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 |
|---|---|---|---|---|---|---|---|---|
| Attention Placebo Control Group | Instructions on general pregnancy and infant care Attention placebo control: Participants in the control group will receive usual prenatal care from physicians, nurses, or social workers. They will receive best standard care on smoking cessation and breastfeeding, including referral to the New York State Smokers' Quitline and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). | 0 | None | 0 | 20 | 0 | 20 | View |
| Integrated Intervention | Integrated intervention of smoking cessation and breastfeeding Integrated intervention of smoking cessation and breastfeeding: The intervention group will receive an integrated intervention of smoking cessation and breastfeeding: education and counseling, monitoring and feedback, and contingent financial incentives. | 0 | None | 0 | 20 | 0 | 20 | View |