Table 4.
Body system event | TRAEs, n (% of patients) | TEAEs, n (% of patients) |
---|---|---|
Skin and subcutaneous tissue/rash | 40 (12) | 45 (14) |
Nervous system | 19 (6) | 31 (9) |
General disorders | 16 (5) | 26 (8) |
Cardiac | 2 (<1) | 8 (2) |
Musculosketetal, connective tissue, and bone disorders | 1 (<1) | 7 (2) |
Infections | 0 | 7 (2) |
Eye | 3 (1) | 4 (1) |
Psychiatric | 2 (<1) | 4 (1) |
Respiratory, thoracic, and mediastinal | 0 | 4 (1) |
Immune system | 3 (<1) | 3 (<1) |
Vascular | 1 (<1) | 2 (<1) |
Ear/labyrinth | 1 (<1) | 2 (<1) |
Renal and urinary | 0 | 2 (<1) |
Injury and poisoning | 1 (<1) | 1 (<1) |
Neoplasms, benign, and malignant | 0 | 1 (<1) |
Surgical and medical | 0 | 1 (<1) |
Abbreviations: TEAE, treatment-emergent adverse event; TRAE, treatment-related adverse event.