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 @ 2:55 PM
Ignite Modification Date: 2025-12-25 @ 1:20 PM
NCT ID: NCT03860259
Description: Adverse event data was collected for the duration of the subject's 90-day study participation using the electronic medical record and via patient report at day 5, 14, 30, 60, and 90 follow-ups.
Frequency Threshold: 0
Time Frame: Adverse event data was collected for the duration of the subject's participation in the study (90 days post-operative).
Study: NCT03860259
Study Brief: Auriculotherapy for Surgical Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Auriculotherapy Without Nitrogen Gas Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with an empty cryopuncture with no nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device without nitrogen gas: Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy 0 None 0 25 4 19 View
Auriculotherapy With Nitrogen Gas Auriculotherapy will be performed by certified research staff using a cryopuncture device in the post-anesthesia recovery room with nitrogen gas. The patient will receive an interscalene nerve block, standard of care treatment for surgery, post-operative pain management, and physical therapy. Auriculotherapy cryopuncture device with nitrogen gas: Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy 0 None 0 25 10 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Postoperative Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View