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 @ 2:51 AM
Ignite Modification Date: 2025-12-26 @ 1:32 AM
NCT ID: NCT01863433
Description: The other AEs presented include solicited and unsolicited AEs. The Safety Population included all participants who received Trivalent Influenza Vaccine and provided follow-up safety data.
Frequency Threshold: 5
Time Frame: For solicited AEs: During the 4 days after vaccination (Day 0 plus 3 days); For unsolicited AEs and serious AEs (SAEs): After vaccination until the end of the study (approximately 21 days).
Study: NCT01863433
Study Brief: A Study to Assess the Immunogenicity and Safety of a Trivalent Influenza Vaccine Containing the 2013/2014 Formulation of Enzira® Vaccine in Healthy Volunteers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Trivalent Influenza Vaccine Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection. None None 0 120 81 120 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chills SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Injection site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View