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 @ 2:38 AM
Ignite Modification Date: 2025-12-26 @ 1:16 AM
NCT ID: NCT02211534
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT02211534
Study Brief: Pilot Study of PEMF Therapy in Treatment of Post-operative Pain Following Total Knee Arthroplasty
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pulsed Electromagnetic Field Device Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes. Pulsed Electromagnetic Field Device (Provant): The PEMF device delivers non-thermal, non-ionizing pulsed electromagnetic energy to the target tissue, using 27.12 megahertz pulses lasting 42 microseconds and delivered 1000 times per second. The system generates an electromagnetic field that is continuously monitored and regulated to ensure consistent dosing. The therapeutic electromagnetic field is delivered by means of an applicator pad that is placed against the treatment site. The active and sham devices will be identical in appearance and all other physical characteristics in order to maintain the masking of the treatment. None None 0 24 6 24 View
Sham Pulsed Electromagnetic Field Device Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes. Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device. None None 0 11 4 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Arrhythemia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Burns second degree SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Synovitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View