|
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)
|
- Abbreviations: GEM gemcitabine, CIS cisplatin, ALAT alanine aminotransferase
- aMultiple adverse events per patient possible
- bPre-existing conditions are reported only in case of worsening during study treatment
- cElevated gamma-GT
- dHypoalbumia, decreased Vitamin K level
