Table 2.
Description of adverse events collected.
| Adverse event | n (%) | Withdrawal |
|---|---|---|
| Disorders of the blood and lymphatic system | 0 (0) | - |
| Heart disorders | 1 (0.6) | 1/1 |
| Congenital, familial and genetic disorders | 0 (0) | - |
| Disorders of the ear and vestibular maze | 1 (0.6) | 1/1 |
| Endocrine disorders | 0 (0) | - |
| Eye disorders | 0 (0) | - |
| Gastrointestinal disorders | 6 (3.8) | 6/6 |
| General symptoms and local injection site reactions | 0 (0) | - |
| Hepatobiliary disorders | 0 (0) | - |
| Immune system disorders | 0 (0) | - |
| Traumatic injuries, intoxications and complications of therapeutic procedures | 0 (0) | - |
| Disorders of metabolism and nutrition | 0 (0) | - |
| Musculoskeletal and connective tissue disorders | 0 (0) | - |
| Disorders of the nervous system | 0 (0) | - |
| Pregnancy, puerperium and perinatal diseases | 0 (0) | - |
| Psychiatric disorders | 1 (0.6) | 1/1 |
| Kidney and urinary disorders | 0 (0) | - |
| Reproductive and breast disorders | 0 (0) | - |
| Respiratory, thoracic and mediastinal disorders | 1 (0.6) | 1/1 |
| Disorders of the skin and subcutaneous tissue | 5 (3) | 5/5 |
| Social circumstances | 0 (0) | - |
| Vascular disorders | 0 (0) | - |
| Infections | 5 (3) | 4/5 |
| Neoplasms | 2 (1) | 2/2 |
Cells include n (%).
Withdrawal: No. patients in whom the adverse event led to discontinuation of the drug.