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 @ 11:16 PM
Ignite Modification Date: 2025-12-25 @ 8:53 PM
NCT ID: NCT03252756
Description: Study clinicians monitored study participants for adverse events at every follow-up visit, and recorded information on a standardized adverse event form.
Frequency Threshold: 0
Time Frame: 12 Weeks
Study: NCT03252756
Study Brief: Effects of Cannabidiol in Alcohol 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
Placebo 600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks). 0 None 0 13 7 13 View
Phytocannabinoid Cannabidiol (CBD) 600mg CBD/day for 4 weeks, immediately followed by 1200mg CBD/day for an additional 4 weeks (8 total weeks). 0 None 1 13 10 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization for Ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Loose Stool SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Drowsiness SYSTEMATIC_ASSESSMENT General disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Runny Nose SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sore Throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Muscle Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Appetite Increase SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Increased Bowl Movement SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Body Ache SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Gum Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
Shortness of Breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Irregular Heartbeat SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Light-Headedness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Drowsy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gum Problems SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomach/Abdominal Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Taste Abnormality SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Cognitive Slowing SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Increased Thirst SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Queasiness SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Euphoria SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Perceptual Problems SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hair Problems SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Feeling "High" SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Perceptual Enhancement SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Relaxed Breathing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Tiredness/Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Elevated Heptic Enzymes SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Vivid Dreaming SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Increased Alcohol Craving SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Concentration Difficulty SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Heartburn / Acid Reflux SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Memory Problems SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Rash / Skin Irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Flu SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pink Eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Vivid Dreams SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View