TriangleNCT00073307 · OUTCOME
Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- days
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
What was measured
Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.
Analysis population: Evaluations based on ITT population. Subjects alive at time of analysis were censored at last date of follow-up (FU) (last visit or contact or at data cut-off date). In case of incomplete date, day was missing, day 15 was used.
Groups in this outcome
Sorafenib (Nexavar, BAY43-9006)
Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
Placebo
Subjects received matching placebo tablets administered orally twice a day. \[until \~31 May 2005\]
| Group | Source count |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 451 |
| Placebo | 452 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 542 | Not reported | 500 | 598 | Not reported |
| Placebo | 461 | Not reported | 408 | 526 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.74
- ci Pct Value
- 95
- ci Upper Limit
- 1.04
- estimate Comment
- Two treatment groups compared using log-rank test (Sorafenib over Placebo) stratified by country and Motzer category
- group Description
- Sample size based on primary efficacy endpoint of OS. Clinically meaningful improvement defined as 33.3% improvement in median OS (i.e. HR of 0.75, Sorafenib over Placebo). With overall two-sided alpha of 0.04, 90% power and randomization of 1:1, two formal interim analyses and one final analysis were planned using O'Brien-Fleming type error spending function, and a total of approximately 540 events (deaths) were required for the final analysis.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.146
- p Value Comment
- According to O'Brien-Fleming type alpha spending function and total actual deaths at final analysis, threshold for statistical significance was alpha=0.037 (two-sided).
- param Type
- Hazard Ratio (HR)
- param Value
- 0.88
- statistical Method
- Log Rank
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- 0.74
- ci Pct Value
- 95
- ci Upper Limit
- 1.04
- estimate Comment
- Two treatment groups compared using log-rank test (Sorafenib over Placebo) stratified by country and Motzer category
- group Description
- Sample size based on primary efficacy endpoint of OS. Clinically meaningful improvement defined as 33.3% improvement in median OS (i.e. HR of 0.75, Sorafenib over Placebo). With overall two-sided alpha of 0.04, 90% power and randomization of 1:1, two formal interim analyses and one final analysis were planned using O'Brien-Fleming type error spending function, and a total of approximately 540 events (deaths) were required for the final analysis.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.146
- p Value Comment
- According to O'Brien-Fleming type alpha spending function and total actual deaths at final analysis, threshold for statistical significance was alpha=0.037 (two-sided).
- param Type
- Hazard Ratio (HR)
- param Value
- 0.88
- statistical Method
- Log Rank
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 500
- upper Limit
- 598
- value
- 542
- group Id
- OG001
- lower Limit
- 408
- upper Limit
- 526
- value
- 461
- denoms
- counts
- group Id
- OG000
- value
- 451
- group Id
- OG001
- value
- 452
- units
- Participants
- description
- Overall survival determined as the time (days) from the date of randomization at start of study to the date of death, due to any cause. Outcome measure was assessed regularly, i.e. every 3 weeks for the first 24 weeks during treatment and every 4 weeks thereafter and approximately every 3 months during post-treatment.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
- id
- OG000
- title
- Sorafenib (Nexavar, BAY43-9006)
- description
- Subjects received matching placebo tablets administered orally twice a day. \[until \~31 May 2005\]
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- Evaluations based on ITT population. Subjects alive at time of analysis were censored at last date of follow-up (FU) (last visit or contact or at data cut-off date). In case of incomplete date, day was missing, day 15 was used.
- reporting Status
- POSTED
- time Frame
- From start of randomization of the first subject (1Dec2003) until the data cut-off (8Sep2006) for the final OS analysis, approximately 33 months later
- title
- Final Overall Survival (OS) - Primary Analysis in the ITT (Intent To Treat) Population
- type
- PRIMARY
- unit Of Measure
- days
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Preserved source evidence · Not medical advice