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: 2025-12-26 @ 5:23 PM
Ignite Modification Date: 2025-12-26 @ 5:23 PM
NCT ID: NCT01924806
Description: None
Frequency Threshold: 0
Time Frame: AEs were collected from the time of enrollment until study completion at 12 weeks post debridement, study withdrawal, or study termination, whichever came first.
Study: NCT01924806
Study Brief: A Pilot Study of the WoundWand™ Debridement Device on Infection Prevention
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
WoundWand™ Debridement Device Group I - Coblator IQTM Controller plus WoundWand™ Debridement Device. Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound. WoundWand™ Debridement Device: Group I - Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound 0 None 0 5 4 5 View
Standard of Care Sharp Debridement Group II - Standard of Care (SoC) surgical (sharp) debridement. Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound. Standard of Care sharp debridement: Group II - Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound 0 None 0 4 2 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
2:1 AV block and bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders Proprietary SOC syst View
Micro groin wound infection SYSTEMATIC_ASSESSMENT Infections and infestations Proprietary SOC syst View
Infection to wound SYSTEMATIC_ASSESSMENT Infections and infestations Proprietary SOC syst View
Chronic wound SYSTEMATIC_ASSESSMENT Infections and infestations Proprietary SOC syst View
Infection to foot ulcer SYSTEMATIC_ASSESSMENT Infections and infestations Proprietary SOC syst View
Serratia growth on bone SYSTEMATIC_ASSESSMENT Infections and infestations Proprietary SOC syst View