TABLE 4.
MedDRA classification of ADEs related to treatment safety (N = 152).
| MedDRA system organ class (No., %) | MedDRA preferred term | No. |
|---|---|---|
| Gastrointestinal disorders (31, 20.4%) | Gastroduodenal hemorrhage | 10 |
| Intestinal hemorrhage | 7 | |
| Diarrhea | 3 | |
| Gastric ulcer perforation | 3 | |
| Pancreatitis | 1 | |
| Gastrooesophageal reflux disease | 1 | |
| Gastritis | 1 | |
| Esophagitis | 1 | |
| Duodenal perforation | 1 | |
| Abdominal discomfort | 1 | |
| Dyspepsia | 1 | |
| Nausea | 1 | |
| Metabolism and nutrition disorders (26, 17.1%) | Hyponatremia | 12 |
| Hypoglycemia | 6 | |
| Hyperglycemia | 3 | |
| Dehydration | 2 | |
| Hyperkalemia | 2 | |
| Calciphylaxis | 1 | |
| Blood and lymphatic system disorders (18, 11.8%) | Bone marrow toxicity | 10 |
| Microcytic anemia | 7 | |
| Anemia folate deficiency | 1 | |
| Nervous system disorders (17, 11.1%) | Cerebral hemorrhage | 6 |
| Depressed level of consciousness | 8 | |
| Subdural hemorrhage | 2 | |
| Diplopia | 1 | |
| Infections and infestations (14, 9.2%) | Infection susceptibility increased | 10 |
| Clostridium difficile colitis | 4 | |
| Cardiac disorders (12, 7.9%) | Bradycardia | 7 |
| Atrioventricular block | 3 | |
| Hypertension | 1 | |
| Cardiomyopathy | 1 | |
| Vascular disorders (10, 6.6%) | Hypotension | 4 |
| Hematoma | 3 | |
| Syncope | 2 | |
| Hemorrhage | 1 | |
| Renal and urinary disorders (8, 5.3%) | Hematuria | 4 |
| Prerenal failure | 4 | |
| Respiratory, thoracic, and mediastinal disorders (7, 4.6%) | Hemoptysis | 3 |
| Pulmonary embolism | 1 | |
| Pulmonary alveolar hemorrhage | 1 | |
| Interstitial lung disease | 1 | |
| Epistaxis | 1 | |
| Immune system disorders (4, 2.6%) | Drug hypersensitivity | 4 |
| Psychiatric disorders (2, 1.3%) | Confusional state | 1 |
| Disorientation | 1 | |
| Endocrine disorders (1, 0.7%) | Sec. adrenocortical insufficiency | 1 |
| General disorders and administration site conditions (1, 0.7%) | Fatigue | 1 |
| Injury, poisoning, and procedural complications (1, 0.7%) | Fall | 1 |
ADE, Adverse Drug Event; MedDRA, Medical Dictionary for Regulatory Activities.