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 @ 7:13 PM
Ignite Modification Date:
2025-12-25 @ 4:49 PM
NCT ID:
NCT00692003
Group ID:
EG001
Title:
Zonisamide
Description:
25-400 mg capsules orally once daily in the evening.
Maximum study duration of 28 weeks comprising:
Baseline Period (Week-8/-4 to Week 0) no treatment
Titration Period (Week 0 to Week 4) \<12 years old: 1 mg/kg; \>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4
Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)
Down Titration Period (4 weeks)
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
5
Other Number Affected:
2
Other Number At Risk:
5
Study:
NCT00692003
Results Section:
NCT00692003
Adverse Events Module:
NCT00692003