Table 2 Treatment-emergent adverse events by grade according to the NCI-CTCAE (version 4.03) and with a frequency of at least 5% in any grade
Safety Population (n = 36) | ||||
|---|---|---|---|---|
Adverse Event Term | Grade 1, n (%) | Grade 2, n (%) | Grade 3, n (%) | Grade 4, n (%) |
Patients with any TEAE | 27 (75.0) | 27 (75.0) | 18 (50.0) | 7 (19.4) |
Pyrexia | 10 (27.8) | 1 (2.8) | 0 | 0 |
Fatigue | 11 (30.6) | 10 (27.8) | 2 (5.6) | 0 |
Anemia | 8 (22.2) | 2 (5.6) | 3 (8.3) | 0 |
Nausea | 6 (16.7) | 2 (5.6) | 0 | 0 |
Decreased appetite | 4 (11.1) | 1 (2.8) | 0 | 0 |
Musculoskeletal chest pain | 3 (8.3) | 0 | 0 | 0 |
Pruritus | 3 (8.3) | 0 | 0 | 0 |
Upper respiratory tract infection | 3 (8.3) | 0 | 0 | 0 |
Albuminuria | 2 (5.6) | 0 | 0 | 0 |
Back pain | 2 (5.6) | 0 | 1 (2.8) | 0 |
Hot flush | 2 (5.6) | 0 | 0 | 0 |
Hypothyroidism | 2 (5.6) | 0 | 0 | 0 |
Abdominal pain upper | 1 (2.8) | 2 (5.6) | 0 | 0 |
Elevated AST level | 1 (2.8) | 0 | 2 (5.6) | 0 |
Constipation | 1 (2.8) | 2 (5.6) | 1 (2.8) | 0 |
Diarrhea | 1 (2.8) | 3 (8.3) | 1 (2.8) | 0 |
Dyspnea | 1 (2.8) | 2 (5.6) | 0 | 0 |
Painful skin | 1 (2.8) | 2 (5.6) | 0 | 0 |
Rash | 1 (2.8) | 2 (5.6) | 0 | 0 |
Tachycardia | 1 (2.8) | 2 (5.6) | 0 | 0 |
Hypertension | 0 | 4 (11.1) | 0 | 0 |
Neutrophil count decreased | 0 | 6 (16.7) | 10 (27.8) | 3 (8.3) |
Weight decreased | 0 | 2 (5.6) | 0 | 0 |