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 @ 1:58 PM
Ignite Modification Date: 2025-12-25 @ 12:45 PM
NCT ID: NCT01353495
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01353495
Study Brief: Acellular Porcine Dermal Matrix Wound Dressing in the Management 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
Standard Wound Care Standard Wound care (gels, foams, dressings.) Wound Debridement : Wounds debrided in both arms of study None None 0 19 4 19 View
Treatment With Study Device Treatment with Biotape Acelular Dermis Graft APM Graft (BIOTAPE XMTM) : Patients randomized to the APM group will, following surgical debridement for their diabetic foot wounds, receive a single application of an APM graft (BIOTAPE XMTM, Wright Medical Technology, USA) with dressing changes taking place weekly. All necrotic tissue will be removed from the wound prior to application. BIOTAPE XMTM will be sutured or stapled in place under a silver-based non-adherent dressing (Silverlon, Argenta Medical). Therapy will then be followed by a moisture-retentive dressing (hydrogel bolster) until complete epithelialization has occurred. Wound Debridement : Wounds debrided in both arms of study None None 0 20 3 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
LT HEEL PAIN WITH POSSIBLE ABSCCESS SYSTEMATIC_ASSESSMENT Infections and infestations None View
RT FOOT INFECTION WITH OSTEOMYELITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
SHORTNESS OF BREATH SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
CELLULITIS TO THE RIGHT FOOT. SYSTEMATIC_ASSESSMENT Infections and infestations None View
DEHYDRATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
RESPIRATORY FAILURE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
DEHYDRATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View