<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/NCT02968368</url>
  </required_header>
  <id_info>
    <org_study_id>ST10-01-303</org_study_id>
    <nct_id>NCT02968368</nct_id>
  </id_info>
  <brief_title>Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease</brief_title>
  <acronym>AEGIS-CKD</acronym>
  <official_title>A Phase 3, Randomized, Placebo Controlled, Prospective, Multicenter Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shield Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shield Therapeutics</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the efficacy of oral ferric maltol compared with placebo in the treatment of IDA&#xD;
      in subjects with CKD&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Actual">October 10, 2018</completion_date>
  <primary_completion_date type="Actual">January 18, 2018</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Hb Concentration From Baseline to Week 16</measure>
    <time_frame>16 weeks</time_frame>
    <description>Change in hemoglobin concentration from baseline to Week 16.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 16</measure>
    <time_frame>16 weeks</time_frame>
    <description>Number of subjects that achieve an increase in Hemoglobin concentration of ≥1 g/dL at Week 16</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects That Achieve a Hb Concentration of ≥11 g/dL at Week 16</measure>
    <time_frame>16 weeks</time_frame>
    <description>Number of subjects that achieve a Hemoglobin concentration of ≥11 g/dL at week 16</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hb Concentration From Baseline to Week 8</measure>
    <time_frame>8 weeks</time_frame>
    <description>Change in Hemoglobin concentration from baseline to Week 8</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 16</measure>
    <time_frame>16 weeks</time_frame>
    <description>Number of subjects that achieve an increase in Hemoglobin concentration of ≥2 g/dL at Week 16</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Ferritin From Baseline to Week 16</measure>
    <time_frame>baseline to week 16</time_frame>
    <description>Changes in iron parameter - ferritin - from baseline to week 16</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With (TEAEs)</measure>
    <time_frame>Week 16</time_frame>
    <description>Number of Participants with Treatment-Emergent Adverse Events (TEAEs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)</measure>
    <time_frame>Week 16</time_frame>
    <description>Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the double blind phase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in TSAT From Baseline to Week 16</measure>
    <time_frame>baseline to week 16</time_frame>
    <description>Changes in iron parameters - TSAT - from baseline to week 16</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Iron Parameter From Baseline to Week 16</measure>
    <time_frame>from baseline to week 16</time_frame>
    <description>Changes in iron parameters - serum iron - from baseline to week 16</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</measure>
    <time_frame>Week 52</time_frame>
    <description>Number of Participants with Treatment-Emergent Adverse Events (TEAEs) during the open label phase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)</measure>
    <time_frame>Week 52</time_frame>
    <description>Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the open label phase</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">167</enrollment>
  <condition>Renal Insufficiency, Chronic</condition>
  <condition>Iron-Deficiency Anemia</condition>
  <arm_group>
    <arm_group_label>Oral ferric maltol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30mg capsules BID</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Oral placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Matching placebo capsules BID</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ferric maltol</intervention_name>
    <arm_group_label>Oral ferric maltol</arm_group_label>
    <other_name>Feraccru</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Oral placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ability to understand the information given in the Independent Ethics Committee (IEC)&#xD;
             or Institutional Review Board (IRB) approved information sheet and consent form. Must&#xD;
             sign and date the informed consent and authorization to use protected health&#xD;
             information (PHI) in accordance with national and local subject privacy regulations&#xD;
             prior to any study mandated procedure.&#xD;
&#xD;
          2. Willing and able to comply with study requirements.&#xD;
&#xD;
          3. Age ≥ 18 years at the time of informed consent.&#xD;
&#xD;
          4. A current diagnosis of CKD with an estimated glomerular filtration rate (eGFR) of &lt;60&#xD;
             mL/min/1.73m2 and ≥15 mL/min/1.73m2, as calculated using the abbreviated version of&#xD;
             the Modified Diet in Renal Disease equation (MDRD) assessed via screening laboratory&#xD;
             results.&#xD;
&#xD;
          5. Iron deficiency anemia defined by the following criteria assessed via screening&#xD;
             laboratory results:&#xD;
&#xD;
               1. Hb &lt;11.0g/dL and ≥8.0g/dL&#xD;
&#xD;
               2. AND ferritin &lt;250ng/mL with a Transferrin saturation (TSAT) &lt;25% OR ferritin&#xD;
