Maximum on-treatment grade 3 and 4 laboratory abnormalities reported for ≥5% of patients
Laboratory abnormality, n (%) . | CP2L . | CP3L . | ADV (n = 166) . | Total (n = 570) . | |||||
---|---|---|---|---|---|---|---|---|---|
IM-R (n = 196) . | IM-I (n = 90)* . | Total (n = 286) . | IM-R/I + D-R (n = 38) . | IM-R/I + D-I (n = 50)* . | IM-R/I + N-R (n = 26) . | Total† (n = 118) . | |||
Hematologic | |||||||||
Thrombocytopenia | |||||||||
Grade 3 | 30 (15) | 19 (21) | 49 (17) | 7 (18) | 8 (16) | 3 (12) | 18 (15) | 32 (19) | 99 (17) |
Grade 4 | 14 (7) | 9 (10) | 23 (8) | 1 (3) | 7 (14) | 5 (19) | 13 (11) | 67 (40) | 103 (18) |
Lymphopenia | |||||||||
Grade 3 | 23 (12) | 15 (17) | 38 (13) | 5 (13) | 4 (8) | 3 (12) | 13 (11) | 27 (16) | 78 (14) |
Grade 4 | 5 (3) | 1 (1) | 6 (2) | 1 (3) | 2 (4) | 3 (12) | 6 (5) | 16 (10) | 28 (5) |
Neutropenia | |||||||||
Grade 3 | 20 (10) | 16 (18) | 36 (13) | 5 (13) | 4 (8) | 2 (8) | 11 (9) | 25 (15) | 72 (13) |
Grade 4 | 7 (4) | 6 (7) | 13 (5) | 2 (5) | 6 (12) | 4 (15) | 13 (11) | 42 (25) | 68 (12) |
Anemia | |||||||||
Grade 3 | 15 (8) | 16 (18) | 31 (11) | 4 (11) | 0 | 1 (4) | 5 (4) | 41 (25) | 77 (14) |
Grade 4 | 9 (5) | 1 (1) | 10 (3) | 1 (3) | 4 (8) | 0 | 5 (4) | 16 (10) | 31 (5) |
Leukopenia | |||||||||
Grade 3 | 13 (7) | 10 (11) | 23 (8) | 1 (3) | 4 (8) | 0 | 5 (4) | 28 (17) | 56 (10) |
Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 20 (12) | 20 (4) |
Nonhematologic | |||||||||
Hypermagnesemia | |||||||||
Grade 3 | 14 (7) | 17 (19) | 31 (11) | 1 (3) | 13 (26) | 0 | 14 (12) | 14 (8) | 59 (10) |
Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Increased ALT | |||||||||
Grade 3 | 19 (10) | 10 (11) | 29 (10) | 0 | 2 (4) | 4 (15) | 6 (5) | 9 (5) | 44 (8) |
Grade 4 | 1 (1) | 2 (2) | 3 (1) | 0 | 0 | 1 (4) | 1 (1) | 0 | 4 (1) |
Hypophosphatemia | |||||||||
Grade 3 | 20 (10) | 7 (8) | 27 (9) | 0 | 3 (6) | 1 (4) | 4 (3) | 12 (7) | 43 (8) |
Grade 4 | 1 (1) | 0 | 1 (<1) | 0 | 0 | 0 | 0 | 1 (1) | 2 (<1) |
Increased lipase | |||||||||
Grade 3 | 19 (10) | 7 (8) | 26 (9) | 2 (5) | 3 (6) | 2 (8) | 7 (6) | 4 (2) | 37 (6) |
Grade 4 | 1 (1) | 1 (1) | 2 (1) | 0 | 1 (2) | 0 | 1 (1) | 1 (1) | 4 (1) |
Hyperglycemia | |||||||||
Grade 3 | 4 (2) | 5 (6) | 9 (3) | 0 | 1 (2) | 0 | 1 (1) | 10 (6) | 20 (4) |
Grade 4 | 1 (1) | 0 | 1 (<1) | 0 | 0 | 0 | 0 | 0 | 1 (<1) |
Hyponatremia | |||||||||
Grade 3 | 2 (1) | 3 (3) | 5 (2) | 1 (3) | 0 | 0 | 1 (1) | 10 (6) | 16 (3) |
Grade 4 | 4 (2) | 0 | 4 (1) | 0 | 0 | 0 | 0 | 0 | 4 (1) |
Laboratory abnormality, n (%) . | CP2L . | CP3L . | ADV (n = 166) . | Total (n = 570) . | |||||
---|---|---|---|---|---|---|---|---|---|
