Table 2.
Treatment-emergent AEs
| CP-CML, n = 270 | AP-CML, n = 85 | BP-CML, n = 62 | Ph+ ALL, n = 32 | Total, N = 449 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Any grade | Grade 3/4 | Any grade | Grade 3/4 | Any grade | Grade 3/4 | Any grade | Grade 3/4 | Any grade | Grade 3/4 | |
| Nonhematologic AEs, n (%) | ||||||||||
| Abdominal pain | 125 (46) | 28 (10) | 36 (42) | 7 (8) | 21 (34) | 5 (8) | 10 (31) | 2 (6) | 192 (43) | 42 (9) |
| Rash* | 127 (47) | 10 (4) | 32 (38) | 4 (5) | 22 (35) | 3 (5) | 7 (22) | 1 (3) | 188 (42) | 18 (4) |
| Constipation | 112 (41) | 7 (3) | 25 (29) | 2 (2) | 17 (27) | 0 | 17 (53) | 1 (3) | 171 (38) | 10 (2) |
| Headache | 116 (43) | 9 (3) | 26 (31) | 1 (1) | 19 (31) | 2 (3) | 8 (25) | 0 | 169 (38) | 12 (3) |
| Dry skin | 114 (42) | 9 (3) | 27 (32) | 1 (1) | 16 (26) | 1 (2) | 8 (25) | 0 | 165 (37) | 11 (2) |
| Fatigue | 81 (30) | 6 (2) | 32 (38) | 4 (5) | 16 (26) | 3 (5) | 9 (28) | 0 | 138 (31) | 13 (3) |
| Hypertension† | 99 (37) | 37 (14) | 22 (26) | 9 (11) | 13 (21) | 5 (8) | 8 (25) | 3 (9) | 142 (32) | 54 (12) |
| Pyrexia | 70 (26) | 3 (1) | 34 (40) | 6 (7) | 23 (37) | 2 (3) | 8 (25) | 0 | 135 (30) | 11 (2) |
| Arthralgia | 90 (33) | 8 (3) | 29 (34) | 2 (2) | 12 (19) | 0 | 4 (13) | 0 | 135 (30) | 10 (2) |
| Nausea | 79 (29) | 2 (<1) | 27 (32) | 0 | 21 (34) | 1 (2) | 7 (22) | 0 | 134 (30) | 3 (<1) |
| Diarrhea | 54 (20) | 2 (<1) | 25 (29) | 2 (2) | 15 (24) | 2 (3) | 4 (13) | 1 (3) | 98 (22) | 7 (2) |
| Increased lipase | 73 (27) | 34 (13) | 13 (15) | 11 (13) | 9 (15) | 8 (13) | 3 (9) | 2 (6) | 98 (22) | 55 (12) |
| Vomiting | 50 (19) | 4 (1) | 23 (27) | 0 | 17 (27) | 1 (2) | 8 (25) | 0 | 98 (22) | 5 (1) |
| Myalgia | 65 (24) | 3 (1) | 18 (21) | 0 | 11 (18) | 0 | 2 (6) | 0 | 96 (21) | 3 (<1) |
| Pain in extremity | 65 (24) | 8 (3) | 17 (20) | 0 | 8 (13) | 0 | 4 (13) | 0 | 94 (21) | 8 (2) |
| Hematologic AEs, n (%) | ||||||||||
| Thrombocytopenia | 123 (46) | 95 (35) | 45 (53) | 37 (44) | 23 (37) | 22 (35) | 7 (22) | 6 (19) | 198 (44) | 160 (36) |
| Neutropenia | 53 (20) | 45 (17) | 31 (37) | 31 (37) | 22 (35) | 18 (29) | 8 (25) | 7 (22) | 114 (25) | 101 (22) |
| Anemia | 53 (20) | 28 (10) | 31 (37) | 19 (22) | 21 (34) | 20 (32) | 8 (25) | 6 (19) | 113 (25) | 73 (16) |
Treatment-emergent AEs of any grade occurring in ≥20% of the total population are listed.
AE, adverse event. Other abbreviations are explained in Table 1.
*
Combines the terms erythematous, macular, and papular rash.
†
At baseline, 379 of 449 patients (84%) had elevated blood pressure (212 of 449 [47%] had blood pressure ≥140/90 mm Hg); 307 of 449 patients (68%) experienced any increase from baseline in blood pressure on study.