TriangleNCT03298451 · OUTCOME
Overall Survival (OS) - Durva 1500 mg vs Sora 400 mg
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 the date of randomization until death due to any cause, assessed up to the data cut-off date (27Aug2021, to a maximum of approximately 46 months).
What was measured
OS was defined as the time from the date of randomization until death due to any cause, regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Any participant not known to have died at the DCO date was censored based on the last recorded date on which the participant was known to be alive. If the last known date alive or if the date of death was after the DCO date, participants were censored at the DCO date. This secondary outcome measure presents OS analysis of Durva 1500 mg vs Sora 400 mg at the time of the final analysis DCO (27Aug2021).
Analysis population: The FAS included all participants who were randomized. T75+D arm was closed during study.
Groups in this outcome
Durva 1500 mg
Durvalumab 1500 mg every 4 weeks (Q4W)
Treme 300 mg x1 Dose + Durva 1500 mg
Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W
Treme 75 mg x4 Doses + Durva 1500 mg
Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W
Sora 400 mg
Sorafenib 400 mg twice daily (BID)
| Group | Source count |
|---|---|
| Durva 1500 mg | 389 |
| Treme 300 mg x1 Dose + Durva 1500 mg | 389 |
| Treme 75 mg x4 Doses + Durva 1500 mg | 153 |
| Sora 400 mg | 389 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Durva 1500 mg | 16.56 | Not reported | 14.06 | 19.12 | Not reported |
| Treme 300 mg x1 Dose + Durva 1500 mg | 16.43 | Not reported | 14.16 | 19.58 | Not reported |
| Treme 75 mg x4 Doses + Durva 1500 mg | 16.36 | Not reported | 12.39 | 19.65 | Not reported |
| Sora 400 mg | 13.77 | Not reported | 12.25 | 16.13 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.73
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95.67
- ci Upper Limit
- 1.03
- estimate Comment
- The 95.67% confidence interval were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.
- group Description
- The analysis was performed using a Cox proportional hazards model adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). Values of the variables used for adjustment were obtained from IVRS.
- group Ids
- OG000
- OG003
- non Inferiority Comment
- Non-interiority for the comparison of arm Durva 1500 mg vs Sora 400 mg is declared if the upper limit of the two-sided alpha adjusted CI for HR is less than the NI margin of 1.08.
- non Inferiority Type
- NON_INFERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.86
- statistical Method
- Regression, Cox
- group Description
- The analysis was performed using stratified log-rank test adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). The values of the stratification factors were obtained from IVRS.
- group Ids
- OG000
- OG003
- non Inferiority Comment
- Superiority was tested sequentially per protocol as non-inferiority was satisfied.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0674
- p Value Comment
- The adjusted alpha levels (0.0433) for the two-sided superiority test were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.73
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95.67
- ci Upper Limit
- 1.03
- estimate Comment
- The 95.67% confidence interval were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.
- group Description
- The analysis was performed using a Cox proportional hazards model adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). Values of the variables used for adjustment were obtained from IVRS.
- group Ids
- OG000
- OG003
- non Inferiority Comment
- Non-interiority for the comparison of arm Durva 1500 mg vs Sora 400 mg is declared if the upper limit of the two-sided alpha adjusted CI for HR is less than the NI margin of 1.08.
- non Inferiority Type
- NON_INFERIORITY
- param Type
- Hazard Ratio (HR)
- param Value
- 0.86
- statistical Method
- Regression, Cox
- group Description
- The analysis was performed using stratified log-rank test adjusting for treatment, etiology of liver disease (HBV versus HCV versus others), ECOG (0 versus 1), and macro-vascular invasion (yes versus no). The values of the stratification factors were obtained from IVRS.
- group Ids
- OG000
- OG003
- non Inferiority Comment
- Superiority was tested sequentially per protocol as non-inferiority was satisfied.
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0674
- p Value Comment
- The adjusted alpha levels (0.0433) for the two-sided superiority test were derived based upon the exact number of OS events for each comparison using the Lan and DeMets approach that approximates the O'Brien Fleming spending function.
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 14.06
- upper Limit
- 19.12
- value
- 16.56
- group Id
- OG001
- lower Limit
- 14.16
- upper Limit
- 19.58
- value
- 16.43
- group Id
- OG002
- lower Limit
- 12.39
- upper Limit
- 19.65
- value
- 16.36
- group Id
- OG003
- lower Limit
- 12.25
- upper Limit
- 16.13
- value
- 13.77
- denoms
- counts
- group Id
- OG000
- value
- 389
- group Id
- OG001
- value
- 389
- group Id
- OG002
- value
- 153
- group Id
- OG003
- value
- 389
- units
- Participants
- description
- OS was defined as the time from the date of randomization until death due to any cause, regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy. Any participant not known to have died at the DCO date was censored based on the last recorded date on which the participant was known to be alive. If the last known date alive or if the date of death was after the DCO date, participants were censored at the DCO date. This secondary outcome measure presents OS analysis of Durva 1500 mg vs Sora 400 mg at the time of the final analysis DCO (27Aug2021).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Durvalumab 1500 mg every 4 weeks (Q4W)
- id
- OG000
- title
- Durva 1500 mg
- description
- Tremelimumab 300 mg × 1 dose + durvalumab 1500 mg Q4W
- id
- OG001
- title
- Treme 300 mg x1 Dose + Durva 1500 mg
- description
- Tremelimumab 75 mg Q4W × 4 doses + durvalumab 1500 mg Q4W
- id
- OG002
- title
- Treme 75 mg x4 Doses + Durva 1500 mg
- description
- Sorafenib 400 mg twice daily (BID)
- id
- OG003
- title
- Sora 400 mg
- param Type
- MEDIAN
- population Description
- The FAS included all participants who were randomized. T75+D arm was closed during study.
- reporting Status
- POSTED
- time Frame
- From the date of randomization until death due to any cause, assessed up to the data cut-off date (27Aug2021, to a maximum of approximately 46 months).
- title
- Overall Survival (OS) - Durva 1500 mg vs Sora 400 mg
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice