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 |
|---|---|---|---|---|---|---|---|---|
| B-Randomized Clinical Trial | Patients diagnosed with asymptomatic catheter-related DVT who are randomized to close observation vs enoxaparin for 6 weeks | 0 | None | 0 | 0 | 0 | 0 | View |
| A-Prospective Screening for Asymptomatic Catheter-related DVT | Patients \</=18 years of age with cancer and a first indwelling catheter expected to be in place for 3 months are enrolled. They are screened with either contrast venogram or ultrasound for asymptomatic catheter-related DVT if they have had at least 2 complications including line occlusion requiring thrombolysis or catheter infection that did not result in removal of the line. If they have a positive screening study they are eligible for Arm B | 0 | None | 16 | 136 | 0 | 136 | View |