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 |
|---|---|---|---|---|---|---|---|---|
| Outpatient Foley Catheter (Randomized & Prospective) | This arm reflects enrolled women who were (A) randomized to the outpatient Foley catheter group (RCT design) or (B) chose the outpatient Foley catheter group (Modified Prospective study design). NOTE: Adverse events were only collected on women who were accrued, meaning they met eligibility criteria for randomization (RCT design) or met eligibility criteria upon presentation to the Family Birth Center for induction (Modified Prospective study design). No participants in the modified Prospective study design were accrued due to screen failure. Participants underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exams the evening before their scheduled induction in the Family Birth Center. A Foley catheter was placed for cervical ripening. After fetal monitoring, they were dismissed to home, to return to the Family Birth Center in the morning for continuation of their labor inductions in the inpatient setting. | 0 | None | 0 | 4 | 0 | 4 | View |
| Inpatient Usual Care (Randomized & Prospective) | This arm reflects enrolled women who were (A) randomized to the inpatient usual care group (RCT design) or (B) chose the inpatient usual care group (Modified Prospective study design). NOTE: Adverse events were only collected on women who were accrued, meaning they met eligibility criteria for randomization (RCT design) or met eligibility criteria upon presentation to the Family Birth Center for induction (Modified Prospective study design). No participants in the modified Prospective study design were accrued due to screen failure. Participants presented to the Family Birth Center in the evening for their scheduled induction of labor. They underwent basic history review, fetal nonstress testing, ultrasound for presentation and amniotic fluid index, and cervical exam. Cervical ripening commenced with either a Foley catheter or vaginal misoprostol per the discretion of the managing obstetric team. They remained in the inpatient setting throughout their entire labor induction course. | 0 | None | 0 | 4 | 0 | 4 | View |