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 |
|---|---|---|---|---|---|---|---|---|
| Metoclopramide (Reglan) | Patients will receive 10 mg of intravenous (IV) metoclopramide following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine. Metoclopramide: Patients receive 10 mg of intravenous (IV) metoclopramide. Normal Saline: All patients receive a 1-liter bolus of normal saline (NS) Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine. | 0 | None | 0 | 26 | 0 | 26 | View |
| Haloperidol (Haldol) | Patients will receive 2.5 mg of intravenous (IV) haloperidol following a 1-liter bolus of normal saline (NS) and 25 mg of IV diphenhydramine. Haloperidol: Patients receive 2.5 mg of IV haloperidol. Normal Saline: All patients receive a 1-liter bolus of normal saline (NS) Diphenhydramine: All patients receive 25 mg of intravenous (IV) diphenhydramine. | 0 | None | 0 | 23 | 0 | 23 | View |