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 @ 12:32 AM
Ignite Modification Date: 2025-12-25 @ 10:39 PM
NCT ID: NCT04544267
Description: Analysis was performed on the expanded safety analysis set.
Frequency Threshold: 5
Time Frame: From first dose of study vaccine administration (Day 1) up to 6 months after the last vaccine administration (vaccines administered at Days 0 and 28), approximately 210 days.
Study: NCT04544267
Study Brief: Study on a High-Dose Quadrivalent Influenza Vaccine Compared With Standard-Dose Quadrivalent Influenza Vaccine in Children 6 Months Through 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
Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High-Dose Participants who were previously vaccinated against influenza received 1 dose of QIV-HD IM injection on Day 0. Participants who were not previously vaccinated against influenza received 1 dose of QIV-HD IM injection on Day 0 and 1 dose on Day 28. 0 None 1 100 65 100 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Otitis Media Acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDra 27.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDra 27.1 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra 27.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra 27.1 View
Crying SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Injection Site Bruising SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Injection Site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Injection Site Induration SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Injection Site Swelling SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDra 27.1 View