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 |
|---|---|---|---|---|---|---|---|---|
| Primary Insomnia (PI) | PI sufferers enrolled will meet Research Diagnostic Criteria for insomnia disorder, score \> 14 on the Insomnia Severity Index, report insomnia for \> 3 months, have sleep difficulties \> 3 nights per week, score \< 3 on the Epworth Sleepiness Scale (ESS), score \> 40 on the Hyperarousal Scale10 and report an inability to nap in the daytime. Multiple Sleep Latency Test (MSLT): The daytime protocol will include a 4-trial Multiple Sleep Latency Test (MSLT) along with 4-trials of a computer -administered battery of reaction time tasks. The assessment protocol will start two to three hours after participants' respective morning rising times and will begin with a battery of the neuro-cognitive testing followed by an MSLT nap. Per standard MSLT procedures, the daytime testing will be scheduled so the four performance testing and sleepiness assessment trials occur two hours apart. All daytime testing will be conducted under the supervision of trained laboratory technologists. | 0 | None | 0 | 36 | 0 | 36 | View |
| Normal Sleepers (NS) | The normal sleepers enrolled will report general satisfaction with sleep and no sleep/wake complaints, score \< 10 on the ESS, score \< 35 on the Hyperarousal Scale10, and deny a practice of routine daytime napping. Multiple Sleep Latency Test (MSLT): The daytime protocol will include a 4-trial Multiple Sleep Latency Test (MSLT) along with 4-trials of a computer -administered battery of reaction time tasks. The assessment protocol will start two to three hours after participants' respective morning rising times and will begin with a battery of the neuro-cognitive testing followed by an MSLT nap. Per standard MSLT procedures, the daytime testing will be scheduled so the four performance testing and sleepiness assessment trials occur two hours apart. All daytime testing will be conducted under the supervision of trained laboratory technologists. | 0 | None | 0 | 53 | 0 | 53 | View |