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 @ 3:47 AM
Ignite Modification Date: 2025-12-26 @ 2:34 AM
NCT ID: NCT02915302
Description: All AEs were presented.
Frequency Threshold: 5
Time Frame: Adverse event (AE) data were collected from Day 0 (post-vaccination) up to Day 28 post-final vaccination.
Study: NCT02915302
Study Brief: Safety and Immunogenicity of Fluzone® Quadrivalent Vaccine Administered to Healthy Children
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Fluzone Quadrivalent Vaccine, 0.25-mL Participants received a 0.25-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.25-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28. 0 None 5 949 698 949 View
Fluzone Quadrivalent Vaccine, 0.5-mL Participants received a 0.5-mL dose of Fluzone Quadrivalent vaccine, intramuscularly, at Day 0. For participants for whom 2 doses of influenza vaccine were recommended per ACIP guidance, a second 0.5-mL dose of Fluzone Quadrivalent vaccine was administered at Day 28. 0 None 5 992 737 992 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 19.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 19.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 19.0 View
Accidental exposure to product by child SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra 19.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 19.0 View
Bronchial hyperreactivity SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 19.0 View
Urticaria chronic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra 19.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 19.0 View
Respiratory syncytial virus bronchiolitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 19.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 19.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDra 19.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDra 19.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 19.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 19.0 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 19.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 19.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra 19.0 View
Crying SYSTEMATIC_ASSESSMENT General disorders MedDra 19.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDra 19.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDra 19.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 19.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra 19.0 View