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: 2025-12-25 @ 2:55 AM
Ignite Modification Date: 2025-12-26 @ 1:36 AM
NCT ID: NCT04081233
Description: None
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT04081233
Study Brief: Surgical Stabilization for Rib Fractures
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Early Surgical Stabilization This arm will include early surgical stabilization (within 72 hours of admission) in addition to the usual care received for patients with multiple rib fractures. Usual care will involve pain management. surgical stabilization: Surgical procedure utilizing any commercially available internal rib fixation system 0 None 12 42 6 42 View
Usual Care This arm will be usual care only. Usual care will include pain managment. Usual care: Usual care typically consists of breathing exercises and pain control,often including opioids 0 None 8 42 2 42 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Surgical site infection SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Deep vein Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Seroma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Retained Hemothorax SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View