TriangleNCT00073307 · OUTCOME
Final Progression-Free Survival (PFS) - Independent Radiological Review
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 start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
What was measured
PFS determined as the time (days) from the date of randomization at start of study to the actual date of disease progression (PD) (radiological or clinical) or death due to any cause, if death occurred before PD. Outcome measure was assessed approximately every 8 weeks using RECIST v1.0 criteria by independent radiologic review. Radiological PD defined as at least 20% increase in sum of longest diameter (LD) of measured lesions taking as reference smallest sum LD recorded since treatment started or appearance of new lesions.
Analysis population: Evaluations based on ITT population as of 28Jan2005 data cut; 769 subjects randomized at that time. PFS determined as time from randomization to actual date of disease progression (PD) (radiological or clinical) or death, if death occurred before PD. Subjects without PD or death at time of analysis were censored at last date of tumor assessment.
Groups in this outcome
Sorafenib (Nexavar, BAY43-9006)
Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
Placebo
Placebo tablets matching in appearance were to be orally administered twice a day.
| Group | Source count |
|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 384 |
| Placebo | 385 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | 167 | Not reported | 139 | 174 | Not reported |
| Placebo | 84 | Not reported | 78 | 91 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.35
- ci Pct Value
- 95
- ci Upper Limit
- 0.55
- estimate Comment
- Two treatment groups compared using log-rank test (Sorafenib over Placebo) stratified by country and Motzer category
- group Description
- The planned final PFS analysis was to be performed when approximately 363 progressions or deaths (if death occurred before progression) were observed. The analysis had power of 90% to detect a 50% increase in PFS using a two-sided alpha of 0.01
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.000001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.44
- statistical Method
- Log Rank
- tested Non Inferiority
- false
Complete source fields
- analyses
- ci Lower Limit
- 0.35
- ci Pct Value
- 95
- ci Upper Limit
- 0.55
- estimate Comment
- Two treatment groups compared using log-rank test (Sorafenib over Placebo) stratified by country and Motzer category
- group Description
- The planned final PFS analysis was to be performed when approximately 363 progressions or deaths (if death occurred before progression) were observed. The analysis had power of 90% to detect a 50% increase in PFS using a two-sided alpha of 0.01
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.000001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.44
- statistical Method
- Log Rank
- tested Non Inferiority
- false
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 139
- upper Limit
- 174
- value
- 167
- group Id
- OG001
- lower Limit
- 78
- upper Limit
- 91
- value
- 84
- denoms
- counts
- group Id
- OG000
- value
- 384
- group Id
- OG001
- value
- 385
- units
- Participants
- description
- PFS determined as the time (days) from the date of randomization at start of study to the actual date of disease progression (PD) (radiological or clinical) or death due to any cause, if death occurred before PD. Outcome measure was assessed approximately every 8 weeks using RECIST v1.0 criteria by independent radiologic review. Radiological PD defined as at least 20% increase in sum of longest diameter (LD) of measured lesions taking as reference smallest sum LD recorded since treatment started or appearance of new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
- id
- OG000
- title
- Sorafenib (Nexavar, BAY43-9006)
- description
- Placebo tablets matching in appearance were to be orally administered twice a day.
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- Evaluations based on ITT population as of 28Jan2005 data cut; 769 subjects randomized at that time. PFS determined as time from randomization to actual date of disease progression (PD) (radiological or clinical) or death, if death occurred before PD. Subjects without PD or death at time of analysis were censored at last date of tumor assessment.
- reporting Status
- POSTED
- time Frame
- From start of randomization of the first subject (1Dec2003) until the data cut-off (28Jan2005), approximately 14 months later, tumors assessed every 8 weeks.
- title
- Final Progression-Free Survival (PFS) - Independent Radiological Review
- type
- SECONDARY
- unit Of Measure
- days
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Preserved source evidence · Not medical advice