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 @ 11:40 PM
Ignite Modification Date: 2025-12-25 @ 9:31 PM
NCT ID: NCT03921151
Description: During the practice MRI visit, adverse events (AEs) were recorded using the 24 hour questionnaire. During the Dose 1 and Dose 2 MRI visits, AEs were recorded using the 24 questionnaire (pre dose), Drug Effects Questionnaire (pre dose, 1.25 hr post dose, 3.75 hr post dose, 4.5 hr post dose), and neurological exam (5 hr post dose completed by physician). All AEs were entered into a secure REDCap database.
Frequency Threshold: 0
Time Frame: Adverse events were monitored during the first study visit (practice MRI) through the last study visit (Dose 2 MRI) approximately 1 week.
Study: NCT03921151
Study Brief: 5HT2CR Balance in Brain Connectivity in Cocaine Dependence
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cocaine-dependent Participants who use and are dependent on cocaine Mirtazapine 15 MG Oral Tablet: The intervention will be a 15mg of mirtazapine oral tablet given to participants prior to their treatment scan and assessments. In order to ensure that biases or social desirability do not contaminate baseline assessments, all participants will also be given a tablet consisting of dextrose in gelatin prior to their baseline scan and assessment. 0 None 0 35 0 35 View
Non-drug Using Healthy Controls Participants who are not drug users Mirtazapine 15 MG Oral Tablet: The intervention will be a 15mg of mirtazapine oral tablet given to participants prior to their treatment scan and assessments. In order to ensure that biases or social desirability do not contaminate baseline assessments, all participants will also be given a tablet consisting of dextrose in gelatin prior to their baseline scan and assessment. 0 None 0 28 1 28 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea and dizziness SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View