Table 2.
Adverse Events
| Adverse events*, n (%) | Total (n = 24) | |
|---|---|---|
| All Grades† | Grade 3 or 4 | |
| Any adverse events | 23 (95.8) | 6 (25) |
| General and constitutional events | ||
| Nausea | 12 (50) | — |
| Fatigue | 10 (41.7) | — |
| Anorexia | 9 (37.5) | — |
| Weight loss | 5 (20.8) | — |
| Muscle weakness | 4 (16.7) | — |
| Dehydration | 3 (12.5) | — |
| Fall | 3 (12.5) | — |
| Fever | 2 (8.3) | — |
| Arthralgia | 2 (8.3) | — |
| Allergic rhinitis | 2 (8.3) | — |
| Hematologic events‡ | ||
| Thrombocytopenia | 7 (29.2) | 3 (12.5) |
| Hypokalemia | 5 (20.8) | 1 (4.2) |
| Neutropenia | 4 (16.7) | 4 (16.7) |
| Lymphocytopenia | 3 (12.5) | 2 (8.3) |
| Anemia | 2 (8.3) | 2 (8.3) |
| Low bicarbonate | 2 (8.3) | — |
| Hyperchloremia | 2 (8.3) | — |
| Gastrointestinal events | ||
| Constipation | 6 (25) | — |
| Diarrhea | 5 (20.8) | — |
| Vomiting | 5 (20.8) | — |
| Dysphagia | 4 (16.7) | 1 (4.2) |
| Dysgeusia | 2 (8.3) | — |
| Xerostomia | 2 (8.3) | — |
| Cardiovascular events | ||
| Thromboembolic event | 4 (16.7) | 1 (4.2) |
| Hypertension | 4 (16.7) | — |
| Extremity edema | 2 (8.3) | — |
| Extremity pain | 2 (8.3) | — |
| Genitourinary events | ||
| Urinary frequency | 5 (20.8) | — |
| Urinary tract infection | 3 (12.5) | 1 (4.2) |
| Dermatologic events | ||
| Urticaria | 2 (8.3) | — |
| Neurologic and psychiatric events | ||
| Paresthesia | 11 (45.8) | — |
| Confusion | 7 (29.2) | 2 (8.3) |
| Memory impairment | 6 (25) | — |
| Seizure | 5 (20.8) | 1 (4.2) |
| Insomnia | 5 (20.8) | — |
| Headache | 4 (16.7) | — |
| Tremor | 4 (16.7) | — |
| Agitation | 3 (12.5) | — |
| Dysphasia | 3 (12.5) | 1 (4.2) |
| Dysesthesia | 3 (12.5) | — |
| Gait disturbance | 3 (12.5) | — |
| Aphasia | 3 (12.5) | — |
| Tinnitus | 2 (8.3) | — |
| Hallucinations | 2 (8.3) | — |
| Cognitive disturbance | 2 (8.3) | — |
Note: *Data only include events occurring at >5% frequency for all adverse event grades.
†There were no recorded Grade 5 adverse events.
‡Among the aggregated cases of Grade 3 or 4 thrombocytopenia, 2 cases were Grade 3 and 1 was Grade 4. Among the aggregated cases of Grade 3 or 4 neutropenia, 2 cases were Grade 3 and 2 cases were Grade 4.