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 |
|---|---|---|---|---|---|---|---|---|
| Cohort 1 | Cohort 1- Study group-Home discharge. Patients randomized to this group will be provided with the X4 brace and trained on the use of Motion Intelligence platform. DJO X4 brace with Motion Intelligence Platform: The X4 Knee brace with the Motion Intelligence platform uses both a bio-measurement equipment with an interactive application thereby providing the patient with immediate feedback on their exercise regime. The X4 Knee brace is a postoperative brace worn by a patient to monitor compliance to prescribed protocol based on the movement and function of the knee joint. The device also connects wirelessly to a companion mobile application, Motion Intelligence, and streams both real-time and collected data for review and record collection. Prescribed exercises are uploaded into the patient application, with a number of the exercises actively tracked by the Mi360 sensor housed in the X4 brace. Compliance can be tracked by the physician in real-time between postoperative visits and any medical staff on a separate dashboard. | 0 | None | 0 | 8 | 0 | 8 | View |
| Cohort 2 | Cohort 2- Control group-Home discharge. Patients randomized to this group will serve as the control group. There will be no changes to the standard of care recovery for a TKA patient. | 0 | None | 0 | 8 | 0 | 8 | View |
| Cohort 4 | Cohort 4- Control group-Transfer to an inpatient rehabilitation center. Patients randomized to this group will serve as the control group. There will be no changes to the standard of care recovery for a TKA patient. | 0 | None | 0 | 0 | 0 | 0 | View |
| Cohort 3 | Cohort 3- Study group-Transfer to an inpatient rehabilitation center. Patients randomized to this group will be provided with the X4 brace and trained on the use of Motion Intelligence platform. DJO X4 brace with Motion Intelligence Platform: The X4 Knee brace with the Motion Intelligence platform uses both a bio-measurement equipment with an interactive application thereby providing the patient with immediate feedback on their exercise regime. The X4 Knee brace is a postoperative brace worn by a patient to monitor compliance to prescribed protocol based on the movement and function of the knee joint. The device also connects wirelessly to a companion mobile application, Motion Intelligence, and streams both real-time and collected data for review and record collection. Prescribed exercises are uploaded into the patient application, with a number of the exercises actively tracked by the Mi360 sensor housed in the X4 brace. Compliance can be tracked by the physician in real-time between postoperative visits and any medical staff on a separate dashboard. | 0 | None | 0 | 0 | 0 | 0 | View |