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 @ 10:29 PM
Ignite Modification Date: 2025-12-25 @ 8:02 PM
NCT ID: NCT02295735
Description: Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. Note: This definition includes events related to the investigational medical device or the comparator. This definition includes events related to the procedures involved. For users or other persons, this definition is restricted to events related to investigational medical devices.
Frequency Threshold: 0.47
Time Frame: Adverse events were recorded every day until the Patient was discharged from the Hospital,an average of 12.6 (SD +/-12.7) days
Study: NCT02295735
Study Brief: Effectiveness of Two Silicone Dressings for Sacral and Heel Pressure Ulcer 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
Intervention Group For patients in the intervention group, dressings were applied on both heels (Mepilex Border Heel, Moelnlycke Health Care, Gothenburg, Sweden) and on the sacral areas (Mepilex Border Sacrum, Moelnlycke Health Care) according to manufacturers instructions in addition to the standard care. 0 None 0 212 2 212 View
Control Group Standard pressure ulcer prevention according to hospital standard 0 None 0 210 0 210 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Burning pain and warm sensation under the sacral dressing SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Peeling of the outer layers of the skin under the sacral dressing SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View