TriangleNCT01072175 · OUTCOME
Part C (Crossover): Progression-free Survival (PFS) as Assessed by the Investigator
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 the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to approximately 7 years)
What was measured
PFS is defined as the interval between the first dose of study medication and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. Participants received anti-cancer therapy prior to the date of documented events, and censored at the last adequate assessment, prior to the initiation of therapy. If the participant did not have a documented date of events, PFS and survival were censored at the date of the last adequate assessment.
Analysis population: Crossover Population
Groups in this outcome
Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg
Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
| Group | Source count |
|---|---|
| Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg | 45 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg | 3.6 | Not reported | 1.8 | 3.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.8
- upper Limit
- 3.9
- value
- 3.6
- denoms
- counts
- group Id
- OG000
- value
- 45
- units
- Participants
- description
- PFS is defined as the interval between the first dose of study medication and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. Participants received anti-cancer therapy prior to the date of documented events, and censored at the last adequate assessment, prior to the initiation of therapy. If the participant did not have a documented date of events, PFS and survival were censored at the date of the last adequate assessment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
- id
- OG000
- title
- Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg
- param Type
- MEDIAN
- population Description
- Crossover Population
- reporting Status
- POSTED
- time Frame
- From the first dose of study medication to the earliest date of disease progression (PD) or death due to any cause (up to approximately 7 years)
- title
- Part C (Crossover): Progression-free Survival (PFS) as Assessed by the Investigator
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice