Table 2.
Adverse events experienced by at least 10% of patients by severity
| AE, n (%) | Total (N = 30) | Grade 1 | Grade 2 | Grades 3 and 4 |
|---|---|---|---|---|
| Any AE, highest grade experienceda | 29 (97) | 2 (7) | 8 (27) | 18 (60) |
| ALT elevation | 12 (40) | 5 (17) | 5 (17) | 2 (7) |
| AST elevation | 12 (40) | 7 (23) | 4 (13) | 1 (3) |
| Fatigue | 11 (37) | 4 (13) | 5 (17) | 2 (7) |
| Thrombocytopenia | 9 (30) | 2 (7) | 2 (7) | 5 (17) |
| Nausea | 6 (20) | 2 (7) | 3 (10) | 1 (3) |
| Anemia | 5 (17) | 2 (7) | 2 (7) | 1 (3) |
| Hypomagnesemia | 5 (17) | 5 (17) | 0 | 0 |
| Peripheral edema | 5 (17) | 3 (10) | 2 (7) | 0 |
| Alkaline phosphatase elevation | 4 (13) | 3 (10) | 1 (3) | 0 |
| Dysphagia | 4 (13) | 3 (10) | 0 | 1 (3) |
| Dyspnea | 4 (13) | 2 (7) | 2 (7) | 0 |
| Hypercalcemia | 4 (13) | 1 (3) | 2 (7) | 1 (3) |
| Hypokalemia | 4 (13) | 3 (10) | 0 | 1 (3) |
| Hyponatremia | 4 (13) | 3 (10) | 0 | 1 (3) |
| Neutropenia | 4 (13) | 1 (3) | 0 | 3 (10) |
| Vomiting | 4 (13) | 4 (13) | 0 | 0 |
| Abdominal pain | 3 (10) | 1 (3) | 2 (7) | 0 |
| Anorexia | 3 (10) | 1 (3) | 2 (7) | 0 |
| Asthenia | 3 (10) | 1 (3) | 1 (3) | 1 (3) |
| Constipation | 3 (10) | 3 (10) | 0 | 0 |
| Creatinine elevated | 3 (10) | 2 (7) | 1 (3) | 0 |
| Diarrhea | 3 (10) | 3 (10) | 0 | 0 |
| Upper respiratory tract infection | 3 (10) | 1 (3) | 2 (7) | 0 |
| Urinary tract infection | 3 (10) | 1 (3) | 2 (7) | 0 |
Abbreviations: AE adverse event, AST aspartate transaminase, ALT alanine transaminase
aIncludes one patient who died of acute respiratory failure (Grade 5 AE) unrelated to the study medication while on trial