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 @ 5:10 PM
Ignite Modification Date:
2025-12-25 @ 2:47 PM
NCT ID:
NCT00723450
Group ID:
EG000
Title:
Open-Label and Open-Label Taper Phases: LTG
Description:
Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of : 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks. Participants discontinuing from the study during the Open-Label Phase entered an open Taper and Follow-up Phase.The Taper and Follow-up Phase may last up to 4 weeks, dependent on the dose of LTG the participant received during the Open-Label Phase.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
19
Serious Number At Risk:
298
Other Number Affected:
177
Other Number At Risk:
298
Study:
NCT00723450
Results Section:
NCT00723450
Adverse Events Module:
NCT00723450