, once daily. Cetuximab: Standard of care.
- id
- OG001
- title
- Phase 3:Doublet Arm
- param Type
- MEDIAN
- population Description
- The Phase 3 Response Efficacy Set consisted of the first 330 participants randomized into the Phase 3 portion of the study and any additional participants randomized on the same day as the 330th randomized participant. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- From time of response to PD or death due to underlying disease (maximum treatment exposure of 277.4 weeks for triplet arm and 268 weeks for doublet arm)
- title
- (Phase 3) Comparison of Duration of Response (DOR) in Triplet Arm vs Doublet Arm by BICR
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice