TEAEs reported for ≥10% of patients
| TEAE, 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)† . | |||
| Diarrhea | |||||||||
| All grades | 168 (86) | 77 (86) | 245 (86) | 30 (79) | 42 (84) | 22 (85) | 98 (83) | 122 (74) | 465 (82) |
| Grade 3/4 | 19 (10) | 10 (11) | 29 (10) | 3 (8) | 5 (10) | 2 (8) | 10 (9) | 8 (5) | 47 (8) |
| Nausea | |||||||||
| All grades | 85 (43) | 47 (52) | 132 (46) | 20 (53) | 23 (46) | 12 (46) | 57 (48) | 80 (48) | 269 (47) |
| Grade 3/4 | 1 (1) | 3 (3) | 4 (1) | 1 (3) | 0 | 0 | 1 (1) | 3 (2) | 8 (1) |
| Vomiting | |||||||||
| All grades | 73 (37) | 34 (38) | 107 (37) | 14 (37) | 24 (48) | 7 (27) | 45 (38) | 72 (43) | 224 (39) |
| Grade 3/4 | 3 (2) | 8 (9) | 11 (4) | 1 (3) | 0 | 0 | 1 (1) | 6 (4) | 18 (3) |
| Thrombocytopenia‡ | |||||||||
| All grades | 77 (39) | 43 (48) | 120 (42) | 11 (29) | 19 (38) | 13 (50) | 45 (38) | 74 (45) | 239 (42) |
| Grade 3/4 | 45 (23) | 29 (32) | 74 (26) | 7 (18) | 16 (32) | 8 (31) | 31 (26) | 65 (39) | 170 (30) |
| Rash | |||||||||
| All grades | 63 (32) | 39 (43) | 102 (36) | 10 (26) | 18 (36) | 3 (12) | 32 (27) | 51 (31) | 185 (33) |
| Grade 3/4 | 15 (8) | 11 (12) | 26 (9) | 0 | 3 (6) | 0 | 3 (3) | 6 (4) | 35 (6) |
| Pyrexia | |||||||||
| All grades | 57 (29) | 17 (19) | 74 (26) | 6 (16) | 8 (16) | 3 (12) | 18 (15) | 64 (39) | 156 (27) |
| Grade 3/4 | 1 (1) | 1 (1) | 2 (1) | 0 | 0 | 0 | 0 | 5 (3) | 7 (1) |
| Anemia‡ | |||||||||
| All grades | 51 (26) | 25 (28) | 76 (27) | 8 (21) | 7 (14) | 6 (23) | 22 (19) | 64 (39) | 162 (28) |
| Grade 3/4 | 23 (12) | 9 (10) | 32 (11) | 3 (8) | 4 (8) | 1 (4) | 8 (7) | 42 (25) | 82 (14) |
| Fatigue | |||||||||
| All grades | 49 (25) | 25 (28) | 74 (26) | 8 (21) | 14 (28) | 2 (8) | 27 (23) | 35 (21) | 136 (24) |
| Grade 3/4 | 1 (1) | 2 (2) | 3 (1) | 0 | 1 (2) | 0 | 2 (2) | 7 (4) | 12 (2) |
| Abdominal pain | |||||||||
| All grades | 50 (26) | 25 (28) | 75 (26) | 9 (24) | 12 (24) | 7 (27) | 28 (24) | 35 (21) | 138 (24) |
| Grade 3/4 | 3 (2) | 2 (2) | 5 (2) | 0 | 1 (2) | 0 | 1 (1) | 4 (2) | 10 (2) |
| Headache | |||||||||
| All grades | 35 (18) | 18 (20) | 53 (19) | 8 (21) | 14 (28) | 8 (31) | 31 (26) | 31 (19) | 115 (20) |
| Grade 3/4 | 0 | 0 | 0 | 1 (3) | 3 (6) | 0 | 4 (3) | 7 (4) | 11 (2) |
| Cough | |||||||||
