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 @ 10:09 PM
Ignite Modification Date: 2025-12-25 @ 7:45 PM
NCT ID: NCT00358735
Description: SAE did not include VTE events(DVT and PE) and Major bleeding complications as these are outcome measures
Frequency Threshold: 4
Time Frame: SAE data were collected Up to 3 months post-op
Study: NCT00358735
Study Brief: Deep Vein Thrombosis (DVT) Prevention in Total Hip Arthroplasty: Continuous Enhanced Circulation Therapy (CECT) Versus Low Molecular Weight Heparin (LMWH)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ActiveCare+SFT (Experimental) The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital). None None 3 198 89 198 View
LMWH (Enoxaparin) (Active Comparator) Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital). None None 10 194 102 194 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac Disorders SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dislocation SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fever due to aspiration SYSTEMATIC_ASSESSMENT Infections and infestations None View
Parkinson (new event) SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Stress fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
supraventricular cardiac arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Thrombocytopenia (HIT?) SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Minor Bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Edema SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View