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 @ 3:32 AM
Ignite Modification Date: 2025-12-26 @ 2:14 AM
NCT ID: NCT06403605
Description: None
Frequency Threshold: 5
Time Frame: From enrollment until end of follow-up (up to 12 weeks)
Study: NCT06403605
Study Brief: Bioresorbable Glass Fiber Matrix in the Treatment of Diabetic Foot Ulcers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SOC primary dressing with MIRRAGEN™ Mirragen Advanced Wound Matrix is intended for the use in the management of wounds including diabetic ulcers. Wound matrix to be used per manufacturer instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing. 1 None 6 67 5 67 View
SOC primary dressing with FIBRACOL™ A commercially available wound dressing to be used per manufacturer's instructions for use in conjunction with offloading and additional (outer) dressing application with moisture retention dressing. 0 None 3 66 5 66 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Osteomyelitis of sacrum SYSTEMATIC_ASSESSMENT Infections and infestations None View
Death (due to underlying comorbidities) SYSTEMATIC_ASSESSMENT General disorders None View
Cellulitis, right leg SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Deep space infection of left plantar mid foot SYSTEMATIC_ASSESSMENT Infections and infestations None View
Postoperative infection of non-study wound SYSTEMATIC_ASSESSMENT Infections and infestations None View
Necrotizing fasciitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Non-study diabetic foot wound infection with osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septicemia (gram negative, from right foot abscess/cellulitis) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acute toxic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anasarca SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bilateral pleural effusions SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Index wound infection SYSTEMATIC_ASSESSMENT Infections and infestations None View