                  &lt;500ng/mL with a TSAT of &lt;15%&#xD;
&#xD;
          6. Female subjects of childbearing potential (including perimenopausal females who have&#xD;
             had a menstrual period within 1 year prior to screening) must agree to use a reliable&#xD;
             method of contraception until study completion and for at least 4 weeks following&#xD;
             their final study visit. Reliable contraception is defined as a method which results&#xD;
             in a low failure rate, i.e., less than 1% per year when used consistently and&#xD;
             correctly, such as implants, injectables, some intrauterine contraceptive devices&#xD;
             (IUDs), complete sexual abstinence, a vasectomized partner and oral contraceptive&#xD;
             medications. Female subjects who are surgically sterile (bilateral tubal ligation,&#xD;
             bilateral oophorectomy or hysterectomy) or postmenopausal (defined as no menstrual&#xD;
             period within 1 year of screening) are also allowed to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Anemia due to any cause other than iron deficiency, including, but not limited to:&#xD;
&#xD;
               1. Untreated or untreatable severe malabsorption syndrome.&#xD;
&#xD;
               2. Myelosuppression use (permitted if taken at a stable dose and frequency for at&#xD;
                  least 12 weeks prior to randomization and are expected to stay stable throughout&#xD;
                  the double-blind treatment period so long as there is no clinical evidence of the&#xD;
                  myelosuppression contributing to the subject's anemia).&#xD;
&#xD;
          2. Administration with any of the following prior to randomization:&#xD;
&#xD;
               1. IV iron injection within the previous 4 weeks or administration of intramuscular&#xD;
                  or depot iron preparation within the previous 12 weeks.&#xD;
&#xD;
               2. Single agent oral iron supplementation, taken specifically to treat anemia (e.g.&#xD;
                  ferrous sulfate, fumarate and gluconate) within the previous 2 weeks.&#xD;
                  Multivitamins are permitted.&#xD;
&#xD;
               3. Use if ferric citrate and sucroferric oxyhydroxide within the previous 1 week.&#xD;
&#xD;
               4. ESAs within the previous 4 weeks&#xD;
&#xD;
               5. Blood transfusion or donation within the previous 12 weeks.&#xD;
&#xD;
               6. Dimercaprol or cloramphenicol within the previous 7 days.&#xD;
&#xD;
               7. Current use of methyldopa.&#xD;
&#xD;
          3. Currently receiving dialysis or initiation of dialysis is considered likely during the&#xD;
             study.&#xD;
&#xD;
          4. Renal transplant within 12 months prior to randomization or is considered likely&#xD;
             during the study.&#xD;
&#xD;
          5. Known hypersensitivity or allergy to the active substance or excipients of ferric&#xD;
             maltol or placebo capsules.&#xD;
&#xD;
          6. Contraindication for treatment with iron preparations, e.g. hemochromatosis, chronic&#xD;
             hemolytic disease, sideroblastic anemia, thalassemia, or lead intoxication induced&#xD;
             anemia.&#xD;
&#xD;
          7. Impaired liver function as indicated by alanine aminotransferase (ALT) or aspartate&#xD;
             transaminase (AST) &gt; 3 times the upper limit of normal as assessed via screening&#xD;
             laboratory results.&#xD;
&#xD;
          8. Clinically significant vitamin B12 or folic acid deficiency as determined by the&#xD;
             screening laboratory results (retest following at least 2 weeks of starting treatment&#xD;
             with vitamin B12 or folate replacement is permitted).&#xD;
&#xD;
          9. Pregnant or breast feeding.&#xD;
&#xD;
         10. Concomitant medical conditions with significant active bleeding likely to initiate or&#xD;
             prolong anemia; for example coagulation disorders or recurrent GI bleeding.&#xD;
&#xD;
         11. Scheduled or expected major surgery during the course of the study. (Minor surgeries&#xD;
             not associated with significant blood loss, in the Investigator's judgement, are&#xD;
             permitted e.g. surgery related to fistulae or vascular access, minor dental&#xD;
             extractions, incision and drainage of abscess or simple excisions).&#xD;
&#xD;
         12. Participation in any other interventional clinical study within 30 days prior to&#xD;
             screening.&#xD;
&#xD;
         13. Cardiovascular, liver, renal, hematologic, psychiatric, neurologic, gastrointestinal,&#xD;
             immunologic, endocrine, metabolic, or central nervous system disease that, in the&#xD;
             opinion of the Investigator, may adversely affect the safety of the subject and/or&#xD;
             efficacy of the study drug or severely limit the lifespan of the subject.&#xD;
&#xD;
         14. Any other unspecified reason that, in the opinion of the Investigator or the Sponsor&#xD;
             make the subject unsuitable for enrolment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mark Sampson, MBChB</last_name>
    <role>Study Director</role>
