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 @ 9:58 PM
Ignite Modification Date: 2025-12-25 @ 7:36 PM
NCT ID: NCT04656132
Description: PI monitored for adverse events systematically at the followup visit, and informally during the study period with self-reporting by the subjects.
Frequency Threshold: 0
Time Frame: 3 months
Study: NCT04656132
Study Brief: PAVS in Cardiology
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Participants With Cardiovascular Disease or Cardiovascular Disease Risk Factors Population We will recruit 59 males and females age \> 18 being seen in the NYU Langone Center for Prevention of Cardiovascular Disease (4F). Participants have cardiovascular disease or cardiovascular disease risk factors. Physical activity assessment, promotion and monitoring in a preventive cardiology clinic: physical activity assessment promotion and remote home step-count monitoring in a clinical cardiology center 0 None 1 63 1 63 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization for an Asthma Exacerbation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hip Fracture SYSTEMATIC_ASSESSMENT General disorders None View