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 |
|---|---|---|---|---|---|---|---|---|
| Ketamine | Ketamine is an FDA-approved anesthetic agent that is commonly used to induce surgical anesthesia due to its low incidence of significant respiratory depression and hypotension. It as a N-methyl-D-aspartate (NMDA) receptor antagonist and glutamatergic modulator, and has been demonstrated in multiple controlled clinical trials to have rapidly acting antidepressant and anti-suicidal effects in adults. Ketamine infusion: The dose of ketamine established in prior research (0.5 mg/kg over 40 minutes) will be used in this study to minimize risks. The maximum total single dose allowed in this study will be 40mg, corresponding to a weight of 80kg. | 0 | None | 0 | 1 | 1 | 1 | View |
| Midazolam | Midazolam, the active control in this study, is a medication that is approved by the Food and Drug Administration as a sedative for both children and adults.It is a benzodiazepine with a short half-life that was chosen so as to blind the psychotomimetic effects of Ketamine. Midazolam infusion: The weight-based midazolam dosing established in prior ketamine trials in adults (0.045mg/kg) will be used to minimize risks, as this is considered a very low dose compared to the sedation literature. The maximum total dose allowed in this study will be 3.6mg per infusion, corresponding to a weight of 80kg. | 0 | None | 0 | 2 | 2 | 2 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diplopia | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Numbness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Blurred Vision | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Shortness of Breath | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Hearing Changes | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Pruritus at Infusion Site | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Tics | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Lightheadedness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Joint Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Stress Fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |