TriangleNCT00105443 · OUTCOME
Time to Symptomatic Progression (TTSP)
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 the first documented symptomatic progression until an average 5.7 months later up to the data cut-off date approximately 23 months after start of enrollment
What was measured
TTSP was defined as the time from randomization to the first documented symptomatic progression
Analysis population: For subjects (in the ITT population) who had not progressed symptomatically at the time of interim analysis, TTSP was censored at the date of last FACT FHSI-8 questionnaire assessment (upon an interim review by the Data Monitoring Committee on 09 Feb 2007), when the study was considered positive for its primary endpoint, OS, and was stopped early.
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) | 127 | Not reported | 106 | 152 | Not reported |
| Placebo | 148 | Not reported | 132 | 195 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 106
- upper Limit
- 152
- value
- 127
- group Id
- OG001
- lower Limit
- 132
- upper Limit
- 195
- value
- 148
- denoms
- counts
- group Id
- OG000
- value
- 299
- group Id
- OG001
- value
- 303
- units
- Participants
- description
- TTSP was defined as the time from randomization to the first documented symptomatic progression
- 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
- For subjects (in the ITT population) who had not progressed symptomatically at the time of interim analysis, TTSP was censored at the date of last FACT FHSI-8 questionnaire assessment (upon an interim review by the Data Monitoring Committee on 09 Feb 2007), when the study was considered positive for its primary endpoint, OS, and was stopped early.
- reporting Status
- POSTED
- time Frame
- from randomization to the first documented symptomatic progression until an average 5.7 months later up to the data cut-off date approximately 23 months after start of enrollment
- title
- Time to Symptomatic Progression (TTSP)
- type
- POST_HOC
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice