;<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
Table 8: Selected WHO–Graded Adverse Events From Comparative Trial of Gemzar and 5–FU in Pancreatic Cancer WHO Grades (% incidence)* *
Grade based on criteria from the World Health Organization (WHO).
N=58–63; all Gemzar patients with laboratory or non–laboratory data.
N=61–63; all 5–FU patients with laboratory or non–laboratory data.
Regardless of causality.
Non–laboratory events were graded only if assessed to be possibly drug–related.
Gemzar
5–FU
All Grades
Grade
3
Grade
4
All
Grades
Grade
3
Grade
4
Laboratory
Hematologic
Anemia
65
7
3
45
0
0
Leukopenia
71
10
0
15
2
0
Neutropenia
62
19
7
18
2
3
Thrombocytopenia
47
10
0
15
2
0
Hepatic
ALT
72
8
2
38
0
0
AST
72
10
2
52
2
&