    <affiliation>Shield Therapeutics</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Peoria</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Prescott</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Roseville</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Coral Springs</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Edgewater</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lauderdale Lakes</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Macon</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pontiac</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Roseville</city>
        <state>Michigan</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Asheville</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Hampton</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 30, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <results_first_submitted>November 19, 2019</results_first_submitted>
  <results_first_submitted_qc>April 21, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">May 1, 2020</results_first_posted>
  <last_update_submitted>October 5, 2020</last_update_submitted>
  <last_update_submitted_qc>October 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Renal Insufficiency</mesh_term>
    <mesh_term>Anemia</mesh_term>
    <mesh_term>Anemia, Iron-Deficiency</mesh_term>
    <mesh_term>Iron Deficiencies</mesh_term>
    <mesh_term>Deficiency Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ferric maltol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 12, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT02968368/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Oral Ferric Maltol</title>
          <description>30mg capsules BID&#xD;
Ferric maltol</description>
        </group>
        <group group_id="P2">
          <title>Oral Placebo</title>
          <description>Matching placebo capsules BID&#xD;
Placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Double Blind Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="111"/>
                <participants group_id="P2" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="90"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Open Label Phase</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="86"/>
                <participants group_id="P2" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Oral Ferric Maltol</title>
          <description>30mg capsules BID&#xD;
Ferric maltol</description>
        </group>
        <group group_id="B2">
          <title>Oral Placebo</title>
          <description>Matching placebo capsules BID&#xD;
Placebo</description>
        </group>
        <group group_id="B3">
          <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="111"/>
            <count group_id="B2" value="56"/>
            <count group_id="B3" value="167"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.5" spread="12.43"/>
                    <measurement group_id="B2" value="65.2" spread="12.79"/>
                    <measurement group_id="B3" value="67.4" spread="12.61"/>
                  </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="78"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="117"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="84"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="126"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </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="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="123"/>
                  </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_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="111"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="167"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Hb Concentration From Baseline to Week 16</title>
        <description>Change in hemoglobin concentration from baseline to Week 16.</description>
        <time_frame>16 weeks</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Ferric Maltol</title>
            <description>30mg capsules BID&#xD;
Ferric maltol</description>
          </group>
          <group group_id="O2">
            <title>Oral Placebo</title>
            <description>Matching placebo capsules BID&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Hb Concentration From Baseline to Week 16</title>
          <description>Change in hemoglobin concentration from baseline to Week 16.</description>
          <population>ITT</population>
          <units>g/dl</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.50" spread="0.122"/>
                    <measurement group_id="O2" value="-0.02" spread="0.165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0149</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.52</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.210</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.102</ci_lower_limit>
            <ci_upper_limit>0.930</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 16</title>
        <description>Number of subjects that achieve an increase in Hemoglobin concentration of ≥1 g/dL at Week 16</description>
        <time_frame>16 weeks</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Ferric Maltol</title>
            <description>30mg capsules BID&#xD;
Ferric maltol</description>
          </group>
          <group group_id="O2">
            <title>Oral Placebo</title>
            <description>Matching placebo capsules BID&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 16</title>
          <description>Number of subjects that achieve an increase in Hemoglobin concentration of ≥1 g/dL at Week 16</description>
