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 4.8 months later up to the data cut-off date approximately 19 months after start of enrollment
What was measured
TTSP was defined as the time from randomization to the first documented symptomatic progression.
Analysis population: This analysis was for the ITT population. For subjects who had not progressed symptomatically at the time of interim analysis, TTSP was censored at the date of their last Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index (FHSI-8) questionnaire assessment.
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) | 126 | Not reported | 105 | 126 | Not reported |
| Placebo | 148 | Not reported | 129 | 192 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.8837
- ci Pct Value
- 95
- ci Upper Limit
- 1.3110
- estimate Comment
- This is the sorafenib to placebo hazard ratio.
- group Description
- The 2 arms were compared using a 1-sided log-rank test with an overall alpha of 0.005 stratified by region, ECOG PS and "tumor burden". This was a co-primary endpoint with overall survival. No alpha-spending adjustments were necessary as it was only to be analyzed at the end of study.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.7676
- param Type
- Hazard Ratio (HR)
- param Value
- 1.0764
- statistical Method
- Log Rank
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- 0.8837
- ci Pct Value
- 95
- ci Upper Limit
- 1.3110
- estimate Comment
- This is the sorafenib to placebo hazard ratio.
- group Description
- The 2 arms were compared using a 1-sided log-rank test with an overall alpha of 0.005 stratified by region, ECOG PS and "tumor burden". This was a co-primary endpoint with overall survival. No alpha-spending adjustments were necessary as it was only to be analyzed at the end of study.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.7676
- param Type
- Hazard Ratio (HR)
- param Value
- 1.0764
- statistical Method
- Log Rank
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 105
- upper Limit
- 126
- value
- 126
- group Id
- OG001
- lower Limit
- 129
- upper Limit
- 192
- 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
- This analysis was for the ITT population. For subjects who had not progressed symptomatically at the time of interim analysis, TTSP was censored at the date of their last Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index (FHSI-8) questionnaire assessment.
- reporting Status
- POSTED
- time Frame
- from randomization to the first documented symptomatic progression until an average 4.8 months later up to the data cut-off date approximately 19 months after start of enrollment
- title
- Time to Symptomatic Progression (TTSP)
- type
- PRIMARY
- unit Of Measure
- days
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice