Table 2.
Summary of Adverse Events (N= 30 subjects)
| Adverse Event | Number of patients (%) | ||
|---|---|---|---|
| Any Grade | Grade | Grade 4 | |
| Mucositis- clinical exam | 29 (97) | 6 (20) | 1 (3) |
| Fatigue | 29 (97) | 3 (10) | 0 |
| Low hemoglobin | 29 (97) | 1 (3) | 0 |
| Nausea | 28 (93) | 6 (20) | 0 |
| Constipation | 28 (93) | 0 | 0 |
| Lymphopenia | 27 (90) | 16 (53) | 11 (37) |
| Weight loss | 27 (90) | 4 (13) | 0 |
| Dysphagia | 26 (87) | 9 (30) | 1 (3) |
| Leukopenia | 26 (87) | 7 (23) | 1 (3) |
| Rash, acne/acneiform | 26 (87) | 3 (10) | 0 |
| Hypoalbuminemia | 25 (83) | 0 | 0 |
| Pain- throat/pharynx/larynx | 24 (80) | 4 (13) | 0 |
| Mucositis- functional | 23 (77) | 11 (37) | 0 |
| Hyponatremia | 23 (77) | 3 (10) | 0 |
| ALT elevation | 22 (73) | 2 (7) | 0 |
| Thrombocytopenia | 19 (63) | 1 (3) | 0 |
| Vomiting | 17 (57) | 2 (7) | 0 |
| Hypomagnesemia | 17 (57) | 0 | 0 |
| AST elevation | 15 (50) | 0 | 0 |
| Pain - headache | 14 (47) | 0 | 0 |
| Diarrhea | 13 (43) | 0 | 0 |
| Neutropenia | 12 (40) | 2 (7) | 1 (3) |
| Creatinine elevation | 12 (40) | 2 (7) | 0 |
| Cough | 12 (40) | 0 | 0 |
| Hyperkalemia | 12 (40) | 0 | 0 |
| Hypokalemia | 11 (37) | 3 (10) | 0 |
| Fever (without neutropenia) | 10 (33) | 0 | 0 |
| Epistaxis | 10 (33) | 0 | 0 |
| Thrombosis/embolism | 6 (20) | 5 (17) | 0 |
| Hypophosphatemia | 6 (20) | 3 (10) | 0 |
| Febrile neutropenia | 3 (10) | 3 (10) | 0 |
| Pain – abdomen | 3 (10) | 3 (10) | 0 |
| Allergic reaction/hypersensitivity | 3 (10) | 2 (7) | 0 |