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 @ 4:15 PM
Ignite Modification Date: 2025-12-25 @ 2:13 PM
NCT ID: NCT00710866
Description: None
Frequency Threshold: 0
Time Frame: Solicited and unsolicited adverse events were recorded using memory aid after immunization for days 0 to 7 after each injection; reports shown for days 0 to 3 after either injection.
Study: NCT00710866
Study Brief: Influenza Vaccine Dose-Response in Infants and Toddlers: Immunogenicity and Reactogenicity
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
0.5mL VAXIGRIP® 2 doses 0.5mL VAXIGRIP® at months 0, 1 None None 0 124 108 124 View
0.25mL VAXIGRIP® 2 doses 0.25mL VAXIGRIP® at months 0, 1 None None 1 128 107 126 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Redness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Swelling SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Induration SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Tenderness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Irritability SYSTEMATIC_ASSESSMENT General disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT General disorders None View
Drowsiness SYSTEMATIC_ASSESSMENT General disorders None View
Sleep disturbance SYSTEMATIC_ASSESSMENT General disorders None View
Upper Respiratory NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ocular NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Gastrointestinal NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Teething NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Miscellaneous NON_SYSTEMATIC_ASSESSMENT General disorders None View