Table 2. Treatment-Related Adverse Events.
| System Organ Class, Preferred Terma | Patients With Adverse Event, No. (%) | |
|---|---|---|
| Grade 1 or 2 | Grade ≥3 | |
| Skin and subcutaneous tissue disorders | ||
| Rash | 9 (22) | 0 |
| Alopecia | 5 (12) | 0 |
| Palmar-plantar erythrodysaesthesia syndrome | 3 (7) | 0 |
| Ear and labyrinth disorders: hypoacousia or hyperacousia | 2 (5) | 0 |
| Renal and urinary tract disorders: renal failure | 3 (7) | 0 |
| Nervous system disorders | ||
| Peripheral sensorimotor neuropathy | 11 (27) | 0 |
| Taste alteration | 8 (20) | 0 |
| Gastrointestinal tract disorders | ||
| Nausea | 18 (44) | 2 (5) |
| Abdominal pain | 12 (29) | 5 (12) |
| Vomiting | 12 (29) | 1 (2) |
| Diarrhea | 10 (24) | 2 (5) |
| Dysphagia | 2 (5) | 0 |
| Constipation | 7 (17) | 0 |
| Ascites | 2 (5) | 3 (7) |
| Blood and lymphatic system disorders | ||
| Neutropenia | 9 (22) | 21 (51) |
| Febrile neutropenia | 0 | 1 (2) |
| Anemia | 19 (46) | 8 (20) |
| Thrombocytopenia | 16 (39) | 10 (24) |
| Lymphopenia | 4 (10) | 3 (7) |
| Hepatobiliary disorders | ||
| Abnormal liver function test | 5 (12) | 1 (2) |
| Acute hepatic failure | 1 (2) | 2 (5) |
| Cholecystitis acute | 1 (2) | 1 (2) |
| Cholangitis | 0 (0) | 1 (2) |
| Respiratory, thoracic, and mediastinal disorders: epistaxis | 4 (10) | 0 |
| Vascular disorders: venous thrombosis | 2 (5) | 1 (2) |
| Infections and infestations: oral fungal infection | 5 (12) | 0 |
| Metabolism and nutrition disorders | ||
| Decreased appetite | 21 (51) | 3 (7) |
| Weight decreased | 8 (20) | 1 (2) |
| General disorders and administration site conditions | ||
| Asthenia | 32 (78) | 9 (22) |
| Pain | 7 (17) | 0 |
| Mucosal inflammation | 5 (12) | 0 |
| Edema | 6 (15) | 0 |
| Administration site reaction | 6 (15) | 0 |
| General physical health deterioration | 0 | 2 (5) |
a
According to Medical Dictionary for Regulatory Activities, version 18.1.