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 @ 4:51 PM
Ignite Modification Date: 2025-12-25 @ 2:35 PM
NCT ID: NCT03887650
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected up to 60 postoperative days.
Study: NCT03887650
Study Brief: LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Liposomal Bupivacaine 1.3% 10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block 0 None 0 45 18 45 View
Bupivacaine 0.5% With Adjuncts 20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block 0 None 0 45 21 45 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Swelling SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Inflammation SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Bruising SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Ringing in ears SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Numbness and tingling SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea and vomiting SYSTEMATIC_ASSESSMENT General disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View