Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-25 @ 4:07 PM
NCT ID:
NCT02312557
Group ID:
EG000
Title:
Treatment (Pembrolizumab)
Description:
INITIAL TREATMENT PHASE: Patients who are progressing on enzalutamide will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily.
MONITORING PHASE: After completion of the initial treatment phase, patients continue to receive standard of care enzalutamide PO daily for the duration of the trial.
RETREATMENT PHASE: Patients with disease response or stability after the initial treatment phase will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for an additional 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily for the duration of the trial.
Enzalutamide: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pembrolizumab: Given IV
Deaths Number Affected:
3
Deaths Number At Risk:
None
Serious Number Affected:
27
Serious Number At Risk:
58
Other Number Affected:
55
Other Number At Risk:
58
Study:
NCT02312557
Results Section:
NCT02312557
Adverse Events Module:
NCT02312557