TriangleNCT03673501 · OUTCOME
Overall Survival (OS) in the KIT Exon 11 Intent to Treat (ITT) Population
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 date of randomization until death due to any cause (up to 3.33 years)
What was measured
OS was defined as the time from the date of randomization until death due to any cause.
Analysis population: The KIT Exon 11 Intent to Treat (ITT) Population is defined as all patients who are designated as having a mutation in KIT Exon 11 at the time of randomization. Patients in this population will be analyzed according to the treatment they were scheduled to receive.
Groups in this outcome
Ripretinib
Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
Sunitinib
Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
| Group | Source count |
|---|---|
| Ripretinib | 163 |
| Sunitinib | 164 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ripretinib | 34.0 | Not reported | 29.3 | NA | Upper limit of 95% confidence interval (CI) was not estimable due to fewer number of participants with events |
| Sunitinib | 31.5 | Not reported | 29.4 | NA | Upper limit of 95% confidence interval (CI) was not estimable due to fewer number of participants with events |
Source statistical analyses
- ci Lower Limit
- 0.75
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.48
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7733
- param Type
- Hazard Ratio (HR)
- param Value
- 1.05
- statistical Comment
- Strata: intolerance to imatinib treatment
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.75
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.48
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7733
- param Type
- Hazard Ratio (HR)
- param Value
- 1.05
- statistical Comment
- Strata: intolerance to imatinib treatment
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Upper limit of 95% confidence interval (CI) was not estimable due to fewer number of participants with events
- group Id
- OG000
- lower Limit
- 29.3
- upper Limit
- NA
- value
- 34.0
- comment
- Upper limit of 95% confidence interval (CI) was not estimable due to fewer number of participants with events
- group Id
- OG001
- lower Limit
- 29.4
- upper Limit
- NA
- value
- 31.5
- denoms
- counts
- group Id
- OG000
- value
- 163
- group Id
- OG001
- value
- 164
- units
- Participants
- description
- OS was defined as the time from the date of randomization until death due to any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Ripretinib (150 mg) once a day continuous dosing for 6-week (42 days) cycles
- id
- OG000
- title
- Ripretinib
- description
- Sunitinib (50 mg) once a day in 6-week (42 days) cycles with 4 weeks continuous dosing followed by 2 week break.
- id
- OG001
- title
- Sunitinib
- param Type
- MEDIAN
- population Description
- The KIT Exon 11 Intent to Treat (ITT) Population is defined as all patients who are designated as having a mutation in KIT Exon 11 at the time of randomization. Patients in this population will be analyzed according to the treatment they were scheduled to receive.
- reporting Status
- POSTED
- time Frame
- From date of randomization until death due to any cause (up to 3.33 years)
- title
- Overall Survival (OS) in the KIT Exon 11 Intent to Treat (ITT) Population
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice