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 @ 11:52 PM
Ignite Modification Date: 2025-12-25 @ 9:47 PM
NCT ID: NCT02484651
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data were collected by the researchers up to 3 days after surgery.
Study: NCT02484651
Study Brief: Can Adequacy of Anesthesia Depth and Quality of Recovery be Influenced by the Level of Neuromuscular Blockade?
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard Group Standard Clinical Practice Group - standard neuromuscular block, with a standard rocuronium dose for intubation (0.6 mg/kg). If required, the reversal of neuromuscular block is performed with neostigmine. 0 None 0 35 2 35 View
Deep NMB Group Deep Neuromuscular Block group - with a standard rocuronium dose for intubation (0.6 mg/kg), followed by a constant infusion of rocuronium (10-15 ug/kg/min) to guarantee a PTC less or equal to 2 on the TOF monitor (PTC is evaluated every 5 minutes). The reversal of neuromuscular block is performed with Sugammadex (4 mg/kg). Sugammadex: Reversal of deep neuromuscular block Rocuronium: Maintenance of deep neuromuscular block 0 None 0 35 6 35 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Emergence delirium SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Neck pain SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Nausea and urinary retention SYSTEMATIC_ASSESSMENT General disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Asystole of 20 seconds SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Post-operative hypertension SYSTEMATIC_ASSESSMENT General disorders None View
Post-operative dyspnea and anxiety SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View