TriangleNCT02684006 · OUTCOME
Percentage of Participants With DC in Biomarker-Positive Subgroup
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From date of randomization until PD or death, whichever occurred first (maximum up to approximately 26 months)
What was measured
DC was defined as a best overall response of CR, PR, or stable disease (SD) according to the RECIST v.1.1 recorded from randomization until disease progression or death due to any cause, whichever occurred first. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis\<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. SD was defined as PR that the sum increases by less than 20% from the nadir, (smallest sum of diameters consider baseline and all assessments prior to the time point under evaluation), but enough that a previously documented 30% decrease no longer holds.
Analysis population: Biomarker positive subset in FAS included participants who had at least one biomarker baseline assessment.
Groups in this outcome
Avelumab + Axitinib
Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.
Sunitinib
Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
| Group | Source count |
|---|---|
| Avelumab + Axitinib | 270 |
| Sunitinib | 290 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Avelumab + Axitinib | 84.4 | Not reported | 79.6 | 88.6 | Not reported |
| Sunitinib | 71.0 | Not reported | 65.4 | 76.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 79.6
- upper Limit
- 88.6
- value
- 84.4
- group Id
- OG001
- lower Limit
- 65.4
- upper Limit
- 76.2
- value
- 71.0
- denoms
- counts
- group Id
- OG000
- value
- 270
- group Id
- OG001
- value
- 290
- units
- Participants
- description
- DC was defined as a best overall response of CR, PR, or stable disease (SD) according to the RECIST v.1.1 recorded from randomization until disease progression or death due to any cause, whichever occurred first. CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. All lymph nodes must decrease to normal size (short axis\<10 mm). All target lesions must be assessed. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. All target lesions must be assessed. SD was defined as PR that the sum increases by less than 20% from the nadir, (smallest sum of diameters consider baseline and all assessments prior to the time point under evaluation), but enough that a previously documented 30% decrease no longer holds.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with aRCC received avelumab 10 mg/kg, IV at Q2W in a 6-week cycle plus axitinib 5 mg, orally BID. Each treatment cycle was 42 days.
- id
- OG000
- title
- Avelumab + Axitinib
- description
- Participants with aRCC received sunitinib 50 mg orally, QD on a schedule of 4 weeks on treatment followed by 2 weeks off treatment (schedule 4/2 in 6-week cycles). Each treatment cycle was of 42 days.
- id
- OG001
- title
- Sunitinib
- param Type
- NUMBER
- population Description
- Biomarker positive subset in FAS included participants who had at least one biomarker baseline assessment.
- reporting Status
- POSTED
- time Frame
- From date of randomization until PD or death, whichever occurred first (maximum up to approximately 26 months)
- title
- Percentage of Participants With DC in Biomarker-Positive Subgroup
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice