Table 4.
Major Treatment Related Toxicities
| Arm A (n = 17) | Arm B (n = 18) | |||
| Grade 1-2a | Grade 3 + b | Grade 1-2a | Grade 3 + b | |
| Adverse Event (CTCAE term) | n (%) | n (%) | n (%) | n (%) |
| Overall | 10 (59) | 6 (35) | 8 (44) | 10 (56) |
| All non-hematologic | 10 (59) | 6 (35) | 8 (44) | 10 (56) |
| Blood and Lymphatic System Disorders | ||||
| Anemia | 4 (24) | 0 | 3 (17) | 0 |
| Cardiac Disorders | ||||
| Cardiac arrest | 0 | 0 | 0 | 1 (6) |
| Sinus bradycardia | 2 (12) | 0 | 5 (28) | 0 |
| Eye Disorders | ||||
| Blurred Vision | 4 (24) | 0 | 0 | 0 |
| Gastrointestinal Disorders | ||||
| Diarrhea | 3 (18) | 0 | 5 (28) | 0 |
| Nausea | 7 (41) | 0 | 7 (39) | 0 |
| General Disorders | ||||
| Edema limbs | 3 (18) | 0 | 7 (39) | 0 |
| Fatigue | 7 (41) | 1 (6) | 8 (44) | 1 (6) |
| Pain | 2 (12) | 0 | 2 (11) | 0 |
| Investigations | ||||
| Creatinine increased | 5 (29) | 0 | 10 (56) | 0 |
| Lymphocyte count decreased | 2 (12) | 0 | 2 (11) | 1 (6) |
| Platelet count decreased | 3 (18) | 0 | 3 (17) | 0 |
| Weight gain | 2 (12) | 0 | 4 (22) | 1 (6) |
| White blood cells decreased | 1 (6) | 0 | 4 (22) | 0 |
| Metabolism and Nutrition Disorders | ||||
| Anorexia | 2 (12) | 0 | 2 (11) | 0 |
| Hyperglycemia | 0 | 1 (6) | 0 | 0 |
| Hyperkalemia | 2 (12) | 0 | 4 (22) | 0 |
| Hypoalbuminemia | 1 (6) | 0 | 6 (33) | 0 |
| Hypocalcemia | 2 (12) | 0 | 3 (17) | 0 |
| Hypokalemia | 0 | 1 (6) | 0 | 0 |
| Hyponatremia | 3 (18) | 0 | 4 (22) | 1 (6) |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 3 (18) | 0 | 2 (11) | 0 |
| Back pain | 2 (12) | 1 (6) | 3 (17) | 1 (6) |
| Neck pain | 0 | 0 | 0 | 1 (6) |
| Pain in extremity | 3 (18) | 0 | 4 (22) | 0 |
| Nervous System Disorders | ||||
| Dizziness | 3 (18) | 0 | 2 (11) | 0 |
| Headache | 4 (24) | 0 | 1 (6) | 0 |
| Psychiatric disorders | ||||
| Insomnia | 2 (12) | 0 | 2 (11) | 0 |
| Renal and Urinary Disorders | ||||
| Proteinuria | 4 (24) | 0 | 7 (39) | 0 |
| Respiratory, Thoracic and Mediastinal Disorders | ||||
| Dyspnea | 5 (29) | 1 (6) | 1 (6) | 1 (6) |
| Pleural effusion | 0 | 1 (6) | 0 | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Rash maculo-papular | 1 (6) | 0 | 3 (17) | 0 |
| Vascular Disorders | ||||
| Hypertension | 2 (12) | 3 (18) | 7 (39) | 4 (22) |
aToxicities of any grade occurring in 4 or more individuals in either arm.
bGrade 3 or higher toxicities occurring in 1 or more individuals in either arm.