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 @ 2:40 PM
Ignite Modification Date: 2025-12-25 @ 1:12 PM
NCT ID: NCT02445859
Description: None
Frequency Threshold: 0
Time Frame: 30 days
Study: NCT02445859
Study Brief: Continuous Antibiotic Prophylaxis in 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
Standard Regimen Cefuroxime 1.5grams pre-operatively Repeated every 4 hours Cefuroxime bolus-continuous infusion: Cefuroxime 1.5 grams pre-operatively, repeated 4 hourly during surgery. 0 None 3 43 0 43 View
Interventional Regimen Cefuroxime continuous infusion targeting 64mg/l serum concentrations. Cefuroxime 4 hourly bolus: Cefuroxime loading dose followed by a continuous infusion dosed according to renal function. Dosed to target a serum concentration of 64mg/L. 0 None 5 42 0 42 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anastomotic leak SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Unplanned surgical procedure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastrointestinal bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pleural effusion with pleural drain insertion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View