TriangleNCT02684006 · OUTCOME
Overall Survival (OS) in PD-L1 Positive Participants
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 the date of randomization to the date of death due to any cause or censoring date, whichever occurred first (maximum up to approximately 89 months)
What was measured
OS was defined as the time from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.
Analysis population: FAS included all participants who are randomized. Analysis was performed on subset of randomized participants, who were PD-L1 positive.
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 | 43.2 | Not reported | 36.5 | 51.7 | Not reported |
| Sunitinib | 36.2 | Not reported | 29.8 | 44.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.701
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.057
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1509
- p Value Comment
- 2-sided p-value
- param Type
- Hazard Ratio (HR)
- param Value
- 0.86
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.701
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.057
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1509
- p Value Comment
- 2-sided p-value
- param Type
- Hazard Ratio (HR)
- param Value
- 0.86
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 36.5
- upper Limit
- 51.7
- value
- 43.2
- group Id
- OG001
- lower Limit
- 29.8
- upper Limit
- 44.2
- value
- 36.2
- denoms
- counts
- group Id
- OG000
- value
- 270
- group Id
- OG001
- value
- 290
- units
- Participants
- description
- OS was defined as the time from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.
- 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
- MEDIAN
- population Description
- FAS included all participants who are randomized. Analysis was performed on subset of randomized participants, who were PD-L1 positive.
- reporting Status
- POSTED
- time Frame
- From the date of randomization to the date of death due to any cause or censoring date, whichever occurred first (maximum up to approximately 89 months)
- title
- Overall Survival (OS) in PD-L1 Positive Participants
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice