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 @ 4:38 PM
Ignite Modification Date: 2025-12-25 @ 2:28 PM
NCT ID: NCT04544566
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data were collected throughout the study period for a maximum of 27 days. If subject had on-going SAEs at termination, they were followed until the event was solved or until the subject could no longer be followed (lost to follow up). Subjects without SAEs or with terminated SAEs were not followed-up upon after the final termination visit.
Study: NCT04544566
Study Brief: A Clinical Pilot Study of Newly Developed Ostomy Tapes and How They Adhere to the Skin
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Test Product A New Adhesive Material The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin. Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin 0 None 0 12 1 12 View
Test Product B New Adhesion Material The adhesives in the ostomy tapes are developed to make the tape seal to the skin and thereby minimise the risk of leakage episodes. At the same time, the tape should be easy to remove without affecting the skin. Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin 0 None 0 12 1 12 View
Comparator The comparator product is Brava Elastic tape which is already on the market and will be used within the in-tended use in this clinical investigation. Test product A: one new adhesive material which is applied to the baseplate and the subjects peristomal skin Test product B: one new adhesive material which is applied to the baseplate and the subjects peristomal skin Comparator: Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin 0 None 0 12 1 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Non serious adverse event NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Non serious adverse event NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View