TriangleNCT01682083 · OUTCOME
Relapse-free Survival (RFS)
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
- Approximately 4 years
What was measured
Relapse-Free Survival (RFS) was defined as the time from randomization to disease recurrence or death from any cause. RFS events included loco-regional recurrence, distant metastases, new primary melanoma, and death without prior documented recurrence; such deaths were counted as events and not censored. Patients without an event at the analysis cut-off (30-Jun-2017) were censored at the date of the last radiological or non-radiological efficacy assessment. Patients lost to follow-up before recurrence or who initiated subsequent anti-cancer therapy prior to recurrence were censored at the last efficacy assessment before loss to follow-up or therapy initiation. Events after prolonged loss to follow-up were handled per the analysis plan. Malignancies other than new primary melanoma were not considered RFS events and, except for basal cell carcinoma, were reported as serious adverse events. Tumor tissue from any new primary cancer was collected for biomarker analyses.
Analysis population: Intent-to-Treat (ITT) Population
Groups in this outcome
Dabrafenib and Trametinib Combination Therapy
Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
Dabrafenib and Trametinib Placebos
Subjects received matching placebos orally for 12 months
| Group | Source count |
|---|---|
| Dabrafenib and Trametinib Combination Therapy | 438 |
| Dabrafenib and Trametinib Placebos | 432 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dabrafenib and Trametinib Combination Therapy | NA | Not reported | 44.5 | NA | N/A: Not Estimable due to number of events censored |
| Dabrafenib and Trametinib Placebos | 16.6 | Not reported | 12.7 | 22.1 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.39
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.58
- group Description
- The null hypothesis, H0: λ = 1 or reject it in favor of the alternative hypothesis, HA: λ ≠ 1, where λ is the hazard ratio (HR) of combination therapy relative to placebo.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Hazard ratio is obtained from the stratified Pike estimator. A hazard ratio \<1 indicates a lower risk with Dabrafenib + Trametinib compared with Placebo.
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.0001
- param Type
- Hazard Ratio, log
- param Value
- 0.47
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.39
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.58
- group Description
- The null hypothesis, H0: λ = 1 or reject it in favor of the alternative hypothesis, HA: λ ≠ 1, where λ is the hazard ratio (HR) of combination therapy relative to placebo.
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Hazard ratio is obtained from the stratified Pike estimator. A hazard ratio \<1 indicates a lower risk with Dabrafenib + Trametinib compared with Placebo.
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.0001
- param Type
- Hazard Ratio, log
- param Value
- 0.47
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- N/A: Not Estimable due to number of events censored
- group Id
- OG000
- lower Limit
- 44.5
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 12.7
- upper Limit
- 22.1
- value
- 16.6
- denoms
- counts
- group Id
- OG000
- value
- 438
- group Id
- OG001
- value
- 432
- units
- Participants
- description
- Relapse-Free Survival (RFS) was defined as the time from randomization to disease recurrence or death from any cause. RFS events included loco-regional recurrence, distant metastases, new primary melanoma, and death without prior documented recurrence; such deaths were counted as events and not censored. Patients without an event at the analysis cut-off (30-Jun-2017) were censored at the date of the last radiological or non-radiological efficacy assessment. Patients lost to follow-up before recurrence or who initiated subsequent anti-cancer therapy prior to recurrence were censored at the last efficacy assessment before loss to follow-up or therapy initiation. Events after prolonged loss to follow-up were handled per the analysis plan. Malignancies other than new primary melanoma were not considered RFS events and, except for basal cell carcinoma, were reported as serious adverse events. Tumor tissue from any new primary cancer was collected for biomarker analyses.
- dispersion Type
- Full Range
- groups
- description
- Subjects received dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) orally for 12 months.
- id
- OG000
- title
- Dabrafenib and Trametinib Combination Therapy
- description
- Subjects received matching placebos orally for 12 months
- id
- OG001
- title
- Dabrafenib and Trametinib Placebos
- param Type
- MEDIAN
- population Description
- Intent-to-Treat (ITT) Population
- reporting Status
- POSTED
- time Frame
- Approximately 4 years
- title
- Relapse-free Survival (RFS)
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice