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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| PKG+ Group | For subjects in the PKG+ Group, participants will wear the PKG watch prior to all study visits in which the study investigator will review and report on the PKG prior to the visit and use the information to guide the discussion with the subject during the clinical assessment.The PKG will be used to determine if the subject is "controlled" or "uncontrolled" based on scores provided by the PKG. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: * A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. * An application to configure the data logger and transfer the acquired data at the end of a recording. Personal KinetiGraph® (PKG®) Report: The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC. The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: • A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility. | 0 | None | 3 | 23 | 12 | 23 | View |
| PKG- Group | For subjects in the PKG- Group (SOC control group), participants will wear the PKG watch prior to all study visits, however the investigator will not have access to the PKG report and will use standard of care to determine clinical treatment plans. Personal KinetiGraph® (PKG®) Watch: The Personal KinetiGraph (PKG®) Movement Recording System consists of the following: * A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period. * An application to configure the data logger and transfer the acquired data at the end of a recording. | 0 | None | 1 | 18 | 3 | 18 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Bothersome Hallucinations | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Emergency Room Visit | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Unanticipated Clinic Visit | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Orthostatic Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Urgent Care Visit | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |