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 |
|---|---|---|---|---|---|---|---|---|
| Historical Control Group | The investigators will use data from a historical control group discharged on POD 1 after minimally invasive sacrocolpopexy to examine Aim 1 and Aim 2. This is a cohort of 60 women matching our eligibility criteria from a prospective randomized trial of two different types of lightweight polypropylene mesh (IRB #14-354). This study completed recruitment 2017. It consists of a group of women who underwent minimally invasive sacrocolpopexy using the same surgical approaches, at the same institutions | 0 | None | 4 | 61 | 0 | 61 | View |
| Same Day Discharge Group | 47 women will be recruited for same day discharge after laparoscopic sacrocolpopexy. We will compare aim 1 and 2 (serious adverse events and procedure-related costs) between the two groups Same day discharge: Patients will be discharged home from the hospital on the day of her surgery. | 0 | None | 3 | 47 | 0 | 47 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | Clavien Dindo | View |
| Bowel obstruction | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | Clavien Dindo | View |
| Cardiopulmonary | SYSTEMATIC_ASSESSMENT | Cardiac disorders | Clavien Dindo | View |
| Neurologic injury | SYSTEMATIC_ASSESSMENT | Nervous system disorders | Clavien Dindo | View |