<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03799627</url>
  </required_header>
  <id_info>
    <org_study_id>AKB-6548-CI-0025</org_study_id>
    <nct_id>NCT03799627</nct_id>
  </id_info>
  <brief_title>Study of Vadadustat in Hemodialysis Participants With Anemia Switching From Epoetin Alfa</brief_title>
  <acronym>FO2RWARD-2</acronym>
  <official_title>Phase 2, Randomized, Open-Label, Active-Controlled, Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Oral Vadadustat for the Treatment of Anemia in Hemodialysis Subjects Converting From Epoetin Alfa (FO2RWARD-2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Akebia Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Akebia Therapeutics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 2 open-label efficacy, safety, and pharmacokinetic/pharmacodynamic (PK/PD)&#xD;
      study to evaluate oral Vadadustat for the treatment of anemia in hemodialysis participants&#xD;
      converting from Epoetin Alfa therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 2, randomized, open-label study to evaluate efficacy and safety of oral&#xD;
      Vadadustat for the treatment of anemia in hemodialysis participants converting from Epoetin&#xD;
      Alfa therapy. The study will be conducted in two parts running in parallel: Part 1, Main&#xD;
      Study in a hemodialysis population on maintenance treatment with Epoetin Alfa; Part 2 is in a&#xD;
      hemodialysis population that are erythropoiesis-stimulating agent (ESA) hyporesponders on&#xD;
      maintenance treatment with Epoetin Alfa. For all participants (Main and ESA hyporesponder&#xD;
      parallel study), the study will include a Screening Period, a Treatment Period, and a Safety&#xD;
      Follow-Up Period. PK and PD sampling will be done throughout the study. The aim is to achieve&#xD;
      and maintain hemoglobin (Hb) levels within the target range of 10.0 to 11.0 grams per&#xD;
      deciliter (g/dL), inclusive, while targeting the middle of the range and minimizing&#xD;
      excursions outside the target range.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2019</start_date>
  <completion_date type="Actual">July 15, 2020</completion_date>
  <primary_completion_date type="Actual">June 5, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized, Open-Label, Active-Controlled</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP)</measure>
    <time_frame>Baseline; Week 10 to Week 12</time_frame>
    <description>Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values</measure>
    <time_frame>Up to Week 24</time_frame>
    <description>Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Classified as Hb Outliers</measure>
    <time_frame>Weeks 13 - 20</time_frame>
    <description>The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or &lt;8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Hb Values Within the Target Range at the PEP</measure>
    <time_frame>Week 10 to Week 12</time_frame>
    <description>The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12</measure>
    <time_frame>Week 10 to Week 12; Week 18 to Week 20</time_frame>
    <description>Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for &quot;Vadadustat Total (TIW dosing regimen)&quot;. For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change in Hb Between Baseline and the SEP</measure>
    <time_frame>Baseline; Week 18 to Week 20</time_frame>
    <description>Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Hb Values Within the Target Range at the SEP</measure>
    <time_frame>Week 18 to Week 20</time_frame>
    <description>The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing</measure>
    <time_frame>Week 18 to Week 20</time_frame>
    <description>The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for &quot;Vadadustat Total (TIW dosing regimen)&quot;. For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP</measure>
    <time_frame>Week 10 to Week 12</time_frame>
    <description>The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP</measure>
    <time_frame>Week 18 to Week 20</time_frame>
    <description>The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation</measure>
    <time_frame>Up to Week 20</time_frame>
    <description>Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue</measure>
    <time_frame>Up to Week 20</time_frame>
    <description>ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Requiring Red Blood Cell (RBC) Transfusion</measure>
    <time_frame>Up to Week 20</time_frame>
    <description>RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group</measure>
    <time_frame>Baseline; Week 1 (pre-dose), Week 1 +1 (Day 8; pre-dose), Week 11 (pre-dose), and Week 13 (pre-dose)</time_frame>
    <description>Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Reticulocyte Count</measure>
    <time_frame>Baseline; Week 1, Week 4, Week 8, Week 11, Week 12, Week 13, Week 16, and Week 20</time_frame>
    <description>Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Iron Concentration</measure>
    <time_frame>Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20</time_frame>
    <description>Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Ferritin Concentration</measure>
    <time_frame>Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20</time_frame>
    <description>Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Total Iron Binding Capacity</measure>
    <time_frame>Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20</time_frame>
    <description>Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Hepcidin Concentration</measure>
    <time_frame>Baseline; Week 12 and Week 20</time_frame>
    <description>Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose</measure>
    <time_frame>Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose</time_frame>
    <description>Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose</measure>
    <time_frame>Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose</time_frame>
    <description>Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose</measure>
    <time_frame>Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose</time_frame>
    <description>Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose</measure>
    <time_frame>Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose</time_frame>
    <description>Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose</measure>
    <time_frame>Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose</time_frame>
    <description>Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose</measure>
    <time_frame>Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose</time_frame>
    <description>Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose</measure>
    <time_frame>Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose</time_frame>
    <description>Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">175</enrollment>
  <condition>Anemia</condition>
  <condition>Dialysis-dependent Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>Vadadustat</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The initial dose of Vadadustat (300, 450, or 600 milligrams [mg]) will be based upon the dose of Epoetin Alfa dose participants had received prior to Vadadustat treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vadadustat TIW</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to Vadadustat (Main and erythropoiesis-stimulating agent [ESA] hyporesponder parallel studies) who complete a once-daily dosing regimen treatment period and meet eligibility criteria for transition to three times weekly (TIW) dosing will switch to TIW dosing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Epoetin Alfa</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Epoetin Alfa</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vadadustat</intervention_name>
    <description>Vadadustat Tablets 150 mg</description>
    <arm_group_label>Vadadustat</arm_group_label>
    <other_name>AKB-6548</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epoetin Alfa</intervention_name>
    <description>Epoetin Alfa</description>
    <arm_group_label>Epoetin Alfa</arm_group_label>
    <other_name>Procrit</other_name>
    <other_name>Epogen</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vadadustat TIW</intervention_name>
    <description>Oral Vadadustat</description>
    <arm_group_label>Vadadustat TIW</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥18 years of age, providing informed consent&#xD;
&#xD;
          -  Receiving chronic, outpatient in-center hemodialysis (TIW) for end-stage renal disease&#xD;
             for at least 12 weeks prior to Screening&#xD;
&#xD;
          -  Maintained on intravenous Epoetin Alfa therapy for 8 weeks prior to and including&#xD;
             Screening through Screening Visit 2 (SV2)&#xD;
&#xD;
          -  Eligibility in the Main study and erythropoiesis-stimulating agent (ESA) hyporesponder&#xD;
             parallel study is based on the following mean weekly Epoetin Alfa doses:&#xD;
&#xD;
               1. Main study: Mean weekly Epoetin Alfa dose &lt;300 Units per kilogram per week&#xD;
                  (U/kg/week) for 8 weeks prior to SV2;&#xD;
&#xD;
               2. ESA hyporesponder parallel study: Mean weekly Epoetin Alfa dose ≥300 U/kg/week&#xD;
                  for 8 weeks prior to SV2&#xD;
&#xD;
          -  Two Hb values measured by the central laboratory at least 4 days apart between&#xD;
             Screening Visit 1 (SV1) and SV2 as indicated:.&#xD;
&#xD;
               1. Main study: 2 Hb values between 8.5 and 11.0 g/dL, inclusive;&#xD;
&#xD;
               2. ESA hyporesponder parallel study: 2 Hb values between 8.0 and 10.0 grams per&#xD;
                  deciliter (g/dL), inclusive&#xD;
&#xD;
          -  Serum ferritin ≥100 nanograms per milliliter (ng/mL) and transferrin saturation (TSAT)&#xD;
             ≥20% during Screening&#xD;
&#xD;
          -  Folate and vitamin B12 measurements ≥ lower limit of normal during Screening&#xD;
&#xD;
          -  Hemodialysis adequacy as indicated by single-pool Kt/Vurea ≥1.2 using the most recent&#xD;
             historical measurement within 8 weeks prior to or during Screening&#xD;
&#xD;
          -  Understands the procedures and requirements of the study and provides written informed&#xD;
             consent and authorization for protected health information disclosure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anemia due to a cause other than chronic kidney disease (e.g., sickle cell disease,&#xD;
             myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma,&#xD;
             hemolytic anemia, thalassemia, or pure red cell aplasia)&#xD;
&#xD;
          -  Active bleeding or recent blood loss within 8 weeks prior to randomization&#xD;
&#xD;
          -  Red blood cell (RBC) transfusion within 8 weeks prior to randomization&#xD;
&#xD;
          -  Anticipated to discontinue hemodialysis during the study&#xD;
&#xD;
          -  Judged by the Investigator that the participant is likely to need rescue therapy (ESA&#xD;
             administration or RBC transfusion) immediately after enrollment in the study&#xD;
&#xD;
          -  History of chronic liver disease (e.g., chronic infectious hepatitis, chronic&#xD;
             autoimmune liver disease, cirrhosis or fibrosis of the liver)&#xD;
&#xD;
          -  Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT),&#xD;
             alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT), or total&#xD;
             bilirubin &gt;1.5 x upper limit of normal (ULN) during Screening. Participants with a&#xD;
             history of Gilbert's syndrome are not excluded.&#xD;
&#xD;
          -  Current uncontrolled hypertension as determined by the Investigator that would&#xD;
             contraindicate the use of Epoetin Alfa&#xD;
&#xD;
          -  Acute coronary syndrome (hospitalization for unstable angina or myocardial&#xD;
             infarction), surgical or percutaneous intervention for coronary, cerebrovascular or&#xD;
             peripheral artery disease (aortic or lower extremity), surgical or percutaneous&#xD;
             valvular replacement or repair, sustained ventricular tachycardia, hospitalization for&#xD;
             heart failure (HF) or New York Heart Association Class IV HF, or stroke within 12&#xD;
             weeks prior to or during Screening&#xD;
&#xD;
          -  History of new or recurrent malignancy within 2 years prior to and during Screening or&#xD;
             currently receiving treatment or suppressive therapy for cancer. Participants with&#xD;
             treated basal cell carcinoma of skin, curatively resected squamous cell carcinoma of&#xD;
             skin, or cervical carcinoma in situ are not excluded.&#xD;
&#xD;
          -  History of deep vein thrombosis or pulmonary embolism within 12 weeks prior to or&#xD;
             during Screening&#xD;
&#xD;
          -  History of hemosiderosis or hemochromatosis&#xD;
&#xD;
          -  History of prior organ transplantation (participants with a history of failed kidney&#xD;
             transplant or corneal transplants are not excluded)&#xD;
&#xD;
          -  Scheduled organ transplant from a living donor and participants on the kidney&#xD;
             transplant wait-list who are expected to receive a transplant within 6 months&#xD;
&#xD;
          -  History of a prior hematopoietic stem cell or bone marrow transplant (stem cell&#xD;
             therapy for knee arthritis is not excluded)&#xD;
&#xD;
          -  Known hypersensitivity to Vadadustat, Epoetin Alfa, or any of their excipients&#xD;
&#xD;
          -  Any prior use of a hypoxia-inducible factor prolyl-hydroxylase (HIF-PH) inhibitor or&#xD;
             any use of an investigational medication within 30 days or 5 half-lives of the&#xD;
             investigational medication (whichever is longer), prior to randomization&#xD;
&#xD;
          -  For female participants of non-childbearing potential:&#xD;
&#xD;
               1. inability to confirm surgical sterility (e.g., hysterectomy, bilateral tubal&#xD;
                  ligation, bilateral oophorectomy) at least 1 month prior to Screening;&#xD;
&#xD;
               2. not considered post-menopausal (no menses for &gt;1 year with follicle stimulating&#xD;
                  hormone &gt;40 U/Liter at Screening)&#xD;
&#xD;
          -  For female participants of childbearing potential:&#xD;
&#xD;
               1. lack of confirmation of the use of acceptable forms of contraception* for a&#xD;
                  minimum of one complete menstrual cycle prior to Screening;&#xD;
&#xD;
               2. positive serum pregnancy test at SV2;&#xD;
&#xD;
               3. unwilling to use two acceptable forms of contraception* (at least one of which&#xD;
                  must be a barrier method) starting Baseline/Day 1, throughout the Treatment&#xD;
                  Period and for 30 days after the final study drug administration&#xD;
&#xD;
          -  Breastfeeding during Screening or throughout the Treatment Period and for 30 days&#xD;
             after the final study drug administration&#xD;
&#xD;
          -  Donation of ova starting at Screening, throughout the Treatment Period, and for 30&#xD;
             days after the final study drug administration&#xD;
&#xD;
          -  Male participants who have not had a vasectomy and do not agree to the following: use&#xD;
             of an acceptable form of contraception* during the study and for 30 days after the&#xD;
             last dose of the study drug; to not donate semen during the study and for at least 30&#xD;
             days after the last dose of Vadadustat&#xD;
&#xD;
          -  Participants with bilateral native nephrectomy&#xD;
&#xD;
          -  Any other reason, which in the opinion of the Investigator, would make the participant&#xD;
             not suitable for participation in the study&#xD;
&#xD;
               -  Acceptable forms of contraception include:&#xD;
&#xD;
                    -  Established use of oral, injected or implanted hormonal methods of&#xD;
                       contraception;&#xD;
&#xD;
                    -  Placement of an intrauterine device or intrauterine system;&#xD;
&#xD;
                    -  Barrier methods of contraception: condom or occlusive cap (diaphragm or&#xD;
                       cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chief Medical Officer</last_name>
    <role>Study Director</role>
    <affiliation>Akebia Therapeutics Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Granada Hills</city>
        <state>California</state>
        <zip>91344</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site #1</name>
      <address>
        <city>San Dimas</city>
        <state>California</state>
        <zip>91773</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site #2</name>
      <address>
        <city>San Dimas</city>
        <state>California</state>
        <zip>91773</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Gabriel</city>
        <state>California</state>
        <zip>91776</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tarzana</city>
        <state>California</state>
        <zip>91356</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Vacaville</city>
        <state>California</state>
        <zip>95688</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Victorville</city>
        <state>California</state>
        <zip>92394</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bridgeport</city>
        <state>Connecticut</state>
        <zip>06606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hartford</city>
        <state>Connecticut</state>
        <zip>06762</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33126</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33150</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Winter Park</city>
        <state>Florida</state>
        <zip>32789</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Statesboro</city>
        <state>Georgia</state>
        <zip>30458</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Roseville</city>
        <state>Michigan</state>
        <zip>48066</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site #1</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site #2</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <zip>28801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Canton</city>
        <state>Ohio</state>
        <zip>44718</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79915</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78258</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chesapeake</city>
        <state>Virginia</state>
        <zip>23320</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wauwatosa</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <results_first_submitted>April 27, 2022</results_first_submitted>
  <results_first_submitted_qc>September 1, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 29, 2022</results_first_posted>
  <disposition_first_submitted>June 4, 2021</disposition_first_submitted>
  <disposition_first_submitted_qc>September 1, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">September 29, 2022</disposition_first_posted>
  <last_update_submitted>September 1, 2022</last_update_submitted>
  <last_update_submitted_qc>September 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vadadustat</keyword>
  <keyword>AKB-6548</keyword>
  <keyword>Anemia</keyword>
  <keyword>Chronic kidney disease (CKD)</keyword>
  <keyword>erythropoietin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Anemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epoetin Alfa</mesh_term>
    <mesh_term>Glycine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 27, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT03799627/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/27/NCT03799627/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 540 participants were screened, of which 175 participants were enrolled and randomized into the 2 parts of this study (Main Study; n=165; Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study: n=10). A total of 365 participants failed screening. Participants were randomized to either a Vadadustat or Epoetin Alfa treatment group, and randomization was stratified by mean weekly Epoetin Alfa dose calculated over a period of 8 weeks prior to Screening Visit 2.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
          <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
        </group>
        <group group_id="P2">
          <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
          <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
        </group>
        <group group_id="P3">
          <title>Low Dose of Epoetin Alfa: Epoetin Alfa</title>
          <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
        </group>
        <group group_id="P4">
          <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
          <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
        </group>
        <group group_id="P5">
          <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
          <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
        </group>
        <group group_id="P6">
          <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
          <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
        </group>
        <group group_id="P7">
          <title>High Dose of Epoetin Alfa: Epoetin Alfa</title>
          <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
        </group>
        <group group_id="P8">
          <title>ESA Hyporesponder: Vadadustat 600 mg</title>
          <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
        </group>
        <group group_id="P9">
          <title>ESA Hyporesponder: Epoetin Alfa</title>
          <description>In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="34"/>
                <participants group_id="P3" count="23"/>
                <participants group_id="P4" count="18"/>
                <participants group_id="P5" count="21"/>
                <participants group_id="P6" count="21"/>
                <participants group_id="P7" count="13"/>
                <participants group_id="P8" count="5"/>
                <participants group_id="P9" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="23"/>
                <participants group_id="P3" count="22"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="12"/>
                <participants group_id="P6" count="8"/>
                <participants group_id="P7" count="10"/>
                <participants group_id="P8" count="3"/>
                <participants group_id="P9" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="10"/>
                <participants group_id="P5" count="9"/>
                <participants group_id="P6" count="13"/>
                <participants group_id="P7" count="3"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="5"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="2"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="3"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Drug Put on Hold</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Due to Urgent Safety Measures Letter</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Kidney Transplantation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant Was on Rescue Epogen</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Placed on Dose Hold Until End of Treatment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Met Exclusion Criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Investigational Product Noncompliance</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant Relocation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="1"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Eurofin Issue</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Noncompliance with Site Instructions</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant's Last Dose Prior to End of Treatment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Changes In Hemoglobin Values</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="2"/>
                <participants group_id="P7" count="1"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
          <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
        </group>
        <group group_id="B2">
          <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
          <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
        </group>
        <group group_id="B3">
          <title>Low Dose of Epoetin Alfa: Epoetin Alfa</title>
          <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
        </group>
        <group group_id="B4">
          <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
          <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
        </group>
        <group group_id="B5">
          <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
          <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
        </group>
        <group group_id="B6">
          <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
          <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
        </group>
        <group group_id="B7">
          <title>High Dose of Epoetin Alfa: Epoetin Alfa</title>
          <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
        </group>
        <group group_id="B8">
          <title>ESA Hyporesponder: Vadadustat 600 mg</title>
          <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
        </group>
        <group group_id="B9">
          <title>ESA Hyporesponder: Epoetin Alfa</title>
          <description>In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
        </group>
        <group group_id="B10">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="35"/>
            <count group_id="B2" value="34"/>
            <count group_id="B3" value="23"/>
            <count group_id="B4" value="18"/>
            <count group_id="B5" value="21"/>
            <count group_id="B6" value="21"/>
            <count group_id="B7" value="13"/>
            <count group_id="B8" value="5"/>
            <count group_id="B9" value="5"/>
            <count group_id="B10" value="175"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="18"/>
                    <measurement group_id="B6" value="13"/>
                    <measurement group_id="B7" value="7"/>
                    <measurement group_id="B8" value="4"/>
                    <measurement group_id="B9" value="3"/>
                    <measurement group_id="B10" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="2"/>
                    <measurement group_id="B10" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="9"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="4"/>
                    <measurement group_id="B9" value="3"/>
                    <measurement group_id="B10" value="67"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="19"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="14"/>
                    <measurement group_id="B6" value="12"/>
                    <measurement group_id="B7" value="7"/>
                    <measurement group_id="B8" value="1"/>
                    <measurement group_id="B9" value="2"/>
                    <measurement group_id="B10" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="1"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="1"/>
                    <measurement group_id="B10" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="2"/>
                    <measurement group_id="B10" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="13"/>
                    <measurement group_id="B6" value="14"/>
                    <measurement group_id="B7" value="6"/>
                    <measurement group_id="B8" value="2"/>
                    <measurement group_id="B9" value="2"/>
                    <measurement group_id="B10" value="89"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="5"/>
                    <measurement group_id="B7" value="5"/>
                    <measurement group_id="B8" value="3"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP)</title>
        <description>Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1.</description>
        <time_frame>Baseline; Week 10 to Week 12</time_frame>
        <population>Randomized Population: All randomized participants. Analysis of this population was based on the randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>Low Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O7">
            <title>High Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O8">
            <title>ESA Hyporesponder: Vadadustat 600 mg</title>
            <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O9">
            <title>ESA Hyporesponder: Epoetin Alfa</title>
            <description>In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP)</title>
          <description>Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1.</description>
          <population>Randomized Population: All randomized participants. Analysis of this population was based on the randomized treatment.</population>
          <units>grams per deciliter (g/dL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="13"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="23"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="21"/>
                    <count group_id="O7" value="13"/>
                    <count group_id="O8" value="5"/>
                    <count group_id="O9" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.223" spread="0.5805"/>
                    <measurement group_id="O2" value="10.059" spread="0.6769"/>
                    <measurement group_id="O3" value="10.165" spread="0.6806"/>
                    <measurement group_id="O4" value="9.778" spread="0.6832"/>
                    <measurement group_id="O5" value="10.288" spread="0.5445"/>
                    <measurement group_id="O6" value="10.095" spread="0.7150"/>
                    <measurement group_id="O7" value="9.950" spread="0.7950"/>
                    <measurement group_id="O8" value="9.530" spread="0.2864"/>
                    <measurement group_id="O9" value="9.620" spread="0.6925"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change from Baseline at PEP</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="23"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="18"/>
                    <count group_id="O6" value="14"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="4"/>
                    <count group_id="O9" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.371" spread="0.8920"/>
                    <measurement group_id="O2" value="0.072" spread="1.1353"/>
                    <measurement group_id="O3" value="0.160" spread="0.7519"/>
                    <measurement group_id="O4" value="-0.911" spread="1.3515"/>
                    <measurement group_id="O5" value="-0.284" spread="1.0383"/>
                    <measurement group_id="O6" value="-0.418" spread="1.2752"/>
                    <measurement group_id="O7" value="0.268" spread="1.0087"/>
                    <measurement group_id="O8" value="-0.671" spread="0.7643"/>
                    <measurement group_id="O9" value="-0.290" spread="1.7730"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</title>
        <description>An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>Low Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O7">
            <title>High Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O8">
            <title>ESA Hyporesponder: Vadadustat 600 mg</title>
            <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O9">
            <title>ESA Hyporesponder: Epoetin Alfa</title>
            <description>In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs)</title>
          <description>An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported.</description>
          <population>Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="35"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="13"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="12"/>
                    <measurement group_id="O5" value="14"/>
                    <measurement group_id="O6" value="13"/>
                    <measurement group_id="O7" value="9"/>
                    <measurement group_id="O8" value="5"/>
                    <measurement group_id="O9" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values</title>
        <description>Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>Low Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O7">
            <title>High Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O8">
            <title>ESA Hyporesponder: Vadadustat 600 mg</title>
            <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O9">
            <title>ESA Hyporesponder: Epoetin Alfa</title>
            <description>In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values</title>
          <description>Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes.</description>
          <population>Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="35"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="13"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values</title>
        <description>Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes.</description>
        <time_frame>Up to Week 24</time_frame>
        <population>Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>Low Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O7">
            <title>High Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O8">
            <title>ESA Hyporesponder: Vadadustat 600 mg</title>
            <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O9">
            <title>ESA Hyporesponder: Epoetin Alfa</title>
            <description>In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values</title>
          <description>Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes.</description>
          <population>Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="35"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="13"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Classified as Hb Outliers</title>
        <description>The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or &lt;8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period.</description>
        <time_frame>Weeks 13 - 20</time_frame>
        <population>Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. Only participants with available data were included in the analysis. The rows presenting data for HB &gt; 12.0 g/dL, HB &gt; 13.0 g/dL and HB &gt; 14.0 g/dL are mutually exclusive.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>Low Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O7">
            <title>High Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O8">
            <title>ESA Hyporesponder: Vadadustat 600 mg</title>
            <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O9">
            <title>ESA Hyporesponder: Epoetin Alfa</title>
            <description>In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Classified as Hb Outliers</title>
          <description>The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or &lt;8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period.</description>
          <population>Safety Population. Analysis of this population was based on the actual treatment received. Participants who received Vadadustat and Epoetin Alfa in error were classified by the more frequently received drug. Only participants with available data were included in the analysis. The rows presenting data for HB &gt; 12.0 g/dL, HB &gt; 13.0 g/dL and HB &gt; 14.0 g/dL are mutually exclusive.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="27"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="16"/>
                <count group_id="O6" value="13"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hb &gt;12.0 g/dL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hb &gt;13.0 g/dL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hb &gt;14.0 g/dL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hb &lt;8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hb increase &gt;1.0 g/dL within any 2-week interval</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="6"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Hb Values Within the Target Range at the PEP</title>
        <description>The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12.</description>
        <time_frame>Week 10 to Week 12</time_frame>
        <population>Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>Low Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O7">
            <title>High Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O8">
            <title>ESA Hyporesponder: Vadadustat 600 mg</title>
            <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O9">
            <title>ESA Hyporesponder: Epoetin Alfa</title>
            <description>In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Hb Values Within the Target Range at the PEP</title>
          <description>The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12.</description>
          <population>Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="18"/>
                <count group_id="O6" value="14"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="4"/>
                <count group_id="O9" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="4"/>
                    <measurement group_id="O6" value="4"/>
                    <measurement group_id="O7" value="6"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12</title>
        <description>Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for &quot;Vadadustat Total (TIW dosing regimen)&quot;. For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing.</description>
        <time_frame>Week 10 to Week 12; Week 18 to Week 20</time_frame>
        <population>Randomized Population. Analysis of this population was based on the randomized treatment. Only those who switched from Vadadustat QD to TIW dosing after Week 12 were included in the analysis (17 participants overall in Main Study and 0 participants in ESA Hyporesponder Parallel Study).</population>
        <group_list>
          <group group_id="O1">
            <title>Vadadustat 300 mg (Starting Dose in TIW Dosing Regimen)</title>
            <description>After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 300 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [150 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Vadadustat 450 mg (Starting Dose in TIW Dosing Regimen)</title>
            <description>After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 450 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [300 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>Vadadustat 600 mg (Starting Dose in TIW Dosing Regimen)</title>
            <description>After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 600 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [450 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O4">
            <title>Vadadustat 750 mg (Starting Dose in TIW Dosing Regimen)</title>
            <description>After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 750 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [600 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>Vadadustat Total (TIW Dosing Regimen)</title>
            <description>After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 1 tablet greater (150 mg) than final dose in QD dosing regimen. Vadadustat Total comprises all participants who switched from Vadadustat QD to TIW dosing regimen in the Main Study (i.e., combined arm for starting doses of 300mg, 450 mg, 600 mg and 750 mg). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>ESA Hyporesponder Parallel Study: Vadadustat ≤ 750 mg (TIW Dosing Regimen)</title>
            <description>After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat ≤ 750 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12</title>
          <description>Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for &quot;Vadadustat Total (TIW dosing regimen)&quot;. For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing.</description>
          <population>Randomized Population. Analysis of this population was based on the randomized treatment. Only those who switched from Vadadustat QD to TIW dosing after Week 12 were included in the analysis (17 participants overall in Main Study and 0 participants in ESA Hyporesponder Parallel Study).</population>
          <units>g/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="17"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.050" spread="NA">Standard deviation cannot be calculated due to only one participant with data</measurement>
                    <measurement group_id="O2" value="-1.021" spread="1.0961"/>
                    <measurement group_id="O3" value="-0.360" spread="0.4894"/>
                    <measurement group_id="O4" value="-0.103" spread="1.9225"/>
                    <measurement group_id="O5" value="-0.422" spread="1.1708"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change in Hb Between Baseline and the SEP</title>
        <description>Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20.</description>
        <time_frame>Baseline; Week 18 to Week 20</time_frame>
        <population>Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>Low Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O7">
            <title>High Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O8">
            <title>ESA Hyporesponder: Vadadustat 600 mg</title>
            <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O9">
            <title>ESA Hyporesponder: Epoetin Alfa</title>
            <description>In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change in Hb Between Baseline and the SEP</title>
          <description>Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20.</description>
          <population>Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.</population>
          <units>g/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="14"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.197" spread="1.1597"/>
                    <measurement group_id="O2" value="-0.186" spread="0.8703"/>
                    <measurement group_id="O3" value="0.070" spread="0.9545"/>
                    <measurement group_id="O4" value="0.114" spread="1.0242"/>
                    <measurement group_id="O5" value="-0.421" spread="0.8370"/>
                    <measurement group_id="O6" value="-0.545" spread="0.9771"/>
                    <measurement group_id="O7" value="0.343" spread="0.8897"/>
                    <measurement group_id="O8" value="-0.283" spread="0.7371"/>
                    <measurement group_id="O9" value="-0.400" spread="1.0157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Hb Values Within the Target Range at the SEP</title>
        <description>The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20.</description>
        <time_frame>Week 18 to Week 20</time_frame>
        <population>Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>Low Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O7">
            <title>High Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O8">
            <title>ESA Hyporesponder: Vadadustat 600 mg</title>
            <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O9">
            <title>ESA Hyporesponder: Epoetin Alfa</title>
            <description>In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Hb Values Within the Target Range at the SEP</title>
          <description>The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20.</description>
          <population>Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="14"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="6"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing</title>
        <description>The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for &quot;Vadadustat Total (TIW dosing regimen)&quot;. For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing.</description>
        <time_frame>Week 18 to Week 20</time_frame>
        <population>Randomized Population. Analysis of this population was based on the randomized treatment. Only those who switched from Vadadustat QD to TIW dosing after Week 12 were included in the analysis (17 participants overall in Main Study and 0 participants in ESA Hyporesponder Parallel Study).</population>
        <group_list>
          <group group_id="O1">
            <title>Vadadustat 300 mg (Starting Dose in TIW Dosing Regimen)</title>
            <description>After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 300 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [150 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Vadadustat 450 mg (Starting Dose in TIW Dosing Regimen)</title>
            <description>After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 450 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [300 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>Vadadustat 600 mg (Starting Dose in TIW Dosing Regimen)</title>
            <description>After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 600 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [450 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O4">
            <title>Vadadustat 750 mg (Starting Dose in TIW Dosing Regimen)</title>
            <description>After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 750 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen [600 mg]). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>Vadadustat Total (TIW Dosing Regimen)</title>
            <description>After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat 1 tablet greater (150 mg) than final dose in QD dosing regimen. Vadadustat Total comprises all participants who switched from Vadadustat QD to TIW dosing regimen in the Main Study (i.e., combined arm for starting doses of 300mg, 450 mg, 600 mg and 750 mg). Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>ESA Hyporesponder Parallel Study: Vadadustat ≤ 750 mg (TIW Dosing Regimen)</title>
            <description>After completing the 12-week QD dosing regimen, eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing to receive a starting dose of Vadadustat ≤ 750 mg (1 tablet greater [150 mg] than final dose in QD dosing regimen. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing</title>
          <description>The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for &quot;Vadadustat Total (TIW dosing regimen)&quot;. For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing.</description>
          <population>Randomized Population. Analysis of this population was based on the randomized treatment. Only those who switched from Vadadustat QD to TIW dosing after Week 12 were included in the analysis (17 participants overall in Main Study and 0 participants in ESA Hyporesponder Parallel Study).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="4"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="17"/>
                <count group_id="O6" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP</title>
        <description>The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12.</description>
        <time_frame>Week 10 to Week 12</time_frame>
        <population>Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>Low Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O7">
            <title>High Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O8">
            <title>ESA Hyporesponder: Vadadustat 600 mg</title>
            <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O9">
            <title>ESA Hyporesponder: Epoetin Alfa</title>
            <description>In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP</title>
          <description>The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12.</description>
          <population>Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="18"/>
                <count group_id="O6" value="14"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="4"/>
                <count group_id="O9" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="6"/>
                    <measurement group_id="O7" value="8"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP</title>
        <description>The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20.</description>
        <time_frame>Week 18 to Week 20</time_frame>
        <population>Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Stratum 1 (Epoetin Alfa ≤90 U/kg/Week): Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Stratum 1 (Epoetin Alfa ≤90 U/kg/Week): Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>Stratum 1 (Epoetin Alfa ≤90 U/kg/Week): Epoetin Alfa</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O7">
            <title>High Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O8">
            <title>ESA Hyporesponder (Epoetin Alfa ≥300 U/kg/Week): Vadadustat 600 mg</title>
            <description>In the erythropoiesis-stimulating agent (ESA) hyporesponder parallel study participants who were maintained on ≥300 U/kg/week dose of Epoetin Alfa prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with an oral dose of Vadadustat 600 mg tablet per day.</description>
          </group>
          <group group_id="O9">
            <title>ESA Hyporesponder (Epoetin Alfa ≥300 U/kg/Week): Epoetin Alfa</title>
            <description>In the ESA hyporesponder parallel study participants who were maintained on ≥300 U/kg/week dose of Epoetin Alfa prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three TIW dose of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP</title>
          <description>The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20.</description>
          <population>Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="7"/>
                <count group_id="O5" value="14"/>
                <count group_id="O6" value="10"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="3"/>
                <count group_id="O9" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="8"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation</title>
        <description>Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%.</description>
        <time_frame>Up to Week 20</time_frame>
        <population>Randomized Population. Analysis of this population was based on the randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>Low Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O7">
            <title>High Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O8">
            <title>ESA Hyporesponder: Vadadustat 600 mg</title>
            <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O9">
            <title>ESA Hyporesponder: Epoetin Alfa</title>
            <description>In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation</title>
          <description>Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%.</description>
          <population>Randomized Population. Analysis of this population was based on the randomized treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="13"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="16"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="14"/>
                    <measurement group_id="O6" value="18"/>
                    <measurement group_id="O7" value="10"/>
                    <measurement group_id="O8" value="4"/>
                    <measurement group_id="O9" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue</title>
        <description>ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL.</description>
        <time_frame>Up to Week 20</time_frame>
        <population>Randomized Population. Analysis of this population was based on the randomized treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>Low Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O7">
            <title>High Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O8">
            <title>ESA Hyporesponder: Vadadustat 600 mg</title>
            <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O9">
            <title>ESA Hyporesponder: Epoetin Alfa</title>
            <description>In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue</title>
          <description>ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL.</description>
          <population>Randomized Population. Analysis of this population was based on the randomized treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="13"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="3"/>
                    <measurement group_id="O7" value="1"/>
                    <measurement group_id="O8" value="3"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Requiring Red Blood Cell (RBC) Transfusion</title>
        <description>RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood.</description>
        <time_frame>Up to Week 20</time_frame>
        <population>Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>Low Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three times a week (TIW) dose of Epoetin Alfa based on the participant's central laboratory hemoglobin (Hb) value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O7">
            <title>High Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O8">
            <title>ESA Hyporesponder: Vadadustat 600 mg</title>
            <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O9">
            <title>ESA Hyporesponder: Epoetin Alfa</title>
            <description>In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Requiring Red Blood Cell (RBC) Transfusion</title>
          <description>RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood.</description>
          <population>Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="13"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="2"/>
                    <measurement group_id="O7" value="0"/>
                    <measurement group_id="O8" value="1"/>
                    <measurement group_id="O9" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group</title>
        <description>Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
        <time_frame>Baseline; Week 1 (pre-dose), Week 1 +1 (Day 8; pre-dose), Week 11 (pre-dose), and Week 13 (pre-dose)</time_frame>
        <population>Pharmacokinetic (PK) Population: all randomized participants who received study drug and had enough drug concentrations to estimate AUC and Cmax. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with concentrations below the limit of quantitation (BLQ) for all the time points were excluded from the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>ESA Hyporesponder: Vadadustat 600 mg</title>
            <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group</title>
          <description>Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
          <population>Pharmacokinetic (PK) Population: all randomized participants who received study drug and had enough drug concentrations to estimate AUC and Cmax. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with concentrations below the limit of quantitation (BLQ) for all the time points were excluded from the analysis.</population>
          <units>Milliunits per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="15"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="15"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="12"/>
                    <count group_id="O4" value="17"/>
                    <count group_id="O5" value="14"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.33" spread="57.3"/>
                    <measurement group_id="O2" value="9.53" spread="54.0"/>
                    <measurement group_id="O3" value="9.93" spread="83.6"/>
                    <measurement group_id="O4" value="8.77" spread="48.2"/>
                    <measurement group_id="O5" value="6.98" spread="61.6"/>
                    <measurement group_id="O6" value="8.03" spread="53.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="33"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="20"/>
                    <count group_id="O5" value="15"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.1" spread="94.3"/>
                    <measurement group_id="O2" value="17.5" spread="97.0"/>
                    <measurement group_id="O3" value="15.3" spread="72.6"/>
                    <measurement group_id="O4" value="14.1" spread="86.4"/>
                    <measurement group_id="O5" value="20.2" spread="90.8"/>
                    <measurement group_id="O6" value="12.9" spread="54.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 +1 (Day 8)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="12"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.6" spread="76.3"/>
                    <measurement group_id="O2" value="18.9" spread="98.2"/>
                    <measurement group_id="O3" value="16.1" spread="76.0"/>
                    <measurement group_id="O4" value="18.0" spread="49.8"/>
                    <measurement group_id="O5" value="17.4" spread="104.8"/>
                    <measurement group_id="O6" value="9.49" spread="37.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="4"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.2" spread="55.9"/>
                    <measurement group_id="O2" value="14.9" spread="106.2"/>
                    <measurement group_id="O3" value="19.4" spread="78.0"/>
                    <measurement group_id="O4" value="20.6" spread="169.6"/>
                    <measurement group_id="O5" value="17.3" spread="53.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="15.7" spread="107.2"/>
                    <measurement group_id="O3" value="39.2" spread="NA">Dispersion data are not available for a single participant.</measurement>
                    <measurement group_id="O5" value="10.5" spread="47.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Reticulocyte Count</title>
        <description>Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
        <time_frame>Baseline; Week 1, Week 4, Week 8, Week 11, Week 12, Week 13, Week 16, and Week 20</time_frame>
        <population>Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>Low Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O7">
            <title>High Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O8">
            <title>ESA Hyporesponder: Vadadustat 600 mg</title>
            <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O9">
            <title>ESA Hyporesponder: Epoetin Alfa</title>
            <description>In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Reticulocyte Count</title>
          <description>Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
          <population>Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.</population>
          <units>10^3 cells/microliter (µL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="20"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="11"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="32"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="20"/>
                    <count group_id="O6" value="21"/>
                    <count group_id="O7" value="11"/>
                    <count group_id="O8" value="5"/>
                    <count group_id="O9" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.9" spread="27.57"/>
                    <measurement group_id="O2" value="47.2" spread="17.81"/>
                    <measurement group_id="O3" value="48.8" spread="27.27"/>
                    <measurement group_id="O4" value="59.3" spread="42.02"/>
                    <measurement group_id="O5" value="48.4" spread="33.45"/>
                    <measurement group_id="O6" value="51.5" spread="25.14"/>
                    <measurement group_id="O7" value="62.6" spread="25.88"/>
                    <measurement group_id="O8" value="77.6" spread="51.04"/>
                    <measurement group_id="O9" value="83.0" spread="45.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="16"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="16"/>
                    <count group_id="O6" value="16"/>
                    <count group_id="O7" value="10"/>
                    <count group_id="O8" value="5"/>
                    <count group_id="O9" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="24.09"/>
                    <measurement group_id="O2" value="6.9" spread="30.60"/>
                    <measurement group_id="O3" value="1.0" spread="22.42"/>
                    <measurement group_id="O4" value="-18.1" spread="24.81"/>
                    <measurement group_id="O5" value="-3.9" spread="28.51"/>
                    <measurement group_id="O6" value="-6.6" spread="33.80"/>
                    <measurement group_id="O7" value="20.4" spread="48.64"/>
                    <measurement group_id="O8" value="-35.8" spread="45.06"/>
                    <measurement group_id="O9" value="-25.2" spread="29.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="19"/>
                    <count group_id="O6" value="15"/>
                    <count group_id="O7" value="11"/>
                    <count group_id="O8" value="5"/>
                    <count group_id="O9" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.6" spread="32.25"/>
                    <measurement group_id="O2" value="14.9" spread="29.45"/>
                    <measurement group_id="O3" value="0.8" spread="40.68"/>
                    <measurement group_id="O4" value="-5.6" spread="37.38"/>
                    <measurement group_id="O5" value="2.9" spread="39.68"/>
                    <measurement group_id="O6" value="6.1" spread="33.24"/>
                    <measurement group_id="O7" value="22.5" spread="50.53"/>
                    <measurement group_id="O8" value="-26.8" spread="55.44"/>
                    <measurement group_id="O9" value="17.5" spread="26.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="18"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="14"/>
                    <count group_id="O6" value="11"/>
                    <count group_id="O7" value="8"/>
                    <count group_id="O8" value="4"/>
                    <count group_id="O9" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0" spread="31.40"/>
                    <measurement group_id="O2" value="23.9" spread="39.26"/>
                    <measurement group_id="O3" value="23.1" spread="38.98"/>
                    <measurement group_id="O4" value="9.1" spread="46.38"/>
                    <measurement group_id="O5" value="20.4" spread="49.42"/>
                    <measurement group_id="O6" value="23.1" spread="20.33"/>
                    <measurement group_id="O7" value="14.0" spread="54.60"/>
                    <measurement group_id="O8" value="-3.3" spread="67.56"/>
                    <measurement group_id="O9" value="-21.8" spread="69.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="19"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="15"/>
                    <count group_id="O6" value="9"/>
                    <count group_id="O7" value="9"/>
                    <count group_id="O8" value="3"/>
                    <count group_id="O9" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.7" spread="25.06"/>
                    <measurement group_id="O2" value="20.2" spread="25.80"/>
                    <measurement group_id="O3" value="21.0" spread="35.12"/>
                    <measurement group_id="O4" value="26.2" spread="26.2"/>
                    <measurement group_id="O5" value="32.5" spread="70.42"/>
                    <measurement group_id="O6" value="9.2" spread="41.30"/>
                    <measurement group_id="O7" value="3.9" spread="46.15"/>
                    <measurement group_id="O8" value="-6.7" spread="76.89"/>
                    <measurement group_id="O9" value="-27.2" spread="71.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="18"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="14"/>
                    <count group_id="O6" value="11"/>
                    <count group_id="O7" value="9"/>
                    <count group_id="O8" value="4"/>
                    <count group_id="O9" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.1" spread="32.60"/>
                    <measurement group_id="O2" value="16.3" spread="34.27"/>
                    <measurement group_id="O3" value="22.2" spread="26.72"/>
                    <measurement group_id="O4" value="47.7" spread="66.66"/>
                    <measurement group_id="O5" value="20.3" spread="44.30"/>
                    <measurement group_id="O6" value="26.9" spread="52.64"/>
                    <measurement group_id="O7" value="4.6" spread="39.53"/>
                    <measurement group_id="O8" value="3.8" spread="52.72"/>
                    <measurement group_id="O9" value="-17.3" spread="67.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="20"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="12"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="10"/>
                    <count group_id="O8" value="2"/>
                    <count group_id="O9" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" spread="27.07"/>
                    <measurement group_id="O2" value="12.1" spread="43.12"/>
                    <measurement group_id="O3" value="16.4" spread="26.53"/>
                    <measurement group_id="O4" value="46.3" spread="57.25"/>
                    <measurement group_id="O5" value="15.9" spread="43.79"/>
                    <measurement group_id="O6" value="10.5" spread="28.80"/>
                    <measurement group_id="O7" value="0.1" spread="46.05"/>
                    <measurement group_id="O8" value="2.0" spread="83.44"/>
                    <measurement group_id="O9" value="16.3" spread="11.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="21"/>
                    <count group_id="O3" value="19"/>
                    <count group_id="O4" value="5"/>
                    <count group_id="O5" value="9"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="7"/>
                    <count group_id="O8" value="2"/>
                    <count group_id="O9" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.9" spread="35.40"/>
                    <measurement group_id="O2" value="19.6" spread="37.61"/>
                    <measurement group_id="O3" value="8.3" spread="34.16"/>
                    <measurement group_id="O4" value="-2.2" spread="57.32"/>
                    <measurement group_id="O5" value="9.7" spread="30.17"/>
                    <measurement group_id="O6" value="0.2" spread="22.08"/>
                    <measurement group_id="O7" value="26.6" spread="55.82"/>
                    <measurement group_id="O8" value="-31.5" spread="86.97"/>
                    <measurement group_id="O9" value="4.0" spread="16.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="19"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="12"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="10"/>
                    <count group_id="O8" value="3"/>
                    <count group_id="O9" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.5" spread="25.74"/>
                    <measurement group_id="O2" value="13.2" spread="24.50"/>
                    <measurement group_id="O3" value="23.8" spread="26.49"/>
                    <measurement group_id="O4" value="10.3" spread="41.33"/>
                    <measurement group_id="O5" value="16.4" spread="35.54"/>
                    <measurement group_id="O6" value="10.9" spread="29.81"/>
                    <measurement group_id="O7" value="38.5" spread="44.11"/>
                    <measurement group_id="O8" value="-3.3" spread="52.58"/>
                    <measurement group_id="O9" value="40.0" spread="7.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Iron Concentration</title>
        <description>Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
        <time_frame>Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20</time_frame>
        <population>Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>Low Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O7">
            <title>High Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O8">
            <title>ESA Hyporesponder: Vadadustat 600 mg</title>
            <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O9">
            <title>ESA Hyporesponder: Epoetin Alfa</title>
            <description>In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Iron Concentration</title>
          <description>Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
          <population>Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.</population>
          <units>micrograms per deciliter (µg/dL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="13"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="23"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="21"/>
                    <count group_id="O7" value="13"/>
                    <count group_id="O8" value="5"/>
                    <count group_id="O9" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.4" spread="38.46"/>
                    <measurement group_id="O2" value="93.9" spread="36.56"/>
                    <measurement group_id="O3" value="90.1" spread="35.09"/>
                    <measurement group_id="O4" value="57.7" spread="26.71"/>
                    <measurement group_id="O5" value="80.9" spread="36.94"/>
                    <measurement group_id="O6" value="73.1" spread="22.23"/>
                    <measurement group_id="O7" value="65.7" spread="23.93"/>
                    <measurement group_id="O8" value="81.6" spread="37.01"/>
                    <measurement group_id="O9" value="58.4" spread="18.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="20"/>
                    <count group_id="O6" value="15"/>
                    <count group_id="O7" value="13"/>
                    <count group_id="O8" value="5"/>
                    <count group_id="O9" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.0" spread="34.49"/>
                    <measurement group_id="O2" value="-11.2" spread="33.59"/>
                    <measurement group_id="O3" value="-18.3" spread="22.83"/>
                    <measurement group_id="O4" value="3.3" spread="35.23"/>
                    <measurement group_id="O5" value="9.6" spread="29.67"/>
                    <measurement group_id="O6" value="1.7" spread="23.37"/>
                    <measurement group_id="O7" value="-6.6" spread="32.86"/>
                    <measurement group_id="O8" value="8.6" spread="17.36"/>
                    <measurement group_id="O9" value="3.8" spread="25.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="17"/>
                    <count group_id="O6" value="12"/>
                    <count group_id="O7" value="11"/>
                    <count group_id="O8" value="4"/>
                    <count group_id="O9" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.5" spread="45.04"/>
                    <measurement group_id="O2" value="-15.0" spread="40.51"/>
                    <measurement group_id="O3" value="-8.6" spread="44.30"/>
                    <measurement group_id="O4" value="4.5" spread="24.06"/>
                    <measurement group_id="O5" value="-5.9" spread="36.91"/>
                    <measurement group_id="O6" value="11.7" spread="40.33"/>
                    <measurement group_id="O7" value="-12.6" spread="26.55"/>
                    <measurement group_id="O8" value="0.3" spread="11.09"/>
                    <measurement group_id="O9" value="2.0" spread="20.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="18"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="14"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="9"/>
                    <count group_id="O8" value="4"/>
                    <count group_id="O9" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.7" spread="38.24"/>
                    <measurement group_id="O2" value="-22.2" spread="43.14"/>
                    <measurement group_id="O3" value="-26.0" spread="33.03"/>
                    <measurement group_id="O4" value="-2.8" spread="40.49"/>
                    <measurement group_id="O5" value="-0.4" spread="40.20"/>
                    <measurement group_id="O6" value="-5.1" spread="27.54"/>
                    <measurement group_id="O7" value="-16.1" spread="22.88"/>
                    <measurement group_id="O8" value="-2.5" spread="43.94"/>
                    <measurement group_id="O9" value="-12.6" spread="28.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="10"/>
                    <count group_id="O8" value="2"/>
                    <count group_id="O9" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.8" spread="39.39"/>
                    <measurement group_id="O2" value="-18.3" spread="39.85"/>
                    <measurement group_id="O3" value="-17.9" spread="53.89"/>
                    <measurement group_id="O4" value="-0.7" spread="10.26"/>
                    <measurement group_id="O5" value="5.2" spread="30.27"/>
                    <measurement group_id="O6" value="-4.6" spread="30.31"/>
                    <measurement group_id="O7" value="-13.9" spread="44.05"/>
                    <measurement group_id="O8" value="19.5" spread="53.03"/>
                    <measurement group_id="O9" value="-12.0" spread="24.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="3"/>
                    <count group_id="O9" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.2" spread="41.11"/>
                    <measurement group_id="O2" value="-9.5" spread="27.87"/>
                    <measurement group_id="O3" value="-16.6" spread="46.49"/>
                    <measurement group_id="O4" value="28.7" spread="67.73"/>
                    <measurement group_id="O5" value="-3.1" spread="32.43"/>
                    <measurement group_id="O6" value="13.4" spread="16.03"/>
                    <measurement group_id="O7" value="-8.4" spread="28.94"/>
                    <measurement group_id="O8" value="-15.3" spread="43.19"/>
                    <measurement group_id="O9" value="-10.3" spread="21.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Ferritin Concentration</title>
        <description>Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
        <time_frame>Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20</time_frame>
        <population>Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>Low Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O7">
            <title>High Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O8">
            <title>ESA Hyporesponder: Vadadustat 600 mg</title>
            <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O9">
            <title>ESA Hyporesponder: Epoetin Alfa</title>
            <description>In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Ferritin Concentration</title>
          <description>Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
          <population>Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.</population>
          <units>micrograms per liter (µg/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="13"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="23"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="21"/>
                    <count group_id="O7" value="13"/>
                    <count group_id="O8" value="5"/>
                    <count group_id="O9" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="939.3" spread="478.64"/>
                    <measurement group_id="O2" value="1043.6" spread="359.10"/>
                    <measurement group_id="O3" value="919.3" spread="298.27"/>
                    <measurement group_id="O4" value="910.2" spread="408.03"/>
                    <measurement group_id="O5" value="745.2" spread="362.98"/>
                    <measurement group_id="O6" value="739.5" spread="329.66"/>
                    <measurement group_id="O7" value="723.6" spread="484.29"/>
                    <measurement group_id="O8" value="1182.2" spread="508.67"/>
                    <measurement group_id="O9" value="449.6" spread="423.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="20"/>
                    <count group_id="O6" value="15"/>
                    <count group_id="O7" value="13"/>
                    <count group_id="O8" value="5"/>
                    <count group_id="O9" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.1" spread="185.45"/>
                    <measurement group_id="O2" value="-101.9" spread="204.51"/>
                    <measurement group_id="O3" value="-23.7" spread="274.39"/>
                    <measurement group_id="O4" value="41.4" spread="335.00"/>
                    <measurement group_id="O5" value="152.9" spread="347.97"/>
                    <measurement group_id="O6" value="45.5" spread="320.50"/>
                    <measurement group_id="O7" value="-145.6" spread="211.10"/>
                    <measurement group_id="O8" value="34.8" spread="470.43"/>
                    <measurement group_id="O9" value="-61.5" spread="17.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="26"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="17"/>
                    <count group_id="O6" value="12"/>
                    <count group_id="O7" value="11"/>
                    <count group_id="O8" value="4"/>
                    <count group_id="O9" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-120.8" spread="273.28"/>
                    <measurement group_id="O2" value="-185.4" spread="298.19"/>
                    <measurement group_id="O3" value="24.9" spread="334.28"/>
                    <measurement group_id="O4" value="29.4" spread="361.29"/>
                    <measurement group_id="O5" value="-5.6" spread="255.10"/>
                    <measurement group_id="O6" value="-87.8" spread="285.30"/>
                    <measurement group_id="O7" value="-78.3" spread="254.98"/>
                    <measurement group_id="O8" value="111.3" spread="609.61"/>
                    <measurement group_id="O9" value="397.8" spread="453.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="14"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="9"/>
                    <count group_id="O8" value="4"/>
                    <count group_id="O9" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-118.5" spread="220.40"/>
                    <measurement group_id="O2" value="-194.8" spread="288.47"/>
                    <measurement group_id="O3" value="-42.4" spread="356.19"/>
                    <measurement group_id="O4" value="-68.0" spread="275.11"/>
                    <measurement group_id="O5" value="-23.8" spread="303.39"/>
                    <measurement group_id="O6" value="-30.1" spread="386.24"/>
                    <measurement group_id="O7" value="-195.3" spread="304.63"/>
                    <measurement group_id="O8" value="-0.5" spread="237.99"/>
                    <measurement group_id="O9" value="-35.0" spread="157.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="10"/>
                    <count group_id="O8" value="2"/>
                    <count group_id="O9" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-92.0" spread="309.88"/>
                    <measurement group_id="O2" value="-70.9" spread="288.34"/>
                    <measurement group_id="O3" value="99.5" spread="567.19"/>
                    <measurement group_id="O4" value="-144.0" spread="358.78"/>
                    <measurement group_id="O5" value="27.8" spread="244.67"/>
                    <measurement group_id="O6" value="-97.2" spread="188.15"/>
                    <measurement group_id="O7" value="-81.8" spread="447.01"/>
                    <measurement group_id="O8" value="80.0" spread="243.24"/>
                    <measurement group_id="O9" value="62.3" spread="186.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="3"/>
                    <count group_id="O9" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-113.6" spread="327.06"/>
                    <measurement group_id="O2" value="-166.6" spread="298.67"/>
                    <measurement group_id="O3" value="26.5" spread="497.52"/>
                    <measurement group_id="O4" value="-199.4" spread="370.32"/>
                    <measurement group_id="O5" value="4.8" spread="331.76"/>
                    <measurement group_id="O6" value="-51.6" spread="253.07"/>
                    <measurement group_id="O7" value="-104.8" spread="347.53"/>
                    <measurement group_id="O8" value="249.0" spread="636.33"/>
                    <measurement group_id="O9" value="607.0" spread="607.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Total Iron Binding Capacity</title>
        <description>Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
        <time_frame>Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20</time_frame>
        <population>Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>Low Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O7">
            <title>High Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O8">
            <title>ESA Hyporesponder: Vadadustat 600 mg</title>
            <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O9">
            <title>ESA Hyporesponder: Epoetin Alfa</title>
            <description>In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Total Iron Binding Capacity</title>
          <description>Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
          <population>Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.</population>
          <units>µg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="23"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="13"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="23"/>
                    <count group_id="O4" value="18"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="21"/>
                    <count group_id="O7" value="13"/>
                    <count group_id="O8" value="5"/>
                    <count group_id="O9" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="237.8" spread="39.28"/>
                    <measurement group_id="O2" value="230.7" spread="39.09"/>
                    <measurement group_id="O3" value="234.8" spread="44.76"/>
                    <measurement group_id="O4" value="210.1" spread="33.33"/>
                    <measurement group_id="O5" value="235.7" spread="38.80"/>
                    <measurement group_id="O6" value="223.6" spread="34.31"/>
                    <measurement group_id="O7" value="218.2" spread="33.80"/>
                    <measurement group_id="O8" value="211.0" spread="42.99"/>
                    <measurement group_id="O9" value="225.6" spread="98.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="29"/>
                    <count group_id="O3" value="20"/>
                    <count group_id="O4" value="16"/>
                    <count group_id="O5" value="20"/>
                    <count group_id="O6" value="15"/>
                    <count group_id="O7" value="13"/>
                    <count group_id="O8" value="5"/>
                    <count group_id="O9" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.9" spread="27.11"/>
                    <measurement group_id="O2" value="27.7" spread="33.58"/>
                    <measurement group_id="O3" value="-13.4" spread="26.02"/>
                    <measurement group_id="O4" value="27.6" spread="28.49"/>
                    <measurement group_id="O5" value="41.0" spread="26.22"/>
                    <measurement group_id="O6" value="48.2" spread="37.78"/>
                    <measurement group_id="O7" value="-0.5" spread="21.44"/>
                    <measurement group_id="O8" value="44.2" spread="53.58"/>
                    <measurement group_id="O9" value="7.8" spread="14.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="27"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="17"/>
                    <count group_id="O6" value="12"/>
                    <count group_id="O7" value="11"/>
                    <count group_id="O8" value="4"/>
                    <count group_id="O9" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.3" spread="28.42"/>
                    <measurement group_id="O2" value="37.0" spread="40.99"/>
                    <measurement group_id="O3" value="-1.1" spread="18.38"/>
                    <measurement group_id="O4" value="26.3" spread="23.98"/>
                    <measurement group_id="O5" value="49.4" spread="27.34"/>
                    <measurement group_id="O6" value="58.8" spread="24.54"/>
                    <measurement group_id="O7" value="-7.4" spread="19.26"/>
                    <measurement group_id="O8" value="56.0" spread="58.15"/>
                    <measurement group_id="O9" value="-24.8" spread="58.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="25"/>
                    <count group_id="O3" value="18"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="14"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="9"/>
                    <count group_id="O8" value="4"/>
                    <count group_id="O9" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.4" spread="27.10"/>
                    <measurement group_id="O2" value="37.2" spread="43.09"/>
                    <measurement group_id="O3" value="-9.9" spread="25.85"/>
                    <measurement group_id="O4" value="25.1" spread="33.90"/>
                    <measurement group_id="O5" value="41.0" spread="39.05"/>
                    <measurement group_id="O6" value="54.5" spread="44.05"/>
                    <measurement group_id="O7" value="-3.8" spread="25.42"/>
                    <measurement group_id="O8" value="58.0" spread="14.45"/>
                    <measurement group_id="O9" value="-0.6" spread="15.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="10"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="10"/>
                    <count group_id="O8" value="2"/>
                    <count group_id="O9" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.0" spread="43.00"/>
                    <measurement group_id="O2" value="27.8" spread="35.16"/>
                    <measurement group_id="O3" value="-3.0" spread="25.44"/>
                    <measurement group_id="O4" value="55.3" spread="28.63"/>
                    <measurement group_id="O5" value="53.1" spread="58.33"/>
                    <measurement group_id="O6" value="60.9" spread="70.50"/>
                    <measurement group_id="O7" value="-13.7" spread="31.46"/>
                    <measurement group_id="O8" value="42.5" spread="62.93"/>
                    <measurement group_id="O9" value="-2.5" spread="18.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="12"/>
                    <count group_id="O8" value="3"/>
                    <count group_id="O9" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.0" spread="28.15"/>
                    <measurement group_id="O2" value="44.9" spread="30.71"/>
                    <measurement group_id="O3" value="-9.5" spread="29.29"/>
                    <measurement group_id="O4" value="51.7" spread="37.50"/>
                    <measurement group_id="O5" value="68.4" spread="43.40"/>
                    <measurement group_id="O6" value="67.9" spread="58.44"/>
                    <measurement group_id="O7" value="-5.4" spread="29.78"/>
                    <measurement group_id="O8" value="66.7" spread="35.22"/>
                    <measurement group_id="O9" value="-6.0" spread="21.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Hepcidin Concentration</title>
        <description>Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
        <time_frame>Baseline; Week 12 and Week 20</time_frame>
        <population>Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>Low Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O7">
            <title>High Dose of Epoetin Alfa: Epoetin Alfa</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
          </group>
          <group group_id="O8">
            <title>ESA Hyporesponder: Vadadustat 600 mg</title>
            <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O9">
            <title>ESA Hyporesponder: Epoetin Alfa</title>
            <description>In the ESA hyporesponder parallel study participants who were maintained on ≥300 U/kg/week dose of Epoetin Alfa prior to and including the screening period for a minimum of 8 weeks prior to screening visit 2, were administered with three TIW dose of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive.(US) Package Insert (PI) for adult participants with CKD on dialysis. Dose was adjusted to achieve and maintain Hb levels within the target range of 10.0 and 11.0 g/dL, inclusive&quot;</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Hepcidin Concentration</title>
          <description>Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.</description>
          <population>Randomized Population. Analysis of this population was based on the randomized treatment. Participants with non-missing values were included in the analysis.</population>
          <units>nanograms per milliliter (ng/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="34"/>
                <count group_id="O3" value="21"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="21"/>
                <count group_id="O6" value="21"/>
                <count group_id="O7" value="13"/>
                <count group_id="O8" value="5"/>
                <count group_id="O9" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="34"/>
                    <count group_id="O3" value="21"/>
                    <count group_id="O4" value="17"/>
                    <count group_id="O5" value="21"/>
                    <count group_id="O6" value="21"/>
                    <count group_id="O7" value="13"/>
                    <count group_id="O8" value="5"/>
                    <count group_id="O9" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="194.870" spread="113.9348"/>
                    <measurement group_id="O2" value="208.816" spread="85.1667"/>
                    <measurement group_id="O3" value="259.161" spread="134.9995"/>
                    <measurement group_id="O4" value="185.852" spread="105.6611"/>
                    <measurement group_id="O5" value="215.608" spread="130.7350"/>
                    <measurement group_id="O6" value="160.760" spread="102.6261"/>
                    <measurement group_id="O7" value="143.519" spread="124.6749"/>
                    <measurement group_id="O8" value="239.958" spread="151.3859"/>
                    <measurement group_id="O9" value="74.748" spread="40.2119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="24"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="7"/>
                    <count group_id="O5" value="14"/>
                    <count group_id="O6" value="10"/>
                    <count group_id="O7" value="9"/>
                    <count group_id="O8" value="3"/>
                    <count group_id="O9" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-50.565" spread="57.6474"/>
                    <measurement group_id="O2" value="-53.675" spread="92.1185"/>
                    <measurement group_id="O3" value="-66.646" spread="152.3178"/>
                    <measurement group_id="O4" value="-55.283" spread="77.1648"/>
                    <measurement group_id="O5" value="-34.868" spread="89.7176"/>
                    <measurement group_id="O6" value="-74.797" spread="126.1667"/>
                    <measurement group_id="O7" value="-62.787" spread="96.1842"/>
                    <measurement group_id="O8" value="-128.587" spread="262.6300"/>
                    <measurement group_id="O9" value="-1.062" spread="30.4842"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="24"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="17"/>
                    <count group_id="O4" value="6"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="8"/>
                    <count group_id="O7" value="10"/>
                    <count group_id="O8" value="3"/>
                    <count group_id="O9" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-86.025" spread="100.4382"/>
                    <measurement group_id="O2" value="-38.627" spread="75.0555"/>
                    <measurement group_id="O3" value="-83.685" spread="95.7049"/>
                    <measurement group_id="O4" value="-93.412" spread="115.2839"/>
                    <measurement group_id="O5" value="-83.012" spread="98.7521"/>
                    <measurement group_id="O6" value="-43.701" spread="80.8411"/>
                    <measurement group_id="O7" value="-80.680" spread="125.2481"/>
                    <measurement group_id="O8" value="-152.243" spread="218.9284"/>
                    <measurement group_id="O9" value="-9.023" spread="80.4001"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose</title>
        <description>Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose.</description>
        <time_frame>Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose</time_frame>
        <population>PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>ESA Hyporesponder: Vadadustat 600 mg</title>
            <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose</title>
          <description>Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose.</description>
          <population>PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.</population>
          <units>Micrograms per milliliter (μg/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="17"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="17"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.0" spread="87.9"/>
                    <measurement group_id="O2" value="40.8" spread="54.8"/>
                    <measurement group_id="O3" value="26.5" spread="59.3"/>
                    <measurement group_id="O4" value="47.0" spread="38.2"/>
                    <measurement group_id="O5" value="56.5" spread="39.2"/>
                    <measurement group_id="O6" value="44.2" spread="73.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 +1 (Day 8)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.1" spread="174.4"/>
                    <measurement group_id="O2" value="37.6" spread="78.9"/>
                    <measurement group_id="O3" value="23.8" spread="69.0"/>
                    <measurement group_id="O4" value="44.2" spread="29.6"/>
                    <measurement group_id="O5" value="60.1" spread="41.6"/>
                    <measurement group_id="O6" value="31.6" spread="151.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="4"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.6" spread="49.3"/>
                    <measurement group_id="O2" value="24.4" spread="350.6"/>
                    <measurement group_id="O3" value="32.4" spread="26.9"/>
                    <measurement group_id="O4" value="38.1" spread="99.0"/>
                    <measurement group_id="O5" value="41.2" spread="77.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="30.6" spread="102.7"/>
                    <measurement group_id="O3" value="11.5" spread="NA">Dispersion data are not available for a single participant</measurement>
                    <measurement group_id="O5" value="60.2" spread="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose</title>
        <description>Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose.</description>
        <time_frame>Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose</time_frame>
        <population>PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>ESA Hyporesponder: Vadadustat 600 mg</title>
            <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose</title>
          <description>Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose.</description>
          <population>PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.</population>
          <units>hours*µg/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="13"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="19"/>
                    <count group_id="O5" value="12"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="338" spread="63.8"/>
                    <measurement group_id="O2" value="518" spread="71.1"/>
                    <measurement group_id="O3" value="342" spread="81.7"/>
                    <measurement group_id="O4" value="605" spread="54.5"/>
                    <measurement group_id="O5" value="786" spread="36.6"/>
                    <measurement group_id="O6" value="464" spread="80.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 +1 (Day 8)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="28"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="289" spread="76.6"/>
                    <measurement group_id="O2" value="465" spread="80.8"/>
                    <measurement group_id="O3" value="310" spread="94.7"/>
                    <measurement group_id="O4" value="566" spread="41.1"/>
                    <measurement group_id="O5" value="847" spread="54.8"/>
                    <measurement group_id="O6" value="388" spread="112.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="4"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="344" spread="53.5"/>
                    <measurement group_id="O2" value="338" spread="282.0"/>
                    <measurement group_id="O3" value="402" spread="70.8"/>
                    <measurement group_id="O4" value="450" spread="68.2"/>
                    <measurement group_id="O5" value="588" spread="52.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose</title>
        <description>Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose.</description>
        <time_frame>Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose</time_frame>
        <population>PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>ESA Hyporesponder: Vadadustat 600 mg</title>
            <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose</title>
          <description>Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose.</description>
          <population>PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="17"/>
                    <count group_id="O3" value="7"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="5"/>
                    <count group_id="O6" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.53" lower_limit="5.36" upper_limit="26.6"/>
                    <measurement group_id="O2" value="10.5" lower_limit="3.26" upper_limit="21.1"/>
                    <measurement group_id="O3" value="12.5" lower_limit="7.33" upper_limit="20.7"/>
                    <measurement group_id="O4" value="10.3" lower_limit="6.33" upper_limit="18.3"/>
                    <measurement group_id="O5" value="11.0" lower_limit="6.51" upper_limit="18.0"/>
                    <measurement group_id="O6" value="9.01" lower_limit="8.45" upper_limit="9.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 +1 (Day 8)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.82" lower_limit="5.80" upper_limit="22.9"/>
                    <measurement group_id="O2" value="8.83" lower_limit="4.98" upper_limit="70.0"/>
                    <measurement group_id="O3" value="10.1" lower_limit="4.79" upper_limit="17.9"/>
                    <measurement group_id="O4" value="12.4" lower_limit="5.73" upper_limit="47.8"/>
                    <measurement group_id="O5" value="14.6" lower_limit="5.61" upper_limit="31.3"/>
                    <measurement group_id="O6" value="11.7" lower_limit="11.3" upper_limit="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="3"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.73" lower_limit="3.55" upper_limit="22.1"/>
                    <measurement group_id="O2" value="10.4" lower_limit="6.46" upper_limit="13.8"/>
                    <measurement group_id="O3" value="6.49" lower_limit="3.22" upper_limit="9.75"/>
                    <measurement group_id="O4" value="3.95" lower_limit="3.95" upper_limit="3.95"/>
                    <measurement group_id="O5" value="5.65" lower_limit="5.26" upper_limit="7.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="11.0" lower_limit="11.0" upper_limit="11.0"/>
                    <measurement group_id="O5" value="5.01" lower_limit="5.01" upper_limit="5.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose</title>
        <description>Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose.</description>
        <time_frame>Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose</time_frame>
        <population>PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>ESA Hyporesponder: Vadadustat 600 mg</title>
            <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose</title>
          <description>Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose.</description>
          <population>PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.</population>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="14"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="17"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="17"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.08" lower_limit="0.00" upper_limit="11.50"/>
                    <measurement group_id="O2" value="2.72" lower_limit="1.83" upper_limit="5.03"/>
                    <measurement group_id="O3" value="3.48" lower_limit="1.92" upper_limit="10.50"/>
                    <measurement group_id="O4" value="3.50" lower_limit="1.58" upper_limit="9.00"/>
                    <measurement group_id="O5" value="2.00" lower_limit="1.75" upper_limit="5.03"/>
                    <measurement group_id="O6" value="3.28" lower_limit="1.83" upper_limit="4.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 +1 (Day 8)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="14"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.28" lower_limit="1.75" upper_limit="6.75"/>
                    <measurement group_id="O2" value="2.11" lower_limit="0.00" upper_limit="5.23"/>
                    <measurement group_id="O3" value="3.33" lower_limit="1.80" upper_limit="5.00"/>
                    <measurement group_id="O4" value="3.30" lower_limit="0.00" upper_limit="5.00"/>
                    <measurement group_id="O5" value="2.17" lower_limit="1.75" upper_limit="5.05"/>
                    <measurement group_id="O6" value="3.42" lower_limit="1.80" upper_limit="4.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="4"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.23" lower_limit="0.00" upper_limit="4.50"/>
                    <measurement group_id="O2" value="3.50" lower_limit="1.75" upper_limit="10.83"/>
                    <measurement group_id="O3" value="3.50" lower_limit="2.00" upper_limit="4.67"/>
                    <measurement group_id="O4" value="2.03" lower_limit="1.75" upper_limit="3.63"/>
                    <measurement group_id="O5" value="2.11" lower_limit="1.80" upper_limit="5.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="4"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="2"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.98" lower_limit="1.75" upper_limit="5.00"/>
                    <measurement group_id="O3" value="4.25" lower_limit="4.25" upper_limit="4.25"/>
                    <measurement group_id="O5" value="2.04" lower_limit="1.97" upper_limit="2.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose</title>
        <description>Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose.</description>
        <time_frame>Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose</time_frame>
        <population>PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>ESA Hyporesponder: Vadadustat 600 mg</title>
            <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose</title>
          <description>Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose.</description>
          <population>PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.</population>
          <units>1/hour</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="17"/>
                    <count group_id="O3" value="7"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="5"/>
                    <count group_id="O6" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0797" spread="38.7"/>
                    <measurement group_id="O2" value="0.0665" spread="50.5"/>
                    <measurement group_id="O3" value="0.0560" spread="41.6"/>
                    <measurement group_id="O4" value="0.0681" spread="32.7"/>
                    <measurement group_id="O5" value="0.0608" spread="46.9"/>
                    <measurement group_id="O6" value="0.0771" spread="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 +1 (Day 8)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="16"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0720" spread="44.2"/>
                    <measurement group_id="O2" value="0.0615" spread="70.0"/>
                    <measurement group_id="O3" value="0.0714" spread="53.9"/>
                    <measurement group_id="O4" value="0.0469" spread="72.2"/>
                    <measurement group_id="O5" value="0.0469" spread="74.4"/>
                    <measurement group_id="O6" value="0.0594" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="3"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0925" spread="65.5"/>
                    <measurement group_id="O2" value="0.0687" spread="26.5"/>
                    <measurement group_id="O3" value="0.124" spread="92.0"/>
                    <measurement group_id="O4" value="0.175" spread="NA">Dispersion data are not available for a single participant</measurement>
                    <measurement group_id="O5" value="0.116" spread="15.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                    <count group_id="O5" value="1"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.0632" spread="NA">Dispersion data are not available for a single participant</measurement>
                    <measurement group_id="O5" value="0.138" spread="NA">Dispersion data are not available for a single participant</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose</title>
        <description>Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose.</description>
        <time_frame>Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose</time_frame>
        <population>PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>ESA Hyporesponder: Vadadustat 600 mg</title>
            <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose</title>
          <description>Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose.</description>
          <population>PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.</population>
          <units>liters per hour</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="21"/>
                <count group_id="O5" value="13"/>
                <count group_id="O6" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                    <count group_id="O2" value="23"/>
                    <count group_id="O3" value="11"/>
                    <count group_id="O4" value="19"/>
                    <count group_id="O5" value="12"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.888" spread="63.8"/>
                    <measurement group_id="O2" value="0.869" spread="71.1"/>
                    <measurement group_id="O3" value="0.877" spread="81.7"/>
                    <measurement group_id="O4" value="0.744" spread="54.5"/>
                    <measurement group_id="O5" value="0.763" spread="36.6"/>
                    <measurement group_id="O6" value="1.29" spread="80.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 +1 (Day 8)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="28"/>
                    <count group_id="O3" value="13"/>
                    <count group_id="O4" value="21"/>
                    <count group_id="O5" value="13"/>
                    <count group_id="O6" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.04" spread="76.6"/>
                    <measurement group_id="O2" value="0.967" spread="80.8"/>
                    <measurement group_id="O3" value="0.968" spread="94.7"/>
                    <measurement group_id="O4" value="0.795" spread="41.1"/>
                    <measurement group_id="O5" value="0.708" spread="54.8"/>
                    <measurement group_id="O6" value="1.55" spread="112.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="4"/>
                    <count group_id="O5" value="8"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.872" spread="53.5"/>
                    <measurement group_id="O2" value="1.33" spread="282.0"/>
                    <measurement group_id="O3" value="0.747" spread="70.8"/>
                    <measurement group_id="O4" value="1.00" spread="68.2"/>
                    <measurement group_id="O5" value="1.02" spread="52.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose</title>
        <description>Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose.</description>
        <time_frame>Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose</time_frame>
        <population>PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O2">
            <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O3">
            <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O4">
            <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O5">
            <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
            <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
          <group group_id="O6">
            <title>ESA Hyporesponder: Vadadustat 600 mg</title>
            <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose</title>
          <description>Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose.</description>
          <population>PK Population. Analysis of this population was based on the dose amount taken at the date of PK sampling for the Vadadustat group. Participants with non-missing values were included in the analysis. PK parameter of plasma Vadadustat concentration for Vadadustat treatment groups without dose normalization by strata of Epoetin Alfa dose group were included for the analysis.</population>
          <units>Liters</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="7"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="5"/>
                    <count group_id="O6" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9" spread="36.2"/>
                    <measurement group_id="O2" value="14.3" spread="53.4"/>
                    <measurement group_id="O3" value="13.7" spread="69.7"/>
                    <measurement group_id="O4" value="12.1" spread="38.6"/>
                    <measurement group_id="O5" value="13.8" spread="16.7"/>
                    <measurement group_id="O6" value="15.8" spread="56.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1 +1 (Day 8)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="15"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                    <count group_id="O5" value="6"/>
                    <count group_id="O6" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" spread="36.6"/>
                    <measurement group_id="O2" value="13.7" spread="41.0"/>
                    <measurement group_id="O3" value="17.4" spread="50.4"/>
                    <measurement group_id="O4" value="15.3" spread="67.4"/>
                    <measurement group_id="O5" value="15.6" spread="27.2"/>
                    <measurement group_id="O6" value="12.4" spread="35.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 11</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="1"/>
                    <count group_id="O5" value="3"/>
                    <count group_id="O6" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.2" spread="28.7"/>
                    <measurement group_id="O2" value="10.7" spread="37.6"/>
                    <measurement group_id="O3" value="10.1" spread="10.3"/>
                    <measurement group_id="O4" value="8.24" spread="NA">Dispersion data are not available for a single participant</measurement>
                    <measurement group_id="O5" value="8.76" spread="18.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Week 24 (from first dose of study drug to last dose + 4 weeks of follow-up)</time_frame>
      <desc>TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported. Safety Population: all participants in the Randomized Population who received at least 1 dose of study drug. Analysis of this population was based on actual treatment received. One participant randomized to the Low Dose of Epoetin Alfa: Vadadustat 300 mg arm inadvertently received 450 mg of Vadadustat.</desc>
      <group_list>
        <group group_id="E1">
          <title>Low Dose of Epoetin Alfa: Vadadustat 300 mg</title>
          <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 units per kilogram per week [U/kg/week]) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 milligram (mg) tablet per day (QD) until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to three times per week (TIW) dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target hemoglobin (Hb) levels during Week 12 to Week 14. Non-eligile participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 grams per deciliter (g/dL) were eligible for a dose increase by another 150 mg until Week 20.</description>
        </group>
        <group group_id="E2">
          <title>Low Dose of Epoetin Alfa: Vadadustat 450 mg</title>
          <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
        </group>
        <group group_id="E3">
          <title>Low Dose of Epoetin Alfa: Epoetin Alfa</title>
          <description>Participants who were maintained on the low dose of Epoetin Alfa (≤90 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa United States (US) Package Insert (PI) for adult participants with chronic kidney disease (CKD) on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
        </group>
        <group group_id="E4">
          <title>High Dose of Epoetin Alfa: Vadadustat 300 mg</title>
          <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 300 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (300 mg) plus a 150 mg greater dose (450 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
        </group>
        <group group_id="E5">
          <title>High Dose of Epoetin Alfa: Vadadustat 450 mg</title>
          <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 450 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (450 mg) plus a 150 mg greater dose (600 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
        </group>
        <group group_id="E6">
          <title>High Dose of Epoetin Alfa: Vadadustat 600 mg</title>
          <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 mg) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
        </group>
        <group group_id="E7">
          <title>High Dose of Epoetin Alfa: Epoetin Alfa</title>
          <description>Participants who were maintained on the high dose of Epoetin Alfa (&gt;90 to &lt;300 U/kg/week) prior to and including the Screening Period were administered TIW dosing of Epoetin Alfa for the entire Treatment Period based on the participant's Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
        </group>
        <group group_id="E8">
          <title>ESA Hyporesponder: Vadadustat 600 mg</title>
          <description>In the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered an oral dose of Vadadustat 600 mg tablet QD until Week 12. Eligible participants based on investigator's discretion were switched from daily dosing to TIW dosing of the starting Vadadustat dose (600 mg) plus a 150 mg greater dose (750 ng) to maintain target Hb levels during Week 12 to Week 14. Non-eligible participants continued with daily dosing. Participants who reported a decline in Hb ≥0.5 g/dL were eligible for a dose increase by another 150 mg until Week 20.</description>
        </group>
        <group group_id="E9">
          <title>ESA Hyporesponder: Epoetin Alfa</title>
          <description>In the ESA Hyporesponder Parallel Study, participants who were maintained on a ≥300 U/kg/week dose of Epoetin Alfa prior to and including the Screening Period for a minimum of 8 weeks prior to Screening Visit 2 were administered TIW dosing of Epoetin Alfa based on the participant's central laboratory Hb value and the approved Epoetin Alfa US PI for adult participants with CKD on dialysis. The dose was adjusted to achieve and maintain target Hb levels of 10.0-11.0 g/dL, inclusive.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="6" subjects_at_risk="21"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="5" subjects_at_risk="13"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="3" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Nephrogenic anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Acute left ventricular failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Incarcerated inguinal hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Incarcerated umbilical hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Catheter site thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Liver injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Gangrene</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Staphylococcal bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous fistula site complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="2" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Arteriovenous fistula thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Arteriovenous graft thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Facial bones fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Vascular pseudoaneurysm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="2" subjects_affected="2" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hypertensive encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Metabolic encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Subcapsular renal haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Nipple pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Uterine mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute pulmonary oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Pancreas transplant</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Accelerated hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hypertensive urgency</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Subclavian artery stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="34"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="23"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="9" subjects_at_risk="21"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="21"/>
                <counts group_id="E7" subjects_affected="8" subjects_at_risk="13"/>
                <counts group_id="E8" subjects_affected="4" subjects_at_risk="5"/>
                <counts group_id="E9" subjects_affected="2" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Nephrogenic anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Bundle branch block right</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Diastolic dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Left atrial enlargement</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Mitral valve incompetence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Right atrial enlargement</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Sinus tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Systolic dysfunction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="23"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="18"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E6" events="4" subjects_affected="4" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="3" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acarodermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Nail infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous fistula thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Graft thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Transfusion reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Vascular access complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Vascular pseudoaneurysm ruptured</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hypovolaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Intervertebral disc degeneration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Costovertebral angle tenderness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Uterine haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="34"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Pulmonary hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Pulmonary oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="2" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Uraemic pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="1" subjects_affected="1" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="34"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E6" events="3" subjects_affected="3" subjects_at_risk="21"/>
                <counts group_id="E7" events="1" subjects_affected="1" subjects_at_risk="13"/>
                <counts group_id="E8" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Hypovolaemic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Shock haemorrhagic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
              <event>
                <sub_title>Vascular calcification</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="34"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E7" events="0" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E8" events="0" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E9" events="0" subjects_affected="0" subjects_at_risk="5"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Conclusions were drawn from results of the Main Study (n=165). As the sample size in the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study (n=10) was small in both the Vadadustat and Epoetin Alfa treatment groups, these results did not allow to meaningful interpretation of the data.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Akebia Therapeutics, Inc</name_or_title>
      <organization>Akebia Therapeutics, Inc</organization>
      <phone>617-844-6128</phone>
      <email>trials@akebia.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03799627
org study id: AKB-6548-CI-0025
nct id: NCT03799627
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 2 open-label efficacy, safety, and pharmacokinetic/pharmacodynamic (PK/PD)
      study to evaluate oral Vadadustat for the treatment of anemia in hemodialysis participants
      converting from Epoetin Alfa therapy.
This is a Phase 2, randomized, open-label study to evaluate efficacy and safety of oral
      Vadadustat for the treatment of anemia in hemodialysis participants converting from Epoetin
      Alfa therapy. The study will be conducted in two parts running in parallel: Part 1, Main
      Study in a hemodialysis population on maintenance treatment with Epoetin Alfa; Part 2 is in a
      hemodialysis population that are erythropoiesis-stimulating agent (ESA) hyporesponders on
      maintenance treatment with Epoetin Alfa. For all participants (Main and ESA hyporesponder
      parallel study), the study will include a Screening Period, a Treatment Period, and a Safety
      Follow-Up Period. PK and PD sampling will be done throughout the study. The aim is to achieve
      and maintain hemoglobin (Hb) levels within the target range of 10.0 to 11.0 grams per
      deciliter (g/dL), inclusive, while targeting the middle of the range and minimizing
      excursions outside the target range.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, Open-Label, Active-Controlled
primary purpose: Treatment
masking: None (Open Label)
measure: Mean Change in Hemoglobin (Hb) Between Baseline and the Primary Evaluation Period (PEP)
time frame: Baseline; Week 10 to Week 12
description: Change from Baseline in Hb value was calculated as the PEP Hb value minus the Baseline Hb value. The PEP value was the average Hb value from Week 10 to Week 12. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1.
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
time frame: Up to Week 24
description: An adverse event (AE) was defined as any untoward medical occurrence (including a clinically significant abnormal laboratory finding) that occurred in the protocol-specified AE reporting period. An AE included medical conditions, signs, and symptoms not previously observed in the participant that emerged during the protocol-specified AE reporting period, including signs or symptoms associated with pre-existing underlying conditions that were not present prior to the AE reporting period. TEAEs, defined as AEs that began (or pre-existing AEs that worsened) on or after the first dose through each participant's last participation date, are reported.
measure: Number of Participants With Clinically Significant Changes From Baseline in Laboratory Parameter Values
time frame: Up to Week 24
description: Parameters assessed for laboratory values included hematology (excluding the primary and secondary efficacy endpoint results related to Hb), clinical chemistry, lipid profiles, and glucose. The investigator was responsible for reviewing laboratory results for clinically significant changes.
measure: Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Values
time frame: Up to Week 24
description: Parameters assessed for vital signs included sitting (at rest for a minimum of 5 minutes) heart rate, respiratory rate, body temperature, and blood pressure. The investigator was responsible for reviewing vital sign values for clinically significant changes.
measure: Number of Participants Classified as Hb Outliers
time frame: Weeks 13 - 20
description: The target range for Hb was from 10.0 to 11.0 grams per deciliter (g/dL). Hb outliers included participants with a Hb increase of more than 12.0 g/dL or <8.0 g/dL and decline in Hb ≥0.5 g/dL from Baseline, and a Hb increase to more than 1.0 g/dL within any 2-week interval during the Study Period.
measure: Number of Participants With Hb Values Within the Target Range at the PEP
time frame: Week 10 to Week 12
description: The target range for Hb was from 10.0 to 11.0 g/dL, inclusive. The PEP was comprised of Week 10 to Week 12.
measure: Mean Change in Hb From the PEP to the Secondary Evaluation Period (SEP) in Participants Who Transitioned to Three Times Per Week (TIW) Vadadustat Dosing After Week 12
time frame: Week 10 to Week 12; Week 18 to Week 20
description: Change from PEP was calculated as the SEP value minus the PEP value. The PEP value was the average Hb value from Week 10 to Week 12. The SEP value was the average Hb value from Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing.
measure: Mean Change in Hb Between Baseline and the SEP
time frame: Baseline; Week 18 to Week 20
description: Change from Baseline was calculated as the SEP value minus the Baseline value. The Baseline Hb value was defined as the average of the final two Hb values prior to start of dosing on Day 1. The SEP value was the average Hb value from Week 18 to Week 20.
measure: Number of Participants With Hb Values Within the Target Range at the SEP
time frame: Week 18 to Week 20
description: The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20.
measure: Number of Participants With Hb Values Within the Target Range at the SEP in Participants Who Transitioned to TIW Vadadustat Dosing
time frame: Week 18 to Week 20
description: The target range for Hb was from 10.0 to 11.0 g/dL. The SEP was comprised of Week 18 to Week 20. For the Main Study, analysis is presented per dose level according to the starting dose in TIW regimen, as well as being presented as a combined arm for "Vadadustat Total (TIW dosing regimen)". For the ESA Hyporesponder Parallel Study, a starting dose classification for TIW dosing regimen was not applicable due to no participants switching from Vadadustat QD to TIW dosing.
measure: Number of Participants With a Mean Increase in Hb From Baseline to the PEP ≥0.5 g/dL or With Hb Values Within the Target Range at the PEP
time frame: Week 10 to Week 12
description: The target range for Hb was from 10.0 to 11.0 g/dL. The PEP was comprised of Week 10 to Week 12.
measure: Number of Participants With a Mean Increase in Hb From Baseline to the SEP ≥0.5 g/dL or With Hb Values Within the Target Range at the SEP
time frame: Week 18 to Week 20
description: The target range for Hb was from 10.0 to 11.0 grams per g/dL. The SEP was comprised of Week 18 to Week 20.
measure: Number of Participants Requiring at Least One Intravenous (IV) Elemental Iron Supplementation
time frame: Up to Week 20
description: Iron supplementation was performed to maintain ferritin ≥200 nanograms/milliliters (ng/mL) and transferrin saturation (TSAT) ≥20%.
measure: Number of Participants Requiring Erythropoiesis-stimulating Agent (ESA) Rescue
time frame: Up to Week 20
description: ESA rescue therapy was administered in participants with Hb ≥8.5 g/dL, and was stopped when Hb reached ≥9.0 g/dL.
measure: Number of Participants Requiring Red Blood Cell (RBC) Transfusion
time frame: Up to Week 20
description: RBC transfusion was administered as rescue therapy in the event of an acute or severe loss of blood.
measure: Mean Serum Concentration of Erythropoietin (EPO) for Vadadustat Treatment Groups by Strata of Epoetin Alfa Dose Group
time frame: Baseline; Week 1 (pre-dose), Week 1 +1 (Day 8; pre-dose), Week 11 (pre-dose), and Week 13 (pre-dose)
description: Blood samples were collected from participants at defined time points for the assessment of EPO concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
measure: Mean Change From Baseline in Reticulocyte Count
time frame: Baseline; Week 1, Week 4, Week 8, Week 11, Week 12, Week 13, Week 16, and Week 20
description: Blood samples were collected from participants at defined time points for the assessment of reticulocyte count. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
measure: Mean Change From Baseline in Iron Concentration
time frame: Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20
description: Blood samples were collected from participants at defined time points for the assessment of iron indices, including iron concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
measure: Mean Change From Baseline in Ferritin Concentration
time frame: Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20
description: Blood samples were collected from participants at defined time points for the assessment of iron indices, including ferritin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
measure: Mean Change From Baseline in Total Iron Binding Capacity
time frame: Baseline; Week 4, Week 8, Week 12, Week 16, and Week 20
description: Blood samples were collected from participants at defined time points for the assessment of iron indices, including Total Iron Binding Capacity. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
measure: Mean Change From Baseline in Hepcidin Concentration
time frame: Baseline; Week 12 and Week 20
description: Blood samples were collected from participants at defined time points for the assessment of hepcidin concentration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
measure: Geometric Mean Maximum Observed Plasma Concentration (Cmax) of Vadadustat Following a Single Dose
time frame: Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose
description: Blood samples were collected from participants at defined time points for the assessment of Cmax of Vadadustat following a single dose.
measure: Geometric Mean Area Under the Concentration-time Curve (AUC) From Time 0 to 24 Hours (AUC0-24) of Vadadustat Following a Single Dose
time frame: Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose
description: Blood samples were collected from participants at defined time points for the assessment of AUC and AUC0-24 of Vadadustat following a single dose.
measure: Median Terminal Half-life (t1/2) of Vadadustat Following a Single Dose
time frame: Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose
description: Blood samples were collected from participants at defined time points for the assessment of t1/2 of Vadadustat following a single dose.
measure: Median Time to Reach Cmax (Tmax) of Vadadustat Following a Single Dose
time frame: Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose
description: Blood samples were collected from participants at defined time points for the assessment of Tmax of Vadadustat following a single dose.
measure: Geometric Mean Elimination Rate Constant (λz) of Vadadustat Following a Single Dose
time frame: Day 1; Week 1, Week 1 +1 (Day 8), Week 11, Week 13: pre-dose, 2 hours (h), 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose
description: Blood samples were collected from participants at defined time points for the assessment of λz of Vadadustat following a single dose.
measure: Geometric Mean Apparent Total Body Clearance (CLss/F) of Vadadustat Following a Single Dose
time frame: Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose
description: Blood samples were collected from participants at defined time points for the assessment of CLss/F of Vadadustat following a single dose.
measure: Geometric Mean Apparent Volume of Distribution (Vz/F) of Vadadustat Following a Single Dose
time frame: Day 1; Week 1, Week 1 +1 (Day 8), Week 11: pre-dose, 2h, 3.5h, and 5h post-dose, and additionally at 7h and 10.5h post-dose
description: Blood samples were collected from participants at defined time points for the assessment of Vz/F of Vadadustat following a single dose.
arm group label: Vadadustat
arm group type: Experimental
description: The initial dose of Vadadustat (300, 450, or 600 milligrams [mg]) will be based upon the dose of Epoetin Alfa dose participants had received prior to Vadadustat treatment
arm group label: Vadadustat TIW
arm group type: Experimental
description: Participants randomized to Vadadustat (Main and erythropoiesis-stimulating agent [ESA] hyporesponder parallel studies) who complete a once-daily dosing regimen treatment period and meet eligibility criteria for transition to three times weekly (TIW) dosing will switch to TIW dosing
arm group label: Epoetin Alfa
arm group type: Active Comparator
description: Epoetin Alfa
intervention type: Drug
intervention name: Vadadustat
description: Vadadustat Tablets 150 mg
arm group label: Vadadustat
other name: AKB-6548
intervention type: Drug
intervention name: Epoetin Alfa
description: Epoetin Alfa
arm group label: Epoetin Alfa
other name: Procrit
other name: Epogen
intervention type: Drug
intervention name: Vadadustat TIW
description: Oral Vadadustat
arm group label: Vadadustat TIW
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Chief Medical Officer
role: Study Director
affiliation: Akebia Therapeutics Inc.
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country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Anemia
mesh term: Epoetin Alfa
mesh term: Glycine
sharing ipd: No
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limitations and caveats: Conclusions were drawn from results of the Main Study (n=165). As the sample size in the Erythropoiesis-stimulating Agent (ESA) Hyporesponder Parallel Study (n=10) was small in both the Vadadustat and Epoetin Alfa treatment groups, these results did not allow to meaningful interpretation of the data.
point of contact: 