Table 2.
Adverse events related to Sunitinib and Dasatinib
| Adverse events | Sunitiniba (N=96) |
Dasatiniba (N=107) |
||||
|---|---|---|---|---|---|---|
|
| ||||||
| Any grade | Grade 1–2 | ≥Grade 3b | Any grade | Grade 1–2 | ≥Grade 3b | |
|
Patients, n (%) | ||||||
| Any | 92 (96) | 48 (50) | 44 (46) | 90 (84) | 64 (60) | 26 (24) |
|
| ||||||
| Most common (≥5% of patients) c | ||||||
|
| ||||||
| Fatigue | 52 (54) | 40 (42) | 12 (13) | 54 (50) | 48 (45) | 6 (6) |
|
| ||||||
| Abnormal liver function testsd | 48 (50) | 45 (47) | 3 (3) | 43 (40) | 43 (40) | - |
|
| ||||||
| Nausea/Vomiting | 43 (45) | 40 (42) | 3 (3) | 31 (29) | 29 (27) | 2 (2) |
|
| ||||||
| Diarrhea | 30 (31) | 29 (30) | 1 (1) | 26 (24) | 25 (23) | 1 (1) |
|
| ||||||
| Anemia | 17 (18) | 16 (17) | 1 (1) | 25 (23) | 19 (18) | 6 (6) |
|
| ||||||
| Dyspnea | 10 (10) | 8 (8) | 2 (2) | 23 (21) | 19 (18) | 4 (4) |
|
| ||||||
| Edema | 9 (9) | 9 (9) | - | 22 (21) | 21 (20) | 1 (1) |
|
| ||||||
| Electrolyte disorders | ||||||
| Hypokalemia | 20 (21) | 16 (17) | 4 (4) | 21 (20) | 21 (20) | - |
| Other | 29 (30) | 27 (28) | 2 (2) | 17 (16) | 14 (13) | 3 (3) |
|
| ||||||
| Anorexia | 8 (8) | 8 (8) | - | 14 (13) | 13 (12) | 1 (1) |
|
| ||||||
| Dyspepsia | 13 (14) | 13 (14) | - | 10 (9) | 9 (8) | 1 (1) |
|
| ||||||
| Hypertension | 33 (34) | 15 (16) | 18 (19) | 9 (8) | 7 (7) | 2 (2) |
|
| ||||||
| Dysgeusia | 33 (34) | 33 (34) | - | 9 (8) | 9 (8) | - |
|
| ||||||
| Pleural Effusion | - | - | - | 8 (7) | 8 (7) | - |
|
| ||||||
| Platelet count decreased | 19 (20) | 16 (17) | 3 (3) | 7 (7) | 7 (7) | - |
|
| ||||||
| Constipation | 6 (6) | 6 (6) | - | 7 (7) | 7 (7) | - |
|
| ||||||
| Rash maculo-papular | 11 (11) | 10 (10) | 1 (1) | 7 (7) | 7 (7) | - |
|
| ||||||
| Cardiac Disorderse | 5 (5) | 4 (4) | 1 (1) | 5 (5) | 3 (3) | 2 (2) |
|
| ||||||
| White blood cell count decreased | 29 (30) | 27 (28) | 2 (2) | 5 (5) | 5 (5) | - |
| Neutrophil count decreased | 19 (20) | 15 (16) | 4 (4) | 2 (2) | 2 (2) | - |
| Lymphocyte count increased | 6 (6) | 5 (5) | 1 (1) | - | - | - |
|
| ||||||
| Headache | 10 (10) | 9 (9) | 1 (1) | 5 (5) | 5 (5) | - |
|
| ||||||
| Dizziness | 8 (8) | 8 (8) | - | 5 (5) | 5 (5) | - |
|
| ||||||
| Dry skin | 4 (4) | 4 (4) | - | 5 (5) | 5 (5) | - |
|
| ||||||
| Generalized muscle weakness | 5 (5) | 5 (5) | - | 4 (4) | 3 (3) | 1 (1) |
|
| ||||||
| Weight loss | 5 (5) | 4 (4) | 1 (1) | 3 (3) | 3 (3) | - |
|
| ||||||
| Skin Hypopigmentation | 17 (18) | 17 (18) | - | 2 (2) | 2 (2) | - |
|
| ||||||
| Creatinine increased | 8 (8) | 8 (8) | - | 1 (1) | - | 1 (1) |
|
| ||||||
| Mucositis Oral | 25 (26) | 23 (24) | 2 (2) | 1 (1) | 1 (1) | - |
|
| ||||||
| Gastroesophagel reflux | 6 (6) | 6 (6) | - | 1 (1) | 1 (1) | - |
|
| ||||||
| Bruising | 5 (5) | 5 (5) | - | 1 (1) | 1 (1) | - |
|
| ||||||
| Palmar-plantar erythrodysesthesia syndrome | 14 (15) | 14 (15) | - | 1 (1) | 1 (1) | - |
|
| ||||||
| Dry mouth | 5 (5) | 5 (5) | - | - | - | - |
a
Table includes all patients who received Sunitinib/Dasatinib at any time point (i.e. after randomization or cross-over)
b
No Grade 5 adverse events related to Dasatinib were reported. 1 Grade 5 adverse event related to Sunitinib was reported (pneumonia).
c
Listed are the adverse events occurring in at least 5% in either group.
d
Abnormal liver function tests include alanine aminotransferase (ALT) increase, aspartate aminotransferase (AST) increase, alkaline phosphatase increase, and bilirubin increase.
e
Cardiac disorders include cardiac chest-pain, pericardial effusion, palpitations, atrial fibrillation, and other, bigeminal premature atrial contractions.