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 @ 3:56 AM
Ignite Modification Date: 2025-12-26 @ 2:46 AM
NCT ID: NCT02148302
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data was collected from enrollment to subject completion (12 weeks).
Study: NCT02148302
Study Brief: Clinical Trial to Evaluate Blister Graft Utilizing a Novel Harvesting Device for Treatment of Venous Leg 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
Harvesting Device (CelluTome©) open-label trial designed to evaluate the safety and effectiveness of Epidermal grafting plus multi-layer compression therapy versus multi-layer compression alone in the healing of venous leg ulcers. Epidermal grafting will be applied up to three times in the treatment arm: at day zero, week 4 and week 8. A run-in period of two weeks followed by twelve weeks of active treatment Harvesting Device (CelluTome©): Subjects who continue to meet eligibility criteria will be randomized to one of two groups: (1) Up to 3 applications of Epidermal grafting harvested utilizing the CelluTome® system at day zero, week 4 and week 8, visits plus standard of care (multi-layer compression) (2) Multilayer compression alone. 0 None 5 57 15 57 View
Control: SOC Alone The Standard of Care therapy in this study is multi-layer compression therapy. A number of compression bandaging systems are commercially available. The trial will utilize Coban-2 (3M, Minneapolis, MN). 0 None 6 66 17 66 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infection SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cold SYSTEMATIC_ASSESSMENT General disorders None View