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 @ 7:46 PM
Ignite Modification Date:
2025-12-25 @ 5:23 PM
NCT ID:
NCT00078403
Group ID:
EG002
Title:
OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)
Description:
At week 12 (end of initial run-in period, Step 1) participants were found to be HCV RNA negative (HCV RNA \< 60 IU/mL) or had more than a 2 log decrease in HCV RNA from Baseline. Participants were assigned to remain in the Open Label (OL) part of the study continuing the run-in treatment (PEG-IFN 180 mcg weekly \& ribavirin \[RBV\] 1-1.2 g/day based on weight). At the beginning of week 36, participants were retested and, if found to be HCV RNA positive (HCV RNA \> 60 IU/mL), participants could be randomized to OL PEG-IFN or Observation.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
37
Serious Number At Risk:
169
Other Number Affected:
166
Other Number At Risk:
169
Study:
NCT00078403
Results Section:
NCT00078403
Adverse Events Module:
NCT00078403