Table 3.
Serious adverse events and serious adverse drug reactions.
| SAEs | SADRs | |||
|---|---|---|---|---|
| Incidence, N (%) | Events | Incidence, N (%) | Events | |
| Skin and subcutaneous tissue disorders | 2 (0.3) | 2 | 1 (0.1) | 1 |
| Rash | 1 (0.1) | 1 | 1 (0.1) | 1 |
| Swelling face | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Gastrointestinal disorders | 5 (0.7) | 5 | 1 (0.1) | 1 |
| Abdominal pain upper | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Gastritis | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Chronic gastritis | 1 (0.1) | 1 | 1 (0.1) | 1 |
| Gastric hemorrhage | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Mechanical ileus | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Musculoskeletal and connective tissue disorders | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Fracture nonunion | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Infections and infestations | 5 (0.7) | 5 | 0 (0.0) | 0 |
| Atypical pneumonia | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Infectious colitis | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Pharyngitis | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Pseudomembranous colitis | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Urinary tract infection | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Blood and lymphatic system disorders | 2 (0.3) | 3 | 1 (0.1) | 2 |
| Thrombocytopenia | 1 (0.1) | 1 | 1 (0.1) | 1 |
| Neutropenia | 1 (0.1) | 1 | 1 (0.1) | 1 |
| Lymphadenitis | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Nervous system disorders | 4 (0.6) | 4 | 2 (0.3) | 2 |
| Headache | 2 (0.3) | 2 | 1 (0.1) | 1 |
| Cerebral artery occlusion | 1 (0.1) | 1 | 1 (0.1) | 1 |
| Thalamic infarction | 1 (0.1) | 1 | 0 (0.0) | 0 |
| General disorders and administration site conditions | 3 (0.4) | 4 | 1 (0.1) | 2 |
| Pyrexia | 2 (0.3) | 2 | 0 (0.0) | 0 |
| Asthenia | 1 (0.1) | 2 | 1 (0.1) | 2 |
| Hepatobiliary disorders | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Cholecystitis chronic | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Respiratory, thoracic, and mediastinal disorders | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Pleural effusion | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Cardiac disorders | 3 (0.4) | 3 | 0 (0.0) | 0 |
| Palpitations | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Angina unstable | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Cardiac failure congestive | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Renal and urinary disorders | 3 (0.4) | 4 | 0 (0.0) | 0 |
| Acute kidney injury | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Renal disorder | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Tubulointerstitial nephritis | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Ureteral disorder | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Injury, poisoning, and procedural complications | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Foot fracture | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Neoplasms benign, malignant, and unspecified (incl cysts and polyps) | 2 (0.3) | 2 | 0 (0.0) | 0 |
| Malignant neoplasm progression | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Malignant palate neoplasm | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Product issues | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Device dislocation | 1 (0.1) | 1 | 0 (0.0) | 0 |
| Total | 30 (4.5) | 37 | 5 (0.7) | 8 |
Incidence (%): N/(N of safety evaluation patients)×100. Coding dictionary: MedDRA 19.1.
Abbreviations: SADRs, serious adverse drug reactions; SAEs, serious adverse events.