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Eloxatin

Clinical Pharmacology
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Clinical Pharmacology

The following tables show the baseline characteristics and dosing of the patient population entered into this study. The baseline characteristics were well balanced between arms.

Table 16 - Patient Characteristics in Adjuvant Therapy Study

  ELOXATIN + infusional 5-FU/LV
N=1123
Infusional 5-FU/LV
N=1123
Sex: Male (%) 56.1 52.4
Female (%) 43.9 47.6
Median age (years) 61.0 60.0
< 65 years of age (%) 64.4 66.2
≥ 65 years of age (%) 35.6 33.8
Karnofsky Performance Status (KPS) (%)
100 29.7 30.5
90 52.2 53.9
80 4.4 3.3
70 13.2 11.9
&le60 0.6 0.4
Primary site (%)
Colon including cecum 54.6 54.4
Sigmoid 31.9 33.8
Recto sigmoid 12.9 10.9
Other including rectum 0.6 0.9
Bowel obstruction (%)
Yes 17.9 19.3
Perforation (%)
Yes 6.9 6.9
Stage at Randomization (%)
II (T=3,4 N=0, m=0) 40.1 39.9
III (T=any, N=1,2, m=0) 59.6 59.3
IV (T=any, N=any, m=1) 0.4 0.8
Staging – T (%)
T1 0.5 0.7
T2 4.5 4.8
T3 76.0 75.9
T4 19.0 18.5
Staging – N (%)
N0 40.2 39.9
N1 39.4 39.4
N2 20.4 20.7
Staging – m(%)
M1 0.4 0.8

Table 17 - Dosing in Adjuvant Therapy Study

  ELOXATIN + infusional 5-FU/LV
N=1108
Infusional 5-FU/LV
N=1111
Median Relative Dose Intensity (%)
5-FU 84.4 97.7
ELOXATIN 80.5 N/A
Median Number of Cycles 12 12
Median Number of cycles with ELOXATIN 11 N/A

Brand Name: Eloxatin
Generic Name: Oxaliplatin Injection
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