Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 4:30 AM
Ignite Modification Date: 2025-12-26 @ 3:33 AM
NCT ID: NCT03947918
Description: None
Frequency Threshold: 0
Time Frame: No adverse events occurred during the duration of the study (1 year, 9 months).
Study: NCT03947918
Study Brief: Summertime: Kids in Motion
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Short Sleep No more than 8 hours of sleep for 4 consecutive nights. Short sleep: Child will be asked to sleep for less than 8 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent daily text messages or phone call reminders. Long sleep: Child will be asked to sleep for more than 10 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent text messages or phone call reminders. 0 None 0 17 0 17 View
Long Sleep At least 10 hours of sleep for 4 consecutive nights Short sleep: Child will be asked to sleep for less than 8 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent daily text messages or phone call reminders. Long sleep: Child will be asked to sleep for more than 10 hours. Study team will help parent design a sleep schedule for that week. Study team will send parent text messages or phone call reminders. 0 None 0 17 0 17 View
Serious Events(If Any):
Other Events(If Any):