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 |
|---|---|---|---|---|---|---|---|---|
| Bright Light Therapy (BLT) | The intervention will consist of daily BLT sessions lasting 30 minutes at approximately 10AM (since many CF and COPD patients may not awaken until this time) starting on the day of admission through discharge for a goal of seven consecutive days. The intervention will use a 10,000-lux light box placed approximately 16-24 inches from the patient's face. Bright Light Therapy (BLT) Lamp: With its built in automatic timer shut-off function, the bedside RN would not need to return to the room to turn off this lamp after 30 minutes because the lamp will automatically shut off on its own. | 0 | None | 0 | 4 | 0 | 4 | View |