4. Outcomes
The primary endpoint was 16-week CR rate. Secondary endpoints were
32-week CR rate, treatment-related adverse events, recurrent rate and
pregnancy rate. Safety assessment was assessed and graded following the
National Cancer Institute Common Toxicity Criteria version 4.0 at
baseline (prior to treatment), during treatment, and at completion of
treatment. Serious adverse events would be reported within 24 hours. The
maximum extent of weight change during treatment was also measured.