TriangleNCT00105443 · OUTCOME
Disease Control (DC)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- time from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment
What was measured
The DC is defined as the number of subjects with a best response rating of complete response (CR), partial response (PR), or stable disease (SD) that is maintained at least 28 days from the first manifestation of that rating. Definitions: CR = disappearance of all clinical and radiological tumor lesions; PR = at least 30% decrease in sum of the longest diameters of tumor lesions; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease.
Analysis population: In this study, the DC for the ITT population was determined by independent radiological review and also by investigator assessment (both by using response evaluation criteria in solid tumors \[RECIST\])
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) | 130 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 96 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- -19.56
- ci Pct Value
- 95
- ci Upper Limit
- -4.35
- estimate Comment
- Sorafenib minus placebo difference
- group Description
- Disease control rates were compared between treatment groups using the Cochran Mantel Haenszel (CMH) test with a 1-sided alpha of 0.025, adjusting for region, ECOG PS, and "tumor burden".
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.001641
- param Type
- Risk Difference (RD)
- param Value
- -11.95
- statistical Method
- Cochran-Mantel-Haenszel
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- -19.56
- ci Pct Value
- 95
- ci Upper Limit
- -4.35
- estimate Comment
- Sorafenib minus placebo difference
- group Description
- Disease control rates were compared between treatment groups using the Cochran Mantel Haenszel (CMH) test with a 1-sided alpha of 0.025, adjusting for region, ECOG PS, and "tumor burden".
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.001641
- param Type
- Risk Difference (RD)
- param Value
- -11.95
- statistical Method
- Cochran-Mantel-Haenszel
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- value
- 130
- group Id
- OG001
- value
- 96
- denoms
- counts
- group Id
- OG000
- value
- 299
- group Id
- OG001
- value
- 303
- units
- Participants
- description
- The DC is defined as the number of subjects with a best response rating of complete response (CR), partial response (PR), or stable disease (SD) that is maintained at least 28 days from the first manifestation of that rating. Definitions: CR = disappearance of all clinical and radiological tumor lesions; PR = at least 30% decrease in sum of the longest diameters of tumor lesions; SD = neither sufficient shrinkage to qualify for PR nor sufficient increase for progressive disease.
- 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
- NUMBER
- population Description
- In this study, the DC for the ITT population was determined by independent radiological review and also by investigator assessment (both by using response evaluation criteria in solid tumors \[RECIST\])
- reporting Status
- POSTED
- time Frame
- time from randomization to end of treatment up to the data cutoff date approximately 19 months after start of enrollment
- title
- Disease Control (DC)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice