TriangleNCT00105443 · OUTCOME
Overall Survival
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 randomization to death due to any cause until an average 8.5 months later up to the data cut-off date approximately 23 months after start of enrollment
What was measured
Overall Survival was defined as the time from date of starting treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
Analysis population: The OS data (ITT population) are descriptive only (no p-values) from the date of randomization to the date of death due to any cause. For patients alive at the time of analysis, time to death was censored at the date of last follow-up or at the data cutoff date of 09 Feb 2007 when subjects were given the option to crossover to sorafenib treatment
Groups in this outcome
Sorafenib (Nexavar, BAY43-9006)
Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
Placebo
Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
| Group | Source count |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 299 |
| Placebo | 303 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 327 | Not reported | 287 | 400 | Not reported |
| Placebo | 243 | Not reported | 206 | 289 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 287
- upper Limit
- 400
- value
- 327
- group Id
- OG001
- lower Limit
- 206
- upper Limit
- 289
- value
- 243
- denoms
- counts
- group Id
- OG000
- value
- 299
- group Id
- OG001
- value
- 303
- units
- Participants
- description
- Overall Survival was defined as the time from date of starting treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
- id
- OG000
- title
- Sorafenib (Nexavar, BAY43-9006)
- description
- Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- The OS data (ITT population) are descriptive only (no p-values) from the date of randomization to the date of death due to any cause. For patients alive at the time of analysis, time to death was censored at the date of last follow-up or at the data cutoff date of 09 Feb 2007 when subjects were given the option to crossover to sorafenib treatment
- reporting Status
- POSTED
- time Frame
- from randomization to death due to any cause until an average 8.5 months later up to the data cut-off date approximately 23 months after start of enrollment
- title
- Overall Survival
- type
- POST_HOC
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice