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 @ 5:24 PM
Ignite Modification Date: 2025-12-25 @ 2:58 PM
NCT ID: NCT02921750
Description: None
Frequency Threshold: 0
Time Frame: Adverse event were collected while subjects participated in the study, i.e. from the baseline visit, to 6 or 24 weeks follow-up, or until wound healing/premature study termination. h
Study: NCT02921750
Study Brief: Investigation to Evaluate the Efficacy and Safety of Exufiber Versus Aquacel Extra in Moderately or Strongly Exuding Venous and Mixed Ulcers of Predominantly Venous Origin
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Exufiber Investigational device, Exufiber Gelling fibre dressing 1 None 5 124 18 124 View
Aquacel Comparator, Aquacel® Extra™ Hydrofiber® Dressing with Strengthening Fibre 1 None 8 124 19 124 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fracture and hospitalisation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hip fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Erysipelas right leg NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Gastric hemorrhage with hospitalization NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Death NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Infection exacerbated COPD NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Erysipelas PDK, hospitalize NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Intensification of depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Circulatory insufficiency with dehydration and dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Congestive heart failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin reaction around the wound SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Scheduled hernia surgery SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Infection at study wound SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Wound infection right leg SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Increased wound liquid SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin blister SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Aggravation of known psoriasis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Strong itching in the marginal area of the wound SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Gastroenteritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infection of the target ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fall at home with wound in the right leg SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Headache, tiredness SYSTEMATIC_ASSESSMENT General disorders None View
Cough and inceased temperature SYSTEMATIC_ASSESSMENT Infections and infestations None View
Erysipel of nonstudy leg - left leg SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Burning, erhema of the scalp. SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Aquacel dressing intolerance (burn and redness) SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Increasing the ulcer with inflammatory reaction SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
New ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Local infection in study wound SYSTEMATIC_ASSESSMENT Infections and infestations None View
Periwound skin irritation and blistering in study wound SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Flu infectious for 3 weeks SYSTEMATIC_ASSESSMENT Infections and infestations None View
Tooth Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Redness and irritation on Periwound Skin on left leg study ulcer . SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Swollen right ankle/foot. SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Ulcer exacerbation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Stinging or burning while wearing study product SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Local signs of infection at the target wound SYSTEMATIC_ASSESSMENT Infections and infestations None View
Eczema with tingling and pain on right foot SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain in back due to fall SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Stasis dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Pain of the wound unrelated to the dressing SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View