Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 11:03 PM
Ignite Modification Date: 2025-12-25 @ 8:34 PM
NCT ID: NCT02033369
Description: Information was collected on a side effect checklist, with each adverse event rated from 0 (absent) to 3 (severe). A subject was considered to have experienced a side effect during the study if the rating for that adverse event increased in severity at any point during the treatment. Adverse events were not assessed for Healthy Controls, because by study design they did not receive any therapeutic intervention.
Frequency Threshold: 5
Time Frame: 6 weeks
Study: NCT02033369
Study Brief: Imaging Dopamine Release in Depression
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MDD Patients Only patients with MDD received treatment. There was only one arm. 0 None 0 22 22 22 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Decreased Appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased Appetite SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT General disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sweating SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Problems SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bruising SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
tremor SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Impaired Coordination SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
fatigue SYSTEMATIC_ASSESSMENT General disorders None View
somnolence SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sleep Attacks SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
decreased libido SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Sexual Dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Blurry Vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Lightheadedness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Forgetfulness SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Impaired Concentration SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
compulsive behaviorws SYSTEMATIC_ASSESSMENT Psychiatric disorders None View