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 @ 10:52 PM
Ignite Modification Date: 2025-12-25 @ 8:21 PM
NCT ID: NCT02780869
Description: All adverse events (AEs) through final follow-up were collected. An AE is defined according to the European Standard EN ISO 14155 as 'any untoward medical occurrence in a subject.' An AE related to a device (adverse device effect, ADE) is defined as 'any untoward and unintended response to an investigational medical device.'
Frequency Threshold: 0
Time Frame: Enrollment until completion of 6-week follow-up visit
Study: NCT02780869
Study Brief: HEMOBLAST Pivotal Clinical Investigation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Investigational HEMOBLAST Bellows 0 None 19 175 84 175 View
Control Absorbable gelatin sponge, USP with thrombin 3 None 11 83 47 83 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Delirium SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Ascites SYSTEMATIC_ASSESSMENT General disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT General disorders None View
Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypotension SYSTEMATIC_ASSESSMENT General disorders None View
Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Aortic dissection SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RA lead dislodgement SYSTEMATIC_ASSESSMENT Product Issues None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Respiratory insufficiency SYSTEMATIC_ASSESSMENT General disorders None View
Skin rash/hives SYSTEMATIC_ASSESSMENT Immune system disorders None View
Syncope SYSTEMATIC_ASSESSMENT General disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT General disorders None View
Stroke SYSTEMATIC_ASSESSMENT General disorders None View
Vomiting SYSTEMATIC_ASSESSMENT General disorders None View
Dehisence SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Seroma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hemothorax SYSTEMATIC_ASSESSMENT General disorders None View
Melena SYSTEMATIC_ASSESSMENT General disorders None View
Right bronchopleural fistula SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Wound related SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Constipation/ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Arrythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fluid overload SYSTEMATIC_ASSESSMENT General disorders None View
Abnormal bloodwork SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View