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 @ 2:56 PM
Ignite Modification Date: 2025-12-25 @ 1:20 PM
NCT ID: NCT03896659
Description: None
Frequency Threshold: 0
Time Frame: The period of observation for the collection of adverse events extended from the time the subject gave informed consent until study completion, an average of 40 days.
Study: NCT03896659
Study Brief: Exploring the Effects of Corticosteroids on the Human Hippocampus
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Depressed: Hydrocortisone Participants in the "Depressed' arm who received Hydrocortisone 160 mg tablet every day for 3 days as the first or second intervention. 0 None 0 19 3 19 View
Depressed: Placebo Participants in the "Depressed' arm who received Placebo tablet (matching Hydrocortisone 160 mg tablet) every day for 3 days as the first or second intervention. 0 None 1 21 3 21 View
Healthy Controls: Hydrocortisone Participants in the "Healthy Controls' arm first received Hydrocortisone 160 mg tablet every day for 3 days as the first or second intervention. 0 None 0 42 6 42 View
Healthy Controls: Placebo Participants in the "Healthy Controls' arm first received Placebo tablet (matching Hydrocortisone 160 mg tablet) every day for 3 days as the first or second intervention. 0 None 0 37 5 37 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acne Exacerbation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Abdominal Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Daytime Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Difficulty Sleeping SYSTEMATIC_ASSESSMENT General disorders None View
Flushing in Face SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
MRI Abnormality SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Increased Energy SYSTEMATIC_ASSESSMENT General disorders None View
Hives SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Restlessness SYSTEMATIC_ASSESSMENT General disorders None View
Loose Stool SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Eczema Flare SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Racing Thoughts SYSTEMATIC_ASSESSMENT General disorders None View
Fever Blister SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nightmares SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Burning Sensation in Stomach SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View