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 @ 3:31 PM
Ignite Modification Date: 2025-12-25 @ 1:45 PM
NCT ID: NCT03694392
Description: None
Frequency Threshold: 0
Time Frame: Up to 8 months
Study: NCT03694392
Study Brief: Flublok v. Standard Dose Vaccine Effectiveness Among Kaiser Permanente Northern California Adults 18-64 Years
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Flublok Recipients Kaiser Permanente Northern California members aged 18-64 years who receive Flublok Quadrivalent vaccine. Flublok Quadrivalent: Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs. 352 None 0 632962 0 632962 View
SD-IIV Recipients Kaiser Permanente Northern California members aged 18-64 years who receive standard dose inactivated influenza vaccine (SD-IIV). Standard Dose Inactivated Influenza Vaccine (SD-IIV): For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent. 501 None 0 997366 0 997366 View
Serious Events(If Any):
Other Events(If Any):