;17 (3)
Blood and Lymphatic System Disorders
Thrombocytopenia 163 (40) 105 (26) 59 (42) 52 (37) 222 (41) 157 (29)
Anemia 94 (23) 35 (9) 52 (37) 37 (26) 146 (27) 72 (13)
Neutropenia 65 (16) 43 (11) 26 (19) 25 (18) 91 (17) 68 (12)
General Disorders and Administrative Site Conditions
Fatigue† 104 (26) 6 (1) 28 (20) 6 (4) 132 (24) 12 (2)
Pyrexia 90 (22) 2 (<1) 51 (36) 4 (3) 141 (26) 6 (1)
Edema‡ 56 (14) 1 (<1) 19 (14) 1 (1) 75 (14) 2 (<1)
Asthenia 45 (11) 5 (1) 14 (10) 1 (1) 59 (11) 6 (1)
Infections and Infestations
Respiratory tract infection§ 49 (12) 2 (<1) 14 (10) 0 63 (12) 2 (<1)
Nasopharyngitis 47 (12) 0 7 (5) 0 54 (10) 0
Investigations
Alanine aminotransferase increased 81 (20) 30 (7) 14(10) 7(5) 95(17) 37(7)
Aspartate aminotransferase increased 64 (16) 15 (4) 15(11) 4 (3) 79(14) 19(3)
Metabolism and nutrition disorder
Decreased appetite 53 (13) 3 (1) 19 (14) 0 72 (13) 3 (1)
Musculoskeletal and Connective Tissue Disorder
Arthalgia 58 (14) 2 (<1) 18 (13) 0 76 (14) 2 (<1)
Back pain 49 (12) 3 (1) 10 (7) 2 (1) 59 (11) 5 (1)
Nervous System Disorders
Headache 82 (20) 3 (1) 25 (18) 6 (4) 107 (20) 9 (2)
Dizziness 39 (10) 0 18 (13) 1 (1) 57 (10) 1 (<1)
Respiratory, Thoracic and Mediastinal Disorders
Dyspnea 41 (10) 4 (1) 26 (19) 8 (6) 67 (12) 12 (2)
Cough 80(20) 0 30(21) 0 110(20) 0
Skin and Subcutaneous Disorders
Rash¶ 140 (34) 32 (8) 49 (35) 6 (4) 189 (35) 38 (7)
Pruritus 43 (11) 3 (1) 11 (8) 0 54 (10) 3 (1)
In the single-arm Phase 1/2 clinical trial, one patient (0.2%) experienced QTcF interval of greater than 500 ms. Patients with uncontrolled or significant cardiovascular disease including QT interval prolongation were excluded by protocol.
Table 3 identifies the clinically relevant or severe Grade 3/4 laboratory test abnormalities for the Phase 1/2 CML safety population.
Table 3: Number (%) of Patients with Clinically Relevant or Severe Grade 3/4 Laboratory Test Abnormalities In the Phase 1/2 Clinical Study, Safety Population
CP CML
N=406
n (%) AdvP CML
N=140
n (%) All CP and AdvP CML
N=546
n (%)
Hemat |
