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 |
|---|---|---|---|---|---|---|---|---|
| Telerehabilitation + Sinemet | Patients will receive 36 telerehabilitation (TR) sessions targeting arm motor function. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6-8 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. A study pill (Sinemet) is taken one hour before starting TR, for the first 18 sessions. Telerehabilitation: The telerehabilitation system will deliver rehabilitation treatment sessions via a secured internet-connected computer. TR sessions will be a combination of games, exercises, stroke education, assessments, in addition to videoconferencing with therapists to discuss progress, issues, goals, and changes to the treatment plan. | 0 | None | 1 | 6 | 2 | 6 | View |
| Telerehabilitation + Placebo | Patients will receive 36 telerehabilitation (TR) sessions targeting arm motor function. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6-8 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. A study pill (placebo) is taken one hour before starting TR, for the first 18 sessions. Telerehabilitation: The telerehabilitation system will deliver rehabilitation treatment sessions via a secured internet-connected computer. TR sessions will be a combination of games, exercises, stroke education, assessments, in addition to videoconferencing with therapists to discuss progress, issues, goals, and changes to the treatment plan. | 0 | None | 3 | 10 | 1 | 10 | View |
| Usual Care | Participants in the usual care group will receive no TR or study pill, but will continue with the recommendations made by their care team. All participants will be offered TR at the end of the study. | 0 | None | 4 | 9 | 0 | 9 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hospitalization (unrelated to study procedures) | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Hospitalization due to GI-related issues (unrelated to study procedures) | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hospitalization due to fluid build-up (unrelated to study procedures) | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hospitalization due to cardiac issues (unrelated to study procedures) | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hospitalization due to neurological issue (unrelated to study procedures) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |