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 @ 1:17 AM
Ignite Modification Date: 2025-12-25 @ 11:26 PM
NCT ID: NCT02989493
Description: None
Frequency Threshold: 5
Time Frame: 8 weeks
Study: NCT02989493
Study Brief: Testing Doxazosin to Treat Stress Mechanisms in Alcoholism
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Doxazosin Participants receive 8 weeks of doxazosin (8mg target dose). Doxazosin: Doxazosin 0 None 0 29 24 29 View
Placebo Participants will receive 8 weeks of matched placebo. Placebo: Placebo 0 None 0 32 28 32 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Orthostatic hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Cardiac arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest pains SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Edema SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Rhinitis SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dry mouth SYSTEMATIC_ASSESSMENT General disorders None View
Nausea or diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blurry vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Polyurea SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
General symptoms, nonspecific SYSTEMATIC_ASSESSMENT General disorders None View
Priapism SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View