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 @ 11:59 AM
Ignite Modification Date: 2025-12-25 @ 11:56 AM
NCT ID: NCT03980561
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data were collected from time of consent through last study visit (approximately 14 weeks).
Study: NCT03980561
Study Brief: UH3 Varenicline for Cannabis Use Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Varenicline 2 mg daily Varenicline: Active medication 0 None 1 90 81 90 View
Placebo 2 mg daily Placebo: Inactive medication 0 None 0 84 70 84 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
dream disturbance NON_SYSTEMATIC_ASSESSMENT General disorders None View
insomnia NON_SYSTEMATIC_ASSESSMENT General disorders None View
irritability NON_SYSTEMATIC_ASSESSMENT General disorders None View
anxiety/depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
musculoskeletal NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
night sweats NON_SYSTEMATIC_ASSESSMENT General disorders None View
other GI NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
URI/cold symptoms NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View