TriangleNCT01212991 · OUTCOME
Number of Participants With Treatment-Emergent Adverse Events (AEs) Greater Than or Equal to (>=) Grade 3, Based on National Cancer Institute Common Terminology Criteria for AEs (CTCAE), Version 4.0
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)
What was measured
An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. As per NCI CTCAE, Grade 3 events =medically significant but not immediately life-threatening, unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment, Grade 4 events =participant to be in imminent danger of death. Grade 5 events =death. A treatment-emergent AE (TEAE) was defined as an AE that occurred from the date and time of the first dose of study drug up to a maximum duration of 6.5 years. Number of participants with AEs of any of the Grade 3 or above (Grade 4, 5) were reported.
Analysis population: The safety analysis set included all randomized participants who received at least 1 dose or partial dose of study drug.
Groups in this outcome
Enzalutamide
Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
Placebo
Participants received placebo, administered as four capsules, once per day by mouth.
Placebo Participants Crossover to Enzalutamide
Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
| Group | Source count |
|---|---|
| Enzalutamide | 871 |
| Placebo | 844 |
| Placebo Participants Crossover to Enzalutamide | 234 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 465 | Not reported | Not reported | Not reported | Not reported |
| Placebo | 318 | Not reported | Not reported | Not reported | Not reported |
| Placebo Participants Crossover to Enzalutamide | 129 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 465
- group Id
- OG001
- value
- 318
- group Id
- OG002
- value
- 129
- denoms
- counts
- group Id
- OG000
- value
- 871
- group Id
- OG001
- value
- 844
- group Id
- OG002
- value
- 234
- units
- Participants
- description
- An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. As per NCI CTCAE, Grade 3 events =medically significant but not immediately life-threatening, unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment, Grade 4 events =participant to be in imminent danger of death. Grade 5 events =death. A treatment-emergent AE (TEAE) was defined as an AE that occurred from the date and time of the first dose of study drug up to a maximum duration of 6.5 years. Number of participants with AEs of any of the Grade 3 or above (Grade 4, 5) were reported.
- groups
- description
- Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
- id
- OG000
- title
- Enzalutamide
- description
- Participants received placebo, administered as four capsules, once per day by mouth.
- id
- OG001
- title
- Placebo
- description
- Participants who received placebo in double-blind period and who agreed to proceed to open-label phase period, received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
- id
- OG002
- title
- Placebo Participants Crossover to Enzalutamide
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The safety analysis set included all randomized participants who received at least 1 dose or partial dose of study drug.
- reporting Status
- POSTED
- time Frame
- Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)
- title
- Number of Participants With Treatment-Emergent Adverse Events (AEs) Greater Than or Equal to (>=) Grade 3, Based on National Cancer Institute Common Terminology Criteria for AEs (CTCAE), Version 4.0
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice