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 |
|---|---|---|---|---|---|---|---|---|
| Robot-Assisted Therapy (RT) | Armeo and Amadeo robot-assisted intensive upper extremity therapy 1 hr sessions 3x week for 6 weeks plus ALPS training Robot-Assisted Therapy (RT): Highly repetitive robot-assisted therapy for paretic arm with Armeo (1 hr sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo (3x week for 3 weeks). Robot training was accompanied with ALPS motor learning program directed toward UE self management and transfer of training to daily activities in home \& community. | 0 | None | 0 | 5 | 0 | 5 | View |
| Robot & Task-Oriented Training (RT-TOT) | Armeo and Amadeo robot-assisted intensive upper extremity therapy 30 mins, 3x week for 6 weeks plus ALPS training. Task oriented training was provided for remaining 30 min of each treatment session Robot \& Task-Oriented Training (RT-TOT): Highly repetitive robot-assisted therapy for paretic arm with Armeo (30 min sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo (3x week for 3 weeks). Task oriented training was delivered for remaining 30 mins of each treatment session. Robot and task oriented training was accompanied with ALPS motor learning program directed toward UE self management and transfer of training to daily activities in home \& community. | 0 | None | 0 | 5 | 0 | 5 | View |