TriangleNCT00974311 · OUTCOME
Number of Participants With Any Newly Clinically Significant Abnormal Finding in Electrocardiogram (ECG)
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 end of DB phase or unscheduled visit (up to 24 months)
What was measured
Any new post baseline abnormality was defined as any abnormal ECG finding that appeared after baseline assessment which was not seen at the screening or baseline ECG assessment. Where, criteria of abnormality was QTcF interval \> 470 millisecond (msec). Participants were counted once only for a specific abnormality. This outcome measure was planned to be analysed in double blind phase only. 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).
| Group | Source count |
|---|---|
| Enzalutamide | 800 |
| Placebo: DB Phase | 399 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Enzalutamide | 28 | Not reported | Not reported | Not reported | Not reported |
| Placebo: DB Phase | 13 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 13
- denoms
- counts
- group Id
- OG000
- value
- 800
- group Id
- OG001
- value
- 399
- units
- Participants
- description
- Any new post baseline abnormality was defined as any abnormal ECG finding that appeared after baseline assessment which was not seen at the screening or baseline ECG assessment. Where, criteria of abnormality was QTcF interval \> 470 millisecond (msec). Participants were counted once only for a specific abnormality. This outcome measure was planned to be analysed in double blind phase only. 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
- 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 end of DB phase or unscheduled visit (up to 24 months)
- title
- Number of Participants With Any Newly Clinically Significant Abnormal Finding in Electrocardiogram (ECG)
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice