Table 2 TEAEs of special interest.
Bosutinib (n = 268) | Imatinib (n = 265) | |
|---|---|---|
TEAE cluster,a n (%) | Any grade | Any grade |
Any gastrointestinal TEAE | 214 (79.9) | 163 (61.5) |
Diarrhea | 201 (75.0) | 107 (40.4) |
Nausea | 100 (37.3) | 112 (42.3) |
Vomiting | 55 (20.5) | 54 (20.4) |
Any myelosuppression TEAE | 128 (47.8) | 125 (47.2) |
Thrombocytopenia | 96 (35.8) | 53 (20.0) |
Anemia | 59 (22.0) | 60 (22.6) |
Neutropenia | 33 (12.3) | 61 (23.0) |
Leukopenia | 18 (6.7) | 34 (12.8) |
Lymphopenia | 15 (5.6) | 8 (3.0) |
Any liver TEAE | 118 (44.0) | 41 (15.5) |
ALT increased | 90 (33.6) | 16 (6.0) |
AST increased | 69 (25.7) | 18 (6.8) |
Blood bilirubin increased | 17 (6.3) | 7 (2.6) |
Blood alkaline phosphatase increased | 17 (6.3) | 7 (2.6) |
Transaminases increased | 8 (3.0) | 2 (0.8) |
Hyperbilirubinemia | 6 (2.2) | 1 (0.4) |
Any rash TEAE | 105 (39.2) | 69 (26.0) |
Rash | 62 (23.1) | 39 (14.7) |
Rash maculo-papular | 14 (5.2) | 16 (6.0) |
Erythema | 13 (4.9) | 6 (2.3) |
Rash pruritic | 10 (3.7) | 1 (0.4) |
Dermatitis acneiform | 9 (3.4) | 2 (0.8) |
Acne | 8 (3.0) | 0 |
Eczema | 7 (2.6) | 8 (3.0) |
Any musculoskeletal TEAE | 95 (35.4) | 158 (59.6) |
Arthralgia | 48 (17.9) | 49 (18.5) |
Back pain | 32 (11.9) | 25 (9.4) |
Pain in extremity | 26 (9.7) | 39 (14.7) |
Myalgia | 13 (4.9) | 48 (18.1) |
Musculoskeletal pain | 12 (4.5) | 12 (4.5) |
Muscle spasms | 10 (3.7) | 81 (30.6) |
Bone pain | 8 (3.0) | 19 (7.2) |
Any edema TEAE | 42 (15.7) | 115 (43.4) |
Edema peripheral | 20 (7.5) | 43 (16.2) |
Weight increased | 8 (3.0) | 20 (7.5) |
Face edema | 7 (2.6) | 17 (6.4) |
Periorbital edema | 4 (1.5) | 44 (16.6) |
Eyelid edema | 3 (1.1) | 24 (9.1) |
Orbital edema | 0 | 6 (2.3) |
Any hypertension TEAE | 28 (10.4) | 29 (10.9) |
Hypertension | 26 (9.7) | 29 (10.9) |
Any renal TEAE | 28 (10.4) | 26 (9.8) |
Blood creatinine increased | 18 (6.7) | 22 (8.3) |
Acute kidney injury | 6 (2.2) | 2 (0.8) |
Any cardiac TEAE | 26 (9.7) | 23 (8.7) |
Sinus bradycardia | 6 (2.2) | 0 |
Electrocardiogram QT prolonged | 4 (1.5) | 10 (3.8) |
Any metabolic TEAE | 24 (9.0) | 21 (7.9) |
Hypercholesterolemia | 13 (4.9) | 1 (0.4) |
Hyperglycemia | 10 (3.7) | 16 (6.0) |
Any vascular TEAE | 20 (7.5) | 9 (3.4) |
Cardiovascular TEAEs | 13 (4.9) | 1 (0.4) |
Angina pectoris | 8 (3.0) | 1 (0.4) |
Myocardial ischemia | 6 (2.2) | 0 |
Cerebrovascular TEAEs | 2 (0.7) | 3 (1.1) |
Peripheral vascular TEAEs | 6 (2.2) | 6 (2.3) |
Any effusion TEAE | 16 (6.0) | 6 (2.3) |
Pleural effusion | 14 (5.2) | 5 (1.9) |
