TriangleNCT04472429 · OUTCOME
Overall Survival
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
- up to 56.5 months
What was measured
Overall survival was defined as the time from the date of randomization until the date of death due to any cause.
Analysis population: Full Analysis Set. Median survival time was estimated using Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
Groups in this outcome
Retifanlimab 500 mg Q4W + Chemotherapy
Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).
Placebo + Chemotherapy
Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
| Group | Source count |
|---|---|
| Retifanlimab 500 mg Q4W + Chemotherapy | 154 |
| Placebo + Chemotherapy | 154 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Retifanlimab 500 mg Q4W + Chemotherapy | 32.8 | Not reported | 25.7 | 44.5 | Not reported |
| Placebo + Chemotherapy | 22.2 | Not reported | 15.7 | 27.2 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.55
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.01
- estimate Comment
- A stratified Cox regression with Efron's method for tie handling was used to estimate the hazard ratio.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0305
- p Value Comment
- based on stratified log-rank test at an overall 1-sided 2.5% level of significance, using O'Brien and Fleming boundary to adjust for alpha spending at interim analysis
- param Type
- Hazard Ratio (HR)
- param Value
- 0.75
- statistical Method
- stratified log-rank test
Complete source fields
- analyses
- ci Lower Limit
- 0.55
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.01
- estimate Comment
- A stratified Cox regression with Efron's method for tie handling was used to estimate the hazard ratio.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0305
- p Value Comment
- based on stratified log-rank test at an overall 1-sided 2.5% level of significance, using O'Brien and Fleming boundary to adjust for alpha spending at interim analysis
- param Type
- Hazard Ratio (HR)
- param Value
- 0.75
- statistical Method
- stratified log-rank test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 25.7
- upper Limit
- 44.5
- value
- 32.8
- group Id
- OG001
- lower Limit
- 15.7
- upper Limit
- 27.2
- value
- 22.2
- denoms
- counts
- group Id
- OG000
- value
- 154
- group Id
- OG001
- value
- 154
- units
- Participants
- description
- Overall survival was defined as the time from the date of randomization until the date of death due to any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W) for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason. Participants also received the standard-of-care chemotherapy regimen of up to 6 induction cycles (24 weeks) of carboplatin (AUC5 on Day 1) and paclitaxel (80 mg per meters squared \[mg/m\^2\] on Days 1, 8, and 15).
- id
- OG000
- title
- Retifanlimab 500 mg Q4W + Chemotherapy
- description
- Participants received matching placebo Q4W for up to thirteen 28-day cycles (1 year) in the absence of disease progression, intolerable toxicity, death, withdrawal of consent, being lost to follow-up, or premature discontinuation of all assigned study drug administration or for any other reason.
- id
- OG001
- title
- Placebo + Chemotherapy
- param Type
- MEDIAN
- population Description
- Full Analysis Set. Median survival time was estimated using Kaplan-Meier method. The confidence interval for median survival time was calculated using the method of Brookmeyer and Crowley.
- reporting Status
- POSTED
- time Frame
- up to 56.5 months
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice