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 @ 4:05 PM
Ignite Modification Date: 2025-12-25 @ 2:06 PM
NCT ID: NCT03040466
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT03040466
Study Brief: Comparing Treatment of Urolithiasis Between Disposable and Reusable Ureteroscope
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Reusable Fiberoptic Ureteroscope For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms. reusable fiberoptic ureteroscope: We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones. 0 None 0 65 9 65 View
Disposable Digital Ureteroscope For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms. disposable digital ureteroscope: We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones. 0 None 0 115 9 115 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Presence of postoperative complications NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View