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 @ 10:54 PM
Ignite Modification Date: 2025-12-25 @ 8:22 PM
NCT ID: NCT06054269
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data were collected from the moment of vaccination to the 7 days following vaccination. In the study, this corresponded to monitoring study participants from first enrollments in November 2022 to final enrollments in January 2023.
Study: NCT06054269
Study Brief: Clinical Trial to Evaluate the Immunogenicity of an Adjuvanted Influenza Vaccine Among HCP
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FLUAD Quadrivalent Participants administered a single dose of adjuvanted egg-based quadrivalent influenza vaccine (FLUAD Quadrivalent by Seqirus, 15 µg of HA from each strain). FLUAD Quadrivalent: 0.5 mL intramuscular dose of FLUAD Quadrivalent 0 None 0 95 70 95 View
FluQuadri Participants administered a single dose of standard dose egg-based quadrivalent influenza vaccine (FluQuadri by Sanofi-Pasteur, 15 µg of HA from each strain). FluQuadri: 0.5 mL intramuscular dose of FluQuadri 0 None 0 97 61 97 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Local pain at the vaccine injection site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Muscle/articular pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Malaise SYSTEMATIC_ASSESSMENT General disorders None View
Local swelling at the vaccine injection site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Local induration at the vaccine injection site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Local redness at the vaccine injection site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Local itchiness at the vaccine injection site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sore throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Measured or subjective fever SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Lack of appetite SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT General disorders None View
Rhinorrhea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Loose stool SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hematoma at the vaccine injection site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Itchiness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Increase of systolic blood pressure SYSTEMATIC_ASSESSMENT Vascular disorders None View
Conjunctivitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Pain in left eye SYSTEMATIC_ASSESSMENT Eye disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Right malar hematoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyposmia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Chest tightness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Itchiness and rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Itchiness and rash at vaccine injection site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View