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: 2025-12-26 @ 1:16 PM
Ignite Modification Date: 2025-12-26 @ 1:16 PM
NCT ID: NCT00611806
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00611806
Study Brief: Effectiveness of Vitamin Supplementation in Treating People With Residual Symptoms of Schizophrenia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Folate With B12 Participants will take folic acid plus B12 for 18 weeks. Folic Acid: Folic acid 2mg po daily B12: B12 400 micrograms po daily None None 4 94 21 94 View
Placebo Participants will take placebo for 18 weeks. Placebo: 1 capsule po daily None None 4 46 16 46 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicidal Tendency SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Vision Decreased SYSTEMATIC_ASSESSMENT Eye disorders None View
Brain Tumor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Irritation of Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hospitalization due to worsening psychosis None Psychiatric disorders None View
Cholelithiasis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Body Numbness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Cholelithiasis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dirrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Enuresis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Numbness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Delusions SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Injury SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Manic Psychosis SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Muscle Spasm SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Psychosis SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Suicidal Tendency SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Back Pain SYSTEMATIC_ASSESSMENT General disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Eye Blood Shot SYSTEMATIC_ASSESSMENT Eye disorders None View
Vision Decreased SYSTEMATIC_ASSESSMENT Eye disorders None View
Asthema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Brain Tumor SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Laboratory Test Abnormality SYSTEMATIC_ASSESSMENT General disorders None View
Irritation of Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View