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 |
|---|---|---|---|---|---|---|---|---|
| Non-culturally Tailored (Non-smokers) | The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3. Non-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women. | 0 | None | 0 | 501 | 0 | 501 | View |
| Culturally Tailored (Current Smokers) | The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult SMW. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3. Culturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women. | 0 | None | 0 | 613 | 0 | 613 | View |
| Non-culturally Tailored (Current Smokers) | The anti-smoking and anti-industry messages will not be culturally tailored. They will receive only messages that are not culturally tailored at baseline and weeks 1, 2 and 3. Non-culturally tailored interventions: Anti-smoking messages that are not culturally tailored for sexual minority women. | 0 | None | 0 | 599 | 0 | 599 | View |
| Culturally Tailored (Non-smokers) | The anti-smoking and anti-industry messages will be culturally tailored to specifically reach out to young adult SMW. They will receive only messages that are culturally tailored at baseline and weeks 1, 2, and 3. Culturally tailored anti-smoking messages: Anti-smoking messages that are culturally tailored for sexual minority women. | 0 | None | 0 | 501 | 0 | 501 | View |