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 @ 6:29 PM
Ignite Modification Date: 2025-12-25 @ 3:59 PM
NCT ID: NCT00858468
Description: None
Frequency Threshold: 5.0
Time Frame: Adverse event data were collected for 6 months post-vaccination.
Study: NCT00858468
Study Brief: Safety and Immunogenicity Testing of Influenza Vaccine in Healthy Children 2 Months and 6 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
Age 6 to 12 Weeks Participants enrolled at 6 to 12 weeks of age None None 4 201 54 201 View
Age 24 to 36 Weeks Participants enrolled at 24 to 36 weeks of age None None 3 192 94 192 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Kawasaki's disease NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 7.1 View
Choking NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 7.1 View
Viral gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 7.1 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 7.1 View
Febrile convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 7.1 View
Fever NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 7.1 View
Bronchiolitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 7.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 7.1 View
Teething NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 7.1 View
Injection site haemorrhage NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 7.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 7.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 7.1 View
Otitis media NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 7.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 7.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 7.1 View
Nasal congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 7.1 View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 7.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 7.1 View