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 @ 5:39 PM
Ignite Modification Date: 2025-12-25 @ 3:09 PM
NCT ID: NCT01777568
Description: None
Frequency Threshold: 5
Time Frame: 30-day postoperatively
Study: NCT01777568
Study Brief: Supplemental Oxygen in Colorectal Surgery: A Quality Improvement Project
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
80% Oxygen Inspired oxygen will be maintained at 80%. 80% oxygen: Inspired oxygen will be maintained at 30%. 20 None 314 2896 150 2896 View
30% Oxygen Inspired oxygen will be maintained at 30%. 30% oxygen: Inspired oxygen will be maintained at 30%. 10 None 314 2853 183 2853 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
SSI (organ space/deep) NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Anastomotic leak NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Intra-abdominal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
wound dehiscence NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
uperficial SSI NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View