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 @ 4:16 PM
Ignite Modification Date: 2025-12-25 @ 2:14 PM
NCT ID: NCT03555266
Description: None
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: NCT03555266
Study Brief: NSS-2 BRIDGE Device in Post-Operative Pain Management
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NSS-2 Bridge and ERAS Protocol The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal. NSS-2 Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care ERAS protocol. 0 None 4 26 0 26 View
Sham NSS-2 BRIDGE and ERAS Protocol The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol Sham NSS-2 BRIDGE: NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol. 0 None 2 27 1 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Surgical complications SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Organ morbidity SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bowel complications SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Device dislodgement SYSTEMATIC_ASSESSMENT Product Issues None View