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 @ 12:17 PM
Ignite Modification Date: 2025-12-25 @ 12:02 PM
NCT ID: NCT02315261
Description: None
Frequency Threshold: 1
Time Frame: 3 days
Study: NCT02315261
Study Brief: Effectiveness of Epidural Anesthesia for Thoracic and Abdominal Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Epidural Group Patients age \> 18 years old scheduled to have thoracic or abdominal surgery under general anesthesia combined with epidural analgesia in Siriraj hospital 0 None 42 364 213 364 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Motor weakness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dural puncture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Postoperative nausea and vomitting NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pruritus NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View