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 @ 6:55 PM
Ignite Modification Date: 2025-12-25 @ 4:28 PM
NCT ID: NCT01158157
Description: AE: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Frequency Threshold: 0
Time Frame: 1 year, 6 months
Study: NCT01158157
Study Brief: VA-006 Vaccinia Vaccine (ACAM2000) for the Production of VIGIV
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ACAM200 Vaccination Dose Participants received a single percutaneous administration of a droplet (2.5 μL) of the ACAM2000 smallpox vaccine using a bifurcated needle on Day 0. 0 None 0 25 15 25 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site scab SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vaccination complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View