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: 2025-12-24 @ 3:32 PM
Ignite Modification Date: 2025-12-25 @ 1:45 PM
NCT ID: NCT00006392
Description: Study site visits, collected by CRA based on participant interview and annual limited physical exam
Frequency Threshold: 5
Time Frame: 6 months
Study: NCT00006392
Study Brief: S0000 Selenium and Vitamin E in Preventing Prostate Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Selenium Alone Selenium + placebo for vitamin E None None 96 8752 2605 8752 View
Combination Selenium + vitamin E None None 93 8702 2550 8702 View
Placebo Placebo for selenium + placebo for vitamin E None None 108 8696 2421 8696 View
Vitamin E Alone Vitamin E + placebo for selenium None None 99 8737 2553 8737 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Arrhythmia, NOS SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Cardiac ischemia/infarction SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
LVEF decrease/CHF SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Supraventricular arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Ventricular arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Eye-other SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (2.0) View
Vision,NOS SYSTEMATIC_ASSESSMENT Eye disorders CTCAE (2.0) View
Dyspepsia/heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
GI-other SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Melena/ GI bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Rectal bleeding/hematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Pain-other SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Reportable adverse event, NOS SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Liver-clinical SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (2.0) View
Liver-other SYSTEMATIC_ASSESSMENT Hepatobiliary disorders CTCAE (2.0) View
Respiratory infect w/o neutrop SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Respiratory infection, unk ANC SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Urinary tr infect w/o neutrop SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (2.0) View
Surgery-hemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications CTCAE (2.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Myalgia/arthralgia, NOS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE (2.0) View
Second primary SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) CTCAE (2.0) View
CNS hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Cerebrovascular ischemia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Cranial neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Neuro-other SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE (2.0) View
Erectile impotence SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCAE (2.0) View
ARDS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Emphysema/COPD SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Rash/desquamation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Aortic Stenosis SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Carotid stenosis SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Cardiovascular-other SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Conduction abnormality/block SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Constitutional symptoms-other SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Hemorrhage w/o 3-4 thrombocyt SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Weight gain SYSTEMATIC_ASSESSMENT Investigations CTCAE (2.0) View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (2.0) View
Seizures SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Sensory neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (2.0) View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (2.0) View
Peripheral arterial ischemia SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Thrombosis/embolism SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (2.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cardiac ischemia/infarction SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE (2.0) View
Halitosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (2.0) View
Fatigue/malaise/lethargy SYSTEMATIC_ASSESSMENT General disorders CTCAE (2.0) View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View
Nail changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (2.0) View