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 @ 4:28 AM
Ignite Modification Date: 2025-12-26 @ 3:31 AM
NCT ID: NCT00718120
Description: For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Frequency Threshold: 5
Time Frame: Solicited adverse events were collected during the 4-day (Day 0-3) post-vaccination period, unsolicited and serious adverse events collected during the 21-day (Day 0-20) post-vaccination period.
Study: NCT00718120
Study Brief: Immunogenicity and Safety Study of GSK Biologicals' Fluviral® (2008 - 2009 Season) in Adults Over 18 Years
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fluviral Adult Group Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine. 0 None 0 55 36 55 View
Fluviral Elderly Group Subjects aged more than 60 years received a single dose of Fluviral® vaccine. 0 None 1 55 13 55 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaphylactic reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cough SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View
Joint pain at other location SYSTEMATIC_ASSESSMENT General disorders None View
Muscle aches SYSTEMATIC_ASSESSMENT General disorders None View
Red eyes SYSTEMATIC_ASSESSMENT General disorders None View
Sore throat SYSTEMATIC_ASSESSMENT General disorders None View
Pain at the injection site SYSTEMATIC_ASSESSMENT General disorders None View