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 @ 3:56 PM
Ignite Modification Date: 2025-12-25 @ 2:00 PM
NCT ID: NCT00938392
Description: Systematically assessed Other Frequent (non-serious) adverse events were reported for subjects with a completed symptom sheet only.
Frequency Threshold: 5
Time Frame: Serious Adverse Events were reported during the entire study (up to Day 21). Other Frequent (non-serious) Adverse Events were reported during a 7-day follow-up period after vaccination.
Study: NCT00938392
Study Brief: Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine for the Elderly
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FluNG Aged Group Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A). None None 1 362 242 362 View
FluNG Fresh Group Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A). None None 1 362 252 362 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Urinary tract infection bacterial NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypertensive crisis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain at the injection site SYSTEMATIC_ASSESSMENT General disorders None View
Swelling at the injection site SYSTEMATIC_ASSESSMENT General disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Muscle aches SYSTEMATIC_ASSESSMENT General disorders None View
Shivering SYSTEMATIC_ASSESSMENT General disorders None View
Redness at the injection site SYSTEMATIC_ASSESSMENT General disorders None View