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 @ 3:44 PM
Ignite Modification Date: 2025-12-25 @ 1:52 PM
NCT ID: NCT03327792
Description: Standard definitions were used. The SAFTEE was utilized, this is a tool for systematic assessment of AE's which includes 1) open-ended questions about any changes in physical/health problems, appearance, or activity level, and 2) yes/no responses to a specific list of symptoms (typically associated with the Investigational Product).
Frequency Threshold: 0
Time Frame: Adverse events were collected over the course of the study from randomization to the 1 week follow-up visit; approximately 3 weeks.
Study: NCT03327792
Study Brief: Mavoglurant in Alcohol Drinking
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
200 mg Mavoglurant 200 mg mavoglurant once daily for 7-10 days Mavoglurant: 200 mg Mavoglurant 0 None 0 17 17 17 View
Placebo Placebo once daily for 7-10 days Placebo: Placebo 0 None 0 17 8 17 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Racing Heart NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Mania/Hyperactivity NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dissociation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Appetite Change SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acid Indigestion NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sore Arm NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back Ache SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Confusion SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Extra sense of focus SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Face Numbness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Feeling High/Intoxicated SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Frequent Urination SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Good Mood / Awake NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hurt Ankle NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Irritable NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Itchy SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Lack of Focus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Memory Loss SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mood Altered NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Mouth and Throat Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Moving/Walking Slower NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle Twitch NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nervousness / Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Night Sweats NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nightmares NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pimples/Face Swelling NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sad NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Social Anxiety NON_SYSTEMATIC_ASSESSMENT Social circumstances None View
Strange Feeling Behind the Eyes NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Vision Felt Slower SYSTEMATIC_ASSESSMENT Eye disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Warm Feeling in Heart; the Feeling of God NON_SYSTEMATIC_ASSESSMENT General disorders None View
Lightheaded SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Saw Scary Faces While Sleeping NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sinus Pressure NON_SYSTEMATIC_ASSESSMENT General disorders None View
Closer things looked closer; Farther things looked farther away SYSTEMATIC_ASSESSMENT Eye disorders None View
Hazy Vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Trailing Vision SYSTEMATIC_ASSESSMENT Eye disorders None View