TriangleNCT01946204 · 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
- Up to approximately 43 months
What was measured
Overall survival was defined as the time from randomization to the date of death due to any cause.
Analysis population: ITT population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.
Groups in this outcome
Placebo
Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
Apalutamide
Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
| Group | Source count |
|---|---|
| Placebo | 401 |
| Apalutamide | 806 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 39.03 | Not reported | 39.03 | NA | Here NA signifies that the upper limit of Confidence Interval (CI) was not estimable as upper limit of CI for the survivor function was above 0.5 using log(-log) transformation (the default of SAS Proc Lifetest). |
| Apalutamide | NA | Not reported | NA | NA | The median was not estimable(NA) as Kaplan-Meier(KM) curve did not drop to 0.5 or below. The lower or upper limit was NA as lower or upper limit of CI for survivor function was above 0.5 using log(-log) transformation (default of SAS Proc Lifetest). |
Complete source fields
- classes
- categories
- measurements
- comment
- Here NA signifies that the upper limit of Confidence Interval (CI) was not estimable as upper limit of CI for the survivor function was above 0.5 using log(-log) transformation (the default of SAS Proc Lifetest).
- group Id
- OG000
- lower Limit
- 39.03
- upper Limit
- NA
- value
- 39.03
- comment
- The median was not estimable(NA) as Kaplan-Meier(KM) curve did not drop to 0.5 or below. The lower or upper limit was NA as lower or upper limit of CI for survivor function was above 0.5 using log(-log) transformation (default of SAS Proc Lifetest).
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 401
- group Id
- OG001
- value
- 806
- units
- Participants
- description
- Overall survival was defined as the time from randomization to the date of death due to any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received apalutamide matched placebo tablets orally on a continuous once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
- id
- OG000
- title
- Placebo
- description
- Participants received apalutamide orally at a starting dose of 240 milligram (mg) (8 x 30 mg capsules then 4 x 60 mg tablets) in a continuous treatment cycles (each treatment cycle is of 28 days) once daily dosing regimen along with androgen deprivation therapy (ADT) until disease progression, withdrawal of consent or unacceptable toxicity or death.
- id
- OG001
- title
- Apalutamide
- param Type
- MEDIAN
- population Description
- ITT population included all participants who were randomized into the study, with study drug assignments designated according to initial randomization, regardless of whether participants received what was assigned.
- reporting Status
- POSTED
- time Frame
- Up to approximately 43 months
- title
- Overall Survival
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice