TABLE III.
Treatment-Emergent Adverse Events and Laboratory Abnormalities
| Imatinib-resistant (n = 200) | Imatinib-intolerant (n = 88) | Total (n = 288) | ||||
|---|---|---|---|---|---|---|
| Event, n (%) | All grades | Grade 3/4 | All grades | Grade 3/4 | All grades | Grade 3/4 |
| Nonhematologic TEAEsa | ||||||
| Diarrhea | 168 (84) | 17 (9) | 75 (85) | 11 (13) | 243 (84) | 28 (10) |
| Nausea | 84 (42) | 0 | 45 (51) | 4 (5) | 129 (45) | 4 (1) |
| Vomiting | 70 (35) | 3 (2) | 36 (41) | 8 (9) | 106 (37) | 11 (4) |
| Rash | 63 (32) | 17 (9) | 36 (41) | 10 (11) | 99 (34) | 27 (9) |
| Pyrexia | 54 (27) | 1 (1) | 14 (16) | 0 | 68 (24) | 1 (<1) |
| Abdominal pain | 45 (23) | 2 (1) | 22 (25) | 2 (2) | 67 (23) | 4 (1) |
| Fatigue | 45 (23) | 1 (1) | 22 (25) | 2 (2) | 67 (23) | 3 (1) |
| Elevated ALT | 41 (21) | 13 (7) | 21 (24) | 8 (9) | 62 (22) | 21 (7) |
| Upper abdominal pain | 40 (20) | 1 (1) | 17 (19) | 0 | 57 (20) | 1 (<1) |
| Cough | 44 (22) | 1 (1) | 13 (15) | 0 | 57 (20) | 1 (<1) |
| Elevated AST | 36 (18) | 6 (3) | 18 (21) | 5 (6) | 54 (19) | 11 (4) |
| Headache | 30 (15) | 0 | 18 (21) | 0 | 48 (17) | 0 |
| Arthralgia | 27 (14) | 0 | 13 (15) | 1 (1) | 40 (14) | 1 (<1) |
| Decreased appetite | 27 (14) | 2 (1) | 13 (15) | 0 | 40 (14) | 2 (1) |
| Asthenia | 22 (11) | 5 (3) | 14 (16) | 0 | 36 (13) | 5 (2) |
| Back pain | 16 (8) | 0 | 17 (19) | 0 | 33 (12) | 0 |
| Nasopharyngitis | 24 (12) | 0 | 12 (14) | 0 | 36 (13) | 0 |
| Constipation | 18 (9) | 0 | 15 (17) | 1 (1) | 33 (12) | 1 (<1) |
| Oropharyngeal pain | 22 (11) | 0 | 8 (9) | 0 | 30 (10) | 0 |
| Hematologic laboratory abnormalitiesb | ||||||
| Thrombocytopenia | 131 (66) | 42 (21) | 62 (70) | 28 (32) | 193 (67) | 70 (24) |
| Anemia | 182 (91) | 23 (12) | 76 (86) | 16 (18) | 258 (90) | 39 (14) |
| Leukopenia | 101 (51) | 14 (7) | 46 (52) | 9 (10) | 147 (51) | 23 (8) |
| Neutropenia | 97 (49) | 28 (14) | 45 (51) | 21 (24) | 142 (49) | 49 (17) |
| Nonhematologic laboratory abnormalitiesb | ||||||
| Elevated ALT | 110 (55) | 20 (10) | 58 (66) | 10 (11) | 168 (58) | 30 (10) |
| Elevated AST | 97 (49) | 7 (4) | 48 (55) | 6 (7) | 145 (50) | 13 (5) |
| Hypophosphatemia | 89 (45) | 19 (10) | 36 (41) | 6 (7) | 125 (43) | 25 (9) |
| Hypocalcemia | 82 (41) | 5 (3) | 41 (47) | 6 (7) | 123 (43) | 11 (4) |
| Hyperglycemia | 85 (43) | 4 (2) | 27 (31) | 4 (5) | 112 (39) | 8 (3) |
| Elevated creatinine | 74 (37) | 2 (1) | 36 (41) | 0 | 110 (38) | 2 (1) |
| Elevated alkaline phosphatase | 69 (35) | 0 | 35 (40) | 0 | 104 (36) | 0 |
| Low bicarbonate | 58 (29) | 0 | 30 (34) | 1 (1) | 88 (31) | 1 (<1) |
| Elevated lipase | 52 (26) | 16 (8) | 31 (35) | 8 (9) | 83 (29) | 24 (8) |
| Hypermagnesemia | 50 (25) | 15 (8) | 27 (31) | 18 (21) | 77 (27) | 33 (12) |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; TEAE, treatment-emergent adverse event.
Toxicities were graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.
a
Includes TEAEs reported for ≥10% of patients.
b
Includes on-treatment laboratory abnormalities reported for ≥30% of patients (all grades) and grade 3/4 laboratory abnormalities reported for ≥5% of patients.