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 |
|---|---|---|---|---|---|---|---|---|
| Experimental Group | This group will receive the seated active workstation intervention, the ergonomic intervention and the email intervention for 16 weeks. Active Workstation Intervention: Participants in the experimental group will receive a seated active workstation at their work setting for 16 weeks. Ergonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station. Email Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles). Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application. | None | None | 0 | 30 | 0 | 30 | View |
| Active Control | This group will receive the ergonomic intervention and email intervention only for 16 weeks. This group will not receive a seated active workstation. Ergonomic Intervention: Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station. Email Intervention: Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles). Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application. | None | None | 0 | 30 | 0 | 30 | View |