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 @ 2:28 AM
Ignite Modification Date: 2025-12-26 @ 1:02 AM
NCT ID: NCT02258334
Description: None
Frequency Threshold: 5.00
Time Frame: Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
Study: NCT02258334
Study Brief: Study of Fluzone® Quadrivalent, Fluzone® Intradermal, 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
Group 2 Adults 18 to \< 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine. None None 0 54 28 54 View
Group 3 Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine. None None 1 52 19 52 View
Group 4 Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine. None None 0 52 21 52 View
Group 1 Adults 18 to \< 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine. None None 0 49 26 49 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Haematochezia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Injection site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Injection site Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Injection site Induration SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Injection site Ecchymosis SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.0 View
Shivering SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.0 View