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 |
|---|---|---|---|---|---|---|---|---|
| SLEEPSMART PROGRAM | Arm: Experimental -Each child and parent will partner with a sleep coach to review weekly goals and choose treatment goals. The modules will focus on improving wind down and wake up routines, sleep hygiene, relaxation strategies, correcting unhelpful beliefs about sleep, and the sleep environment. The intervention will last 7 weeks.. | 0 | None | 0 | 25 | 0 | 25 | View |
| Placebo Comparator (Usual Care) | Arm: Placebo Comparator (Usual care)-This treatment arm will receive usual JIA care, including annual Rheumatology clinic visits, medications, routine clinical and laboratory tests, physical therapy, follow-up appointments, and no sleep intervention. | 0 | None | 0 | 21 | 0 | 21 | View |