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 @ 2:02 PM
Ignite Modification Date: 2025-12-25 @ 12:47 PM
NCT ID: NCT04145895
Description: adverse event data not collected from parents
Frequency Threshold: 0
Time Frame: 6 months post procedure
Study: NCT04145895
Study Brief: Postoperative Activity Restrictions in Children
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Physician-directed Postoperative Activity Restriction Postoperative activity restrictions prescribed by physician. Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc. 0 None 0 20 2 20 View
Self-directed Postoperative Activity Restriction Postoperative activity restrictions self-determined (parent/guardian and/or patient). Postoperative activity restrictions: Recommendations for return to full activity including return to school, sports, exercise, etc. 0 None 0 62 5 62 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
infection requiring antibiotics SYSTEMATIC_ASSESSMENT Infections and infestations None View
skin inflammation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
anesthesia reaction SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
drug rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View