Table 2.
Adverse events
| Adverse event | Safety analysis population (n=33) |
||
|---|---|---|---|
| Total | Grade 1/2 | Grade 3/4 | |
| Most common adverse events (≥ 20%) | |||
| Fever | 13 (39.3) | 9/3 (36.3) | 1/1 (6.0) |
| Neutrophil count decreased | 10 (30.3) | 3/7 (30.3) | |
| Peripheral sensory neuropathy | 9 (27.3) | 8/1 (27.3) | |
| Fatigue | 8 (24.2) | 2/3 (15.1) | 3/0 (9.1) |
| Nausea | 7 (21.2) | 2/3 (15.1) | 2/0 (6.0) |
| Platelet count decreased | 7 (21.2) | 1/0 (3.0) | 2/4 (18.2) |
| Abdominal pain | 7 (21.2) | 2/3 (15.1) | 2/0 (6.0) |
| Common adverse events (≥ 10%) | |||
| Diarrhea | 6 (18.1) | 3/3 (18.1) | - |
| Vomiting | 6 (18.1) | 2/3 (15.1) | 1/0 (3.0) |
| Anorexia | 6 (18.1) | 2/3 (15.1) | 1/0 (3.0) |
| Edema (facial, periorbital, or leg) | 5 (15.1) | 2/2 (12.1) | 1/0 (3.0) |
| Myalgia | 5 (15.1) | 2/3 (15.1) | - |
| Skin rash | 5 (15.1) | 2/2 (12.1) | 1/0 (3.0) |
| Anemia | 4 (12.1) | 0/1 (3.0) | 3/0 (9.1) |
| Rhinosinusitis | 4 (12.1) | 0/3 (9.1) | 1/0 (3.0) |
| Upper respiratory infection | 4 (12.1) | 2/2 (12.1) | - |
| ALT/AST increased | 4 (12.1) | 2/0 (6.0) | 1/1 (6.0) |
| Pruritus | 4 (12.1) | 2/2 (12.1) | - |
| Less common events (≥ 5%) | |||
| Dyspnea | 3 (9.0) | 1/1 (6.0) | 1/0 (3.0) |
| Sore throat | 3 (9.0) | 1/2 (9.0) | - |
| Cough | 3 (9.0) | 1/2 (9.0) | - |
| Febrile neutropenia | 2 (6.0) | 2/0 (6.0) | |
| Abdominal distension | 2 (6.0) | 1/1 (6.0) | - |
| Oral mucositis | 2 (6.0) | 1/0 (3.0) | 1/0 (3.0) |
| Herpes zoster | 2 (6.0) | 1/1 (6.0) | - |
| Creatinine increased | 2 (6.0) | 1/1 (6.0) | - |
| Back pain | 2 (6.0) | 0/1 (3.0) | 1/0 (3.0) |
| Neck pain | 2 (6.0) | 1/1 (6.0) | - |
| Dizziness | 2 (6.0) | 1/1 (6.0) | - |
| Headache | 2 (6.0) | 1/1 (6.0) | - |
| Urinary frequency | 2 (6.0) | 1/1 (6.0) | - |
| Laryngospasm | 2 (6.0) | 0/2 (6.0) | - |
| Anxiety/Depressive mood | 2 (6.0) | 2/0 (6.0) | |
| Chest pain | 2 (6.0) | 1/0 (3.0) | 1/0 (3.0) |
| Rare events (1 case reported) | |||
| Constipation | 1 (3.0) | 0/1 (3.0) | |
| Dyspepsia | 1 (3.0) | 0/1 (3.0) | |
| Hemorrhoid bleeding | 1 (3.0) | 1/0 (3.0) | |
| Perianal abscess | 1 (3.0) | 0/1 (3.0) | |
| Gout | 1 (3.0) | 1/0 (3.0) | |
| Urinary tract infection | 1 (3.0) | 1/0 (3.0) | |
| Hypocalcemia | 1 (3.0) | 0/1 (3.0) | |
| Stroke | 1 (3.0) | 1/0 (3.0) | |
| Insomnia | 1 (3.0) | 0/1 (3.0) | |
| Suicide attempt | 1 (3.0) | 0/1 (3.0) | |
| Hoarseness | 1 (3.0) | 1/0 (3.0) | |
| Pneumonia | 1 (3.0) | 1/0 (3.0) | |
| Phlebitis | 1 (3.0) | 0/1 (3.0) | |
Values are presented as number (%). ALT, alanine transaminase; AST, aspartate aminotransferase.