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:
EG003
Title:
Extension Period: Treat to Target
Description:
From Week 48, participants continued to receive SC ustekinumab 90 mg in the long-term extension (LTE) period up to Week 104. The frequency of ustekinumab dosing with escalation/de-escalation between once in 12 weeks (q12w)/q8w/q4w was based on the following targets: endoscopic remission (CD \[SES-CD\] score \<=2) and corticosteroid (CS)-free clinical remission (CDAI score of \<150 points of \>=16 weeks duration) at Week 48; and later, on CS-free clinical remission and biomarker remission (C-reactive protein \<=10 milligrams per liter \[mg/L\] and fecal calprotectin \<=250 micrograms per gram \[mcg/g\]) at 2 consecutive visits 8 weeks apart. Participants on q4w dosing failing to reach targets were discontinued.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
21
Serious Number At Risk:
147
Other Number Affected:
125
Other Number At Risk:
147
Study:
NCT03107793
Results Section:
NCT03107793
Adverse Events Module:
NCT03107793