TriangleNCT03673501 · OUTCOME
Progression Free Survival (PFS) in the All Patient (AP) 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 to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years)
What was measured
PFS is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review using modified RECIST Version 1.1-(mRECIST 1.1) Gastrointestinal stromal tumor (GIST) specific, or death due to any cause. Per mRECIST 1.1, progression was defined using mRECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Analysis population: All patient (AP) Intent to Treat (ITT) Population is defined as all patients who are randomized. 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 | 226 |
| Sunitinib | 227 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ripretinib | 8.0 | Not reported | 6.5 | 10.8 | Not reported |
| Sunitinib | 8.3 | Not reported | 6.3 | 11.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.82
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.33
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7153
- p Value Comment
- Two-sided P-value
- param Type
- Hazard Ratio (HR)
- param Value
- 1.05
- statistical Comment
- Strata: mutation status (KIT exon 9 vs. 11 vs. KIT/PDGFRA WT vs. other KIT {absence of exon 9 or 11}/PDGFRA) and intolerance to imatinib treatment
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.82
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.33
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.7153
- p Value Comment
- Two-sided P-value
- param Type
- Hazard Ratio (HR)
- param Value
- 1.05
- statistical Comment
- Strata: mutation status (KIT exon 9 vs. 11 vs. KIT/PDGFRA WT vs. other KIT {absence of exon 9 or 11}/PDGFRA) and intolerance to imatinib treatment
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.5
- upper Limit
- 10.8
- value
- 8.0
- group Id
- OG001
- lower Limit
- 6.3
- upper Limit
- 11.0
- value
- 8.3
- denoms
- counts
- group Id
- OG000
- value
- 226
- group Id
- OG001
- value
- 227
- units
- Participants
- description
- PFS is defined as the interval between the date of randomization and the earliest documented evidence of disease progression based on the independent radiologic review using modified RECIST Version 1.1-(mRECIST 1.1) Gastrointestinal stromal tumor (GIST) specific, or death due to any cause. Per mRECIST 1.1, progression was defined using mRECIST 1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- 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
- All patient (AP) Intent to Treat (ITT) Population is defined as all patients who are randomized. 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 to earliest documented evidence of disease progression, or death due to any cause (up to 2.1 years)
- title
- Progression Free Survival (PFS) in the All Patient (AP) Intent to Treat (ITT) Population
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice