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 @ 1:03 AM
Ignite Modification Date: 2025-12-25 @ 11:16 PM
NCT ID: NCT03077893
Description: Definition does not differ.
Frequency Threshold: 5
Time Frame: Adverse events were collected and recorded for approximately 9 months, from 16 March 2017 to 21 December 2017. Adverse Events are separated out between the "2 month lead-in active", "sham group" and "active group".
Study: NCT03077893
Study Brief: Study of PEMF to Evaluate VPT and Thermal Sensory in Subjects With Diabetic Peripheral Neuropathy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
2 Month Lead-in Active Group Treatment with active Provant Therapy System. Subjects treated with active device during the lead-in part of the study (prior to randomization). 8 None 2 44 2 44 View
Active Group Subjects randomized to treat with active Provant Therapy System. 3 None 0 44 0 44 View
Sham Group Subjects randomized to treat with sham device. 2 None 0 44 0 44 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Elevated troponins and shortness of breath NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Concussion / Cerebrovascular Accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain in feet/foot NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View