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 @ 9:21 PM
Ignite Modification Date: 2025-12-25 @ 7:08 PM
NCT ID: NCT05038904
Description: This study followed the FDA Guidance For Industry ("Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventative vaccine clinical trials") grading system for adverse events.
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT05038904
Study Brief: Preventing Anaphylaxis With Acalabrutinib
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Acalabrutinib All participants who received acalabrutinib 0 None 3 10 5 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sports-related concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Sports-related injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Emergency room visit after baseline food challenge SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Elevated liver function tests SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
COVID-19 infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hypokalemia SYSTEMATIC_ASSESSMENT General disorders None View
Hypoalbuminemia SYSTEMATIC_ASSESSMENT General disorders None View