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 |
|---|---|---|---|---|---|---|---|---|
| Placebo | 100 cc normal saline Placebo: 100 cc normal saline | 12 | None | 1 | 137 | 57 | 137 | View |
| Intervention | 100 cc normal saline with 1g of tranexamic acid in solution Tranexamic Acid Injectable Solution: 100 cc normal saline mixed with 1g of tranexamic acid in solution | 16 | None | 3 | 146 | 69 | 146 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hyperglycemia (worsening of condition -> death) | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Acute infarct in R parietal region (pt released on hospice) | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Post-operative respiratory failure with hypercarbia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |