7
<1
<1
Hepatic
<1
ALT
68
8
2
72
10
1
AST
67
6
2
78
12
5
Alkaline Phosphatase
55
7
2
77
16
4
Bilirubin
13
2
<1
26
6
2
Renal
<1
Proteinuria
45
<1
0
32
<1
0
Hematuria
35
<1
0
23
0
0
BUN
16
0
0
15
0
0
Creatinine
8
<1
0
6
0
0
Non–laboratory#
Nausea and Vomiting
69
13
1
71
10
2
<1
Pain
48
9
<1
42
6
<1
<1
Fever
41
2
0
38
2
0
<1
Rash
30
<1
0
28
<1
0
<1
Dyspnea
23
3
<1
10
0
<1
<1
Constipation
23
1
<1
31
3
<1
0
Diarrhea
19
1
0
30
3
0
0
Hemorrhage
17
<1
<1
4
2
<1
<1
Infection
16
1
<1
10
2
<1
<1
Alopecia
15
<1
0
16
0
0
0
Stomatitis
11
<1
0
10
<1
0
<1
Somnolence
11
<1
<1
11
2
<1
<1
Paresthesias
10
<1
0
10
<1
0
0
Grade based on criteria from the World Health Organization (WHO).
N=699–974; all patients with laboratory or non–laboratory data.
N=161–241; all pancreatic cancer patients with laboratory or non–laboratory data.
N=979.
Regardless of causality.
Table includes non–laboratory data with incidence for all patients ≥10%. For approximately 60% of the patients, non–laboratory events were graded only if assessed to be possibly drug–related.
All Patients
Pancreatic Cancer
Patients
Discontinuations
(%)
All
Grades
Grade
3
Grade
4
All
Grades
Grade
3
Grade
4
All
Patients
Laboratory¶
Hematologic
Anemia
68
7
1
73
8
2
<1
Leukopenia
62
9
<1
64
8
1
<1
Neutropenia
63
19
6
61
17
7
-
Thrombocytopenia
24
4
1
36
7
|
