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 @ 12:58 AM
Ignite Modification Date: 2025-12-25 @ 11:12 PM
NCT ID: NCT01474993
Description: None
Frequency Threshold: 5
Time Frame: 22 weeks
Study: NCT01474993
Study Brief: Sulforaphane-rich Broccoli Sprout Extract for Autism
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 15 participants were randomized to placebo. One participant in placebo group dropped out before starting study drug. 14 participants completed the study and were analyzed. None None 0 14 4 14 View
Sulforaphane-rich Broccoli Sprout Extract 29 subjects were randomized to receive sulforaphane-rich Broccoli Sprout Extract. Of these, 2 were lost to follow up and 1 discontinued intervention. 26 sulforaphane participants completed the study and were analyzed. None None 0 26 5 26 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased aggressions SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seasonal allergy exacerbation SYSTEMATIC_ASSESSMENT General disorders None View
Seizures SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Increased stubbornness SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Increased agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Crying spells SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hyperactivity SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Increased appetite SYSTEMATIC_ASSESSMENT General disorders None View
Increased anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Lethargy SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Increased burping SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abnormal platelet count SYSTEMATIC_ASSESSMENT Investigations None View
Abnormal WBC count SYSTEMATIC_ASSESSMENT Investigations None View
SGPT outside of reference range SYSTEMATIC_ASSESSMENT Investigations None View
SGOT outside of reference range SYSTEMATIC_ASSESSMENT Investigations None View
TSH outside of reference range SYSTEMATIC_ASSESSMENT Investigations None View