Table 3.
Incidences of drug‐related adverse events according to Common Terminology Criteria for Adverse Events grades
| Treatment‐related adverse events | Cohort 1 0.3 mg/body | Cohort 2 1 mg/body | Cohort 3 3 mg/body | Cohort 4 6 mg/body | Total | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| N = 6 | N = 6 | N = 6 | N = 6 | N = 24 | ||||||
| All | ≥ G3 | All | ≥ G3 | All | ≥ G3 | All | ≥ G3 | All | ≥ G3 | |
| Gastrointestinal disorders | ||||||||||
| Nausea | 1 | 1 | ||||||||
| Vomiting | 1 | 1 | ||||||||
| General disorders and administration site condition | ||||||||||
| Pyrexia | 1 | 1 | 2 | |||||||
| Fatigue | 1 | 1 | ||||||||
| Injection site reaction | 1 | 1 | 3 | 1 | 6 | |||||
| Injection site induration | 1 | 1 | ||||||||
| Injection site erythema | 1 | 1 | ||||||||
| Induration | 1 | 1 | ||||||||
| Skin and s.c. tissue disorders | ||||||||||
| Pruritus | 2 | 2 | ||||||||
| Metabolism and nutrition disorders | ||||||||||
| Diabetes mellitus | 1 | 1 | 1 | 1 | ||||||
| Hyponatremia | 1 | 1 | 1 | 1 | ||||||
| Renal and urinary disorders | ||||||||||
| Proteinuria | 1 | 1 | 2 | |||||||
| Investigations | ||||||||||
| Eosinophil count increased | 1 | 1 | ||||||||
| Lymphocyte count decreased | 1 | 1 | ||||||||
| Vascular disorders | ||||||||||
| Hypertension | 1 | 1 | ||||||||
| Blood and lymphatic system disorders | ||||||||||
| Anemia | 1 | 1 | ||||||||
| Injury, poisoning and procedural complications | ||||||||||
| Infusion‐related reaction | 1 | 1 | ||||||||
Drug‐related adverse events were reported using Medical Dictionary for Regulatory Activities (MedDRA) version 18.0 and graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 (Japanese version). All, total incidences of treatment‐emergent adverse events (TEAE) (grades 1 to 4); ≥ G3, total incidences of ≥Grade 3 TEAE.