Adverse Events Module

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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 @ 10:32 PM
Ignite Modification Date: 2025-12-25 @ 8:05 PM
NCT ID: NCT01732835
Description: None
Frequency Threshold: 4
Time Frame: Through 2 years for the 49 participants receiving the implant
Study: NCT01732835
Study Brief: The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
HAART 300 Annuloplasty Device Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair None None 23 49 38 49 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders None View
aortic insufficiency SYSTEMATIC_ASSESSMENT Cardiac disorders None View
arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
cardiac decompensation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
syncope SYSTEMATIC_ASSESSMENT Cardiac disorders None View
GI bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
reflux esophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations None View
systemic inflammatory response syndrome SYSTEMATIC_ASSESSMENT Infections and infestations None View
worsening of wound healing disorder SYSTEMATIC_ASSESSMENT Infections and infestations None View
wound infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
bleeding SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
loosening of wire cerclages SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
presternal abscess SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
lumbago SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
bronchopulmonary infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pleuropneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pulmonary spasticity SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
bleeding event SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
thoracic pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
aortic insufficiency SYSTEMATIC_ASSESSMENT Cardiac disorders None View
arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
edema SYSTEMATIC_ASSESSMENT Cardiac disorders None View
pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders None View
syncope SYSTEMATIC_ASSESSMENT Cardiac disorders None View
abnormal LDH value SYSTEMATIC_ASSESSMENT Endocrine disorders None View
hyperthyreosis SYSTEMATIC_ASSESSMENT Endocrine disorders None View
increased C-reactive protein SYSTEMATIC_ASSESSMENT Infections and infestations None View
sternal pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
respiratory infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View