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: 2025-12-25 @ 2:59 AM
Ignite Modification Date: 2025-12-26 @ 1:40 AM
NCT ID: NCT01639833
Description: All adverse events were reported, regardless of relationship to study device.
Frequency Threshold: 5
Time Frame: Adverse events were collected through the 90 day follow-up visit.
Study: NCT01639833
Study Brief: A Premarket, Prospective, Randomized, Single-Blind Study to Compare the Veriset™ Hemostatic Patch to TachoSil® as an Adjunct to Hemostasis in Subjects Undergoing Cardiovascular Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Veriset™ Hemostatic Patch Topical Hemostat Veriset™ Hemostatic Patch: Topical hemostat None None 13 44 23 44 View
TachoSil® Topical Hemostat TachoSil®: Topical Hemostat None None 11 45 21 45 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.1 View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.1 View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.1 View
Low cardiac output syndrome NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.1 View
Pericardial effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.1 View
Sick sinus syndrome NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.1 View
Trifascicular block NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.1 View
Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.1 View
Ventricular failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.1 View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Impaired healing NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Multi-organ failure NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Systemic inflammatory response syndrome NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Endocarditis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Pneumonia escherichia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Postoperative wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Staphylococcal sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Vascular graft complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.1 View
Cardiac output decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 14.1 View
Hemianopia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Hemiparesis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.1 View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.1 View
Haemothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Lung disorder NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Pulmonary oedema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Haemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.1 View
Atrial Fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.1 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Atelectasis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 14.1 View
Pericardial effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.1 View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.1 View