TriangleNCT00974311 · OUTCOME
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months)
What was measured
AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE: AE resulting in any of following outcomes or deemed significant and jeopardized participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events which occurred between first dose of study drug and up to the safety follow-up visit or the initiation of another anti-neoplastic therapy, whichever occurred first (up to 101 months). AEs included both serious and non-serious AEs. Clinically significant physical examination abnormalities were reported as AEs. Unscheduled visit was performed at any time during the study whenever necessary to assess for or follow-up on AEs, at the participant's request or if deemed necessary by the investigator.
Analysis population: Safety population was defined as all randomized participants who received at least 1 dose of study drug.
Groups in this outcome
Enzalutamide
In DB Phase, participants received Enzalutamide capsules 160 mg orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received same treatment until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 8.3 months).
Placebo: DB Phase
In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months).
Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
Participants who received placebo in DB phase, completed DB Phase and entered in optional OLE Phase, received Enzalutamide capsules 160 mg orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 7.7 months).
| Group | Source count |
|---|---|
| Enzalutamide | 800 |
| Placebo: DB Phase | 399 |
| Placebo (DB) /Enzalutamide 160 mg (OLE) Phase | 50 |
Reported measurements
AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 789 | Not reported | Not reported | Not reported | Not reported |
| Placebo: DB Phase | 390 | Not reported | Not reported | Not reported | Not reported |
| Placebo (DB) /Enzalutamide 160 mg (OLE) Phase | 48 | Not reported | Not reported | Not reported | Not reported |
SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 319 | Not reported | Not reported | Not reported | Not reported |
| Placebo: DB Phase | 155 | Not reported | Not reported | Not reported | Not reported |
| Placebo (DB) /Enzalutamide 160 mg (OLE) Phase | 25 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 789
- group Id
- OG001
- value
- 390
- group Id
- OG002
- value
- 48
- title
- AEs
- categories
- measurements
- group Id
- OG000
- value
- 319
- group Id
- OG001
- value
- 155
- group Id
- OG002
- value
- 25
- title
- SAEs
- denoms
- counts
- group Id
- OG000
- value
- 800
- group Id
- OG001
- value
- 399
- group Id
- OG002
- value
- 50
- units
- Participants
- description
- AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE: AE resulting in any of following outcomes or deemed significant and jeopardized participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events which occurred between first dose of study drug and up to the safety follow-up visit or the initiation of another anti-neoplastic therapy, whichever occurred first (up to 101 months). AEs included both serious and non-serious AEs. Clinically significant physical examination abnormalities were reported as AEs. Unscheduled visit was performed at any time during the study whenever necessary to assess for or follow-up on AEs, at the participant's request or if deemed necessary by the investigator.
- groups
- description
- In DB Phase, participants received Enzalutamide capsules 160 mg orally per day. Participants who completed DB Phase, entered in optional OLE Phase and received same treatment until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 8.3 months).
- id
- OG000
- title
- Enzalutamide
- description
- In DB Phase, participants received placebo capsules (for Enzalutamide) orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 3.0 months).
- id
- OG001
- title
- Placebo: DB Phase
- description
- Participants who received placebo in DB phase, completed DB Phase and entered in optional OLE Phase, received Enzalutamide capsules 160 mg orally per day until unacceptable toxicity, confirmed disease progression and the participant was scheduled to initiate a new systemic anti-neoplastic therapy, death or withdrawal (median treatment duration was 7.7 months).
- id
- OG002
- title
- Placebo (DB) /Enzalutamide 160 mg (OLE) Phase
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety population was defined as all randomized participants who received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- Baseline, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months)
- title
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice