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 |
|---|---|---|---|---|---|---|---|---|
| Caffeine Arm | Experimental Group: patient group (n =24) receiving a 100 mg dose of caffeine (1/2 of a 200mg tablet to be taken whole or crushed), taken twice daily. This will be an adjuvant to their standard pain control. Caffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet. | 0 | None | 0 | 24 | 0 | 24 | View |
| Placebo Arm | Control group: patient group (n =27) receiving placebo compounded to look similar to the caffeine treatment, taken twice daily. This will be an adjuvant to their standard pain control. Caffeine Tablet: Caffeine is approved by the FDA as a stimulant. A stimulant approved by the United States Food and Drug Administration (FDA) for the treatment to increase mental alertness and in combination with painkiller to treat migraine headaches. It is approved in the form of pill or tablet. Placebo: Placebo, empty opaque dark blue blank capsule, taken twice daily. This will be an adjuvant to their standard pain control. | 0 | None | 0 | 27 | 0 | 27 | View |