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 |
|---|---|---|---|---|---|---|---|---|
| Control | Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride. Control: Administration of 0.9% Sodium Chloride (N/S) | 0 | None | 0 | 7 | 7 | 7 | View |
| Ketamine SC | Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride. Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion). Control: Administration of 0.9% Sodium Chloride (N/S) | 0 | None | 0 | 8 | 6 | 8 | View |
| Ketamine IVI | Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine. Ketamine 50 MG/ML: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion). Control: Administration of 0.9% Sodium Chloride (N/S) | 0 | None | 0 | 8 | 6 | 8 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Shivering | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Sedation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Blurred vision | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Diplopia | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |