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 @ 9:25 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
NCT ID:
NCT03822832
Group ID:
EG000
Title:
Placebo (Week 1-16) and if no Treatment, Week 16-28
Description:
Placebo intravenous (i.v.) infusion in the double blind period from baseline to Week 12 (inclusive) - the drug administered 4 times in total. At Week 16 patients were assessed based on their Eczema Area and Severity Index (EASI) score. Patients with EASI\>=75 were classified as responders and were followed-up from Week 16 to 28, although receiving no further treatment. Patients with EASI\<75 were classified as nonresponders and were offered 600mg Spesolimab treatment in the open label period from Week 16 to 28.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
1
Serious Number At Risk:
18
Other Number Affected:
10
Other Number At Risk:
18
Study:
NCT03822832
Results Section:
NCT03822832
Adverse Events Module:
NCT03822832