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 @ 12:18 AM
Ignite Modification Date: 2025-12-25 @ 10:21 PM
NCT ID: NCT04114058
Description: An adverse event is defined as a fall post op.
Frequency Threshold: 0
Time Frame: The adverse events occurred through post op days 1-7 for each patient.
Study: NCT04114058
Study Brief: A Study Comparing Fascia Iliaca Blockade vs Extracapsular Local Field Infiltration With Liposomal Bupivacaine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fascia Iliaca Blockade Preoperatively before hip arthroscopy, a fascia iliaca blockade will be performed for adjunct pain control Fascia iliaca blockade: fascia iliaca compartment blockade 0 None 0 17 6 17 View
Liposomal Bupivicaine Following hip arthroscopy, local field infiltration with liposomal bupivicaine will be performed for adjunct pain control liposomal bupivicaine: local field infiltration 0 None 0 20 0 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
fall SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View