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 |
|---|---|---|---|---|---|---|---|---|
| Healthy | Matching aged people, not having neurological system or orthopedic disease on Upper extremity. The subject reaches to target by non-dominant arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees) | 0 | None | 0 | 0 | 0 | 0 | View |
| Chronic Stroke | The subject consisted of the physician's confirmation of chronic hemiplegia onset ≥ 6 months Mini-mental state examination≥25 Biceps ≤2, Triceps≤2 Ability to Sit on a chair alone FMA upper extremity score ≥ 21points, FMA upper extremity score ≤ 66 points The symptom is mild or moderate level (MAS≤2) and can sit alone. The subject reaches to target by affected arm in 3 directions(medial\_45, forward\_90 and lateral\_135 degrees) | 0 | None | 0 | 0 | 0 | 0 | View |