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 @ 3:56 AM
Ignite Modification Date: 2025-12-26 @ 2:47 AM
NCT ID: NCT03398902
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data were collected from baseline through the 12 week intervention and the following 2-week post-intervention monitoring period.
Study: NCT03398902
Study Brief: Personalizing Sleep Interventions to Prevent Type 2 Diabetes in Community Dwelling Adults With Pre-Diabetes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Sleep Intervention Participants in the sleep extension group will keep daily sleep diaries. Sleep diaries will be reviewed with the participant and an instructor trained in Cognitive Behavioral Therapy for Insomnia (CBTI) on a weekly basis. These weekly sessions will take place by telephone or videoconferencing. Sleep extension: Based on CBTI principles, the instructor will prescribe bed times and wake times each week to allow for gradual increases in sleep opportunity. 0 None 0 99 13 99 View
Control Participants in the habitual sleep group will be instructed to keep their habitual bedtimes and wake times. Participants will keep daily sleep diaries that will we reviewed by a study team member each week. These weekly sessions will take place by telephone or videoconferencing. Habitual sleep: The study team member will monitor and encourage participants to keep bedtimes and wake times that matched their baseline bedtimes and wake times. 0 None 0 92 0 92 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
compalints of "not feeling well" SYSTEMATIC_ASSESSMENT General disorders None View
complaints of a head cold SYSTEMATIC_ASSESSMENT General disorders None View