TriangleNCT00974311 · OUTCOME
Overall Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- During study period (up to 101 months)
What was measured
Survival was defined as time from randomization to death due to any cause. The duration of overall survival was right-censored for participants who were lost to follow-up since randomization or not known to have died at the data analysis cut-off date (this included participants who were known to have died after the data analysis cut-off date).
Analysis population: ITT included all participants who were randomized into the study.
Groups in this outcome
Enzalutamide
In DB Phase, participants received Enzalutamide capsules 160 mg orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received same treatment until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 8.3 months).
Placebo
In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received Enzalutamide capsules 160 mg orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months in DB Phase and 7.7 months in OLE Phase).
| Group | Source count |
|---|---|
| Enzalutamide | 800 |
| Placebo | 399 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 18.4 | Not reported | 17.3 | NA | The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment |
| Placebo | 13.6 | Not reported | 11.3 | 15.8 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.53
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.75
- estimate Comment
- Hazard Ratio and 95% confidence interval are from Cox regression model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.63
- statistical Comment
- Stratified by baseline Eastern Cooperative Oncology Group (ECOG) performance status and mean Brief Pain Inventory - Short Form score (Question #3).
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.53
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.75
- estimate Comment
- Hazard Ratio and 95% confidence interval are from Cox regression model.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.63
- statistical Comment
- Stratified by baseline Eastern Cooperative Oncology Group (ECOG) performance status and mean Brief Pain Inventory - Short Form score (Question #3).
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment
- group Id
- OG000
- lower Limit
- 17.3
- upper Limit
- NA
- value
- 18.4
- group Id
- OG001
- lower Limit
- 11.3
- upper Limit
- 15.8
- value
- 13.6
- denoms
- counts
- group Id
- OG000
- value
- 800
- group Id
- OG001
- value
- 399
- units
- Participants
- description
- Survival was defined as time from randomization to death due to any cause. The duration of overall survival was right-censored for participants who were lost to follow-up since randomization or not known to have died at the data analysis cut-off date (this included participants who were known to have died after the data analysis cut-off date).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- In DB Phase, participants received Enzalutamide capsules 160 mg orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received same treatment until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 8.3 months).
- id
- OG000
- title
- Enzalutamide
- description
- In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received Enzalutamide capsules 160 mg orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months in DB Phase and 7.7 months in OLE Phase).
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- ITT included all participants who were randomized into the study.
- reporting Status
- POSTED
- time Frame
- During study period (up to 101 months)
- title
- Overall Survival
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice