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 |
|---|---|---|---|---|---|---|---|---|
| Intervention | Participants completed a 10-15 minute questionnaire of sociodemographics, and contraceptive behaviors, self-efficacy, knowledge, and attitudes. Afterwards, a research assistant (RA) provided them with a brief orientation to the rPlan app. Participants then used the rPlan app for up to 15 minutes. After viewing rPlan, participants were asked a series of questions regarding the app's usability, helpfulness, and content appropriateness (10 min). The participant then entered into a 10-minute motivational interviewing session with an RA that addressed ambivalence about using and maintaining a contraceptive method of interest. Afterwards, participants entered into their visit with a provider and completed an STI test. 6 week followup: Participants completed a 15-25 minute phone survey of their contraceptive behaviors, knowledge, and attitudes. 3-month followup: Participants returned to the clinic site and completed a questionnaire of contraceptive behaviors, knowledge, and attitudes. | 0 | None | 0 | 104 | 0 | 104 | View |