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 @ 1:33 PM
Ignite Modification Date: 2025-12-25 @ 12:33 PM
NCT ID: NCT02519595
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02519595
Study Brief: Optimal Dosing of Ketamine for Procedural Sedation and Analgesia in Children
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ketamine IV 1 mg/kg Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg None None 0 50 5 50 View
Ketamine IV 1.5 mg/kg Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg None None 0 35 5 35 View
Ketamine IV 2 mg/kg Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg None None 0 40 4 40 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Oxygen Desaturation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Emesis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Unpleasant Recovery Reaction SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Others SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View