| All grades | 44 (22) | 19 (21) | 63 (22) | 7 (18) | 11 (22) | 4 (15) | 23 (20) | 34 (21) | 120 (21) |
| Grade 3/4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Increased ALT | |||||||||
| All grades | 41 (21) | 23 (26) | 64 (22) | 6 (16) | 6 (12) | 5 (19) | 18 (15) | 17 (10) | 99 (17) |
| Grade 3/4 | 15 (8) | 10 (11) | 25 (9) | 0 | 4 (8) | 3 (12) | 7 (6) | 7 (4) | 39 (7) |
| Upper abdominal pain | |||||||||
| All grades | 41 (21) | 17 (19) | 58 (20) | 8 (21) | 9 (18) | 4 (15) | 21 (18) | 17 (10) | 96 (17) |
| Grade 3/4 | 1 (1) | 0 | 1 (<1) | 0 | 0 | 0 | 0 | 3 (2) | 4 (1) |
| Neutropenia‡ | |||||||||
| All grades | 29 (15) | 17 (19) | 46 (16) | 9 (24) | 7 (14) | 7 (27) | 24 (20) | 36 (22) | 106 (19) |
| Grade 3/4 | 16 (8) | 11 (12) | 27 (9) | 6 (16) | 7 (14) | 4 (15) | 18 (15) | 33 (20) | 78 (14) |
| Increased AST | |||||||||
| All grades | 37 (19) | 18 (20) | 55 (19) | 2 (5) | 3 (6) | 4 (15) | 9 (8) | 17 (10) | 81 (14) |
| Grade 3/4 | 6 (3) | 5 (6) | 11 (4) | 0 | 1 (2) | 2 (8) | 3 (3) | 5 (3) | 19 (3) |
| Arthralgia | |||||||||
| All grades | 30 (15) | 15 (17) | 45 (16) | 5 (13) | 10 (20) | 6 (23) | 21 (18) | 22 (13) | 88 (15) |
| Grade 3/4 | 2 (1) | 1 (1) | 3 (1) | 0 | 1 (2) | 0 | 1 (1) | 1 (1) | 5 (1) |
| Decreased appetite | |||||||||
| All grades | 30 (15) | 11 (12) | 41 (14) | 3 (8) | 7 (14) | 4 (15) | 14 (12) | 21 (13) | 76 (13) |
| Grade 3/4 | 2 (1) | 0 | 2 (1) | 0 | 1 (2) | 0 | 1 (1) | 0 | 3 (1) |
| Constipation | |||||||||
| All grades | 22 (11) | 18 (20) | 40 (14) | 2 (5) | 8 (16) | 3 (12) | 15 (13) | 27 (16) | 82 (14) |
| Grade 3/4 | 0 | 1 (1) | 1 (<1) | 0 | 0 | 0 | 0 | 1 (1) | 2 (<1) |
| Dyspnea | |||||||||
| All grades | 23 (12) | 10 (11) | 33 (12) | 2 (5) | 10 (20) | 1 (4) | 13 (11) | 32 (19) | 78 (14) |
| Grade 3/4 | 4 (2) | 0 | 4 (1) | 0 | 1 (2) | 0 | 1 (1) | 9 (5) | 14 (3) |
| Asthenia | |||||||||
| All grades | 25 (13) | 16 (18) | 41 (14) | 2 (5) | 1 (2) | 4 (15) | 8 (7) | 20 (12) | 69 (12) |
| Grade 3/4 | 6 (3) | 0 | 6 (2) | 0 | 0 | 0 | 0 | 1 (1) | 7 (1) |
| Back pain | |||||||||
| All grades | 22 (11) | 17 (19) | 39 (14) | 5 (13) | 5 (10) | 3 (12) | 14 (12) | 15 (9) | 68 (12) |
| Grade 3/4 | 1 (1) | 0 | 1 (<1) | 0 | 2 (4) | 1 (4) | 3 (3) | 3 (2) | 7 (1) |
| Dizziness | |||||||||
| All grades | 17 (9) | 9 (10) | 26 (9) | 5 (13) | 8 (16) | 2 (8) | 16 (14) | 21 (13) | 63 (11) |
| Grade 3/4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1) | 1 (<1) |
| Leukopenia‡ | |||||||||
| All grades | 21 (11) | 14 (16) | 35 (12) | 4 (11) | 0 | 0 | 4 (3) | 23 (14) | 62 (11) |
| Grade 3/4 | 8 (4) | 7 (8) | 15 (5) | 0 | 0 | 0 | 0 | 18 (11) | 33 (6) |
| Peripheral edema | |||||||||
| All grades | 18 (9) | 13 (14) | 31 (11) | 1 (3) | 5 (10) | 4 (15) | 11 (9) | 17 (10) | 59 (10) |
| Grade 3/4 | 1 (1) | 0 | 1 (<1) | 0 | 0 | 0 | 0 | 1 (1) | 2 (<1) |
| Nasopharyngitis | |||||||||
| All grades | 24 (12) | 13 (14) | 37 (13) | 4 (11) | 5 (10) | 4 (15) | 14 (12) | 7 (4) | 58 (10) |
| Grade 3/4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Extremity pain | |||||||||
| All grades | 26 (13) | 5 (6) | 31 (11) | 1 (3) | 5 (10) | 3 (12) | 9 (8) | 18 (11) | 58 (10) |
| Grade 3/4 | 2 (1) | 0 | 2 (1) | 0 | 0 | 0 | 0 | 1 (1) | 3 (1) |
| Pleural effusion | |||||||||
| All grades | 18 (9) | 5 (6) | 23 (8) | 5 (13) | 12 (24) | 1 (4) | 18 (15) | 16 (10) | 57 (10) |
| Grade 3/4 | 4 (2) | 2 (2) | 6 (2) | 2 (5) | 2 (4) | 0 | 4 (3) | 7 (4) | 17 (3) |
| TEAE, 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)† . | |||
| Diarrhea | |||||||||
| All grades | 168 (86) | 77 (86) | 245 (86) | 30 (79) | 42 (84) | 22 (85) | 98 (83) | 122 (74) | 465 (82) |
| Grade 3/4 | 19 (10) | 10 (11) | 29 (10) | 3 (8) | 5 (10) | 2 (8) | 10 (9) | 8 (5) | 47 (8) |
| Nausea | |||||||||
| All grades | 85 (43) | 47 (52) | 132 (46) | 20 (53) | 23 (46) | 12 (46) | 57 (48) | 80 (48) | 269 (47) |
| Grade 3/4 | 1 (1) | 3 (3) | 4 (1) | 1 (3) | 0 | 0 | 1 (1) | 3 (2) | 8 (1) |
| Vomiting | |||||||||
| All grades | 73 (37) | 34 (38) | 107 (37) | 14 (37) | 24 (48) | 7 (27) | 45 (38) | 72 (43) | 224 (39) |
| Grade 3/4 | 3 (2) | 8 (9) | 11 (4) | 1 (3) | 0 | 0 | 1 (1) | 6 (4) | 18 (3) |
| Thrombocytopenia‡ | |||||||||
| All grades | 77 (39) | 43 (48) | 120 (42) | 11 (29) | 19 (38) | 13 (50) | 45 (38) | 74 (45) | 239 (42) |
| Grade 3/4 | 45 (23) | 29 (32) | 74 (26) | 7 (18) | 16 (32) | 8 (31) | 31 (26) | 65 (39) | 170 (30) |
| Rash | |||||||||
| All grades | 63 (32) | 39 (43) | 102 (36) | 10 (26) | 18 (36) | 3 (12) | 32 (27) | 51 (31) | 185 (33) |
| Grade 3/4 | 15 (8) | 11 (12) | 26 (9) | 0 | 3 (6) | 0 | 3 (3) | 6 (4) | 35 (6) |
| Pyrexia | |||||||||
