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 |
|---|---|---|---|---|---|---|---|---|
| Tuberosity Connective Tissue Graft (CTG) | Subjects in this arm will have a tuberosity connective tissue graft at the time of immediate implant placement. Tuberosity Connective Tissue Graft (CTG): CTG will be taken from the patient's own mouth | 0 | None | 0 | 2 | 0 | 2 | View |
| Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft | Subjects in this arm will have Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft at the time of immediate implant placement. Xenogeneic Volume-Stable Collagen Matrix (VCMX) graft No Intervention: No Soft Tissue Augmentation: Fibro-gide is the VCMX | 0 | None | 0 | 8 | 0 | 8 | View |
| No Soft Tissue Augmentation | Subjects in this arm will have no soft tissue augmentation at the time of immediate implant placement. | 0 | None | 0 | 2 | 0 | 2 | View |