TriangleNCT03875235 · OUTCOME
Progression-free Survival (PFS)
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
- Tumor assessments every 6 weeks after randomization for the first 24 weeks and then every 8 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death. Assessed up to maximum of approximately 27 months.
What was measured
PFS based on investigator assessments according to RECIST version 1.1 was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (i.e., PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of ≥5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters, or a measurable increase in a non-target lesion, or the appearance of new lesions. Median PFS was calculated using the Kaplan-Meier technique.
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 | 7.2 | Not reported | 6.7 | 7.4 | Not reported |
| Placebo + Gemcitabine + Cisplatin | 5.7 | Not reported | 5.6 | 6.7 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.63
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95.19
- ci Upper Limit
- 0.89
- estimate Comment
- The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for disease status and primary tumor location.
- group Description
- The 2-sided significance level for PFS at the second interim analysis was 4.81%.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- other Analysis Description
- 95% CI 0.63 to 0.89
- p Value
- 0.001
- p Value Comment
- The p-value is based on a stratified log-rank test adjusting for disease status (initially unresectable versus recurrent) and primary tumor location (IHCC versus EHCC versus GBC), and tested at 0.0481 significance level.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.75
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.63
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95.19
- ci Upper Limit
- 0.89
- estimate Comment
- The HR and CI were estimated from a stratified Cox proportional hazard model adjusting for disease status and primary tumor location.
- group Description
- The 2-sided significance level for PFS at the second interim analysis was 4.81%.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- other Analysis Description
- 95% CI 0.63 to 0.89
- p Value
- 0.001
- p Value Comment
- The p-value is based on a stratified log-rank test adjusting for disease status (initially unresectable versus recurrent) and primary tumor location (IHCC versus EHCC versus GBC), and tested at 0.0481 significance level.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.75
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.7
- upper Limit
- 7.4
- value
- 7.2
- group Id
- OG001
- lower Limit
- 5.6
- upper Limit
- 6.7
- value
- 5.7
- denoms
- counts
- group Id
- OG000
- value
- 341
- group Id
- OG001
- value
- 344
- units
- Participants
- description
- PFS based on investigator assessments according to RECIST version 1.1 was defined as time from date of randomization until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from randomized therapy or received another anticancer therapy prior to progression. Progression (i.e., PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of ≥5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters, or a measurable increase in a non-target lesion, or the appearance of new lesions. Median PFS was calculated using the Kaplan-Meier technique.
- 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
- MEDIAN
- population Description
- Full analysis set
- reporting Status
- POSTED
- time Frame
- Tumor assessments every 6 weeks after randomization for the first 24 weeks and then every 8 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death. Assessed up to maximum of approximately 27 months.
- title
- Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice