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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:30 PM
NCT ID:
NCT03107793
Group ID:
EG000
Title:
Induction Period
Description:
Participants were administered with approximately 6 mg/kg intravenous (IV) injection of ustekinumab at Week 0 and 90 mg subcutaneous (SC) injection of ustekinumab at Week 8. At Week 16, participants who did not achieve a Crohn's Disease Activity Index (CDAI) improvement (non-responders) of greater than or equal to (\>=) 70 points versus Week 0 (CDAI-70), left the study. Participants who achieved CDAI improvement (responders) of at least 70 points versus Week 0 were randomized in open-label maintenance period either with treat to target arm or routine care arm.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
28
Serious Number At Risk:
498
Other Number Affected:
238
Other Number At Risk:
498
Study:
NCT03107793
Results Section:
NCT03107793
Adverse Events Module:
NCT03107793