Table 3. Adverse events.
|
Cohort |
||||||
|---|---|---|---|---|---|---|
|
1 |
2 |
3 |
||||
| Number of subjects | Number of events | Number of subjects | Number of events | Number of subjects | Number of events | |
| Adverse drug reaction | ||||||
| Number (%) of subjects | 2 (66.7) | 5 | 1 (33.3) | 1 | 1 (33.3) | 1 |
| Musculoskeletal and connective tissue disorder | ||||||
| Myalgia | 1 (33.3) | 3 | 0 (0.0) | 0 | 1 (33.3) | 1 |
| General disorders and administration site conditions | ||||||
| Pyrexia | 0 (0.0) | 0 | 1 (33.3) | 1 | 0 (0.0) | 0 |
| Fatigue | 1 (33.3) | 1 | 0 (0.0) | 0 | 0 (0.0) | 0 |
| Skin and subcutaneous tissue disorder | ||||||
| Blister | 1 (33.3) | 1 | 0 (0.0) | 0 | 0 (0.0) | 0 |
| Serious treatment-emergent adverse event | ||||||
| Number (%) of subjects | 2 (66.7) | 5 | 3 (100.0) | 8 | 1 (33.3) | 1 |
| Respiratory, thoracic, and mediastinal disorders | ||||||
| Pleural effusion | 0 (0.0) | 0 | 2 (66.7) | 4 | 0 (0.0) | 0 |
| Dyspnea | 1 (33.3) | 2 | 0 (0.0) | 0 | 0 (0.0) | 0 |
| Pneumothorax | 1 (33.3) | 1 | 0 (0.0) | 0 | 0 (0.0) | 0 |
| Infections and infestations | ||||||
| Pneumonia | 1 (33.3) | 1 | 0 (0.0) | 0 | 0 (0.0) | 0 |
| Wound infection | 0 (0.0) | 0 | 1 (33.3) | 1 | 0 (0.0) | 0 |
| Nervous system disorders | ||||||
| Dizziness | 0 (0.0) | 0 | 1 (33.3) | 1 | 0 (0.0) | 0 |
| Headache | 1 (33.3) | 1 | 0 (0.0) | 0 (0.0) | 0 | |
| Blood and lymphatic system disorders | ||||||
| Febrile neutropenia | 0 (0.0) | 0 | 1 (33.3) | 1 | 0 (0.0) | 0 |
| General disorders and administration site conditions | ||||||
| Chest pain | 0 (0.0) | 0 | 1 (33.3) | 1 | 0 (0.0) | 0 |
| Hepatobiliary disorders | ||||||
| Bile duct obstruction | 0 (0.0) | 0 | 0 (0.0) | 0 | 1 (33.3) | 1 |