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 @ 1:44 AM
Ignite Modification Date: 2025-12-26 @ 12:01 AM
NCT ID: NCT03375294
Description: Does not differ.
Frequency Threshold: 0
Time Frame: 1 week
Study: NCT03375294
Study Brief: Exploring Nitrous Oxide Effects 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
Nitrous Oxide PTSD patients in this arm will receive a single inhalation dose of 50% nitrous oxide and 50% oxygen for 1 hour Nitrous Oxide: One hour inhalation of 50% nitrous oxide, an odorless, colorless gas FDA approved as an induction agent for dental sedation 0 None 0 3 2 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Poor concentration SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Decreased energy SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General malaise SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fingers tingling SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Body warmth SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Increased perspiration SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Blurry vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Restlessness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Fatigue SYSTEMATIC_ASSESSMENT Nervous system disorders None View