TriangleNCT01946204 · OUTCOME
Time to Symptomatic Progression
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
Time to symptomatic progression was defined as the time from randomization to documentation in the CRF of any of the following (whichever occurred earlier): a) development of a skeletal-related event (pathologic fracture, spinal cord compression, or need for surgical intervention or radiation therapy to the bone); b) pain progression or worsening of disease-related symptoms requiring initiation of a new systemic anti-cancer therapy; or c) development of clinically significant symptoms due to loco-regional tumor progression requiring surgical intervention or radiation therapy.
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 | NA | Not reported | 36.83 | NA | NA signifies: median and upper limit of CI were NA. Median was NA as KM curve did not drop to 0.5 or below. Upper limit was NA as upper limit of CI for survivor function was above 0.5 using log(-log) transformation (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). |
Source statistical analyses
- ci Lower Limit
- 0.315
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.634
- group Description
- Statistical Analysis for Time to Symptomatic Progression
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.447
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.315
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.634
- group Description
- Statistical Analysis for Time to Symptomatic Progression
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.447
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- NA signifies: median and upper limit of CI were NA. Median was NA as KM curve did not drop to 0.5 or below. Upper limit was NA as upper limit of CI for survivor function was above 0.5 using log(-log) transformation (default of SAS Proc Lifetest).
- group Id
- OG000
- lower Limit
- 36.83
- upper Limit
- NA
- value
- NA
- 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
- Time to symptomatic progression was defined as the time from randomization to documentation in the CRF of any of the following (whichever occurred earlier): a) development of a skeletal-related event (pathologic fracture, spinal cord compression, or need for surgical intervention or radiation therapy to the bone); b) pain progression or worsening of disease-related symptoms requiring initiation of a new systemic anti-cancer therapy; or c) development of clinically significant symptoms due to loco-regional tumor progression requiring surgical intervention or radiation therapy.
- 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
- Time to Symptomatic Progression
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice