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 @ 2:59 PM
Ignite Modification Date:
2025-12-25 @ 1:23 PM
NCT ID:
NCT02501759
Group ID:
EG000
Title:
Diagnostic (MRI, MRI-guided Biopsy, TRUS-guided Biopsy)
Description:
Patients receive gadodiamide IV and undergo a diagnostic multiparametric endorectal MRI. Patients with lesions visible on the diagnostic multiparametric endorectal MRI undergo transrectal MRI-guided biopsy within 2 weeks of diagnostic multiparametric endorectal MRI. Patients then undergo TRUS-guided biopsy per standard clinical care approximately 2 weeks after transrectal MRI-guided biopsy.
3 Tesla Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast
Gadodiamide: Given IV
Multiparametric Magnetic Resonance Imaging: Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast
Transrectal Biopsy: Undergo transrectal MRI-guided biopsy
Ultrasound-Guided Prostate Biopsy: Undergo TRUS-guided biopsy
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
2
Other Number Affected:
0
Other Number At Risk:
2
Study:
NCT02501759
Results Section:
NCT02501759
Adverse Events Module:
NCT02501759