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 @ 4:55 AM
Ignite Modification Date: 2025-12-26 @ 3:55 AM
NCT ID: NCT03404518
Description: Adverse event would include any report or contact with the clinic to request for additional medication refills, emergency room visit related to the surgery, any additional procedure necessary due to complications from the surgery
Frequency Threshold: 0
Time Frame: Days 1-7 following surgery or until the first follow up appointment with provider up to 14 days following surgery
Study: NCT03404518
Study Brief: Patient Narcotic Requirements After Outpatient Otolaryngology Procedures
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ibuprofen and Norco This group will take Ibuprofen 600mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control. Ibuprofen: Ibuprofen as first line therapy every 6 hours as needed for pain control 0 None 0 88 3 88 View
Norco and Ibuprofen This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control as first line intervention. If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control. Norco: Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control 0 None 0 97 4 97 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Drainage from surgical site NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Uncontrolled pain NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View