TriangleNCT01072175 · OUTCOME
Part C (Randomized): Progression-free Survival (PFS) as Assessed by the Blinded Independent Central Review (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 the date of randomization to the earliest date of disease progression (PD) or death due to any cause (up to approximately 19 months)
What was measured
PFS is defined as the interval between the date of randomization 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 BICR 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 who received anti-cancer therapy prior to the date of documented events, were censored at the last adequate assessment prior to the initiation of therapy. If the participant did not had a documented date of events, PFS and survival were censored at the date of the last adequate assessment
Analysis population: ITT Population
Groups in this outcome
Part C: Dabrafenib 150 mg
Participants received dabrafenib 150 mg gelatin capsules BID.
Part C: Dabrafenib 150 mg + Trametinib 1 mg
Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
Part C: Dabrafenib 150 mg + Trametinib 2 mg
Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
| Group | Source count |
|---|---|
| Part C: Dabrafenib 150 mg | 54 |
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 54 |
| Part C: Dabrafenib 150 mg + Trametinib 2 mg | 54 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part C: Dabrafenib 150 mg | 7.3 | Not reported | 5.5 | 9.4 | Not reported |
| Part C: Dabrafenib 150 mg + Trametinib 1 mg | 8.3 | Not reported | 5.6 | 11.3 | Not reported |
| Part C: Dabrafenib 150 mg + Trametinib 2 mg | 9.2 | Not reported | 7.6 | NA | NA: Not estimable due to insufficient number of participants with events |
Source statistical analyses
- ci Lower Limit
- 0.45
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.18
- estimate Comment
- HRs were estimated using the Pike estimator.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.1667
- param Type
- Hazard Ratio (HR)
- param Value
- 0.73
- statistical Method
- Log Rank
- ci Lower Limit
- 0.32
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.90
- estimate Comment
- HRs were estimated using the Pike estimator.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0119
- param Type
- Hazard Ratio (HR)
- param Value
- 0.54
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.45
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.18
- estimate Comment
- HRs were estimated using the Pike estimator.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.1667
- param Type
- Hazard Ratio (HR)
- param Value
- 0.73
- statistical Method
- Log Rank
- ci Lower Limit
- 0.32
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.90
- estimate Comment
- HRs were estimated using the Pike estimator.
- group Ids
- OG000
- OG002
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0119
- param Type
- Hazard Ratio (HR)
- param Value
- 0.54
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.5
- upper Limit
- 9.4
- value
- 7.3
- group Id
- OG001
- lower Limit
- 5.6
- upper Limit
- 11.3
- value
- 8.3
- comment
- NA: Not estimable due to insufficient number of participants with events
- group Id
- OG002
- lower Limit
- 7.6
- upper Limit
- NA
- value
- 9.2
- denoms
- counts
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 54
- group Id
- OG002
- value
- 54
- units
- Participants
- description
- PFS is defined as the interval between the date of randomization 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 BICR 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 who received anti-cancer therapy prior to the date of documented events, were censored at the last adequate assessment prior to the initiation of therapy. If the participant did not had 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 received dabrafenib 150 mg gelatin capsules BID.
- id
- OG000
- title
- Part C: Dabrafenib 150 mg
- description
- Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
- id
- OG001
- title
- Part C: Dabrafenib 150 mg + Trametinib 1 mg
- description
- Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
- id
- OG002
- title
- Part C: Dabrafenib 150 mg + Trametinib 2 mg
- param Type
- MEDIAN
- population Description
- ITT Population
- reporting Status
- POSTED
- time Frame
- From the date of randomization to the earliest date of disease progression (PD) or death due to any cause (up to approximately 19 months)
- title
- Part C (Randomized): Progression-free Survival (PFS) as Assessed by the Blinded Independent Central Review (BICR)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice