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 @ 3:45 AM
Ignite Modification Date: 2025-12-26 @ 2:32 AM
NCT ID: NCT00796302
Description: Only adverse events for weeks 4 to 9 (when the second medication was used) are reported. After subtracting the 22 participants who were not given the second medication, AE data were available for 80 basic treatment and 73 augmented treatment participants.
Frequency Threshold: 5
Time Frame: 9 weeks
Study: NCT00796302
Study Brief: Treatment of Severe Childhood Aggression (The TOSCA Study)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Basic (Stimulant + PMT + Placebo) Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training. None None 0 80 69 80 View
Augmented (Stimulant + PMT + Risperidone) Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training. None None 0 73 62 73 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Trouble falling asleep SYSTEMATIC_ASSESSMENT General disorders None View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Appetite decrease SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Appetite increase SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Sedation SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View