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 @ 9:56 PM
Ignite Modification Date: 2025-12-25 @ 7:34 PM
NCT ID: NCT04333732
Description: Common Terminology Criteria for Adverse Events (CTACAE; v5.0 27-Nov-2017)
Frequency Threshold: 0
Time Frame: 150 days from the date of administration of the investigational medicinal product
Study: NCT04333732
Study Brief: CROWN CORONATION: COVID-19 Research Outcomes Worldwide Network for CORONAvirus prevenTION
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
M-M-R II ® Education and surveillance plus M-M-R II ® MR or M-M-R II ® vaccine: Education and surveillance plus MR or M-M-R II ® vaccine 0 None 11 1722 0 1722 View
Placebo Education and surveillance plus placebo Placebo: Placebo injection 0 None 5 1689 0 1689 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Ovarian infection NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Thromboembolic event NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Suicide attempt NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Pre-eclampsia NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Right sided calcaneal fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tuberculous meningitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):