Table 2.
Summary of Safety
| Patients (n = 12) | ||||
|---|---|---|---|---|
| All causality | Treatment-related | |||
| All Grades | Grade ≥ 3 | All Grades | Grade ≥ 3 | |
| Patients with any TEAE, n (%)a | 12 (100.0) | 5 (41.7) | 8 (66.7) | 0 |
| Fatigue | 8 (66.7) | 1 (8.3) | 2 (16.7) | 0 |
| Headache | 7 (58.3) | 0 | 1 (8.3) | 0 |
| Vomiting | 6 (50.0) | 1 (8.3) | 0 | 0 |
| Decreased appetite | 4 (33.3) | 0 | 0 | 0 |
| Gait disturbance | 4 (33.3) | 3 (25.0) | 0 | 0 |
| Hyperglycemia | 4 (33.3) | 0 | 0 | 0 |
| Hyponatremia | 4 (33.3) | 0 | 0 | 0 |
| Nausea | 4 (33.3) | 0 | 1 (8.3) | 0 |
| Anemia | 3 (25.0) | 0 | 1 (8.3) | 0 |
| Blood lactate dehydrogenase increased | 3 (25.0) | 0 | 0 | 0 |
| Diarrhea | 3 (25.0) | 0 | 1 (8.3) | 0 |
| Muscular weakness | 3 (25.0) | 0 | 0 | 0 |
| Pyrexia | 3 (25.0) | 0 | 0 | 0 |
| Alanine aminotransferase increased | 2 (16.7) | 0 | 1 (8.3) | 0 |
| Dehydration | 2 (16.7) | 1 (8.3) | 0 | 0 |
| Dysarthria | 2 (16.7) | 0 | 0 | 0 |
| Dysphagia | 2 (16.7) | 1 (8.3) | 0 | 0 |
| Facial nerve disorder | 2 (16.7) | 0 | 0 | 0 |
| Hemiparesis | 2 (16.7) | 1 (8.3) | 0 | 0 |
| Hypercalcemia | 2 (16.7) | 0 | 0 | 0 |
| Hypermagnesemia | 2 (16.7) | 0 | 0 | 0 |
| Hypertension | 2 (16.7) | 1 (8.3) | 1 (8.3) | 0 |
| IIIrd nerve disorder | 2 (16.7) | 0 | 0 | 0 |
| Lymphocyte count decreased | 2 (16.7) | 0 | 1 (8.3) | 0 |
| Vith nerve disorder | 2 (16.7) | 0 | 0 | 0 |
| Accessory nerve disorder | 1 (8.3) | 0 | 0 | 0 |
| Amylase increased | 1 (8.3) | 0 | 1 (8.3) | 0 |
| Anal incontinence | 1 (8.3) | 0 | 0 | 0 |
| Anxiety | 1 (8.3) | 0 | 0 | 0 |
| Aspartate aminotransferase increased | 1 (8.3) | 0 | 0 | 0 |
| Aspiration | 1 (8.3) | 0 | 0 | 0 |
| Ataxia | 1 (8.3) | 0 | 1 (8.3) | 0 |
| Chills | 1 (8.3) | 0 | 0 | 0 |
| Confusional state | 1 (8.3) | 0 | 0 | 0 |
| Conjunctival irritation | 1 (8.3) | 0 | 0 | 0 |
| Conjunctivitis | 1 (8.3) | 0 | 0 | 0 |
| Constipation | 1 (8.3) | 0 | 0 | 0 |
| Cushingoid | 1 (8.3) | 0 | 0 | 0 |
| Dysuria | 1 (8.3) | 0 | 0 | 0 |
| Face edema | 1 (8.3) | 0 | 1 (8.3) | 0 |
| Facial asymmetry | 1 (8.3) | 0 | 0 | 0 |
| Glossopharyngeal nerve disorder | 1 (8.3) | 1 (8.3) | 0 | 0 |
| Hydrocephalus | 1 (8.3) | 1 (8.3) | 0 | 0 |
| Hyperkalaemia | 1 (8.3) | 0 | 0 | 0 |
| Hyperphosphatemia | 1 (8.3) | 0 | 1 (8.3) | 0 |
| Hypocalcemia | 1 (8.3) | 0 | 0 | 0 |
| Hypoglossal nerve disorder | 1 (8.3) | 0 | 0 | 0 |
| Hypomagnesaemia | 1 (8.3) | 0 | 0 | 0 |
| Hypophosphatemia | 1 (8.3) | 0 | 0 | 0 |
| Insomnia | 1 (8.3) | 0 | 1 (8.3) | 0 |
| Intraocular pressure increased | 1 (8.3) | 0 | 0 | 0 |
| Musculoskeletal pain | 1 (8.3) | 0 | 0 | 0 |
| Neuropathy peripheral | 1 (8.3) | 0 | 0 | 0 |
| Edema peripheral | 1 (8.3) | 0 | 0 | 0 |
| Optic nerve disorder | 1 (8.3) | 0 | 0 | 0 |
| Renal colic | 1 (8.3) | 0 | 0 | 0 |
| Sinus tachycardia | 1 (8.3) | 0 | 0 | 0 |
| Skin infection | 1 (8.3) | 0 | 0 | 0 |
| Somnolence | 1 (8.3) | 0 | 0 | 0 |
| Stomatitis | 1 (8.3) | 0 | 0 | 0 |
| Urinary hesitation | 1 (8.3) | 0 | 0 | 0 |
| Urinary incontinence | 1 (8.3) | 0 | 0 | 0 |
| Urinary tract infection | 1 (8.3) | 0 | 0 | 0 |
| Visual impairment | 1 (8.3) | 1 (8.3) | 0 | 0 |
| Weight increased | 1 (8.3) | 0 | 1 (8.3) | 0 |
| White blood cell count decreased | 1 (8.3) | 0 | 0 | 0 |
aSome patients experienced more than one TEAE.s