TriangleNCT01995513 · OUTCOME
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)
What was measured
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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 are events between first dose of study drug and up to 30 days after last dose of study drug that were absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious.
Analysis population: Safety population included all participants who received any amount of study drug.
Groups in this outcome
Enzalutamide 160 mg
Participants who only received enzalutamide 160 mg as four 40 mg capsules, orally once daily in the study.
Enzalutamide Crossing Over to Abiraterone + Prednisone
Participants who received (after switching from enzalutamide) abiraterone 1000 mg as four 250 mg tablets, orally once daily and prednisone 10 mg administered as two 5 mg tablets, orally twice daily in the study.
Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
Placebo+Abiraterone 1000mg+ Prednisone 10mg
Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
| Group | Source count |
|---|---|
| Enzalutamide 160 mg | 509 |
| Enzalutamide Crossing Over to Abiraterone + Prednisone | 13 |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 125 |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 124 |
Reported measurements
AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide 160 mg | 93.5 | Not reported | Not reported | Not reported | Not reported |
| Enzalutamide Crossing Over to Abiraterone + Prednisone | 100 | Not reported | Not reported | Not reported | Not reported |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 91.2 | Not reported | Not reported | Not reported | Not reported |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 92.7 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide 160 mg | 32.0 | Not reported | Not reported | Not reported | Not reported |
| Enzalutamide Crossing Over to Abiraterone + Prednisone | 30.8 | Not reported | Not reported | Not reported | Not reported |
| Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg | 37.6 | Not reported | Not reported | Not reported | Not reported |
| Placebo+Abiraterone 1000mg+ Prednisone 10mg | 29.8 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 93.5
- group Id
- OG001
- value
- 100
- group Id
- OG002
- value
- 91.2
- group Id
- OG003
- value
- 92.7
- title
- AEs
- categories
- measurements
- group Id
- OG000
- value
- 32.0
- group Id
- OG001
- value
- 30.8
- group Id
- OG002
- value
- 37.6
- group Id
- OG003
- value
- 29.8
- title
- SAEs
- denoms
- counts
- group Id
- OG000
- value
- 509
- group Id
- OG001
- value
- 13
- group Id
- OG002
- value
- 125
- group Id
- OG003
- value
- 124
- units
- Participants
- description
- An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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 are events between first dose of study drug and up to 30 days after last dose of study drug that were absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious.
- groups
- description
- Participants who only received enzalutamide 160 mg as four 40 mg capsules, orally once daily in the study.
- id
- OG000
- title
- Enzalutamide 160 mg
- description
- Participants who received (after switching from enzalutamide) abiraterone 1000 mg as four 250 mg tablets, orally once daily and prednisone 10 mg administered as two 5 mg tablets, orally twice daily in the study.
- id
- OG001
- title
- Enzalutamide Crossing Over to Abiraterone + Prednisone
- description
- Participants who received enzalutamide 160 mg as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
- id
- OG002
- title
- Enzalutamide 160mg+Abiraterone 1000mg+ Prednisone 10mg
- description
- Participants who received placebo matched to enzalutamide as four 40 mg capsules, orally once daily along with abiraterone 1000 mg as four 250-mg tablets, orally once daily and prednisone 5 mg tablet, orally twice daily in the study.
- id
- OG003
- title
- Placebo+Abiraterone 1000mg+ Prednisone 10mg
- param Type
- NUMBER
- population Description
- Safety population included all participants who received any amount of study drug.
- reporting Status
- POSTED
- time Frame
- Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first (maximum of 99.4 months)
- title
- Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice