| Outcome Measures: |
Primary: Hemoglobin (Hb) Response Rate from Week 18 to Week 24, Hb response defined as average Hb within the target range, Week 18 to 24 | Secondary: Hb Response Rate from Week 46 to Week 52, Week 46 to 52|Average Hb from Week 18 to Week 24, Week 18 to Week 24|Average Hb from Week 46 to Week 52, Week 46 to Week 52|Change from baseline in the average Hb from Week 18 to Week 24, Baseline and Weeks 18 to 24|Change from baseline in the average Hb from Week 46 to Week 52, Baseline and Weeks 46 to 52|Proportion of participants with Hb values within the target value in each post-dosing time point, Up to Week 52|Change from baseline in Hb to each post-dosing time point, Baseline and Up to Week 52|Proportion of measurement points with target Hb level from Week 18 to Week 24, Week 18 to Week 24|Proportion of measurement points with target Hb level from Week 46 to Week 52, Week 46 to Week 52|Rate of rise in Hb levels (g/dL/week) from week 0 to at the earliest date of week 4, time of discontinuation, or time of dose adjustment, Up to Week 4|Average hematocrit level, Up to Week 52|Average reticulocyte level, Up to Week 52|Average Fe level, Up to Week 52|Average ferritin level, Up to Week 52|Average transferrin level, Up to Week 52|Average total iron binding capacity level, Up to Week 52|Average soluble transferrin receptor level, Up to Week 52|Average transferrin saturation level, Up to Week 52|Average reticulocyte hemoglobin content level, Up to Week 52|Quality of life assessed by SF-36, SF-36: Medical Outcomes Study 36-Item Short-Form Health Survey, Up to Week 52|Quality of life assessed by EQ-5D, EQ-5D: EuroQol 5 Dimension, Up to Week 52|Quality of life assessed by FACT-An, FACT-An: Functional Assessment of Cancer Therapy-Anemia, Up to Week 52|Number of hospitalizations, Up to Week 52|Safety assessed by incidence of adverse events, Up to Week 52|Number of participants with abnormal Vital signs and/or adverse events related to treatment, Vital signs: blood pressure and pulse rate, Up to Week 52|Safety assessed by standard 12-lead electrocardiogram, Up to Week 52|Number of participants with abnormal Laboratory values and/or adverse events related to treatment, Up to Week 52
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| Locations: |
Site JP00017, Aichi, Japan|Site JP00005, Fukuoka, Japan|Site JP00004, Gunma, Japan|Site JP00006, Gunma, Japan|Site JP00018, Hokkaido, Japan|Site JP00019, Hokkaido, Japan|Site JP00021, Hokkaido, Japan|Site JP00023, Hyogo, Japan|Site JP00008, Ibaraki, Japan|Site JP00020, Ishikawa, Japan|Site JP00010, Kumamoto, Japan|Site JP00022, Kumamoto, Japan|Site JP00024, Kumamoto, Japan|Site JP00016, Kyoto, Japan|Site JP00002, Nagano, Japan|Site JP00012, Nagano, Japan|Site JP00015, Nagano, Japan|Site JP00003, Niigata, Japan|Site JP00025, Osaka, Japan|Site JP00007, Saitama, Japan|Site JP00009, Shizuoka, Japan|Site JP00014, Tokyo, Japan|Site JP00013, Tottori, Japan|Site JP00011, Wakayama, Japan|Site JP00001, Yamaguchi, Japan
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