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: 2025-12-26 @ 10:18 PM
Ignite Modification Date: 2025-12-26 @ 10:18 PM
NCT ID: NCT03953612
Description: None
Frequency Threshold: 5
Time Frame: up to 8 weeks
Study: NCT03953612
Study Brief: The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PREG 300 mg/Day Eligible participants will be randomly assigned to 300 mg/day PREG over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC. 0 None 1 20 12 20 View
PREG 500 mg/Day Eligible participants will be randomly assigned to 500 mg/day PREG over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC. 0 None 0 17 13 17 View
Patients Receiving Placebo Eligible participants will be randomly assigned to a placebo (PLA) treatment over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for the first two weeks and then transition to outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient only option where they will participate in the entire study outpatient at YSC. 0 None 0 18 11 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Injury/Pain SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal disorders - Other, specify SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Inflammation/Allergy SYSTEMATIC_ASSESSMENT General disorders None View
Infection/Immune System SYSTEMATIC_ASSESSMENT General disorders None View
Suicidal Thoughts SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Lightheadedness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Psychiatric disorders - Other, specify SYSTEMATIC_ASSESSMENT Psychiatric disorders None View