TriangleNCT02489318 · OUTCOME
Time to Pain 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 57 months
What was measured
Time to pain progression was defined as the time from the date of randomization to the date of the first observation of pain progression. Pain progression was defined as an average increase by 2 points from baseline to greater than (\>) 4 on the Brief Pain Inventory - Short Form (BPI-SF) worst pain intensity (item 3) with no decrease in opioids confirmed greater than equal to (\>=) 3 weeks apart or initiation of chronic opioids, whichever occurred first. BPI-SF is a self-administered questionnaire developed to assess severity of pain and impact of pain on daily functions. Item 3 (worst pain intensity) asks participants to rate worst pain in prior 7-days on a 0-10 numeric rating scale, where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine." A lower score is better.
Analysis population: ITT population included all randomized participants classified according to their assigned treatment group, regardless of the actual treatment received.
Groups in this outcome
Placebo + Androgen Deprivation Therapy (ADT)
Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
Apalutamide + ADT
Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4\*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
| Group | Source count |
|---|---|
| Placebo + Androgen Deprivation Therapy (ADT) | 527 |
| Apalutamide + ADT | 525 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + Androgen Deprivation Therapy (ADT) | NA | Not reported | 51.32 | NA | Here NA signifies that the median and upper limit of CI were not estimable due to lesser number of events. |
| Apalutamide + ADT | NA | Not reported | NA | NA | Here NA signifies that the median, lower limit and upper limit of CI were not estimable due to lesser number of events. |
Source statistical analyses
- ci Lower Limit
- 0.700
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.076
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1966
- param Type
- Hazard Ratio (HR)
- param Value
- 0.868
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.700
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.076
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.1966
- param Type
- Hazard Ratio (HR)
- param Value
- 0.868
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Here NA signifies that the median and upper limit of CI were not estimable due to lesser number of events.
- group Id
- OG000
- lower Limit
- 51.32
- upper Limit
- NA
- value
- NA
- comment
- Here NA signifies that the median, lower limit and upper limit of CI were not estimable due to lesser number of events.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 527
- group Id
- OG001
- value
- 525
- units
- Participants
- description
- Time to pain progression was defined as the time from the date of randomization to the date of the first observation of pain progression. Pain progression was defined as an average increase by 2 points from baseline to greater than (\>) 4 on the Brief Pain Inventory - Short Form (BPI-SF) worst pain intensity (item 3) with no decrease in opioids confirmed greater than equal to (\>=) 3 weeks apart or initiation of chronic opioids, whichever occurred first. BPI-SF is a self-administered questionnaire developed to assess severity of pain and impact of pain on daily functions. Item 3 (worst pain intensity) asks participants to rate worst pain in prior 7-days on a 0-10 numeric rating scale, where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine." A lower score is better.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received matching placebo (4 tablets) orally once daily (qd) along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. In the event of a positive result at interim or final analysis participants in treatment phase had opportunity to receive Apalutamide +ADT. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
- id
- OG000
- title
- Placebo + Androgen Deprivation Therapy (ADT)
- description
- Participants received JNJ-56021927 (apalutamide) 240 milligrams (mg) (4\*60 mg tablets) orally qd along with ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration) as standard of care therapy in each 28-day treatment cycle. The choice of the GnRHa (agonist or antagonist) was at discretion of the investigator. Participants received treatment until radiographic progression or unequivocal clinical progression, unacceptable toxicity, or death.
- id
- OG001
- title
- Apalutamide + ADT
- param Type
- MEDIAN
- population Description
- ITT population included all randomized participants classified according to their assigned treatment group, regardless of the actual treatment received.
- reporting Status
- POSTED
- time Frame
- Up to 57 months
- title
- Time to Pain Progression
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice