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 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
NCT ID:
NCT00867451
Group ID:
EG001
Title:
Delayed Treatment
Description:
Pre-intervention data was collected for four weeks, after which children received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants in the delayed treatment group progressed to the melatonin phase of the intervention.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
4
Other Number Affected:
0
Other Number At Risk:
4
Study:
NCT00867451
Results Section:
NCT00867451
Adverse Events Module:
NCT00867451