TriangleNCT02684006 · OUTCOME
Percentage of Participants With DC as Assessed by Investigator Irrespective of PD-L1 Expression
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 (maximum up to approximately 89 months)
What was measured
DC was defined as a best overall response of CR, PR, non-CR/non-PD or SD according to RECIST v1.1 as assessed by investigator. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. All lymph nodes must decrease to normal size (short axis\<10mm). PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. Non-CR/Non-PD was defined as persistence of any non-target lesions and/or tumor marker level above the normal limits. SD was defined as not to qualify for CR, PR or PD for target lesions and followed PR only if the sum increased 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: FAS included all randomized participants.
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 | 442 |
| Sunitinib | 444 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Avelumab + Axitinib | 85.1 | Not reported | 81.4 | 88.3 | Not reported |
| Sunitinib | 76.4 | Not reported | 72.1 | 80.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 81.4
- upper Limit
- 88.3
- value
- 85.1
- group Id
- OG001
- lower Limit
- 72.1
- upper Limit
- 80.2
- value
- 76.4
- denoms
- counts
- group Id
- OG000
- value
- 442
- group Id
- OG001
- value
- 444
- units
- Participants
- description
- DC was defined as a best overall response of CR, PR, non-CR/non-PD or SD according to RECIST v1.1 as assessed by investigator. CR was defined as complete disappearance of all target and non-target lesions, with the exception of nodal disease and sustained for at least 4 weeks. All lymph nodes must decrease to normal size (short axis\<10mm). PR was defined as at least 30% decrease in the sum of the longest dimensions of target lesions taking as reference the baseline sum longest dimensions. Non-CR/Non-PD was defined as persistence of any non-target lesions and/or tumor marker level above the normal limits. SD was defined as not to qualify for CR, PR or PD for target lesions and followed PR only if the sum increased 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
- FAS included all randomized participants.
- reporting Status
- POSTED
- time Frame
- From date of randomization until PD (maximum up to approximately 89 months)
- title
- Percentage of Participants With DC as Assessed by Investigator Irrespective of PD-L1 Expression
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice