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: 2025-12-25 @ 1:23 AM
Ignite Modification Date: 2025-12-25 @ 11:32 PM
NCT ID: NCT02563093
Description: A participant (18 to \< 65 Years) who was randomly assigned to receive Fluzone Intradermal Quadrivalent vaccine received Fluzone Quadrivalent vaccine instead; this participant was included in the Fluzone Quadrivalent vaccine (18 to \< 65 Years) Group in the Safety Analysis Set.
Frequency Threshold: 5.00
Time Frame: Adverse event data were collected from Day 0 up to Day 21 post-vaccination.
Study: NCT02563093
Study Brief: Study of Fluzone® Quadrivalent, Fluzone® Intradermal Quadrivalent, and Fluzone® High-Dose, Influenza Vaccines in Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fluzone Quadrivalent Vaccine (18 to < 65 Years) Adults 18 to \< 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine None None 0 53 29 53 View
Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years) Adults 18 to \< 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine None None 0 51 29 51 View
Fluzone Quadrivalent Vaccine (≥ 65 Years) Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine None None 0 53 15 53 View
Fluzone High-Dose Vaccine (≥ 65 Years) Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine None None 1 51 22 51 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Cardiac failure acute NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 18.0 View
Transient ischaemic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site Pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Injection site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Injection site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Injection site Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Injection site Induration SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.0 View
Shivering SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.0 View