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 @ 11:21 PM
Ignite Modification Date: 2025-12-25 @ 9:04 PM
NCT ID: NCT04088656
Description: Definition of adverse event / serious adverse event does not differ from that of clinicaltrials.gov. Adverse Events were only monitored/assessed in healthcare worker participants. No healthcare worker participants were at risk in the control arm as no intervention was applied and thus no healthcare workers were exposed or at risk. All-Cause Mortality, Serious Adverse Events, and Other Adverse Events were not monitored/assessed in patient participants.
Frequency Threshold: 0
Time Frame: Through study completion, an average of 3 years.
Study: NCT04088656
Study Brief: Systems Analysis and Improvement Approach for the Hypertension Care Cascade
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Hypertension Systems Analysis and Improvement Eight (8) health facilities will receive the Systems Analysis and Improvement Approach (SAIA-HTN) intervention to optimize hypertension screening and management for people living with HIV/AIDS. Systems Analysis and Improvement Approach for Hypertension Screening and Treatment Optimization: The Systems Analysis and Improvement Approach to Optimize the Hypertension Care Cascade for People Living with HIV (SAIA-HTN) is a five-step systems analysis and iterative improvement cycle intervention which will be implemented by study nurses and district managers in intervention facilities. Components of the intervention include joint care cascade analysis, patient flow mapping and continuous quality improvement, aimed to incrementally improve hypertension screening, diagnosis, treatment and care in the HIV+ population at intervention health facilities. 0 None 0 305 0 305 View
Control Eight (8) health facilities will not receive the Systems Analysis and Improvement Approach (SAIA-HTN) intervention to optimize hypertension screening and management for people living with HIV/AIDS. 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):