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 |
|---|---|---|---|---|---|---|---|---|
| Reduction, Mastopexy No Implant, No Seri | Patients undergoing reduction or mastopexy but no implant is used and no Seri support Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast. | None | None | 0 | 25 | 3 | 25 | View |
| Mastopexy, Implant no Seri Scaffold | Mastopexy with implant, No Seri support is used Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast. | None | None | 0 | 25 | 2 | 25 | View |
| Breast Reduction With Seri Support | Patients undergoing breast reduction with the use of Seri support Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast. | None | None | 3 | 26 | 3 | 26 | View |
| Augmentation Mastopexy, Implant and Seri | Augmentation Mastopexy patients where Seri Scaffold is placed Seri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast. | None | None | 2 | 61 | 2 | 61 | View |