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: 2025-12-26 @ 4:01 PM
Ignite Modification Date: 2025-12-26 @ 4:01 PM
NCT ID: NCT00623506
Description: None
Frequency Threshold: 1
Time Frame: Adverse Events were collected following the one-week placebo-lead phase and at each subsequent study visit and telephone check-in. Adverse events were collected during 11 out of the 12 weeks.
Study: NCT00623506
Study Brief: Adjunctive Pregnenolone in Veterans With Mild TBI
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pregnenolone Pregnenolone Pregnenolone : Pregnenolone 100 mg in divided doses (50 mg, PO, BID) Pregnenolone 300 mg in divided doses (150 mg, PO, BID) Pregnenolone 500 mg in divided doses (250 mg, PO, BID) None None 0 11 6 11 View
Placebo Placebo Subjects received placebo study medication; dispensed exactly as active study medication was dispensed. None None 0 11 6 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia SYSTEMATIC_ASSESSMENT General disorders None View
Hypersomnia SYSTEMATIC_ASSESSMENT General disorders None View
Drowsiness SYSTEMATIC_ASSESSMENT General disorders None View
Cramps SYSTEMATIC_ASSESSMENT General disorders None View
Akathisia SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT General disorders None View
Blurred Vision SYSTEMATIC_ASSESSMENT General disorders None View
Constipation SYSTEMATIC_ASSESSMENT General disorders None View
Excitation and Agitation SYSTEMATIC_ASSESSMENT General disorders None View
Restlessness SYSTEMATIC_ASSESSMENT General disorders None View
Increased motor activity SYSTEMATIC_ASSESSMENT General disorders None View
Decreased Motor Activity SYSTEMATIC_ASSESSMENT General disorders None View
Decreased Interest in Sex SYSTEMATIC_ASSESSMENT General disorders None View
Impaired Sexual Performance SYSTEMATIC_ASSESSMENT General disorders None View
Dermatological SYSTEMATIC_ASSESSMENT General disorders None View
Muscle pain/stiffness SYSTEMATIC_ASSESSMENT General disorders None View
Decreased Appetite SYSTEMATIC_ASSESSMENT General disorders None View
Increased appetite SYSTEMATIC_ASSESSMENT General disorders None View