| All grades | 57 (29) | 17 (19) | 74 (26) | 6 (16) | 8 (16) | 3 (12) | 18 (15) | 64 (39) | 156 (27) |
| Grade 3/4 | 1 (1) | 1 (1) | 2 (1) | 0 | 0 | 0 | 0 | 5 (3) | 7 (1) |
| Anemia‡ | |||||||||
| All grades | 51 (26) | 25 (28) | 76 (27) | 8 (21) | 7 (14) | 6 (23) | 22 (19) | 64 (39) | 162 (28) |
| Grade 3/4 | 23 (12) | 9 (10) | 32 (11) | 3 (8) | 4 (8) | 1 (4) | 8 (7) | 42 (25) | 82 (14) |
| Fatigue | |||||||||
| All grades | 49 (25) | 25 (28) | 74 (26) | 8 (21) | 14 (28) | 2 (8) | 27 (23) | 35 (21) | 136 (24) |
| Grade 3/4 | 1 (1) | 2 (2) | 3 (1) | 0 | 1 (2) | 0 | 2 (2) | 7 (4) | 12 (2) |
| Abdominal pain | |||||||||
| All grades | 50 (26) | 25 (28) | 75 (26) | 9 (24) | 12 (24) | 7 (27) | 28 (24) | 35 (21) | 138 (24) |
| Grade 3/4 | 3 (2) | 2 (2) | 5 (2) | 0 | 1 (2) | 0 | 1 (1) | 4 (2) | 10 (2) |
| Headache | |||||||||
| All grades | 35 (18) | 18 (20) | 53 (19) | 8 (21) | 14 (28) | 8 (31) | 31 (26) | 31 (19) | 115 (20) |
| Grade 3/4 | 0 | 0 | 0 | 1 (3) | 3 (6) | 0 | 4 (3) | 7 (4) | 11 (2) |
| Cough | |||||||||
| All grades | 44 (22) | 19 (21) | 63 (22) | 7 (18) | 11 (22) | 4 (15) | 23 (20) | 34 (21) | 120 (21) |
| Grade 3/4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Increased ALT | |||||||||
| All grades | 41 (21) | 23 (26) | 64 (22) | 6 (16) | 6 (12) | 5 (19) | 18 (15) | 17 (10) | 99 (17) |
| Grade 3/4 | 15 (8) | 10 (11) | 25 (9) | 0 | 4 (8) | 3 (12) | 7 (6) | 7 (4) | 39 (7) |
| Upper abdominal pain | |||||||||
| All grades | 41 (21) | 17 (19) | 58 (20) | 8 (21) | 9 (18) | 4 (15) | 21 (18) | 17 (10) | 96 (17) |
| Grade 3/4 | 1 (1) | 0 | 1 (<1) | 0 | 0 | 0 | 0 | 3 (2) | 4 (1) |
| Neutropenia‡ | |||||||||
| All grades | 29 (15) | 17 (19) | 46 (16) | 9 (24) | 7 (14) | 7 (27) | 24 (20) | 36 (22) | 106 (19) |
| Grade 3/4 | 16 (8) | 11 (12) | 27 (9) | 6 (16) | 7 (14) | 4 (15) | 18 (15) | 33 (20) | 78 (14) |
| Increased AST | |||||||||
| All grades | 37 (19) | 18 (20) | 55 (19) | 2 (5) | 3 (6) | 4 (15) | 9 (8) | 17 (10) | 81 (14) |
| Grade 3/4 | 6 (3) | 5 (6) | 11 (4) | 0 | 1 (2) | 2 (8) | 3 (3) | 5 (3) | 19 (3) |
| Arthralgia | |||||||||
| All grades | 30 (15) | 15 (17) | 45 (16) | 5 (13) | 10 (20) | 6 (23) | 21 (18) | 22 (13) | 88 (15) |
| Grade 3/4 | 2 (1) | 1 (1) | 3 (1) | 0 | 1 (2) | 0 | 1 (1) | 1 (1) | 5 (1) |
| Decreased appetite | |||||||||
