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) |
According to Medical Dictionary for Regulatory Activities, version 18.1.