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 @ 2:17 AM
Ignite Modification Date:
2025-12-26 @ 12:48 AM
NCT ID:
NCT00505934
Group ID:
EG000
Title:
Levetiracetam
Description:
Intravenous 100 mg/mL, twice a day, maximum of 4 days
Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.
* Ages ≥ 1 month to \< 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);
* Ages ≥ 6 months to \< 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).
For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:
* Ages ≥ 1 month to \< 6 months: 14 mg/kg/day (7 mg/kg twice daily).
* Ages ≥ 6 months to \< 4 years: 20 mg/kg/day (10 mg/kg twice daily).
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
4
Serious Number At Risk:
19
Other Number Affected:
10
Other Number At Risk:
19
Study:
NCT00505934
Results Section:
NCT00505934
Adverse Events Module:
NCT00505934