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 @ 5:37 PM
Ignite Modification Date: 2025-12-25 @ 3:08 PM
NCT ID: NCT00430768
Description: None
Frequency Threshold: 5
Time Frame: 1 year active study; 4 years long term follow up
Study: NCT00430768
Study Brief: Experimental Gene Transfer Procedure to Treat Alpha 1-Antitrypsin (AAT) Deficiency
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 1 Low Dose 6.9 x10e12 vector genomes e. Group 1 receives rAAV1-CB-hAAT 6.9 x10e12 vg (vector genomes) None None 1 3 3 3 View
Group 3 High Dose rAAV1-CB-hAAT 6.0 x10e13 vg Group 3 receives rAAV1-CB-hAAT 6.0 x10e13 vg None None 0 3 3 3 View
Group 2 Middle Dose 2.2 x 10e13 vector genomes Group 2 receives rAAV1-CB-hAAT 2.1 x10e13 vg None None 0 3 2 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
E. coli Epididymitis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders vocabulary,MedDRA View
Pharyngoesophageal diverticulum repair with complications NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders vocabulary,MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lacrimation increased NON_SYSTEMATIC_ASSESSMENT Eye disorders vocabulary,MedDRA View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders vocabulary,MedDRA View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders vocabulary,MedDRA View
Injection site hematoma SYSTEMATIC_ASSESSMENT General disorders vocabulary,MedDRA View
Injection site induration SYSTEMATIC_ASSESSMENT General disorders vocabulary,MedDRA View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders vocabulary,MedDRA View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders vocabulary,MedDRA View
Injection site warmth SYSTEMATIC_ASSESSMENT General disorders vocabulary,MedDRA View
Malaise NON_SYSTEMATIC_ASSESSMENT General disorders vocabulary,MedDRA View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders vocabulary,MedDRA View
Escherichia urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations vocabulary,MedDRA View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations vocabulary,MedDRA View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations vocabulary,MedDRA View
Oral candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations vocabulary,MedDRA View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations vocabulary,MedDRA View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations vocabulary,MedDRA View
Tooth infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations vocabulary,MedDRA View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations vocabulary,MedDRA View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications vocabulary,MedDRA View
Limb injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications vocabulary,MedDRA View
Skin injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications vocabulary,MedDRA View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations vocabulary,MedDRA View
Alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations vocabulary,MedDRA View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations vocabulary,MedDRA View
Blood cholesterol increased NON_SYSTEMATIC_ASSESSMENT Investigations vocabulary,MedDRA View
Gamma-glutamyl transferase increased SYSTEMATIC_ASSESSMENT Investigations vocabulary,MedDRA View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders vocabulary,MedDRA View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders vocabulary,MedDRA View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders vocabulary,MedDRA View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders vocabulary,MedDRA View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders vocabulary,MedDRA View
depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders vocabulary,MedDRA View
Dry throat NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders vocabulary,MedDRA View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders vocabulary,MedDRA View
Nasal mucosal disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders vocabulary,MedDRA View
Rhinorrhea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders vocabulary,MedDRA View
Sinus Congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders vocabulary,MedDRA View
Sinus headache NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders vocabulary,MedDRA View
Throat Irritation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders vocabulary,MedDRA View
Wheezing NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders vocabulary,MedDRA View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders vocabulary,MedDRA View
Pharyngoesophageal diverticulum NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders vocabulary,MedDRA View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations vocabulary,MedDRA View
Tooth infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations vocabulary,MedDRA View
Gastrointestinal anastomotic leak NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications vocabulary,MedDRA View
Road Traffic Accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications vocabulary,MedDRA View
Wrist Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications vocabulary,MedDRA View
Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders vocabulary,MedDRA View
Prostate Cancer NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders vocabulary,MedDRA View
Chest Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders vocabulary,MedDRA View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders vocabulary,MedDRA View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders vocabulary,MedDRA View
Subcutaneous abscess NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders vocabulary,MedDRA View