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 @ 2:15 PM
Ignite Modification Date: 2025-12-25 @ 12:53 PM
NCT ID: NCT01974895
Description: For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
Frequency Threshold: 5
Time Frame: Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.
Study: NCT01974895
Study Brief: Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children From 6 to 35 Months of Age
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FluLaval Quadrivalent Group Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status. None None 5 158 115 158 View
Fluzone Group Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status. None None 4 156 103 156 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Respiratory syncytial virus infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abscess neck NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Failure to thrive NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Respiratory syncytial virus bronchiolitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sleep apnoea syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Irritability/fussiness SYSTEMATIC_ASSESSMENT General disorders None View
Loss of appetite SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Drowsiness SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View