Table 2.
Adverse events during phase I trial of GBS‐01 in patients with advanced pancreatic cancer refractory to gemcitabine
| CTC‐AE4.0† | Level 1 (n = 3) | Level 2 (n = 3) | Level 3 (n = 9) | All levels (n = 15) | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| G1 | G2 | G3 | G4 | G1 | G2 | G3 | G4 | G1 | G2 | G3 | G4 | G1–2 (%) | G3–4 (%) | |
| Leukopenia | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 27 | 0 |
| Neutropenia | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 13 | 0 |
| Anemia | 1 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 53 | 0 |
| Thrombocytopenia | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 7 | 0 |
| Diarrhea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 27 | 0 |
| Nausea | 0 | 0 | 0 | – | 0 | 1 | 0 | – | 2 | 3 | 0 | – | 40 | 0 |
| Vomiting | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 27 | 0 |
| Anorexia | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 4 | 1 | 0 | 53 | 7 |
| Fatigue | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 0 | 2 | 0 | 27 | 13 |
| Constipation | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 20 | 0 |
| T‐Bil increased | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 13 | 7 |
| AST increased | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 6 | 1 | 1 | 0 | 67 | 7 |
| ALT increased | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 0 | 1 | 0 | 33 | 7 |
| ALP increased | 2 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 6 | 1 | 1 | 0 | 73 | 7 |
| Γ‐GTP increased | 1 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 2 | 1 | 5 | 0 | 33 | 40 |
| Cr increased | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 7 | 0 |
| Hyperglycemia | 1 | 1 | 1 | 0 | 1 | 0 | 2 | 0 | 3 | 4 | 2 | 0 | 67 | 33 |
†Grading according to the Common Terminology Criteria for Adverse Events, version 4.0. GBS‐01 dose level 1, 3.0 g q.d. (n = 3); dose level 2, 7.5 g q.d. (n = 3); dose level 3, 12.0 g q.d. (n = 9). –, . γ‐GTP, serum γ‐glutamyl transpeptidase; ALP, serum alkaline phosphatase; ALT, serum alanine aminotransferase; AST, serum aspartate aminotransferase; Cr, serum creatinine; T‐Bil, serum total bilirubin.