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: 2025-12-26 @ 12:18 PM
Ignite Modification Date: 2025-12-26 @ 12:18 PM
NCT ID: NCT02724800
Description: None
Frequency Threshold: 0
Time Frame: baseline to 12-month follow-up (approximately 57-60 weeks)
Study: NCT02724800
Study Brief: Implementation of Brief Insomnia Treatments - Clinical Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CBTI CBTI consisted of five in-person sessions within an eight week period. Topics covered included: sleep education, stimulus control, sleep restriction, relaxation strategies, cognitive therapy, and sleep hygiene. CBTI: 32 Veterans with chronic insomnia were randomized to CBTI. The intervention was delivered in 5 face-to-face session within an 8 week time period. The intervention was delivered at the VA Pittsburgh Healthcare System. Treatment visits lasted approximately 45 minutes. 0 None 0 32 0 32 View
BBTI BBTI consisted of one in-person session with three weekly follow-up sessions (in-person or phone) in a four week period. Topics covered included: sleep education, stimulus control, and sleep restriction. BBTI: 31 Veterans with chronic insomnia were randomized to BBTI. The intervention was delivered within 5 weeks, which included individual face-to-face visits on Weeks 1 and 3 (option for telephone) and telephone appointments on Weeks 2 and 4. The intervention was delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit was approximately 45-minutes, and the follow-up visit on Week 3 was approximately 30 minutes. Brief (\<20 minutes) telephone sessions were conducted on Weeks 2 and 4. 0 None 0 31 0 31 View
Serious Events(If Any):
Other Events(If Any):