TriangleNCT00887198 · OUTCOME
Radiographic Progression-free Survival (rPFS)
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
- From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)
What was measured
The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (\>=) 2 new lesions compared to baseline was observed in less than (\<) 12 weeks from randomization and was confirmed by a second bone scan taken \>=6 weeks later showing \>=2 additional new lesions (a total of \>=4 new lesions compared to baseline), b) the first bone scan with \>=2 new lesions compared to baseline was observed in \>=12 weeks from randomization and the new lesions were verified on the next bone scan \>=6 weeks later (a total of \>=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI); 3) death from any cause.
Analysis population: ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.
Groups in this outcome
Abiraterone Acetate + Prednisone (AAP)
Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4\*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
Placebo
Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
| Group | Source count |
|---|---|
| Abiraterone Acetate + Prednisone (AAP) | 546 |
| Placebo | 542 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Abiraterone Acetate + Prednisone (AAP) | NA | Not reported | 11.66 | NA | Data was not estimable due to insufficient number of participants who had the event. |
| Placebo | 8.28 | Not reported | 8.12 | 8.54 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Data was not estimable due to insufficient number of participants who had the event.
- group Id
- OG000
- lower Limit
- 11.66
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 8.12
- upper Limit
- 8.54
- value
- 8.28
- denoms
- counts
- group Id
- OG000
- value
- 546
- group Id
- OG001
- value
- 542
- units
- Participants
- description
- The rPFS was defined as the time from randomization to the occurrence of one of the following: 1) a participant was considered to have progressed by bone scan if - a) the first bone scan with greater than or equal to (\>=) 2 new lesions compared to baseline was observed in less than (\<) 12 weeks from randomization and was confirmed by a second bone scan taken \>=6 weeks later showing \>=2 additional new lesions (a total of \>=4 new lesions compared to baseline), b) the first bone scan with \>=2 new lesions compared to baseline was observed in \>=12 weeks from randomization and the new lesions were verified on the next bone scan \>=6 weeks later (a total of \>=2 new lesions compared to baseline); 2) progression of soft tissue lesions measured by computerized tomography (CT) or magnetic resonance imaging (MRI); 3) death from any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4\*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
- id
- OG000
- title
- Abiraterone Acetate + Prednisone (AAP)
- description
- Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
- id
- OG001
- title
- Placebo
- param Type
- MEDIAN
- population Description
- ITT population included all the randomized participants who were classified according to their assigned treatment group, regardless of the actual treatment received.
- reporting Status
- POSTED
- time Frame
- From randomization (Day 1) up to first radiographic progression or cutoff date (Month 18)
- title
- Radiographic Progression-free Survival (rPFS)
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice