TriangleNCT02726581 · OUTCOME
Overall Survival (OS)
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 death due to any cause (up to approximately 64 months)
What was measured
The time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a participant was known to be alive.
Analysis population: All randomized participants in Arm A and B. Data was pre-specified to be collected only in the N-Pd and Pd arms.
Groups in this outcome
Arm A: N-Pd
Nivolumab: * Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. * Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Pomalidomide: \- 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: * Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle * Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
Arm B: Pd
Pomalidomide: \- 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: * Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle * Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
| Group | Source count |
|---|---|
| Arm A: N-Pd | 75 |
| Arm B: Pd | 71 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: N-Pd | 24.87 | Not reported | 15.61 | 34.40 | Not reported |
| Arm B: Pd | 21.39 | Not reported | 17.91 | 27.56 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.53
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.19
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.79
Complete source fields
- analyses
- ci Lower Limit
- 0.53
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.19
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.79
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 15.61
- upper Limit
- 34.40
- value
- 24.87
- group Id
- OG001
- lower Limit
- 17.91
- upper Limit
- 27.56
- value
- 21.39
- denoms
- counts
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 71
- units
- Participants
- description
- The time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a participant was known to be alive.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nivolumab: * Cycles 1 through 4: 240 mg IV Days 1, 15 of each 28-day cycle. * Cycles 5 and beyond: 480 mg IV Day 1 of each 28-day cycle. Pomalidomide: \- 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: * Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle * Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
- id
- OG000
- title
- Arm A: N-Pd
- description
- Pomalidomide: \- 4 mg PO QD Days 1-21 of each 28-day cycle. Dexamethasone: * Participants \</= 75 years old: 40 mg PO Days (1, 8, 15, and 22) of each cycle * Participants \> 75 years old: 20 mg PO Days (1, 8, 15, and 22) of each cycle.
- id
- OG001
- title
- Arm B: Pd
- param Type
- MEDIAN
- population Description
- All randomized participants in Arm A and B. Data was pre-specified to be collected only in the N-Pd and Pd arms.
- reporting Status
- POSTED
- time Frame
- From randomization to the date of death due to any cause (up to approximately 64 months)
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice