Table 2.
Summary of adverse drug reactions and serious adverse drug reactions reported during the survey period (safety analysis set)
| N = 228 | ||
|---|---|---|
| ADR | Serious ADR | |
| Patients with an event, n (%) | 74 (32.5) | 31 (13.6) |
| Infections and infestations | 33 (14.5) | 13 (5.7) |
| Bronchitis | 1 (0.4) | – |
| Cellulitis | 1 (0.4) | 1 (0.4) |
| Cystitis | 2 (0.9) | – |
| Gastroenteritis | 1 (0.4) | – |
| Herpes zoster | 2 (0.9) | 1 (0.4) |
| Infection | 1 (0.4) | 1 (0.4) |
| Parotitis | 1 (0.4) | 1 (0.4) |
| Pharyngitis | 1 (0.4) | – |
| Pneumonia | 2 (0.9) | 1 (0.4) |
| Pneumonia pneumococcal | 1 (0.4) | 1 (0.4) |
| Sinusitis | 1 (0.4) | – |
| Upper respiratory tract infection | 2 (0.9) | – |
| Urinary tract infection | 4 (1.8) | 2 (0.9) |
| Coronavirus infection | 4 (1.8) | 1 (0.4) |
| Arthritis bacterial | 1 (0.4) | 1 (0.4) |
| COVID-19 | 11 (4.8) | 3 (1.3) |
| COVID-19 pneumonia | 2 (0.9) | 2 (0.9) |
| Neoplasms benign, malignant, and unspecified (including cysts and polyps) | 1 (0.4) | 1 (0.4) |
| Acute myelomonocytic leukemia | 1 (0.4) | 1 (0.4) |
| Blood and lymphatic system disorders | 2 (0.9) | 1 (0.4) |
| Anemia | 1 (0.4) | 1 (0.4) |
| Aplasia pure red cell | 1 (0.4) | 1 (0.4) |
| Iron deficiency anemia | 1 (0.4) | – |
| Immune system disorders | 2 (0.9) | 1 (0.4) |
| Hypersensitivity | 1 (0.4) | 1 (0.4) |
| Hypogammaglobulinemia | 1 (0.4) | – |
| Endocrine disorders | 1 (0.4) | – |
| Autoimmune thyroiditis | 1 (0.4) | – |
| Metabolism and nutrition disorders | 1 (0.4) | – |
| Hyperuricemia | 1 (0.4) | – |
| Psychiatric disorders | 2 (0.9) | 2 (0.9) |
| Anxiety | 1 (0.4) | 1 (0.4) |
| Depressive symptom | 1 (0.4) | 1 (0.4) |
| Nervous system disorders | 5 (2.2) | 2 (0.9) |
| Hypoesthesia | 2 (0.9) | – |
| Myasthenia gravis | 1 (0.4) | 1 (0.4) |
| Neuralgia | 1 (0.4) | 1 (0.4) |
| Somnolence | 1 (0.4) | – |
| Eye disorders | 1 (0.4) | 1 (0.4) |
| Visual impairment | 1 (0.4) | 1 (0.4) |
| Respiratory, thoracic, and mediastinal disorders | 2 (0.9) | 2 (0.9) |
| Acute respiratory distress syndrome | 1 (0.4) | 1 (0.4) |
| Interstitial lung disease | 1 (0.4) | 1 (0.4) |
| Gastrointestinal disorders | 7 (3.1) | 1 (0.4) |
| Colitis ischemic | 1 (0.4) | 1 (0.4) |
| Diarrhea | 2 (0.9) | – |
| Gastritis erosive | 1 (0.4) | – |
| Glossitis | 1 (0.4) | – |
| Nausea | 1 (0.4) | – |
| Pancreatic cyst | 1 (0.4) | – |
| Stomatitis | 1 (0.4) | – |
| Skin and subcutaneous tissue disorders | 4 (1.8) | – |
| Blister | 1 (0.4) | – |
| Pruritus | 1 (0.4) | – |
| Skin swelling | 1 (0.4) | – |
| Nail bed inflammation | 1 (0.4) | – |
| Chronic pigmented purpura | 1 (0.4) | – |
| Musculoskeletal and connective tissue disorders | 6 (2.6) | 2 (0.9) |
| Arthralgia | 1 (0.4) | – |
| Muscle spasms | 2 (0.9) | 2 (0.9) |
| Myalgia | 1 (0.4) | – |
| Pain in extremity | 1 (0.4) | – |
| Rheumatoid arthritis | 1 (0.4) | – |
| Renal and urinary disorders | 2 (0.9) | 1 (0.4) |
| Renal impairment | 2 (0.9) | 1 (0.4) |
| General disorders and administration site conditions | 10 (4.4) | 3 (1.3) |
| Feeling abnormal | 1 (0.4) | – |
| Injection site erythema | 1 (0.4) | – |
| Malaise | 1 (0.4) | – |
| Edema peripheral | 3 (1.3) | – |
| Pyrexia | 3 (1.3) | 1 (0.4) |
| Sudden cardiac death | 1 (0.4) | 1 (0.4) |
| Lithiasis | 1 (0.4) | 1 (0.4) |
| Investigations | 18 (7.9) | 2 (0.9) |
| Blood immunoglobulin G decreased | 7 (3.1) | – |
| Blood immunoglobulin M decreased | 3 (1.3) | – |
| Immunoglobulins decreased | 4 (1.8) | – |
| Lymphocyte count decreased | 4 (1.8) | 2 (0.9) |
| Hepatic enzyme increased | 1 (0.4) | – |
| Anti-aquaporin-4 antibody | 1 (0.4) | – |
| Total complement activity increased | 1 (0.4) | – |
| Injury, poisoning, and procedural complications | 21 (9.2) | 3 (1.3) |
| Infusion-related reaction | 21 (9.2) | 3 (1.3) |
| Surgical and medical procedures | 1 (0.4) | 1 (0.4) |
| Oxygen therapy | 1 (0.4) | 1 (0.4) |
ADR adverse drug reaction