TriangleNCT03915951 · OUTCOME
Time to Response (TTR) by IRR and Investigator Assessments
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- Full Range
- Time frame
- From the date of first dose to the first documentation of confirmed objective response (CR or PR) (up to 36 months)
What was measured
TTR based on IRR and Investigator assessments was defined, for participants with an objective response, as the time, in months, from the date of first dose to the first documentation of objective response (CR or PR) which was subsequently confirmed (by IRR and by Investigator, respectively). TTR was calculated for the subgroup of participants with a confirmed objective tumor response.
Analysis population: Analysis population included all participants who received at least 1 dose of study intervention and who had confirmed objective tumor response (CR or PR). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
Groups in this outcome
Treatment-Naive
Treatment-naïve participants with BRAF V600E-mutant metastatic NSCLC were enrolled to receive encorafenib 450 mg QD and binimetinib 45 mg BID in 28-day (±3 days) cycles and continued until the participants met the protocol-defined criteria for treatment withdrawal.
Previously Treated
Patients who had received 1) first-line treatment with standard platinum-based chemotherapy, or 2) first-line treatment with an anti-PD-1/PD-L1 inhibitor given alone, or in combination with platinum-based chemotherapy, or in combination with immunotherapy (eg, ipilimumab) with or without platinum-based chemotherapy were enrolled to receive encorafenib 450 mg QD and binimetinib 45 mg BID was to be administered in 28-day (±3 days) cycles and continued until the participants met the protocol-defined criteria for treatment withdrawal.
| Group | Source count |
|---|---|
| Treatment-Naive | 59 |
| Previously Treated | 39 |
Reported measurements
TTR by IRR
| Group | Source count |
|---|---|
| Treatment-Naive | 44 |
| Previously Treated | 18 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment-Naive | 1.86 | Not reported | 1.1 | 19.1 | Not reported |
| Previously Treated | 1.74 | Not reported | 1.2 | 7.3 | Not reported |
TTR by Investigator Assessment
| Group | Source count |
|---|---|
| Treatment-Naive | 37 |
| Previously Treated | 16 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment-Naive | 1.84 | Not reported | 1.4 | 14.0 | Not reported |
| Previously Treated | 1.81 | Not reported | 0.8 | 9.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.1
- upper Limit
- 19.1
- value
- 1.86
- group Id
- OG001
- lower Limit
- 1.2
- upper Limit
- 7.3
- value
- 1.74
- denoms
- counts
- group Id
- OG000
- value
- 44
- group Id
- OG001
- value
- 18
- units
- Participants
- title
- TTR by IRR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.4
- upper Limit
- 14.0
- value
- 1.84
- group Id
- OG001
- lower Limit
- 0.8
- upper Limit
- 9.2
- value
- 1.81
- denoms
- counts
- group Id
- OG000
- value
- 37
- group Id
- OG001
- value
- 16
- units
- Participants
- title
- TTR by Investigator Assessment
- denoms
- counts
- group Id
- OG000
- value
- 59
- group Id
- OG001
- value
- 39
- units
- Participants
- description
- TTR based on IRR and Investigator assessments was defined, for participants with an objective response, as the time, in months, from the date of first dose to the first documentation of objective response (CR or PR) which was subsequently confirmed (by IRR and by Investigator, respectively). TTR was calculated for the subgroup of participants with a confirmed objective tumor response.
- dispersion Type
- Full Range
- groups
- description
- Treatment-naïve participants with BRAF V600E-mutant metastatic NSCLC were enrolled to receive encorafenib 450 mg QD and binimetinib 45 mg BID in 28-day (±3 days) cycles and continued until the participants met the protocol-defined criteria for treatment withdrawal.
- id
- OG000
- title
- Treatment-Naive
- description
- Patients who had received 1) first-line treatment with standard platinum-based chemotherapy, or 2) first-line treatment with an anti-PD-1/PD-L1 inhibitor given alone, or in combination with platinum-based chemotherapy, or in combination with immunotherapy (eg, ipilimumab) with or without platinum-based chemotherapy were enrolled to receive encorafenib 450 mg QD and binimetinib 45 mg BID was to be administered in 28-day (±3 days) cycles and continued until the participants met the protocol-defined criteria for treatment withdrawal.
- id
- OG001
- title
- Previously Treated
- param Type
- MEDIAN
- population Description
- Analysis population included all participants who received at least 1 dose of study intervention and who had confirmed objective tumor response (CR or PR). Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
- reporting Status
- POSTED
- time Frame
- From the date of first dose to the first documentation of confirmed objective response (CR or PR) (up to 36 months)
- title
- Time to Response (TTR) by IRR and Investigator Assessments
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice