TriangleNCT00984282 · OUTCOME
Overall Survival (OS)
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
- Not reported
- Time frame
- From randomization of the first subject until the database cut-off (30 AUG 2017), study duration approximately eight years
What was measured
Overall survival was defined as the time (days) from date of randomization to date of death due to any cause. Subjects still alive at the time of analysis were censored at their date of last contact. Since the median value could not be estimated due to censored data, the percentage of participants who died is presented.
Analysis population: Full Analysis Set (FAS)
Groups in this outcome
Sorafenib (Nexavar, BAY43-9006)
Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
Placebo
Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
| Group | Source count |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 207 |
| Placebo | 210 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 52.7 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 54.8 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.2892
- statistical Comment
- stratified by age group and region
- statistical Method
- Log Rank
- ci Lower Limit
- 0.713
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.208
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 0.928
- statistical Comment
- stratified by age group and region
- statistical Method
- Regression, Cox
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.2892
- statistical Comment
- stratified by age group and region
- statistical Method
- Log Rank
- ci Lower Limit
- 0.713
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.208
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- param Type
- Hazard Ratio (HR)
- param Value
- 0.928
- statistical Comment
- stratified by age group and region
- statistical Method
- Regression, Cox
- classes
- categories
- measurements
- group Id
- OG000
- value
- 52.7
- group Id
- OG001
- value
- 54.8
- denoms
- counts
- group Id
- OG000
- value
- 207
- group Id
- OG001
- value
- 210
- units
- Participants
- description
- Overall survival was defined as the time (days) from date of randomization to date of death due to any cause. Subjects still alive at the time of analysis were censored at their date of last contact. Since the median value could not be estimated due to censored data, the percentage of participants who died is presented.
- groups
- description
- Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
- id
- OG000
- title
- Sorafenib (Nexavar, BAY43-9006)
- description
- Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
- id
- OG001
- title
- Placebo
- param Type
- NUMBER
- population Description
- Full Analysis Set (FAS)
- reporting Status
- POSTED
- time Frame
- From randomization of the first subject until the database cut-off (30 AUG 2017), study duration approximately eight years
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice