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:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
NCT ID:
NCT00928434
Group ID:
EG002
Title:
LC (Leuprolide Continuous)
Description:
Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer's labeling directions.
One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer's labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).
On Investigator's discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.
Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each).
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
18
Serious Number At Risk:
178
Other Number Affected:
158
Other Number At Risk:
178
Study:
NCT00928434
Results Section:
NCT00928434
Adverse Events Module:
NCT00928434