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 @ 4:37 PM
Ignite Modification Date: 2025-12-25 @ 2:27 PM
NCT ID: NCT00560066
Description: All enrolled subjects met entry criteria with one exception. One subject was enrolled and randomized to the CTIV group but did not receive the study vaccine due to a protocol deviation. This subject was excluded from both the safety and immunogenicity analyses.
Frequency Threshold: 5
Time Frame: Throughout the study period (day 1 to day 181).
Study: NCT00560066
Study Brief: Safety of a Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs in Adults and Elderly With and Without Underlying Medical Conditions, and Immunogenicity in a Subset of Subjects With Underlying Medical Conditions
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Egg-derived Vaccine (TIV) Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine None None 10 396 204 396 View
Cell Culture-derived Vaccine (cTIV) Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine None None 20 1001 568 1001 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina Pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Aortic Valve Incompetence NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Aortic Valve Stenosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial Fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sudden Hearing Loss NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Haemorrhoidal Haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Device Occlusion NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Herpes Zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Animal Bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Intervertebral Disc Protrusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ovarian Cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Optic Neuritis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transient Ischaemic Attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Urethral Caruncle NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pulmonary Embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Deep Vein Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypertensive Crisis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Acute Chest Syndrome NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Device Related Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Otitis Media NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Joint Dislocation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pancreatic Carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cerebrovascular Accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders None View