TriangleNCT01597908 · OUTCOME
Overall Response Rate (ORR) During Randomized Phase, as Assessed by the Investigator
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization until the first documented complete response or partial response (up to approximately 6 years)
What was measured
Overall response was defined as the percentage of confirmed responders (complete response \[CR\] + partial response \[PR\] per RECIST, Version 1.1) as summarized by Investigator assessment. CR was defined as the disappearance of all evidence of target lesions. PR was defined as at least a 30% reduction from Baseline in the sum of the longest diameter (LD) of all target lesions. Data were reported as those participants with measureable disease at Baseline.
Analysis population: Intent-to-Treat (ITT) Population. Only participants with measurable disease at baseline were included.
Groups in this outcome
Dabrafenib Plus Trametinib
Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.
Vemurafenib
Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.
| Group | Source count |
|---|---|
| Dabrafenib Plus Trametinib | 351 |
| Vemurafenib | 350 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dabrafenib Plus Trametinib | 68 | Not reported | 62.3 | 72.4 | Not reported |
| Vemurafenib | 53 | Not reported | 47.2 | 57.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 62.3
- upper Limit
- 72.4
- value
- 68
- group Id
- OG001
- lower Limit
- 47.2
- upper Limit
- 57.9
- value
- 53
- denoms
- counts
- group Id
- OG000
- value
- 351
- group Id
- OG001
- value
- 350
- units
- Participants
- description
- Overall response was defined as the percentage of confirmed responders (complete response \[CR\] + partial response \[PR\] per RECIST, Version 1.1) as summarized by Investigator assessment. CR was defined as the disappearance of all evidence of target lesions. PR was defined as at least a 30% reduction from Baseline in the sum of the longest diameter (LD) of all target lesions. Data were reported as those participants with measureable disease at Baseline.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Dabrafenib 150 milligrams (mg) orally twice daily (BID) and Trametinib 2 mg orally once daily until disease progression, death, unacceptable toxicity, or withdrawal of consent.
- id
- OG000
- title
- Dabrafenib Plus Trametinib
- description
- Vemurafenib 960 mg orally BID until disease progression, death, unacceptable toxicity, or withdrawal of consent.
- id
- OG001
- title
- Vemurafenib
- param Type
- NUMBER
- population Description
- Intent-to-Treat (ITT) Population. Only participants with measurable disease at baseline were included.
- reporting Status
- POSTED
- time Frame
- From randomization until the first documented complete response or partial response (up to approximately 6 years)
- title
- Overall Response Rate (ORR) During Randomized Phase, as Assessed by the Investigator
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice