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 @ 1:36 PM
Ignite Modification Date: 2025-12-25 @ 12:35 PM
NCT ID: NCT03816995
Description: None
Frequency Threshold: 0
Time Frame: 30 days following surgery
Study: NCT03816995
Study Brief: Prospective, Randomized, Parallel-arm Clinical Trial of CleanCision or Alexis O in Elective Colorectal Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Alexis O Wound Protector Participants will undergo standard surgical procedure using the Alexis O wound protector. Alexis O Wound Protector: wound retraction 1 None 0 327 98 327 View
CleanCision Wound Protector Participants will undergo standard surgical procedure using the CleanCision Wound Retraction and Protection System CleanCision Wound Retraction and Protection System: wound retraction and irrigation 0 None 0 318 95 318 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Post-Op Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Post-Op Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Post-Op Unplanned Intubation SYSTEMATIC_ASSESSMENT General disorders None View
Post-Op Deep Vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Post-Op Pulmonary Embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Post-Op Acute Renal Failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Post-Op Anastomotic Leak SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Post-Op Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Unplanned Reoperation SYSTEMATIC_ASSESSMENT General disorders None View
Readmission SYSTEMATIC_ASSESSMENT Social circumstances None View
Post-Op Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Post-Op C.Diff SYSTEMATIC_ASSESSMENT Infections and infestations None View