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 @ 9:07 PM
Ignite Modification Date: 2025-12-25 @ 6:58 PM
NCT ID: NCT02392104
Description: Major bleeding was defined as a fatal or symptomatic bleed into a critical area or organ, bleeding leading to hospitalization, or transfusion of two units or more of packed red blood cells. This definition is the standard definition used by the Anticoagulation Clinic to report events. Serious bleeding was defined as bleeding leading to emergency or urgent care visit or additional testing required.
Frequency Threshold: 0
Time Frame: 24 months
Study: NCT02392104
Study Brief: Prospective Evaluation of an Extended Interval of INR Follow-up in a VA Anticoagulation Service
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention Arm All patients in the study will be in the intervention arm. Warfarin: If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks. 0 None 15 50 19 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Aortic valve disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Severe AKI SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pulmonary hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Post-op monitoring for vascular procedure SYSTEMATIC_ASSESSMENT Vascular disorders None View
Multiple myeloma SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Chest pain - cardiac SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Colonic hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemorrhoidal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper gastrointestinal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bronchial infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary tract pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
RLE cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Thromboembolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Major bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Serious bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View