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 @ 5:28 PM
Ignite Modification Date: 2025-12-25 @ 3:02 PM
NCT ID: NCT03319368
Description: The only adverse events that were collected during the study were deaths and hospitalizations. Adverse events were assessed without regard to the specific adverse event term.
Frequency Threshold: 0
Time Frame: During the baseline period (2 months) and the intervention period (2 months)
Study: NCT03319368
Study Brief: Preventing the Spread of Infection in Nursing Homes
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 Period Targeted gown and glove use by health care workers in the nursing home. Gowns and gloves were worn when providing high risk care to high risk residents. 0 None 28 167 0 167 View
Baseline Period Normal, day-to-day usage of gowns and gloves by health care workers in nursing homes. 3 None 28 158 0 158 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hospitalization NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):