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
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| ZNN CM Asia With AS2 Technique | Open Reduction and Internal Fixation with AS2 Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail. Bone fragment will be stabilized by additional screw fixation (Anterior Support Screw). Open Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail. ZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System. Anterior Support Screw: Experimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw. | 0 | None | 1 | 121 | 0 | 121 | View |
| ZNN CM Asia Without AS2 Technique | Trochanteric Fracture treated by Open Reduction and Internal Fixation using with ZNN CM Asia nail without additional screw fixation. Open Reduction and Internal Fixation: Fractured bone fragments are reduced and stabilized by intramedullary nail. ZNN CM Asia: Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System. | 0 | None | 0 | 119 | 0 | 119 | View |
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cut-out | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |