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Table 4 Grade 3 and 4 adverse events. Reported is the highest grade observed

From: Adjuvant treatment of resectable biliary tract cancer with cisplatin plus gemcitabine: A prospective single center phase II study

Eventsa Grade 3 - 4b GEM (n = 9) Grade 3 - 4b CIS/GEM (n = 21) Total
  No. (%)
Hematologic toxic effects
 Leukopenia 0 8 (38) 8 (27)
 Neutropenia 3 (33) 12 (57) 15 (50)
 Thrombocytopenia 1 (11) 4 (19) 5 (17)
 Anaemia 0 3 (14) 3 (10)
Non-hematologic toxic effects
 Alopecia 0 2 (10) 2 (7)
 Anorexia 0 2 (10) 2 (7)
 Fatigue 3 (33) 4 (19) 6 (20)
 Nausea 0 1 (5) 1 (3)
 Vomiting 0 1 (5) 1 (3)
 Impaired renal function 0 2 (5) 2 (7)
 Infection 0 (0) 3 (14) 3 (10)
  Without neutropenia 0 0 0 (0)
  With neutropenia 0 3 3 (10)
  Biliary sepsis 0 2 2 (7)
Deep-vein thrombosis 0 1 (5) 1 (3)
Other 1 (11) 5 (24) 6 (20)
Liver function
 Increased ALAT level 0 1 (5) 1 (3)
 Other abnormal liver functionc 0 2 (10) 2 (7)
 Any abnormal liver functiond 0 0 (0) 0 (0)
  1. Abbreviations: GEM gemcitabine, CIS cisplatin, ALAT alanine aminotransferase
  2. aMultiple adverse events per patient possible
  3. bPre-existing conditions are reported only in case of worsening during study treatment
  4. cElevated gamma-GT
  5. dHypoalbumia, decreased Vitamin K level