| All grades | 30 (15) | 11 (12) | 41 (14) | 3 (8) | 7 (14) | 4 (15) | 14 (12) | 21 (13) | 76 (13) |
| Grade 3/4 | 2 (1) | 0 | 2 (1) | 0 | 1 (2) | 0 | 1 (1) | 0 | 3 (1) |
| Constipation | |||||||||
| All grades | 22 (11) | 18 (20) | 40 (14) | 2 (5) | 8 (16) | 3 (12) | 15 (13) | 27 (16) | 82 (14) |
| Grade 3/4 | 0 | 1 (1) | 1 (<1) | 0 | 0 | 0 | 0 | 1 (1) | 2 (<1) |
| Dyspnea | |||||||||
| All grades | 23 (12) | 10 (11) | 33 (12) | 2 (5) | 10 (20) | 1 (4) | 13 (11) | 32 (19) | 78 (14) |
| Grade 3/4 | 4 (2) | 0 | 4 (1) | 0 | 1 (2) | 0 | 1 (1) | 9 (5) | 14 (3) |
| Asthenia | |||||||||
| All grades | 25 (13) | 16 (18) | 41 (14) | 2 (5) | 1 (2) | 4 (15) | 8 (7) | 20 (12) | 69 (12) |
| Grade 3/4 | 6 (3) | 0 | 6 (2) | 0 | 0 | 0 | 0 | 1 (1) | 7 (1) |
| Back pain | |||||||||
| All grades | 22 (11) | 17 (19) | 39 (14) | 5 (13) | 5 (10) | 3 (12) | 14 (12) | 15 (9) | 68 (12) |
| Grade 3/4 | 1 (1) | 0 | 1 (<1) | 0 | 2 (4) | 1 (4) | 3 (3) | 3 (2) | 7 (1) |
| Dizziness | |||||||||
| All grades | 17 (9) | 9 (10) | 26 (9) | 5 (13) | 8 (16) | 2 (8) | 16 (14) | 21 (13) | 63 (11) |
| Grade 3/4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 (1) | 1 (<1) |
| Leukopenia‡ | |||||||||
| All grades | 21 (11) | 14 (16) | 35 (12) | 4 (11) | 0 | 0 | 4 (3) | 23 (14) | 62 (11) |
| Grade 3/4 | 8 (4) | 7 (8) | 15 (5) | 0 | 0 | 0 | 0 | 18 (11) | 33 (6) |
| Peripheral edema | |||||||||
| All grades | 18 (9) | 13 (14) | 31 (11) | 1 (3) | 5 (10) | 4 (15) | 11 (9) | 17 (10) | 59 (10) |
| Grade 3/4 | 1 (1) | 0 | 1 (<1) | 0 | 0 | 0 | 0 | 1 (1) | 2 (<1) |
| Nasopharyngitis | |||||||||
| All grades | 24 (12) | 13 (14) | 37 (13) | 4 (11) | 5 (10) | 4 (15) | 14 (12) | 7 (4) | 58 (10) |
| Grade 3/4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Extremity pain | |||||||||
| All grades | 26 (13) | 5 (6) | 31 (11) | 1 (3) | 5 (10) | 3 (12) | 9 (8) | 18 (11) | 58 (10) |
| Grade 3/4 | 2 (1) | 0 | 2 (1) | 0 | 0 | 0 | 0 | 1 (1) | 3 (1) |
| Pleural effusion | |||||||||
| All grades | 18 (9) | 5 (6) | 23 (8) | 5 (13) | 12 (24) | 1 (4) | 18 (15) | 16 (10) | 57 (10) |
| Grade 3/4 | 4 (2) | 2 (2) | 6 (2) | 2 (5) | 2 (4) | 0 | 4 (3) | 7 (4) | 17 (3) |
TEAEs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0.
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).
Individual hematologic TEAEs were clustered with the related terms from investigations.