Adverse Events Module

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 @ 6:41 PM
Ignite Modification Date: 2025-12-24 @ 6:41 PM
NCT ID: NCT04124757
Description: None
Frequency Threshold: 0
Time Frame: 1 month
Study: NCT04124757
Study Brief: Impact of Deep Versus Standard Muscle Relaxation on Intra-operative Safety
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 Neuromuscular Blockade Subjects will receive regular rocuronium induction dose, followed by bolus foses of 10 mg in case of insufficient conditions 0 None 24 361 65 361 View
Deep Neuromuscular Block Subjects will receive high dose rocuronium induction dose followed by continuous rocuronium administration, to achieve a depth of neuromuscular block of 1-2 twitches post tetanic count Deep neuromuscular block: Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count 0 None 23 362 51 362 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Unplanned readmission SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
postoperative nausea vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View