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:
EG002
Title:
Maintenance Period: Routine Care
Description:
Participants received ustekinumab 90 mg SC dose every 8 weeks or every 12 weeks according to clinical judgment. At Week 16, (that is, 8 weeks after the first SC dose), participants who did not show adequate response based on the investigator's judgment received a second ustekinumab 90 mg SC dose at that time. Clinical assessments in case of disease flare were performed at investigator's discretion. Participants who lost response during 12-weekly could adjust the dosing to 8-weekly maintenance treatment. Participants who previously received 8-weekly ustekinumab treatment were unable to adjust the dose following disease flare and left the study as per investigator's judgment.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
29
Serious Number At Risk:
221
Other Number Affected:
150
Other Number At Risk:
221
Study:
NCT03107793
Results Section:
NCT03107793
Adverse Events Module:
NCT03107793