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 |
|---|---|---|---|---|---|---|---|---|
| AST-OPC1, Cohort 2 | n=6 Dosage of 10 million cells AIS score A | 0 | None | 2 | 6 | 0 | 6 | View |
| AST-OPC1, Cohort 3 | n=6 Dosage of 20 million cells AIS score A | 0 | None | 4 | 6 | 0 | 6 | View |
| AST-OPC1, Cohort 4 | n=6 Dosage of 10 million cells AIS score B | 0 | None | 2 | 6 | 0 | 6 | View |
| AST-OPC1, Cohort 5 | n=4 Dosage of 20 million cells AIS score B | 0 | None | 1 | 4 | 0 | 4 | View |
| AST-OPC1, Cohort 1 | n=3 Dosage of 2 million cells AIS score A | 0 | None | 2 | 3 | 0 | 3 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Acute Renal Failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (18.0) | View |
| Altered Mental Status | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| Aspiration Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Bilateral Decubitus Ulcers | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Bilateral Hip Effusions | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | View |
| Bilateral Pyelonephritis due to UTI | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Buttock Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Cerebrospinal Fluid Leak | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Escherichia Coli Urinary Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Gastrointestinal Bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (18.0) | View |
| Infected Epidural Fluid | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Left Femoral Shaft Fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | View |
| Non-Traumatic Kidney Injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (18.0) | View |
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.0) | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Urinary Tract Infection (UTI) | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Wound Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |