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 @ 11:28 PM
Ignite Modification Date: 2025-12-25 @ 9:15 PM
NCT ID: NCT04505956
Description: None
Frequency Threshold: 0
Time Frame: 30 days postoperatively
Study: NCT04505956
Study Brief: A Comparison of Ureteroscopic Treatment of Nephrolithiasis With and Without Moses Technology
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard Laser Lithotripsy Patients will have flexible URS performed in standard fashion, without deviation from the standard of care. Laser settings will be at the surgeons' discretion but will be within the range identified as standard for dusting technique (between 0.2-0.5 J and 40-80 Hz). The short pulse setting will be utilized for non-Moses settings. Holmium laser lithotripsy without Moses Technology: Holmium laser energy will be delivered for the ureteroscopic fragmenting of kidney stones. Energy will be generated by the commercial available, FDA approved Lumenis PulseTM P120H laser system and Moses laser fiber. Renal stones will be fragmented using a dusting technique. Moses laser settings will be turned off. 0 None 7 79 3 79 View
Moses Laser Lithotripsy Patients will have flexible URS performed in standard fashion, without deviation from the standard of care. Laser settings will be at the surgeons' discretion but will be within the range identified as standard for dusting technique using Moses laser technology. Holmium laser lithotripsy with Moses Technology: Holmium laser energy will be delivered for the ureteroscopic fragmenting of kidney stones. Energy will be generated by the commercial available, FDA approved Lumenis PulseTM P120H laser system and Moses laser fiber. Renal stones will be fragmented using a dusting technique. Moses laser settings will be turned on. 0 None 4 74 3 74 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Severe urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Repeat surgical intervention for pain or stone fragments SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Readmission for pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary retention requiring foley catheter placement SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Present to ED with renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Presented to ED with pain, fevers and treated for UTI SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View