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 @ 7:21 PM
Ignite Modification Date: 2025-12-25 @ 5:00 PM
NCT ID: NCT00749203
Description: None
Frequency Threshold: 0
Time Frame: 24 hours post infusion
Study: NCT00749203
Study Brief: Ketamine as a Rapid Treatment for Post-traumatic Stress Disorder (PTSD)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Midazolam Midazolam: single dose 0.045 mg/kg IV infused over 40 minutes 0 None 31 31 0 31 View
Ketamine Ketamine: Single dose 0.5 mg/kg IV (in the vein) infused over 40 minutes, 0 None 33 38 0 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders PRISE View
Headace SYSTEMATIC_ASSESSMENT Nervous system disorders PRISE View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders PRISE View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders PRISE View
Painful urination SYSTEMATIC_ASSESSMENT Renal and urinary disorders PRISE View
Frequent urination SYSTEMATIC_ASSESSMENT Renal and urinary disorders PRISE View
Sleeping too much SYSTEMATIC_ASSESSMENT General disorders PRISE View
Anxiety SYSTEMATIC_ASSESSMENT General disorders PRISE View
Poor concentration SYSTEMATIC_ASSESSMENT General disorders PRISE View
General malaise SYSTEMATIC_ASSESSMENT General disorders PRISE View
Restlessness SYSTEMATIC_ASSESSMENT General disorders PRISE View
Decreased energy SYSTEMATIC_ASSESSMENT General disorders PRISE View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders PRISE View
Nausea/Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders PRISE View
Palpitation SYSTEMATIC_ASSESSMENT Cardiac disorders PRISE View
Dizziness on standing SYSTEMATIC_ASSESSMENT Cardiac disorders PRISE View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders PRISE View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders PRISE View
Increased perspiration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders PRISE View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders PRISE View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders PRISE View
Tremors SYSTEMATIC_ASSESSMENT Nervous system disorders PRISE View
Poor coordination SYSTEMATIC_ASSESSMENT Nervous system disorders PRISE View
Ringing in ears SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders PRISE View
Difficulty urinating SYSTEMATIC_ASSESSMENT Renal and urinary disorders PRISE View
Difficulty sleeping SYSTEMATIC_ASSESSMENT General disorders PRISE View
Fatigue SYSTEMATIC_ASSESSMENT General disorders PRISE View
Other Events(If Any):