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: 2025-12-25 @ 4:10 AM
Ignite Modification Date: 2025-12-26 @ 3:07 AM
NCT ID: NCT03714620
Description: The reported adverse "effects" were considered known and anticipated with this drug regimen so very much anticipated and many very mild.
Frequency Threshold: 0
Time Frame: 60 minutes
Study: NCT03714620
Study Brief: Sub-dissociative Dose Ketamine Dosing Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
0.15 mg/kg IV Ketamine Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes 0 None 0 49 28 49 View
0.3 mg/kg IV Ketamine Ketamine: Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes 0 None 0 49 31 49 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hearing Changes SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vision Changes SYSTEMATIC_ASSESSMENT Eye disorders None View
Mood Alteration SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Discomfort SYSTEMATIC_ASSESSMENT General disorders None View
Hallucinations SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Feeling of Unreality SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View