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 @ 7:41 PM
Ignite Modification Date: 2025-12-25 @ 5:20 PM
NCT ID: NCT05619003
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were collected from baseline (day 1, visit 1) and at all daily visits until termination visit (latest after 7 days). There was no follow-up after study termination.
Study: NCT05619003
Study Brief: Biatain Silicone Sacral for Pressure Injury Prevention in Hospital-admitted Patients at Risk
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Biatain Silicone Sacral Dressing 67 patients were treated with Biatain Silicone Sacral dressing over the bony prominence of the sacral area as part of a pressure injury prevention protocol 1 None 4 67 5 67 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Death SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Intraabdominal bleeding SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Incision site pain SYSTEMATIC_ASSESSMENT Nervous system disorders None View