TriangleNCT01667419 · OUTCOME
Disease-Free Survival (DFS) as Assessed Using Contrast-Enhanced Magnetic Resonance Imaging (MRI) or Contrast Enhanced Computed Tomography (CT)
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 randomization until the date of the first local, regional, or distant melanoma recurrence, occurrence of new primary melanoma, or death from any cause (up to the April 17, 2017 data cut-off, approximately 4.5 years)
What was measured
DFS was defined as the time from randomization until the date of the first local, regional, or distant melanoma recurrence, occurrence of new primary melanoma, or death from any cause.
Analysis population: The ITT population included all participants enrolled in the study, whether or not they had received study medication.
Groups in this outcome
Cohort 1 Vemurafenib
Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
Cohort 1 Placebo
Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Cohort 2 Vemurafenib
Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
Cohort 2 Placebo
Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
| Group | Source count |
|---|---|
| Cohort 1 Vemurafenib | 157 |
| Cohort 1 Placebo | 157 |
| Cohort 2 Vemurafenib | 93 |
| Cohort 2 Placebo | 91 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 Vemurafenib | NA | Not reported | NA | NA | Not estimable due to low number of events. |
| Cohort 1 Placebo | 36.9 | Not reported | 21.4 | NA | Not estimable due to low number of events. |
| Cohort 2 Vemurafenib | 23.1 | Not reported | 18.6 | 26.5 | Not reported |
| Cohort 2 Placebo | 15.4 | Not reported | 11.1 | 35.9 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.37
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.78
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0010
- param Type
- Hazard Ratio (HR)
- param Value
- 0.54
- statistical Method
- Log Rank
- ci Lower Limit
- 0.54
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.18
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2598
- param Type
- Hazard Ratio (HR)
- param Value
- 0.80
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.37
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.78
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0010
- param Type
- Hazard Ratio (HR)
- param Value
- 0.54
- statistical Method
- Log Rank
- ci Lower Limit
- 0.54
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.18
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.2598
- param Type
- Hazard Ratio (HR)
- param Value
- 0.80
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Not estimable due to low number of events.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Not estimable due to low number of events.
- group Id
- OG001
- lower Limit
- 21.4
- upper Limit
- NA
- value
- 36.9
- group Id
- OG002
- lower Limit
- 18.6
- upper Limit
- 26.5
- value
- 23.1
- group Id
- OG003
- lower Limit
- 11.1
- upper Limit
- 35.9
- value
- 15.4
- denoms
- counts
- group Id
- OG000
- value
- 157
- group Id
- OG001
- value
- 157
- group Id
- OG002
- value
- 93
- group Id
- OG003
- value
- 91
- units
- Participants
- description
- DFS was defined as the time from randomization until the date of the first local, regional, or distant melanoma recurrence, occurrence of new primary melanoma, or death from any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
- id
- OG000
- title
- Cohort 1 Vemurafenib
- description
- Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
- id
- OG001
- title
- Cohort 1 Placebo
- description
- Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
- id
- OG002
- title
- Cohort 2 Vemurafenib
- description
- Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
- id
- OG003
- title
- Cohort 2 Placebo
- param Type
- MEDIAN
- population Description
- The ITT population included all participants enrolled in the study, whether or not they had received study medication.
- reporting Status
- POSTED
- time Frame
- From randomization until the date of the first local, regional, or distant melanoma recurrence, occurrence of new primary melanoma, or death from any cause (up to the April 17, 2017 data cut-off, approximately 4.5 years)
- title
- Disease-Free Survival (DFS) as Assessed Using Contrast-Enhanced Magnetic Resonance Imaging (MRI) or Contrast Enhanced Computed Tomography (CT)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice