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 @ 4:40 PM
Ignite Modification Date: 2025-12-25 @ 2:29 PM
NCT ID: NCT05233566
Description: None
Frequency Threshold: 0
Time Frame: 30 days
Study: NCT05233566
Study Brief: Ketamine for Postoperative Avoidance of Depressive Symptoms: The K-PASS Feasibility Trial
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 Arm Following surgery and extubation, patients will receive ketamine 0.5 mg/kg over 10 minutes followed by an infusion of 0.3 mg/kg/h for 2 hours 50 minutes. Ketamine: NMDA antagonist 0 None 2 16 0 16 View
Control Arm Following surgery and extubation, patients will receive normal saline at an equal rate to that used in the ketamine arm. Normal saline: IV fluid acting as a placebo 1 None 5 16 3 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ramsay Hunt syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Postoperative Apnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Subjective arm/leg weakness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Surgical Site Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Deep Venous Thrombosis NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Death (underlying etiology unable to be determined) NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Transient Ischemic Attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Blisters around incision NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fever and chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nausea and vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View