TriangleNCT02743494 · OUTCOME
Disease-free Survival (DFS)
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 randomization to the date of recurrence or death (up to approximately 46 months)
What was measured
Disease-free survival is defined as the time between randomization date and first date of recurrence or death, whichever occurs first. Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary resected site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as DFS events. For participants who remained alive and without recurrence, DFS was censured on the date of last evaluable disease assessment
Analysis population: All randomized participants
Groups in this outcome
Nivolumab
Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles.
Placebo
Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles
| Group | Source count |
|---|---|
| Nivolumab | 532 |
| Placebo | 262 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Nivolumab | 22.41 | Not reported | 16.62 | 34.00 | Not reported |
| Placebo | 11.04 | Not reported | 8.34 | 14.32 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 96.4
- ci Upper Limit
- 0.86
- estimate Comment
- Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Placebo.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0003
- param Type
- Hazard Ratio (HR)
- param Value
- 0.69
- statistical Method
- Stratified log-rank test
Complete source fields
- analyses
- ci Lower Limit
- 0.56
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 96.4
- ci Upper Limit
- 0.86
- estimate Comment
- Stratified Cox proportional hazard model. Hazard Ratio is Nivolumab over Placebo.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0003
- param Type
- Hazard Ratio (HR)
- param Value
- 0.69
- statistical Method
- Stratified log-rank test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16.62
- upper Limit
- 34.00
- value
- 22.41
- group Id
- OG001
- lower Limit
- 8.34
- upper Limit
- 14.32
- value
- 11.04
- denoms
- counts
- group Id
- OG000
- value
- 532
- group Id
- OG001
- value
- 262
- units
- Participants
- description
- Disease-free survival is defined as the time between randomization date and first date of recurrence or death, whichever occurs first. Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary resected site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as DFS events. For participants who remained alive and without recurrence, DFS was censured on the date of last evaluable disease assessment
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab 240 mg Q2W for 8 cycles (16 weeks) followed by Nivolumab 480 mg Q4W for 9 cycles.
- id
- OG000
- title
- Nivolumab
- description
- Placebo IV Q2W for 8 cycles (16 weeks) followed by Placebo IV Q4W for 9 cycles
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- All randomized participants
- reporting Status
- POSTED
- time Frame
- From randomization to the date of recurrence or death (up to approximately 46 months)
- title
- Disease-free Survival (DFS)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice