Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 10:09 PM
Ignite Modification Date: 2025-12-25 @ 7:45 PM
NCT ID: NCT00124735
Description: All subjects who received rocuronium were included in the safety analyses. Information regarding adverse events were obtained by questioning or examining the subject. At each visit during the treatment period, all new complaints and symptoms were recorded.
Frequency Threshold: 5
Time Frame: None
Study: NCT00124735
Study Brief: A Study to Determine the Dose Requirements of Rocuronium Bromide (Zemuron®) in Pediatric and Adolescent Subjects (21048)(COMPLETED)(P05797)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rocuronium Bolus Maintenance Subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation (includes neonates, infants, toddlers, children, and adolescents). None None 1 64 10 64 View
Rocuronium Continuous Infusion Maintenance Subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation (includes neonates, infants, toddlers, children, and adolescents) None None 0 73 9 73 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (10.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (10.0) View