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 |
|---|---|---|---|---|---|---|---|---|
| UPLIFT Program | Weekly one-hour group sessions for 10 weeks facilitated by a mental health professional. UPLIFT Program: UPLIFT is based on cognitive behavioral therapy and mindfulness-based practices. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home. | 0 | None | 0 | 40 | 0 | 40 | View |
| Pregnancy Skills Group | Weekly one-hour group sessions for 10 weeks facilitated by a registered nurse. Attention Control Group: Program is based on standard prenatal, childbirth, infant feeding, and parenting education curriculum. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home. | 0 | None | 0 | 41 | 0 | 41 | View |