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 |
|---|---|---|---|---|---|---|---|---|
| Technology Arm | 4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting. Rehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training. * With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1). * A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days. Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen. * The training can take place in an outpatient or inpatient setting. * Training will be organized in individual one-to-one or group session | 0 | None | 0 | 14 | 0 | 14 | View |