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 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 12:33 AM
NCT ID:
NCT01964560
Group ID:
EG000
Title:
Lacosamide (All Subjects)
Description:
Participants who participated in primary study \[SP0967 (NCT02477839) or SP0969 (NCT01921205)\] consented and met requirements to participate in current study received LCM 10 milligram/kilogram/day (mg/kg/day) as an oral solution for study participants weighing \<30 kg, LCM 6 mg/kg/day as an oral solution for study participants weighing \>=30 kg to \<50 kg, and LCM 300 mg/day as tablets for study participants weighing \>=50 kg. LCM was administered twice daily (bid) up to Week 96. After 1 week the investigator might adjust the LCM dose during the Treatment based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.
Deaths Number Affected:
7
Deaths Number At Risk:
None
Serious Number Affected:
111
Serious Number At Risk:
540
Other Number Affected:
289
Other Number At Risk:
540
Study:
NCT01964560
Results Section:
NCT01964560
Adverse Events Module:
NCT01964560