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 @ 5:49 PM
Ignite Modification Date: 2025-12-25 @ 3:15 PM
NCT ID: NCT02590068
Description: The number of participants at risk in the Hepatitis C Infected Volunteers group is zero as we didn't enroll any volunteers in that arm of the study and the study is now closed for enrollment.
Frequency Threshold: 5
Time Frame: Up to 22 months
Study: NCT02590068
Study Brief: Effects of Chronic Viral Infection on Immune Response to Zoster Vaccination
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Hepatitis C Infected Volunteers Zoster vaccine live (Zostavax), 0.65 ml dose, administered subcutaneously to Hepatitis C infected volunteers Zoster vaccine live: Single Zostavax vaccine, 0.65 ml dose, administered subcutaneously 0 None 0 0 0 0 View
Healthy Volunteers Zoster vaccine live (Zostavax), 0.65 ml dose, administered subcutaneously to healthy volunteers Zoster vaccine live: Single Zostavax vaccine, 0.65 ml dose, administered subcutaneously 0 None 1 14 4 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dyspnea SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lightheadedness SYSTEMATIC_ASSESSMENT General disorders None View
Mild Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Mild Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dental Filling Fell Out SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View