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 @ 3:18 AM
Ignite Modification Date:
2025-12-26 @ 1:56 AM
NCT ID:
NCT01921205
Group ID:
EG001
Title:
Lacosamide
Description:
This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing \<30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing \>=30kg to \<50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing \>=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
11
Serious Number At Risk:
171
Other Number Affected:
85
Other Number At Risk:
171
Study:
NCT01921205
Results Section:
NCT01921205
Adverse Events Module:
NCT01921205