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 |
|---|---|---|---|---|---|---|---|---|
| Extended Release Epidural Morphine | Four mg (0.4 ml) of EREM will be delivered to the epidural space and flushed with 1 ml of saline Extended Release Epidural Morphine (EREM): A single Four mg (0.4 ml)dose of EREM will be administered into the epidural space and flushed with 1 ml of saline | 0 | None | 0 | 20 | 0 | 20 | View |
| Placebo Group | The epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush Placebo: A single epidural injection will be a placebo consisting of 0.4 ml of saline followed by 1 ml saline flush | 0 | None | 0 | 20 | 1 | 20 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | Hypotension | View |