TriangleNCT03732677 · OUTCOME
Event-free Survival (EFS) Per Central Review Defined as Time From Randomization to Event
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- Up to 48 months
What was measured
EFS is defined as the time from randomization to the first recurrence of disease post radical cystectomy, time of first documented progression in patients who were medically precluded for radical cystectomy, or time of expected surgery in patients who refuse to undergo a radical cystectomy or failure to undergo a radical cystectomy in participants with residual disease, or the time of death due to any cause, whichever occurs first
Analysis population: The full analysis set (FAS) includes all randomized patients
Groups in this outcome
Durvalumab + Gemcitabine + Cisplatin
Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
Gemcitabine + Cisplatin
Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
| Group | Source count |
|---|---|
| Durvalumab + Gemcitabine + Cisplatin | 533 |
| Gemcitabine + Cisplatin | 530 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Durvalumab + Gemcitabine + Cisplatin | NA | Not reported | 13.4 | NA | Median EFS was not reached due to insufficient number of participants with events 75th percentile EFS was not reached due to insufficient number of participants with events. |
| Gemcitabine + Cisplatin | 46.1 | Not reported | 8.6 | NA | 75th percentile EFS was not reached due to insufficient number of participants with events. |
Source statistical analyses
- ci Lower Limit
- 0.554
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95.877
- ci Upper Limit
- 0824
- estimate Comment
- The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- other Analysis Description
- 95% CI for hazard ratio: 0.558 - 0.817
- p Value
- <0.0001
- p Value Comment
- Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \>T2N0), PDL1 status(high vs low/negative)
- param Type
- Hazard Ratio (HR)
- param Value
- 0.68
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.554
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95.877
- ci Upper Limit
- 0824
- estimate Comment
- The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for renal function (adequate vs borderline), tumor stage (T2N0 vs \>T2N0) and PDL1 status (high vs low/negative)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- other Analysis Description
- 95% CI for hazard ratio: 0.558 - 0.817
- p Value
- <0.0001
- p Value Comment
- Stratified by renal function(adequate vs borderline),tumor stage(T2N0 vs \>T2N0), PDL1 status(high vs low/negative)
- param Type
- Hazard Ratio (HR)
- param Value
- 0.68
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Median EFS was not reached due to insufficient number of participants with events 75th percentile EFS was not reached due to insufficient number of participants with events.
- group Id
- OG000
- lower Limit
- 13.4
- upper Limit
- NA
- value
- NA
- comment
- 75th percentile EFS was not reached due to insufficient number of participants with events.
- group Id
- OG001
- lower Limit
- 8.6
- upper Limit
- NA
- value
- 46.1
- denoms
- counts
- group Id
- OG000
- value
- 533
- group Id
- OG001
- value
- 530
- units
- Participants
- description
- EFS is defined as the time from randomization to the first recurrence of disease post radical cystectomy, time of first documented progression in patients who were medically precluded for radical cystectomy, or time of expected surgery in patients who refuse to undergo a radical cystectomy or failure to undergo a radical cystectomy in participants with residual disease, or the time of death due to any cause, whichever occurs first
- dispersion Type
- Inter-Quartile Range
- groups
- description
- Treatments and dosing regimens: Durvalumab 1500 mg IV q3w (neoadjuvant) 1500 mg IV q4w (adjuvant post-radical cystectomy) Day 1 and Day 8 (gemcitabine 1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
- id
- OG000
- title
- Durvalumab + Gemcitabine + Cisplatin
- description
- Treatments and dosing regimens: Day 1 and Day 8 (gemcitabine1000 mg/m2 IV) of each 21-day cycle (neoadjuvant) Day 1 and Day 8 (cisplatin 35mg/m2 IV) or Day 1 (cisplatin 70 mg/m2 IV) each 21-day cycle (neoadjuvant) Dosing will be adjusted based on renal function
- id
- OG001
- title
- Gemcitabine + Cisplatin
- param Type
- MEDIAN
- population Description
- The full analysis set (FAS) includes all randomized patients
- reporting Status
- POSTED
- time Frame
- Up to 48 months
- title
- Event-free Survival (EFS) Per Central Review Defined as Time From Randomization to Event
- type
- PRIMARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice