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 @ 4:58 AM
Ignite Modification Date: 2025-12-26 @ 3:58 AM
NCT ID: NCT04101318
Description: The relationship to the investigational or comparator product were collected. The Safety population constituted the subjects who have given informed consent and were 79 participants. The participants in each arm represent an adverse event reported that was either: "Not related", "Unlikely related", "Possibly related", "Probably related", or "Definitely related", to the Non-Conformité Européene Marked Product or the Conformité Européene Marked product.
Frequency Threshold: 0
Time Frame: Each subject was enrolled for 2 x 42±3 days in total for the entire investigation, thus for a maximum of 90 days.
Study: NCT04101318
Study Brief: Investigation of a New Stoma Product for People With a Stoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Non-Conformité Européene Marked Product Product is not named at this point 0 None 0 74 27 74 View
Conformité Européene Marked Products 1-piece and 2-piece stoma devices already on the market. 0 None 0 73 28 73 View
Total Safety Population This arm/group constitutes the safety population 0 None 5 79 43 79 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SOC code View
Exacerbated cystic fibrosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SOC code View
Heart attack SYSTEMATIC_ASSESSMENT Cardiac disorders SOC code View
Guillain-barre syndrome SYSTEMATIC_ASSESSMENT Immune system disorders SOC code View
Feeding line infection SYSTEMATIC_ASSESSMENT Infections and infestations SOC code View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dental abscess SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders SOC code View
Hay fever SYSTEMATIC_ASSESSMENT General disorders SOC code View
Osteomyelitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders SOC code View
Sinus pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders SOC code View
Tiredness SYSTEMATIC_ASSESSMENT Surgical and medical procedures SOC code View
Diarrohea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SOC code View
Leakage and bleeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SOC code View
Malaise SYSTEMATIC_ASSESSMENT General disorders SOC code View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SOC code View
Bleeding from stoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SOC code View
Bowel obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SOC code View
Frequent watery stool SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SOC code View
Output more liquid than normal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SOC code View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SOC code View
One bladder at stoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SOC code View
Swollen stoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders SOC code View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations SOC code View
Painful/Sore Throat SYSTEMATIC_ASSESSMENT Infections and infestations SOC code View
Excessive sweating SYSTEMATIC_ASSESSMENT Infections and infestations SOC code View
Prexia (38.1 DEGREES C) SYSTEMATIC_ASSESSMENT Infections and infestations SOC code View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders SOC code View
Muscle cramps in legs SYSTEMATIC_ASSESSMENT Nervous system disorders SOC code View
Shoulder pain SYSTEMATIC_ASSESSMENT Nervous system disorders SOC code View
Broken skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders SOC code View
Burning around stoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders SOC code View
Contact dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders SOC code View
Cuts under stoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders SOC code View
Dark patches of skin around stoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders SOC code View
Dry/flaky skin around stoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders SOC code View
Erosions/Ulcers SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders SOC code View
Pain SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders SOC code View
Itching skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders SOC code View
Redness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders SOC code View
Stinging SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders SOC code View
Skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders SOC code View
Skin complication SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders SOC code View
Leakage and skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders SOC code View
Oozing skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders SOC code View
Blotchy skin around stoma SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders SOC code View
Bleeding skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders SOC code View