aboratory or non–laboratory data. Gemzar at 1000 mg/m2 on Days 1, 8, and 15 and cisplatin at 100 mg/m2 on Day 1 every 28 days.
N=213–248; all cisplatin patients with laboratory or non–laboratory data. Cisplatin at 100 mg/m2 on Day 1 every 28 days.
Regardless of causality.
Percent of patients receiving transfusions. Percent transfusions are not CTC–graded events.
Non–laboratory events were graded only if assessed to be possibly drug–related.
Table 10: Selected WHO–Graded Adverse Events From Comparative Trial of Gemzar Plus Cisplatin Versus Etoposide Plus Cisplatin in NSCLC WHO Grades (% incidence)
Grade based on criteria from the World Health Organization (WHO).
N=67–69; all Gemzar plus cisplatin patients with laboratory or non–laboratory data. Gemzar at 1250 mg/m2 on Days 1 and 8 and cisplatin at 100 mg/m2 on Day 1 every 21 days.
N=57–63; all cisplatin plus etoposide patients with laboratory or non–laboratory data. Cisplatin at 100 mg/m2 on Day 1 and IV etoposide at 100 mg/m2 on Days 1, 2, and 3 every 21 days.
Regardless of causality.
Percent of patients receiving transfusions. Percent transfusions are not WHO–graded events.
Non–laboratory events were graded only if assessed to be possibly drug–related.
Pain data were not collected.
Gemzar plus Cisplatin†
Etoposide plus Cisplatin‡
All Grades
Grade
3
Grade
4
All Grades
Grade
3
Grade
4
Laboratory
Hematologic
Anemia
88
22
0
77
13
2
RBC Transfusions¶
29
21
Leukopenia
86
26
3
87
36
7
Neutropenia
88
36
28
87
20
56
Thrombocytopenia
81
39
16
45
8
5
Platelet Transfusions¶
3
8
Hepatic
ALT
6
0
0
12
0
0
AST
3
0
0
11
0
0
Alkaline Phosphatase
16
0
0
11
0
0
Bilirubin
0
0
0
0
0
0
Renal
Proteinuria
12
0
0
5
0
0
Hematuria
22
0
0
10
0
0
BUN
6
0
0
4
0
0
Creatinine
2
0
0
2
0
0
Non–laboratory#,Þ
Nausea and Vomiting
96
35
4
86
19
7
Fever
6
0
0
3
0
0
Rash
10
0
0
3
0
0
Dyspnea
1
0
1
3
0
0
Constipation
17
0
0
15
0
0
Diarrhea
14
1
1
13
0
2
Hemorrhage
9
0
3
3
0
3
Infection
28
3
1
&
