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 |
|---|---|---|---|---|---|---|---|---|
| Nicotine First, Then Placebo | Transdermal nicotine patch first (single application), then placebo patch (single application, one week after administration of nicotine patch) Doses: non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch | None | None | 0 | 61 | 5 | 61 | View |
| Placebo First, Then Nicotine | Placebo patch first (single application), then transdermal nicotine patch (single application, one week after administration of placebo patch) Doses: non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch | None | None | 0 | 60 | 5 | 60 | View |