TriangleNCT03215706 · OUTCOME
Progression Free Survival (PFS) by BICR
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 date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
What was measured
PFS (primary definition) was defined as the time from the randomization date to the date of the first documented tumor progression based on BICR assessment (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Participants who had not progressed or died were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the randomization date. Participants who started any palliative local therapy or subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the palliative local therapy or subsequent anti-cancer therapy, whichever procedure occurred first.
Analysis population: All Randomized Participants, Global Population
Groups in this outcome
Treatment A
Nivolumab + Ipilimumab + Chemotherapy
Treatment B
Chemotherapy only
| Group | Source count |
|---|---|
| Treatment A | 361 |
| Treatment B | 358 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment A | 6.74 | Not reported | 5.55 | 8.05 | Not reported |
| Treatment B | 5.26 | Not reported | 4.37 | 5.59 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.59
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.82
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Treatment A over Treatment B
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.70
- statistical Method
- Log-rank test stratified
Complete source fields
- analyses
- ci Lower Limit
- 0.59
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.82
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Treatment A over Treatment B
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.70
- statistical Method
- Log-rank test stratified
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.55
- upper Limit
- 8.05
- value
- 6.74
- group Id
- OG001
- lower Limit
- 4.37
- upper Limit
- 5.59
- value
- 5.26
- denoms
- counts
- group Id
- OG000
- value
- 361
- group Id
- OG001
- value
- 358
- units
- Participants
- description
- PFS (primary definition) was defined as the time from the randomization date to the date of the first documented tumor progression based on BICR assessment (per RECIST 1.1), or death from any cause, whichever occurred first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Participants who had not progressed or died were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the randomization date. Participants who started any palliative local therapy or subsequent anticancer therapy without a prior reported progression were censored at the last evaluable tumor assessment prior to initiation of the palliative local therapy or subsequent anti-cancer therapy, whichever procedure occurred first.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab + Ipilimumab + Chemotherapy
- id
- OG000
- title
- Treatment A
- description
- Chemotherapy only
- id
- OG001
- title
- Treatment B
- param Type
- MEDIAN
- population Description
- All Randomized Participants, Global Population
- reporting Status
- POSTED
- time Frame
- From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
- title
- Progression Free Survival (PFS) by BICR
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice