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 |
|---|---|---|---|---|---|---|---|---|
| Control | Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Control Arm will receive no financial incentive. | 0 | None | 0 | 68 | 0 | 68 | View |
| Individual | Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $50 if that participant met the step goal during the prior day. Individual Incentives | 0 | None | 0 | 80 | 0 | 80 | View |
| Team | Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $50 only if all four team members met the step goal during the prior day. Team Incentives | 0 | None | 0 | 76 | 0 | 76 | View |
| Individual Plus Team | Participants receive either an email or text message daily (based on the participant's preference) stating whether the participant achieved the 7000 step goal during the previous day. Each participant will also be notified as to how many of their teammates reached the goal the previous day. Every day one team from the arm will be chosen at random as the winning team. Each participant on the winning team receives $20 if the participant met the step goal during the prior day the participants met their own goal. Each participant will also receive an additional $10 for every one of the other three team members that also met the goal. Individual plus Team Incentives | 0 | None | 0 | 80 | 0 | 80 | View |