TriangleNCT03875235 · OUTCOME
Overall Survival (OS) Rate at 18 Months
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From date of randomization until death due to any cause. Calculated at 18 months using the Kaplan-Meier technique.
What was measured
Overall Survival (OS) was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The second interim analysis was pre-specified after approximately 397 OS events occurred in both arms (59% maturity).
Analysis population: Full analysis set
Groups in this outcome
Durvalumab + Gemcitabine + Cisplatin
Drug: Durvalumab IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Placebo + Gemcitabine + Cisplatin
Drug: Placebo IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
| Group | Source count |
|---|---|
| Durvalumab + Gemcitabine + Cisplatin | 341 |
| Placebo + Gemcitabine + Cisplatin | 344 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Durvalumab + Gemcitabine + Cisplatin | 35.1 | Not reported | 29.1 | 41.2 | Not reported |
| Placebo + Gemcitabine + Cisplatin | 25.6 | Not reported | 19.9 | 31.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 29.1
- upper Limit
- 41.2
- value
- 35.1
- group Id
- OG001
- lower Limit
- 19.9
- upper Limit
- 31.7
- value
- 25.6
- denoms
- counts
- group Id
- OG000
- value
- 341
- group Id
- OG001
- value
- 344
- units
- Participants
- description
- Overall Survival (OS) was defined as the time from the date of randomization until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique. The second interim analysis was pre-specified after approximately 397 OS events occurred in both arms (59% maturity).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Drug: Durvalumab IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
- id
- OG000
- title
- Durvalumab + Gemcitabine + Cisplatin
- description
- Drug: Placebo IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
- id
- OG001
- title
- Placebo + Gemcitabine + Cisplatin
- param Type
- NUMBER
- population Description
- Full analysis set
- reporting Status
- POSTED
- time Frame
- From date of randomization until death due to any cause. Calculated at 18 months using the Kaplan-Meier technique.
- title
- Overall Survival (OS) Rate at 18 Months
- type
- PRIMARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice