TriangleNCT01715285 · 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 66 months
What was measured
Time to pain progression was defined as the time (in months) interval from randomization to the first date a participant experienced a greater than or equal to (\>=) 30 percent (%) increase in Brief Pain Inventory-Short Form (BPI-SF) from baseline in the BPI-SF worst pain intensity (Item 3) observed at 2 consecutive evaluations (\>=4) weeks apart. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 10 with 0 representing "no pain" and 10 representing" pain as bad as you can imagine.
Analysis population: ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.
Groups in this outcome
Abiraterone Acetate+Prednisone+ADT
Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
Placebo + ADT
Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
| Group | Source count |
|---|---|
| Abiraterone Acetate+Prednisone+ADT | 597 |
| Placebo + ADT | 602 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Abiraterone Acetate+Prednisone+ADT | 47.41 | Not reported | 33.15 | NA | Here 'NA' represents that upper limit of 95% CI was not estimable due to lesser number of events. |
| Placebo + ADT | 16.62 | Not reported | 11.07 | 23.95 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Here 'NA' represents that upper limit of 95% CI was not estimable due to lesser number of events.
- group Id
- OG000
- lower Limit
- 33.15
- upper Limit
- NA
- value
- 47.41
- group Id
- OG001
- lower Limit
- 11.07
- upper Limit
- 23.95
- value
- 16.62
- denoms
- counts
- group Id
- OG000
- value
- 597
- group Id
- OG001
- value
- 602
- units
- Participants
- description
- Time to pain progression was defined as the time (in months) interval from randomization to the first date a participant experienced a greater than or equal to (\>=) 30 percent (%) increase in Brief Pain Inventory-Short Form (BPI-SF) from baseline in the BPI-SF worst pain intensity (Item 3) observed at 2 consecutive evaluations (\>=4) weeks apart. BPI-SF was an 11-item questionnaire, designed to assess severity and impact of pain on daily functions. Total score ranged from 0 to 10 with 0 representing "no pain" and 10 representing" pain as bad as you can imagine.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received abiraterone acetate tablet at a total dose of 1000 milligram (mg) plus 5 mg capsule of prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of androgen deprivation therapy (ADT) was administered.
- id
- OG000
- title
- Abiraterone Acetate+Prednisone+ADT
- description
- Participants received placebo matched to abiraterone acetate plus prednisone orally once daily until disease progression, withdrawal of consent or unacceptable toxicity. Stable regimen of ADT was administered.
- id
- OG001
- title
- Placebo + ADT
- param Type
- MEDIAN
- population Description
- ITT analysis set included all subjects randomized into the study and who were classified according to their assigned treatment group, regardless of the actual treatment received.
- reporting Status
- POSTED
- time Frame
- Up to 66 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