TriangleNCT00887198 · OUTCOME
Number of Participants With Treatment Emergent Adverse Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose of study drug up to 30 days after the last dose of study drug
What was measured
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.
Analysis population: Safety analysis set included all participants in the randomized population who received any study drug.
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.
Placebo to Abiraterone Acetate
Participants received initially placebo along with prednisone 5 mg tablet, orally, later on switched to 1,000 milligram (mg) abiraterone acetate tablet (as 4\*250 mg tablets) along with prednisone 5 mg tablet due to disease progression.
| Group | Source count |
|---|---|
| Abiraterone Acetate + Prednisone (AAP) | 542 |
| Placebo | 540 |
| Placebo to Abiraterone Acetate | 93 |
Reported measurements
With Treatment-Emergent Adverse Events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Abiraterone Acetate + Prednisone (AAP) | 541 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 524 | Not reported | Not reported | Not reported | Not reported |
| Placebo to Abiraterone Acetate | 93 | Not reported | Not reported | Not reported | Not reported |
With Treatment-Emergent Serious Adverse Events
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Abiraterone Acetate + Prednisone (AAP) | 208 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 148 | Not reported | Not reported | Not reported | Not reported |
| Placebo to Abiraterone Acetate | 39 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 541
- group Id
- OG001
- value
- 524
- group Id
- OG002
- value
- 93
- title
- With Treatment-Emergent Adverse Events
- categories
- measurements
- group Id
- OG000
- value
- 208
- group Id
- OG001
- value
- 148
- group Id
- OG002
- value
- 39
- title
- With Treatment-Emergent Serious Adverse Events
- denoms
- counts
- group Id
- OG000
- value
- 542
- group Id
- OG001
- value
- 540
- group Id
- OG002
- value
- 93
- units
- Participants
- description
- An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between administration of study drug and up to 30 days after last dose of study drug that were absent before treatment or that worsened relative to pre-treatment state.
- 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
- description
- Participants received initially placebo along with prednisone 5 mg tablet, orally, later on switched to 1,000 milligram (mg) abiraterone acetate tablet (as 4\*250 mg tablets) along with prednisone 5 mg tablet due to disease progression.
- id
- OG002
- title
- Placebo to Abiraterone Acetate
- param Type
- NUMBER
- population Description
- Safety analysis set included all participants in the randomized population who received any study drug.
- reporting Status
- POSTED
- time Frame
- From first dose of study drug up to 30 days after the last dose of study drug
- title
- Number of Participants With Treatment Emergent Adverse Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice