TriangleNCT02853331 · OUTCOME
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review
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
- Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)
What was measured
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data. The PFS for participants is presented.
Analysis population: The analysis population consisted of all randomized participants.
Groups in this outcome
Pembrolizumab + Axitinib
Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
Sunitinib
Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
| Group | Source count |
|---|---|
| Pembrolizumab + Axitinib | 432 |
| Sunitinib | 429 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Pembrolizumab + Axitinib | 15.1 | Not reported | 12.6 | 17.7 | Not reported |
| Sunitinib | 11.0 | Not reported | 8.7 | 12.5 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.84
- estimate Comment
- HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.00012
- param Type
- Hazard Ratio (HR)
- param Value
- 0.69
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.84
- estimate Comment
- HR based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by IMDC risk group (favorable vs. intermediate vs. poor) and geographic region (North America vs. Western Europe vs. Rest of World).
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.00012
- param Type
- Hazard Ratio (HR)
- param Value
- 0.69
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.6
- upper Limit
- 17.7
- value
- 15.1
- group Id
- OG001
- lower Limit
- 8.7
- upper Limit
- 12.5
- value
- 11.0
- denoms
- counts
- group Id
- OG000
- value
- 432
- group Id
- OG001
- value
- 429
- units
- Participants
- description
- PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 was calculated using the product-limit (Kaplan-Meier) method for censored data. The PFS for participants is presented.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received pembrolizumab 200 mg intravenously every 3 weeks PLUS axitinib 5 mg orally twice daily.
- id
- OG000
- title
- Pembrolizumab + Axitinib
- description
- Participants received sunitinib 50 mg orally once daily for 4 weeks and then were off treatment for 2 weeks.
- id
- OG001
- title
- Sunitinib
- param Type
- MEDIAN
- population Description
- The analysis population consisted of all randomized participants.
- reporting Status
- POSTED
- time Frame
- Through Database Cutoff Date of 24-Aug-2018 (up to approximately 22 months)
- title
- Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review
- type
- PRIMARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice