TABLE 5.
Any grade TEAEs of special interest grouping term a , n (%) | 160 mg BID, (n = 34) | 320 mg QD, (n = 10) | Total, (N = 44) |
---|---|---|---|
Patients with ≥1 TEAE of special interest | 30 (88.2) | 10 (100.0) | 40 (90.9) |
Haemorrhage | 11 (32.4) | 4 (40.0) | 15 (34.1) |
Major haemorrhage | 1 (2.9) | 0 (0.0) | 1 (2.3) |
Hypertension | 0 (0.0) | 1 (10.0) | 1 (2.3) |
Infections | 19 (55.9) | 7 (70.0) | 26 (59.1) |
Cytopenias | |||
Anaemia | 14 (41.2) | 4 (40.0) | 18 (40.9) |
Neutropenia | 18 (52.9) | 7 (70.0) | 25 (56.8) |
Thrombocytopenia | 9 (26.5) | 3 (30.0) | 12 (27.3) |
Atrial fibrillation/flutter | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Second primary malignancies | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Tumour lysis syndrome | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Abbreviations: BID, twice daily; MedDRA, Medical Dictionary for Regulatory Activities; QD, once daily; TEAE, treatment‐emergent adverse event.
According to MedDRA Version 23.0.