Table 3.
Adverse events of any cause with an incidence of ≥25%.
| Adverse event | Arm 1 n = 38 |
Arm 2 n = 39 |
||
|---|---|---|---|---|
| Any grade n (%) |
Grade ≥ 3 n (%) |
Any grade n (%) |
Grade ≥ 3 n (%) |
|
| Hyperglycemia | 36 (95) | 4 (11) | 36 (92) | 7 (18) |
| Anemia | 31 (82) | 11 (29) | 34 (87) | 11 (28) |
| Hypoalbuminemia | 26 (68) | 1 (3) | 34 (87) | 1 (3) |
| Hypomagnesemia | 23 (61) | 0 | 30 (77) | 0 |
| Lymphocyte Count Decrease | 20 (53) | 10 (26) | 26 (67) | 15 (38) |
| WBC Decrease | 19 (50) | 0 | 17 (44) | 5 (13) |
| AST Increase | 16 (42) | 1 (3) | 20 (51) | 2 (5) |
| Fatigue | 16 (42) | 0 | 22 (56) | 2 (5) |
| Alkaline Phosphatase Increase | 14 (37) | 1 (3) | 18 (46) | 3 (8) |
| Abdominal Pain | 12 (32) | 0 | 19 (49) | 3 (8) |
| Hyponatremia | 11 (29) | 5 (13) | 15 (38) | 9 (23) |
| Nausea | 11 (29) | 0 | 23 (59) | 2 (5) |
| ALT Increase | 10 (26) | 1 (3) | 14 (36) | 1 (3) |
| INR Increase | 10 (26) | 1 (3) | 12 (31) | 1 (3) |
| Platelet Count Decrease | 10 (26) | 1 (3) | 21 (54) | 1 (3) |
| Arthralgias | 9 (24) | 0 | 4 (10) | 0 |
| Amylase Increase | 8 (21) | 0 | 12 (31) | 0 |
| Hypocalcemia | 8 (21) | 1 (3) | 15 (38) | 3 (8) |
| Pruritis | 8 (21) | 0 | 10 (26) | 0 |
| Constipation | 7 (18) | 0 | 12 (31) | 1 (3) |
| Creatinine Increase | 7 (18) | 0 | 19 (49) | 2 (5) |
| Dyspnea | 7 (18) | 1 (3) | 7 (18) | 0 |
| Pain | 7 (18) | 0 | 11 (28) | 2 (5) |
| Prolonged APTT | 7 (18) | 1 (3) | 14 (36) | 0 |
| Diarrhea | 6 (16) | 1 (3) | 13 (33) | 4 (10) |
| Hyperkalemia | 6 (16) | 1 (3) | 11 (28) | 2 (5) |
| Hypokalemia | 4 (11) | 1 (3) | 13 (33) | 5 (13) |
| Weight loss | 0 | 0 | 10 (26) | 0 |
WBC, white blood count; AST, aspartate aminotransferase; ALT, alanine aminotransferase; INR, international normalized ratio; APTT, activated partial thromboplastin time.