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 |
|---|---|---|---|---|---|---|---|---|
| Arm 1 - Placebo | Infusion of placebo, same infusion rates as for arm 2 | None | None | 0 | 20 | 5 | 20 | View |
| Arm 2 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute | None | None | 0 | 20 | 0 | 20 | View |
| Arm 3 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute | None | None | 0 | 20 | 0 | 20 | View |
| Arm 4 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute | None | None | 0 | 20 | 1 | 20 | View |
| Arm 5 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute | None | None | 0 | 20 | 6 | 20 | View |
| Arm 6 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute | None | None | 0 | 10 | 1 | 10 | View |
| Arm 7 - ICI35,868 (Propofol) | Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute | None | None | 0 | 10 | 2 | 10 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Ventricular Extrasystoles | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 13.1 | View |
| Abdominal Pain Lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 13.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 13.1 | View |
| Blood Pressure Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| Blood Pressure Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| C-Reactive Protein Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| Heart Rate Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| Oxygen Saturation Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 13.1 | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 13.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 13.1 | View |
| Restlessness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 13.1 | View |
| Angiopathy | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 13.1 | View |