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 @ 2:38 AM
Ignite Modification Date: 2025-12-26 @ 1:15 AM
NCT ID: NCT04772534
Description: All treated participants are included.
Frequency Threshold: 5
Time Frame: Up to ~Month 30
Study: NCT04772534
Study Brief: Immunogenicity and Safety of the 9-valent Human Papillomavirus (9vHPV) Vaccine in Japanese Boys and Girls (V503-066)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
3-Dose Regimen: 9 to 15 Year Old Boys 9 to 15 year old boys received a 3-dose regimen of 9vHPV vaccine (Day 1, Month 2 and Month 6). 0 None 0 103 18 103 View
2-dose Regimen: 9 to 14 Year Old Boys 9 to 14 year old boys received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6). 0 None 2 104 12 104 View
2-dose Regimen: 9 to 14 Year Old Girls 9 to 14 year old girls received a 2-dose regimen of 9vHPV vaccine (Day 1 and Month 6). 0 None 3 104 8 104 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 27.0 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View
Tympanic membrane perforation SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 27.0 View
Strabismus SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.0 View