Table 1.

Baseline patient and disease characteristics

Treatment groupPlacebo300 mg600 mg
Number of patients202020
Age, y
 Mean ± SD72.0 ± 12.768.6 ± 9.268.7 ± 9.2
 Median7468.568.5
 Range46–9751–8350–81
Sex
 Male:female15:519:118:2
Race
 White, non-Hispanic202019
 Hispanic or Latino001
ECOG
 0141719
 1331
Weight,a kg
 Mean ± SD78.3 ± 20.180.6 ± 14.190.5 ± 11.0
 Range47.7–134.952.6–111.470.7–112.3
Body mass indexb
 Mean27.0 ± 7.226.3 ± 4.429.5 ± 3.3
 Range16.7–44.018.7–35.424.4–39.05
  • aP value for males only (placebo vs. 600 mg) = 0.008; P value (300 mg vs. 600 mg) = 0.02.

  • bP value for males only (placebo vs. 600 mg) = 0.009; P value (300 mg vs. 600 mg) = 0.031.