TriangleNCT00105443 · OUTCOME
Time to Progression (TTP)
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 disease progression based on radiological assessment until an average 2.8 months later up to the data cut-off date approximately 23 months after start of enrollment
What was measured
TTP was defined as the time from randomization to disease progression (radiological only). Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.
Analysis population: The independent radiological review as initially scheduled for the interim analysis did not continue after 12 May 2006. The primary analysis of TTP for the ITT population after 12 May 2006 up to the cutoff date of 09 Feb 2007 was based on the Investigator radiological assessments
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) | 168 | Not reported | 126 | 210 | Not reported |
| Placebo | 86 | Not reported | 82 | 120 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 126
- upper Limit
- 210
- value
- 168
- group Id
- OG001
- lower Limit
- 82
- upper Limit
- 120
- value
- 86
- denoms
- counts
- group Id
- OG000
- value
- 299
- group Id
- OG001
- value
- 303
- units
- Participants
- description
- TTP was defined as the time from randomization to disease progression (radiological only). Subjects without tumor progression at the time of analysis were censored at their last date of tumor evaluation.
- 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 independent radiological review as initially scheduled for the interim analysis did not continue after 12 May 2006. The primary analysis of TTP for the ITT population after 12 May 2006 up to the cutoff date of 09 Feb 2007 was based on the Investigator radiological assessments
- reporting Status
- POSTED
- time Frame
- from randomization to disease progression based on radiological assessment until an average 2.8 months later up to the data cut-off date approximately 23 months after start of enrollment
- title
- Time to Progression (TTP)
- type
- POST_HOC
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice