Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 10:45 PM
Ignite Modification Date: 2025-12-25 @ 8:15 PM
NCT ID: NCT02096835
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data were collected from the start of anesthesia to 48h after the operation.
Study: NCT02096835
Study Brief: Transcutaneous Electrical Acupoint Stimulation of P6 to Prevent Postoperation Nausea and Vomiting
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Acustimulation Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction. Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm. Dexamethasone: will be given after induction None None 0 53 6 53 View
Tropisetron Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction. Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure. Tropisetron: will be given at the start of skin closure Dexamethasone: will be given after induction None None 0 53 0 53 View
Control Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction. Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure. Dexamethasone: will be given after induction None None 0 51 0 51 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Local redness NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Local itching NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Local skin swelling NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View