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: 2025-12-24 @ 12:47 PM
Ignite Modification Date: 2025-12-25 @ 12:15 PM
NCT ID: NCT03828461
Description: None
Frequency Threshold: 0
Time Frame: up to 16 weeks
Study: NCT03828461
Study Brief: Hoarding Disorder Treatment With Virtual Reality
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BITS + VR Facilitated group therapy with behavioral practice; 16 weeks Facilitated group therapy with behavioral practice; 16 weeks: Facilitated group therapy for hoarding disorder with behavioral practice 0 None 0 9 7 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
general discomfort SYSTEMATIC_ASSESSMENT Nervous system disorders None View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
eye strain SYSTEMATIC_ASSESSMENT Eye disorders None View
difficulty focusing SYSTEMATIC_ASSESSMENT Eye disorders None View
salivation increasing SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
difficulty concentrating SYSTEMATIC_ASSESSMENT Nervous system disorders None View
fullness of head SYSTEMATIC_ASSESSMENT Nervous system disorders None View
veritgo SYSTEMATIC_ASSESSMENT Nervous system disorders None View
stomach awareness SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
fatigue SYSTEMATIC_ASSESSMENT Nervous system disorders None View
blurred vision SYSTEMATIC_ASSESSMENT Eye disorders None View