IM-R (n = 196) . | IM-I (n = 90)* . | Total (n = 286) . | IM-R/I + D-R (n = 38) . | IM-R/I + D-I (n = 50)* . | IM-R/I + N-R (n = 26) . | Total† (n = 118) . | |||
Hematologic | |||||||||
Thrombocytopenia | |||||||||
Grade 3 | 30 (15) | 19 (21) | 49 (17) | 7 (18) | 8 (16) | 3 (12) | 18 (15) | 32 (19) | 99 (17) |
Grade 4 | 14 (7) | 9 (10) | 23 (8) | 1 (3) | 7 (14) | 5 (19) | 13 (11) | 67 (40) | 103 (18) |
Lymphopenia | |||||||||
Grade 3 | 23 (12) | 15 (17) | 38 (13) | 5 (13) | 4 (8) | 3 (12) | 13 (11) | 27 (16) | 78 (14) |
Grade 4 | 5 (3) | 1 (1) | 6 (2) | 1 (3) | 2 (4) | 3 (12) | 6 (5) | 16 (10) | 28 (5) |
Neutropenia | |||||||||
Grade 3 | 20 (10) | 16 (18) | 36 (13) | 5 (13) | 4 (8) | 2 (8) | 11 (9) | 25 (15) | 72 (13) |
Grade 4 | 7 (4) | 6 (7) | 13 (5) | 2 (5) | 6 (12) | 4 (15) | 13 (11) | 42 (25) | 68 (12) |
Anemia | |||||||||
Grade 3 | 15 (8) | 16 (18) | 31 (11) | 4 (11) | 0 | 1 (4) | 5 (4) | 41 (25) | 77 (14) |
Grade 4 | 9 (5) | 1 (1) | 10 (3) | 1 (3) | 4 (8) | 0 | 5 (4) | 16 (10) | 31 (5) |
Leukopenia | |||||||||
Grade 3 | 13 (7) | 10 (11) | 23 (8) | 1 (3) | 4 (8) | 0 | 5 (4) | 28 (17) | 56 (10) |
Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 20 (12) | 20 (4) |
Nonhematologic | |||||||||
Hypermagnesemia | |||||||||
Grade 3 | 14 (7) | 17 (19) | 31 (11) | 1 (3) | 13 (26) | 0 | 14 (12) | 14 (8) | 59 (10) |
Grade 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Increased ALT | |||||||||
Grade 3 | 19 (10) | 10 (11) | 29 (10) | 0 | 2 (4) | 4 (15) | 6 (5) | 9 (5) | 44 (8) |
Grade 4 | 1 (1) | 2 (2) | 3 (1) | 0 | 0 | 1 (4) | 1 (1) | 0 | 4 (1) |
Hypophosphatemia | |||||||||
Grade 3 | 20 (10) | 7 (8) | 27 (9) | 0 | 3 (6) | 1 (4) | 4 (3) | 12 (7) | 43 (8) |
Grade 4 | 1 (1) | 0 | 1 (<1) | 0 | 0 | 0 | 0 | 1 (1) | 2 (<1) |
Increased lipase | |||||||||
Grade 3 | 19 (10) | 7 (8) | 26 (9) | 2 (5) | 3 (6) | 2 (8) | 7 (6) | 4 (2) | 37 (6) |
Grade 4 | 1 (1) | 1 (1) | 2 (1) | 0 | 1 (2) | 0 | 1 (1) | 1 (1) | 4 (1) |
Hyperglycemia | |||||||||
Grade 3 | 4 (2) | 5 (6) | 9 (3) | 0 | 1 (2) | 0 | 1 (1) | 10 (6) | 20 (4) |
Grade 4 | 1 (1) | 0 | 1 (<1) | 0 | 0 | 0 | 0 | 0 | 1 (<1) |
Hyponatremia | |||||||||
Grade 3 | 2 (1) | 3 (3) | 5 (2) | 1 (3) | 0 | 0 | 1 (1) | 10 (6) | 16 (3) |
Grade 4 | 4 (2) | 0 | 4 (1) | 0 | 0 | 0 | 0 | 0 | 4 (1) |
Abbreviations are explained in Table 1.
The subgroups of patients with intolerance to prior TKI therapy.
Includes patients (n = 4) for whom prior imatinib therapy failed and who were intolerant to prior nilotinib therapy or resistant or intolerant to prior nilotinib and dasatinib therapy (because of low n, data not shown separately).