TriangleNCT02101788 · OUTCOME
Progression Free Survival
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
- Time from study entry to time of progression or death, an average of 7 months for SOC and 13 months for the treatment (Trametinib) arm.
What was measured
Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan. RECIST v1.1 defines progression as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Analysis population: Patients with sufficient tissue for analysis
Groups in this outcome
KRAS/BRAF/NRAS Mutant Group (MAPK Pathway) (Trametinib)
KRAS/BRAF/NRAS mutant group (MAPK pathway) (Trametinib treatment) - Whole Exome Sequencing
KRAS/BRAF/NRAS Mutant Group (MAPK Pathway) (SOC)
KRAS/BRAF/NRAS mutant group (MAPK pathway) (Standard of Care treatment) - Whole Exome Sequencing
KRAS/BRAF/NRAS Wild-type (MAPK Pathway) (Trametinib)
KRAS/BRAF/NRAS wild-type (MAPK pathway) (Trametinib treatment) - Whole Exome Sequencing
KRAS/BRAF/NRAS Wild-type (MAPK Pathway) (SOC)
KRAS/BRAF/NRAS wild-type (MAPK pathway) (Standard of Care treatment) - Whole Exome Sequencing
| Group | Source count |
|---|---|
| KRAS/BRAF/NRAS Mutant Group (MAPK Pathway) (Trametinib) | 22 |
| KRAS/BRAF/NRAS Mutant Group (MAPK Pathway) (SOC) | 22 |
| KRAS/BRAF/NRAS Wild-type (MAPK Pathway) (Trametinib) | 48 |
| KRAS/BRAF/NRAS Wild-type (MAPK Pathway) (SOC) | 42 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| KRAS/BRAF/NRAS Mutant Group (MAPK Pathway) (Trametinib) | 13.2 | Not reported | 9.4 | 20.8 | Not reported |
| KRAS/BRAF/NRAS Mutant Group (MAPK Pathway) (SOC) | 11.4 | Not reported | 3.7 | 13.3 | Not reported |
| KRAS/BRAF/NRAS Wild-type (MAPK Pathway) (Trametinib) | 7.3 | Not reported | 5.6 | 12.7 | Not reported |
| KRAS/BRAF/NRAS Wild-type (MAPK Pathway) (SOC) | 6.3 | Not reported | 3.7 | 9.9 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.28
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.07
- estimate Comment
- Estimation of treatment effect; Trametinib vs. SOC among patients with a mutation.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.55
- ci Lower Limit
- 0.39
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.03
- estimate Comment
- Estimation of treatment effect; Trametinib vs. SOC among wild-type patients.
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.64
- ci Lower Limit
- 0.34
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.08
- estimate Comment
- Estimation of mutation effect; mutant vs. wild-type in the SOC group.
- group Description
- Prognostic effect of the mutation status among patients in the SOC arm.
- group Ids
- OG001
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0929
- param Type
- Hazard Ratio (HR)
- param Value
- 0.60
- statistical Method
- Chi-squared
- group Description
- Predictive effect biomarker p-value
- group Ids
- OG000
- OG001
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7195
- statistical Method
- Chi-squared
Complete source fields
- analyses
- ci Lower Limit
- 0.28
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.07
- estimate Comment
- Estimation of treatment effect; Trametinib vs. SOC among patients with a mutation.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.55
- ci Lower Limit
- 0.39
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.03
- estimate Comment
- Estimation of treatment effect; Trametinib vs. SOC among wild-type patients.
- group Ids
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.64
- ci Lower Limit
- 0.34
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.08
- estimate Comment
- Estimation of mutation effect; mutant vs. wild-type in the SOC group.
- group Description
- Prognostic effect of the mutation status among patients in the SOC arm.
- group Ids
- OG001
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0929
- param Type
- Hazard Ratio (HR)
- param Value
- 0.60
- statistical Method
- Chi-squared
- group Description
- Predictive effect biomarker p-value
- group Ids
- OG000
- OG001
- OG002
- OG003
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7195
- statistical Method
- Chi-squared
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.4
- upper Limit
- 20.8
- value
- 13.2
- group Id
- OG001
- lower Limit
- 3.7
- upper Limit
- 13.3
- value
- 11.4
- group Id
- OG002
- lower Limit
- 5.6
- upper Limit
- 12.7
- value
- 7.3
- group Id
- OG003
- lower Limit
- 3.7
- upper Limit
- 9.9
- value
- 6.3
- denoms
- counts
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 22
- group Id
- OG002
- value
- 48
- group Id
- OG003
- value
- 42
- units
- Participants
- description
- Progression free survival (PFS) was defined as the number of months between study enrollment and documentation of disease progression (RECIST 1.1) or death from any cause. Patients still alive and disease free at the last followup were censored on the date of last CT Scan. RECIST v1.1 defines progression as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- KRAS/BRAF/NRAS mutant group (MAPK pathway) (Trametinib treatment) - Whole Exome Sequencing
- id
- OG000
- title
- KRAS/BRAF/NRAS Mutant Group (MAPK Pathway) (Trametinib)
- description
- KRAS/BRAF/NRAS mutant group (MAPK pathway) (Standard of Care treatment) - Whole Exome Sequencing
- id
- OG001
- title
- KRAS/BRAF/NRAS Mutant Group (MAPK Pathway) (SOC)
- description
- KRAS/BRAF/NRAS wild-type (MAPK pathway) (Trametinib treatment) - Whole Exome Sequencing
- id
- OG002
- title
- KRAS/BRAF/NRAS Wild-type (MAPK Pathway) (Trametinib)
- description
- KRAS/BRAF/NRAS wild-type (MAPK pathway) (Standard of Care treatment) - Whole Exome Sequencing
- id
- OG003
- title
- KRAS/BRAF/NRAS Wild-type (MAPK Pathway) (SOC)
- param Type
- MEDIAN
- population Description
- Patients with sufficient tissue for analysis
- reporting Status
- POSTED
- time Frame
- Time from study entry to time of progression or death, an average of 7 months for SOC and 13 months for the treatment (Trametinib) arm.
- title
- Progression Free Survival
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice