TriangleNCT01946204 · OUTCOME
Progression-free Survival (PFS)
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
PFS defined as time from randomization to first documentation of BICR-confirmed radiographic progressive disease (PD) (development of distant/local/regional metastasis)/death due to any cause whichever occurred first. PFS data for participants without loco-regional disease were performed for US/ex-US regulatory purposes. Radiographic scans (bone scans and CT/MRI of chest,abdomen,pelvis) performed for detection of metastasis throughout study. PD based on RECIST v1.1; Subjects with one measurable lesion, At least 20% increase in sum of diameters of target lesions taking as reference smallest sum on study. In addition, sum must demonstrate an absolute increase of at least 5 millimeter(mm). Also, appearance of one/more new lesions was also considered PD. Subjects with non-measurable disease as per CT/MRI scans, unequivocal progression/appearance of one or more new lesions was considered PD. For new bone lesions detected on bone scans, second imaging (CT/MRI) was required to confirm PD.
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
US Regulatory
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 14.72 | Not reported | 14.49 | 18.37 | Not reported |
| Apalutamide | 40.51 | Not reported | NA | NA | NA signifies: lower and upper limit of CI was not estimable (NA) as lower, or upper, or both limits of CI for survivor function were above 0.5 using log(-log) transformation (default of SAS Proc Lifetest). |
EX-US Regulatory
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo | 14.65 | Not reported | 11.27 | 17.97 | Not reported |
| Apalutamide | 40.51 | Not reported | 29.40 | 40.51 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.238
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.356
- group Description
- Statistical Analysis for PFS by BICR (US Regulatory)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.291
- statistical Method
- Log Rank
- ci Lower Limit
- 0.247
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.364
- group Description
- Statistical Analysis for PFS by BICR (EX-US Regulatory)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.300
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.238
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.356
- group Description
- Statistical Analysis for PFS by BICR (US Regulatory)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.291
- statistical Method
- Log Rank
- ci Lower Limit
- 0.247
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.364
- group Description
- Statistical Analysis for PFS by BICR (EX-US Regulatory)
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.0001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.300
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 14.49
- upper Limit
- 18.37
- value
- 14.72
- comment
- NA signifies: lower and upper limit of CI was not estimable (NA) as lower, or upper, or both limits of CI for survivor function were above 0.5 using log(-log) transformation (default of SAS Proc Lifetest).
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 40.51
- title
- US Regulatory
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.27
- upper Limit
- 17.97
- value
- 14.65
- group Id
- OG001
- lower Limit
- 29.40
- upper Limit
- 40.51
- value
- 40.51
- title
- EX-US Regulatory
- denoms
- counts
- group Id
- OG000
- value
- 401
- group Id
- OG001
- value
- 806
- units
- Participants
- description
- PFS defined as time from randomization to first documentation of BICR-confirmed radiographic progressive disease (PD) (development of distant/local/regional metastasis)/death due to any cause whichever occurred first. PFS data for participants without loco-regional disease were performed for US/ex-US regulatory purposes. Radiographic scans (bone scans and CT/MRI of chest,abdomen,pelvis) performed for detection of metastasis throughout study. PD based on RECIST v1.1; Subjects with one measurable lesion, At least 20% increase in sum of diameters of target lesions taking as reference smallest sum on study. In addition, sum must demonstrate an absolute increase of at least 5 millimeter(mm). Also, appearance of one/more new lesions was also considered PD. Subjects with non-measurable disease as per CT/MRI scans, unequivocal progression/appearance of one or more new lesions was considered PD. For new bone lesions detected on bone scans, second imaging (CT/MRI) was required to confirm PD.
- 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
- Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice