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 @ 11:50 PM
Ignite Modification Date: 2025-12-25 @ 9:44 PM
NCT ID: NCT03835351
Description: None
Frequency Threshold: 0
Time Frame: 30 days following surgery
Study: NCT03835351
Study Brief: Urinary Retention After Laparoscopic Inguinal Hernia Repair: Comparing the Use of the Intraoperative Urinary Catheter
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intraoperative Urinary Catheter After induction of general anesthesia, a standard catheterization kit available at the institution where the surgery is being performed will be used to place the urinary catheter using standard sterile technique. Urinary Catheter: An intraoperative urinary catheter will be inserted which will be taken out at the end of the case 0 None 1 241 3 241 View
No Intraoperative Urinary Catheter No intraoperative urinary catheter will be used during the case 0 None 0 250 11 250 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Urethra Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia Requiring Transfusion SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bowel Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View