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: 2025-12-25 @ 1:39 AM
Ignite Modification Date: 2025-12-25 @ 11:54 PM
NCT ID: NCT01673594
Description: None
Frequency Threshold: 0
Time Frame: 6 weeks
Study: NCT01673594
Study Brief: Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist
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 Arm 2: Placebo + SODAS MPH SODAS MPH: Adults with ADHD will receive open-label SODAS MPH None None 0 19 16 19 View
Naltrexone Arm 1: Naltrexone + SODAS MPH SODAS MPH: Adults with ADHD will receive open-label SODAS MPH Naltrexone: Subjects randomized to the "active" double-blind group will receive Naltrexone HCl None None 0 18 18 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cold/Infection/Allergy SYSTEMATIC_ASSESSMENT General disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea/Vomit/Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sedation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Decreased Energy SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Increased Energy SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Cardiovascular SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tense/Jittery SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Agitated/irritable SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sad/Down SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxious/Worried SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Autonomic: Drool/Sweat SYSTEMATIC_ASSESSMENT General disorders None View
Mucosal Dryness SYSTEMATIC_ASSESSMENT General disorders None View
DizzyLightheaded SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Extra Pyramidal Symptoms SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neurological SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Musculoskeletal SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dermatological SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pressure SYSTEMATIC_ASSESSMENT General disorders None View
Feels Warm SYSTEMATIC_ASSESSMENT General disorders None View
Unable to Feel Emotions SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Tingly Feeling in Head and Chest SYSTEMATIC_ASSESSMENT General disorders None View
Menstrual Cramps SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View