Table 3.
Serious adverse events by system organ class and preferred terminology based on the medical dictionary for regulatory activities. N = 15 of 22 patients
| System organ class N = 15 |
Preferred terminology |
|---|---|
| Cardiac disorders (n = 16) | |
| Acute myocardial infarction | 6 |
| Atrioventricular block complete | 1 |
| Cardiac arrest | 2 |
| Cardiac failure acute | 2 |
| Coronary artery disease | 3 |
| Left ventricular failure | 1 |
| Myocardial infarction | 1 |
| Gastrointestinal disorders (n = 2) | |
| Diarrhea | 1 |
| Diverticulum | 1 |
| Hepatobiliary disorders (n = 1) | |
| Cholecystitis acute | 1 |
| Infections and infestations (n = 12) | |
| Cellulitis | 2 |
| Cholecystitis infective | 1 |
| Clostridium difficile infection | 1 |
| Coronavirus infection | 1 |
| Device related infection | 1 |
| Infected bite | 1 |
| Peritonitis | 1 |
| Pneumonia | 2 |
| Sepsis | 1 |
| Staphylococcal infection | 1 |
| Injury (n = 2) | |
| Fall | 1 |
| Patella fracture | 1 |
| Metabolism and nutrition disorders (n = 5) | |
| Dehydration | 1 |
| Hypercalcemia | 1 |
| Hyperkalemia | 3 |
| Musculoskeletal disorders (n = 1) | |
| Meniscal degeneration | 1 |
| Neoplasms benign/malignant (n = 1) | |
| Squamous cell carcinoma of lung | 1 |
| Nervous system disorders (2) | |
| Cerebrovascular accident | 1 |
| Syncope | 1 |
| Psychiatric disorders (1) | |
| Hallucination, visual | 1 |
| Renal and urinary disorders (9) | |
| Acute kidney injury | 8 |
| End-stage renal disease | 1 |
| Respiratory, thoracic, and mediastinal disorders (6) | |
| Acute respiratory failure | 1 |
| Chronic obstructive pulmonary disease | 1 |
| Pneumothorax | 1 |
| Respiratory distress | 1 |
| Respiratory failure | 2 |
| Vascular disorders (3) | |
| Aortic stenosis | 1 |
| Deep vein thrombosis | 1 |
| Hematoma | 1 |
| Total | 61 |