Table 3.
Treatment-related adverse events occurring in 20% or more of patients
| Adverse event category and term | Number of patients n (%) | ||||
|---|---|---|---|---|---|
| All Grades | Grade 1 | Grade 2 | Grade 3 | Grade 4 | |
| Blood and lymphatic system disorders | |||||
| Anemia | 7 (24%) | 3 (10%) | 3 (10%) | 1 (3%) | 0 |
| Skin and subcutaneous tissue disorders | |||||
| Palmar-plantar erythrodysesthesia syndrome | 20 (69%) | 6 (21%) | 5 (17%) | 9 (31%) | 0 |
| Metabolism and nutrition disorders | |||||
| Hypophosphatemia | 18 (62%) | 4 (14%) | 9 (31%) | 5 (17%) | 0 |
| Hypocalcemia | 14 (48%) | 13 (45%) | 1 (3%) | 0 | 0 |
| Hypokalemia | 10 (34%) | 10 (34%) | 0 | 0 | 0 |
| Anorexia | 9 (31%) | 5 (17%) | 4 (14%) | 0 | 0 |
| Hypomagnesemia | 6 (21%) | 6 (21%) | 0 | 0 | 0 |
| Investigations | |||||
| Lymphocyte count decreased | 14 (48%) | 7 (24%) | 2 (7%) | 5 (17%) | 0 |
| Platelet count decreased | 10 (34%) | 8 (28%) | 2 (7%) | 0 | 0 |
| Blood bilirubin increased | 9 (31%) | 5 (17%) | 3 (10%) | 1 (3%) | 0 |
| Lipase increased | 9 (31%) | 3 (10%) | 1 (3%) | 3 (10%) | 2 (7%) |
| Weight loss | 8 (28%) | 8 (28%) | 0 | 0 | 0 |
| Aspartate aminotransferase increased | 7 (24%) | 7 (24%) | 0 | 0 | 0 |
| Vascular disorders | |||||
| Hypertension | 14 (48%) | 1 (3%) | 4 (14%) | 8 (28%) | 1 (3%) |
| Nervous system disorders | |||||
| Dysgeusia | 10 (34%) | 7 (24%) | 3 (10%) | 0 | 0 |
| Headache | 7 (24%) | 4 (14%) | 3 (10%) | 0 | 0 |
| Renal and urinary disorders | |||||
| Proteinuria | 10 (34%) | 6 (21%) | 4 (14%) | 0 | 0 |
| General disorders and administration site conditions | |||||
| Fatigue | 9 (31%) | 1 (3%) | 6 (21%) | 2 (7%) | 0 |
| Gastrointestinal disorders | |||||
| Diarrhea | 8 (28%) | 3 (10%) | 5 (17%) | 0 | 0 |
| Nausea | 6 (21%) | 6 (21%) | 0 | 0 | 0 |
| Respiratory, thoracic and mediastinal disorders | |||||
| Hoarseness | 7 (24%) | 7 (24%) | 0 | 0 | 0 |