Table 3.
Grade 2 and higher adverse events occurring in >3% of patients. Worst grade that is at least possibly related to study drugs is shown for each patient (N = 54 total patients).
| Number of patients | |||
|---|---|---|---|
| Adverse event | Grade 2 | Grade 3 | Grade 4 |
| Endocrine disorders | |||
| Hypothyroidism | 11 | ||
| Gastrointestinal disorders | |||
| Abdominal pain | 2 | 2 | |
| Constipation | 2 | ||
| Diarrhea | 7 | 3 | |
| Dyspepsia | 3 | ||
| Mucositis oral | 3 | 2 | |
| Nausea | 1 | 1 | |
| Oral pain | 2 | ||
| Vomiting | 1 | 1 | |
| General disorders and administration site conditions | |||
| Fatigue | 11 | 2 | |
| Investigations | |||
| Alanine aminotransferase increased | 4 | 2 | |
| Aspartate aminotransferase increased | 3 | ||
| Lipase increased | 1 | 2 | 1 |
| Lymphocyte count decreased | 2 | ||
| Neutrophil count decreased | 7 | 4 | |
| Platelet count decreased | 2 | ||
| Serum amylase increased | 1 | 1 | |
| Weight loss | 7 | 1 | |
| White blood cell decreased | 6 | 1 | |
| Metabolism and nutrition disorders | |||
| Anorexia | 5 | ||
| Dehydration | 1 | 2 | |
| Hypoalbuminemia | 2 | ||
| Hypophosphatemia | 7 | 1 | |
| Musculoskeletal and connective tissue disorders | |||
| Myalgia | 3 | ||
| Nervous system disorders | |||
| Dysgeusia | 3 | ||
| Renal and urinary disorders | |||
| Proteinuria | 7 | ||
| Skin and subcutaneous tissue disorders | |||
| Palmar–plantar erythrodysesthesia syndrome | 11 | 3 | |
| Skin hypopigmentation | 5 | ||
| Vascular disorders | |||
| Hypertension | 21 | 9 | |
| Thromboembolic event | 3 | 1 | |