TriangleNCT02003924 · 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
- From randomization until death (up to a maximum of 68.8 months)
What was measured
Overall survival (OS) was defined as the time (in months) from randomization to death from any cause. For participants who were alive at the time of the analysis data cutoff, OS time was censored at the last date the participant was known to be alive or analysis data cutoff date, whichever was earlier. Participants with no post baseline survival information were censored on the date of randomization. Analysis was based on Kaplan-Meier estimates.
Analysis population: The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.
Groups in this outcome
Enzalutamide 160 mg
Participants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.
Placebo
Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
| Group | Source count |
|---|---|
| Enzalutamide 160 mg | 933 |
| Placebo | 468 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide 160 mg | 67.0 | Not reported | 64.0 | NA | Lower limit for 95% CI could not be estimated because there were insufficient number of participants with event. |
| Placebo | 56.3 | Not reported | 54.4 | 63.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.608
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.885
- estimate Comment
- HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.
- group Description
- To maintain family-wise 2-sided type I error rate at 0.05,parallel testing strategy between OS(with allocated type I error rate 0.03)and remaining key secondary endpoints(time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02)was performed.OS tested at error rate 0.05 when both time to PSA progression and time to first use of new antineoplastic therapy were significant. When either failed to show significance.OS was tested at error 0.03.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0011
- p Value Comment
- P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per interactive voice/web recognition system (IXRS).
- param Type
- Hazard Ratio (HR)
- param Value
- 0.734
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.608
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.885
- estimate Comment
- HR was based on a Cox regression model (with treatment as the only covariate) stratified by factors defined above, and was relative to placebo with \< 1 favoring Enzalutamide.
- group Description
- To maintain family-wise 2-sided type I error rate at 0.05,parallel testing strategy between OS(with allocated type I error rate 0.03)and remaining key secondary endpoints(time to PSA progression and time to first use of new antineoplastic therapy with allocated type I error rate 0.02)was performed.OS tested at error rate 0.05 when both time to PSA progression and time to first use of new antineoplastic therapy were significant. When either failed to show significance.OS was tested at error 0.03.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0011
- p Value Comment
- P-value was based on a stratified log-rank test by PSA doubling time (\< 6 months, \>= 6 months) and prior or concurrent use of a bone targeting agent (yes, no) as per interactive voice/web recognition system (IXRS).
- param Type
- Hazard Ratio (HR)
- param Value
- 0.734
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Lower limit for 95% CI could not be estimated because there were insufficient number of participants with event.
- group Id
- OG000
- lower Limit
- 64.0
- upper Limit
- NA
- value
- 67.0
- group Id
- OG001
- lower Limit
- 54.4
- upper Limit
- 63.0
- value
- 56.3
- denoms
- counts
- group Id
- OG000
- value
- 933
- group Id
- OG001
- value
- 468
- units
- Participants
- description
- Overall survival (OS) was defined as the time (in months) from randomization to death from any cause. For participants who were alive at the time of the analysis data cutoff, OS time was censored at the last date the participant was known to be alive or analysis data cutoff date, whichever was earlier. Participants with no post baseline survival information were censored on the date of randomization. Analysis was based on Kaplan-Meier estimates.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 4 capsules of Enzalutamide 40 mg each (total dose 160 mg per day) orally, once daily in double-blind and open-label phase (up to a maximum of 68.8 months) until radiographic progression. Participants after last dose of study drug, were followed up for safety up to 30 days, and were long term followed up (for survival status and new prostate cancer therapies) from last dose to the death date or last known survival date.
- id
- OG000
- title
- Enzalutamide 160 mg
- description
- Participants received 4 capsules of placebo (matched to Enzalutamide) orally, once daily in double blind phase (up to a maximum of 51.3 months) until radiographic progression. Participants were given an opportunity to switch to open-label enzalutamide after completion of double blind phase. Participants after last dose of study drug, were followed up for safety up to 30 days and were long term followed up (for survival status and new prostate cancer therapies) to the death date or last known survival date.
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- The ITT population was defined as all participants randomly assigned to study treatment and was based on randomized treatment assignment regardless of whether or not treatment was administered.
- reporting Status
- POSTED
- time Frame
- From randomization until death (up to a maximum of 68.8 months)
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice