Table 2.
Adverse events (CTCAE version 3.0) recorded in patients with advanced biliary tract cancer within 6 months after randomization of gemcitabine plus S‐1 combination therapy (GS) or S‐1 alone
| GS (n = 51) | S‐1 (n = 50) | |||||
|---|---|---|---|---|---|---|
| G3 (%) | G4 (%) | All grades (%) | G3 (%) | G4 (%) | All grades (%) | |
| Leucocytes | 29.4 | 0.0 | 90.2 | 2.0 | 0.0 | 40.0 |
| Hemoglobin | 9.8 | 2.0 | 82.4 | 4.0 | 0.0 | 66.0 |
| Platelets | 5.9 | 5.9 | 51.0 | 0.0 | 4.0 | 22.0 |
| Neutrophils | 43.1 | 17.6 | 88.2 | 4.0 | 0.0 | 40.0 |
| Bilirubin | 9.8 | 0.0 | 52.9 | 14.0 | 0.0 | 64.0 |
| ALP | 7.8 | 0.0 | 70.6 | 12.0 | 2.0 | 76.0 |
| AST | 11.8 | 0.0 | 72.5 | 12.0 | 2.0 | 70.0 |
| ALT | 13.7 | 0.0 | 64.7 | 12.0 | 0.0 | 62.0 |
| Creatinine | 0.0 | 0.0 | 29.4 | 0.0 | 0.0 | 12.0 |
| Fatigue | 7.8 | 0.0 | 56.9 | 4.0 | 0.0 | 62.0 |
| Anorexia | 7.8 | 0.0 | 51.0 | 6.0 | 0.0 | 60.0 |
| Nausea | 2.0 | 0.0 | 35.3 | 4.0 | 0.0 | 52.0 |
| Vomiting | 2.0 | 0.0 | 13.7 | 0.0 | 0.0 | 28.0 |
| Rash | 9.8 | 0.0 | 39.2 | 2.0 | 0.0 | 16.0 |
| Fever | 0.0 | 0.0 | 39.2 | 2.0 | 0.0 | 26.0 |
| Mucositis (oral cavity) | 5.9 | 0.0 | 25.5 | 0.0 | 0.0 | 18.0 |
| Cheilitis | 0.0 | – | 15.7 | 0.0 | – | 16.0 |
| Hyperpigmentation | – | – | 23.5 | – | – | 32.0 |
| Taste alteration | – | – | 15.7 | – | – | 18.0 |
| Diarrhea | 2.0 | 0.0 | 19.6 | 6.0 | 0.0 | 34.0 |
| Constipation | 0.0 | 0.0 | 31.4 | 0.0 | 0.0 | 12.0 |
| Alopesia | – | – | 13.7 | – | – | 2.0 |
| Pruritus | 0.0 | – | 11.8 | 0.0 | – | 8.0 |
| Infection with normal ANC | 7.8 | 0.0 | 19.6 | 10.0 | 2.0 | 12.0 |
| Infection with grade 3 or 4 ANC | 4.0 | 0.0 | 7.8 | 0.0 | 0.0 | 0.0 |
| Febrile neutropenia | 2.0 | 0.0 | 2.0 | 0.0 | 0.0 | 0.0 |
Events with a frequency of more than 10.0% or high‐grade events (grades 3,4) are listed. –, not applicable; ALP, alkaline phosphatase; AST, aspartate amino transferase; ALT, alanine aminotransferase; ANC, absolute neutrophil count; CTCAE, Common Terminology Criteria for Adverse Events.