TriangleNCT00887198 · OUTCOME
Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by >=1 Point
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 time interval from the date of randomization to the first date at which there was at least a 1 grade change (worsening) in the ECOG performance status grade. Participants who had no deterioration in ECOG performance status grade at the time of the analysis were censored at the last known date of no deterioration. ECOG is a 5-point scale, where 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead. Participants with no assessment were censored at the date of randomization.
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) | 12.29 | Not reported | 11.33 | 14.29 | Not reported |
| Placebo | 10.87 | Not reported | 9.49 | 11.76 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.33
- upper Limit
- 14.29
- value
- 12.29
- group Id
- OG001
- lower Limit
- 9.49
- upper Limit
- 11.76
- value
- 10.87
- denoms
- counts
- group Id
- OG000
- value
- 546
- group Id
- OG001
- value
- 542
- units
- Participants
- description
- The time interval from the date of randomization to the first date at which there was at least a 1 grade change (worsening) in the ECOG performance status grade. Participants who had no deterioration in ECOG performance status grade at the time of the analysis were censored at the last known date of no deterioration. ECOG is a 5-point scale, where 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all self-care, 3=Capable of limited self-care, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no self-care, totally confined to bed or chair, 5=Dead. Participants with no assessment were censored at the date of randomization.
- 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
- Time to Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Score by >=1 Point
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice