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 |
|---|---|---|---|---|---|---|---|---|
| Postplacental Insertion of Intrauterine Device (IUD) | This was a single arm study. All patients were enrolled into the Postplacental Insertion of Copper T380A IUD arm/group. IUDs were placed into the endometrial cavity through the uterine incision immediately after delivery of the infant and placenta. The IUD was removed from its applicator and manually placed in the most proximal part of the endometrial cavity. Ring forceps were used to place the strings into the cervix. IUD strings were not trimmed at the time of insertion. | 0 | None | 0 | 42 | 23 | 42 | View |