Evaluation of Efficacy and Safety of Roxadustat for the Treatment of Chemotherapy Induced Anemia

Mean Change in Hb Level From Baseline to Week 16 (Without RBC Transfusion)

Baseline Hb was defined as the mean of the assessments from central lab prior to first dose of the study treatment, which included up to 2 latest screening values prior to Day 1 and a value on Day 1. Mean Hb during treatment was computed using the mean area-under-the-curve trapezoid method, from Day 1 to EOT or ET Hb assessment.

Time frame: Baseline, Week 16

Change in Hb From Baseline at Weeks 9, 13, and 16 (Without RBC Transfusion)

Baseline Hb was defined as the mean of the assessments from central lab prior to first dose of the study treatment, which included up to 2 latest screening values prior to Day 1 and a value on Day 1.

Time frame: Baseline, Weeks 9, 13, and 16

Percentage of Participants Who Achieved a ≥1 g/dL Increase in Hb From Baseline Through Week 16

The 95% confidence interval (CI) was based on the exact method of Clopper-Pearson method. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion was excluded.

Time frame: Baseline through Week 16

Time to Achieve a ≥1 g/dL Increase in Hb From Baseline Through Week 16

Median was calculated using Kaplan-Meier product limit method. 95% CI was calculated using the method of Brookmeyer and Crowley. All central lab assessments from Day 1 to EOT or ET were included in the analysis. Hb values within 4 weeks after an RBC transfusion were excluded.