TriangleNCT03036098 · OUTCOME
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Cisplatin-eligible Participants for Sub-study
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 first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months)
What was measured
This measure looks at how long people who can receive cisplatin chemotherapy live without their cancer getting worse after being assigned to a treatment group in the sub-study. Progression-Free Survival (PFS) is the time from when a participant is assigned to a group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment was given. These experts use standard rules (RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand if the treatment helps people eligible for cisplatin live longer without their cancer progressing.
Analysis population: All Cisplatin-eligible Randomized Participants - Sub-study
Groups in this outcome
Treatment 3
Participants received Nivolumab 360 mg in combination with Standard of Care treatment every 3 weeks (Q3W) for up to 6 cycles followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Sub-study
Treatment 4
Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Sub-study
| Group | Source count |
|---|---|
| Treatment 3 | 304 |
| Treatment 4 | 304 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment 3 | 7.92 | Not reported | 7.62 | 9.49 | Not reported |
| Treatment 4 | 7.56 | Not reported | 6.05 | 7.75 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.59
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.88
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0018
- param Type
- Hazard Ratio (HR)
- param Value
- 0.72
- statistical Comment
- Stratified weighted log-rank test
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.59
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.88
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0018
- param Type
- Hazard Ratio (HR)
- param Value
- 0.72
- statistical Comment
- Stratified weighted log-rank test
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.62
- upper Limit
- 9.49
- value
- 7.92
- group Id
- OG001
- lower Limit
- 6.05
- upper Limit
- 7.75
- value
- 7.56
- denoms
- counts
- group Id
- OG000
- value
- 304
- group Id
- OG001
- value
- 304
- units
- Participants
- description
- This measure looks at how long people who can receive cisplatin chemotherapy live without their cancer getting worse after being assigned to a treatment group in the sub-study. Progression-Free Survival (PFS) is the time from when a participant is assigned to a group (randomization) until their cancer is first shown to get worse (progress), based on reviews by independent experts who do not know which treatment was given. These experts use standard rules (RECIST 1.1) to decide if the cancer has progressed. If a participant dies before their cancer is shown to get worse, the date of death will be used as the time their disease progressed. If a participant's cancer does not get worse and they do not die during the study, their PFS will be measured up to the date of their last tumor check. This helps to understand if the treatment helps people eligible for cisplatin live longer without their cancer progressing.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received Nivolumab 360 mg in combination with Standard of Care treatment every 3 weeks (Q3W) for up to 6 cycles followed by Nivolumab monotherapy 480 mg every 4 weeks (Q4W) - Sub-study
- id
- OG000
- title
- Treatment 3
- description
- Participants received Standard of Care treatment every three weeks (Q3W) for up to 6 cycles - Sub-study
- id
- OG001
- title
- Treatment 4
- param Type
- MEDIAN
- population Description
- All Cisplatin-eligible Randomized Participants - Sub-study
- reporting Status
- POSTED
- time Frame
- From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months)
- title
- Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Cisplatin-eligible Participants for Sub-study
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice