| Outcome Measures: |
Primary: Change in hemoglobin from baseline to the effectiveness evaluation period, Change in hemoglobin from baseline (defined as the mean of all available hemoglobin values obtained in the 30 days prior to Day 1) to the effectiveness evaluation period (mean of all available hemoglobin values obtained in the 30 days prior to Day 120)., 120 days | Secondary: The number/proportion of subjects with a hemoglobin in target range of 10-11 g/dL from baseline to effectiveness evaluation period, The number/proportion of subjects with a hemoglobin in target range of 10-11 g/dL from baseline to effectiveness evaluation period, 120 days|The number/proportion of subjects with a change in hemoglobin under 0.5 g/dL from baseline to effectiveness evaluation period, The number/proportion of subjects with a change in hemoglobin under 0.5 g/dL from baseline to effectiveness evaluation period, 120 days|Number of hemoglobin excursions that are < 8.5 g/dL or ≥ 12 g/dL during the treatment period., Number of hemoglobin excursions that are \< 8.5 g/dL or ≥ 12 g/dL during the treatment period., 120 days|Number of dose adjustments in daprodustat per patient during the treatment period, Number of dose adjustments in daprodustat per patient during the treatment period, 120 days|Number of subjects retained on daprodustat therapy from Day 1 through Day 120, Number of subjects retained on daprodustat therapy from Day 1 through Day 120, 120 days|The number/proportion of subjects who receive a refill prescription with the correct prescribed dose with no gap (0 days) in drug supply from the previous prescription, The number/proportion of subjects who receive a refill prescription with the correct prescribed dose with no gap (0 days) in drug supply from the previous prescription, 120 days|The time (in days) from initial and refill prescription to delivery to patient, The time (in days) from initial and refill prescription to delivery to patient, 120 days|Average monthly (percent) compliance with daprodustat daily dosing, per subject report., The average monthly compliance will be calculated from individual subject reported verbal estimates of (percent) compliance with daprodustat daily administration., 120 days
|
