Table 2.
Adverse events
| MedDRA SOC | Number of events | Events/100 patient-years |
|---|---|---|
| Total | 60 | 34.21 |
| Infections and infestations | 18 | 10.26 |
| Respiratory, thoracic, and mediastinal disorders | 5 | 2.85 |
| General disorders and administration site conditions | 20 | 11.40 |
| Hepatobiliary disorders | 3 | 1.71 |
| Gastrointestinal disorders | 5 | 2.85 |
| Skin and subcutaneous tissue disorders | 2 | 1.14 |
| Blood and lymphatic system disorders | 1 | 0.57 |
| Eye disorders | 1 | 0.57 |
| Neoplasms (benign, malignant, and unspecified) | 1 | 0.57 |
| Injury, poisoning, and procedural complications | 1 | 0.57 |
| Investigations | 3 | 1.71 |
MedDRA SOC Medical Dictionary for Regulatory Activities system organ class