Table 3.
Most common TEAEs (reported at any grade in ≥ 2 patients) for maintenance and treatment
| ALL GRADES | GRADE 3 | |
|---|---|---|
| Maintenance ( n = 18) | ||
| Nausea | 7 (39%) | 1 (6%) |
| ALT/AST increase | 5 (28%) | 1 (6%) |
| Fatigue | 5 (28%) | 0 |
| Diarrhoea | 4 (22%) | 0 |
| Creatinine increased | 4 (22%) | 0 |
| ALP increase | 2 (11%) | 1 (6%) |
| Anaemia | 2 (11%) | 2 (11%) |
| Neutropenia | 2 (11%) | 0 |
| Dysgeusia | 2 (11%) | 0 |
| Vomiting | 2 (11%) | 0 |
| Abdominal pain | 2 (11%) | 0 |
| Anorexia | 2 (11%) | 0 |
| Treatment (n=33) | ||
| Anaemia | 13 (39%) | 5 (15%) |
| Thrombocytopenia | 10 (30%) | 2 (6%) |
| Fatigue | 7 (21%) | 2 (6%) |
| Nausea | 5 (15%) | 0 |
| ALT/AST increase | 4 (12%) | 0 |
| Neutropenia | 3 (9%) | 2 (6%) |
| Vomiting | 3 (9%) | 2 (6%) |
| ALP increase | 3 (9%) | 1 (3%) |
| Asthenia | 3 (9%) | 0 |
| Abdominal pain | 2 (6%) | 1 (3%) |
| Hyporexia | 2 (6%) | 0 |
| Constipation | 2 (6%) | 0 |
Data are n (%). TEAEs were graded according to Common Terminology Criteria for Adverse Events version 5.0, with the highest grade reported if patients reported the same event at more than one grade. ALP: alkaline phosphatase. ALT: alanine aminotransferase. AST: aspartate aminotransferase. TEAE: treatment-emergent adverse event.