Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 9:40 PM
Ignite Modification Date: 2025-12-25 @ 7:22 PM
NCT ID: NCT04498832
Description: Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the CRB in terms of diagnosis and/or onset window post-vaccination.
Frequency Threshold: 5
Time Frame: Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.
Study: NCT04498832
Study Brief: Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Japanese Adults 60 Years of Age and Older
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
QIV-HD Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0. 0 None 2 1049 614 1049 View
QIV-SD Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0. 0 None 5 1051 569 1051 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA23.1 View
Femoral Neck Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA23.1 View
Femur Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA23.1 View
Patella Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA23.1 View
Radius Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA23.1 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA23.1 View
Still's Disease SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA23.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection Site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA23.1 View
Injection Site Induration SYSTEMATIC_ASSESSMENT General disorders MedDRA23.1 View
Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA23.1 View
Injection Site Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA23.1 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA23.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA23.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA23.1 View