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 @ 4:37 PM
Ignite Modification Date: 2025-12-25 @ 2:27 PM
NCT ID: NCT00062166
Description: Because this is natural history protocol, deaths or complications from treatments were not considered as AE or SAE. However, because 22 deaths are noted in the mortality module, 22 deaths are also noted in the SAEs per the Results Data Elements Definitions which state that "SAEs include AEs that result in death. Typically, the event(s) leading to death is listed as an AE Term in the SAE table and the number of participants who died due to any cause are reported in the All-Cause Mortality table."
Frequency Threshold: 0
Time Frame: 8 years
Study: NCT00062166
Study Brief: Natural History and Management of Pancreatic Lesions in Von Hippel-Lindau Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Von Hippel Lindau Von Hippel-Lindau disease (VHL) is an inherited cancer syndrome. Patients are at risk for developing pancreatic cysts and tumors. Other tumors include kidney cancers, pheochromocytoma, eye and central nervous system tumors. These tumors occur at a higher frequency rate than normal population. 22 None 22 340 0 340 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Other Events(If Any):