          <population>ITT</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="111"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects That Achieve a Hb Concentration of ≥11 g/dL at Week 16</title>
        <description>Number of subjects that achieve a Hemoglobin concentration of ≥11 g/dL at week 16</description>
        <time_frame>16 weeks</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Ferric Maltol</title>
            <description>30mg capsules BID&#xD;
Ferric maltol</description>
          </group>
          <group group_id="O2">
            <title>Oral Placebo</title>
            <description>Matching placebo capsules BID&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects That Achieve a Hb Concentration of ≥11 g/dL at Week 16</title>
          <description>Number of subjects that achieve a Hemoglobin concentration of ≥11 g/dL at week 16</description>
          <population>ITT</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="111"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Hb Concentration From Baseline to Week 8</title>
        <description>Change in Hemoglobin concentration from baseline to Week 8</description>
        <time_frame>8 weeks</time_frame>
        <population>Where a subject had dropped from the study, we used a LOCF by MI methodology to impute values. Therefore the number of subjects and observations at a given time-point may differ.</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Ferric Maltol</title>
            <description>30mg capsules BID&#xD;
Ferric maltol</description>
          </group>
          <group group_id="O2">
            <title>Oral Placebo</title>
            <description>Matching placebo capsules BID&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Hb Concentration From Baseline to Week 8</title>
          <description>Change in Hemoglobin concentration from baseline to Week 8</description>
          <population>Where a subject had dropped from the study, we used a LOCF by MI methodology to impute values. Therefore the number of subjects and observations at a given time-point may differ.</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="98"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.53" spread="0.901"/>
                    <measurement group_id="O2" value="0.00" spread="0.909"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 16</title>
        <description>Number of subjects that achieve an increase in Hemoglobin concentration of ≥2 g/dL at Week 16</description>
        <time_frame>16 weeks</time_frame>
        <population>ITT</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Ferric Maltol</title>
            <description>30mg capsules BID&#xD;
Ferric maltol</description>
          </group>
          <group group_id="O2">
            <title>Oral Placebo</title>
            <description>Matching placebo capsules BID&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 16</title>
          <description>Number of subjects that achieve an increase in Hemoglobin concentration of ≥2 g/dL at Week 16</description>
          <population>ITT</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="111"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Ferritin From Baseline to Week 16</title>
        <description>Changes in iron parameter - ferritin - from baseline to week 16</description>
        <time_frame>baseline to week 16</time_frame>
        <population>ITT OC</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Ferric Maltol</title>
            <description>30mg capsules BID&#xD;
Ferric maltol</description>
          </group>
          <group group_id="O2">
            <title>Oral Placebo</title>
            <description>Matching placebo capsules BID&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Ferritin From Baseline to Week 16</title>
          <description>Changes in iron parameter - ferritin - from baseline to week 16</description>
          <population>ITT OC</population>
          <units>ug/l</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.13" spread="6.166"/>
                    <measurement group_id="O2" value="-5.90" spread="9.137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0006</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>39.03</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>11.097</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>17.070</ci_lower_limit>
            <ci_upper_limit>60.992</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With (TEAEs)</title>
        <description>Number of Participants with Treatment-Emergent Adverse Events (TEAEs)</description>
        <time_frame>Week 16</time_frame>
        <population>safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Ferric Maltol</title>
            <description>30mg capsules BID&#xD;
Ferric maltol</description>
          </group>
          <group group_id="O2">
            <title>Oral Placebo</title>
            <description>Matching placebo capsules BID&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With (TEAEs)</title>
          <description>Number of Participants with Treatment-Emergent Adverse Events (TEAEs)</description>
          <population>safety population</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="111"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75"/>
                    <measurement group_id="O2" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)</title>
        <description>Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the double blind phase</description>
        <time_frame>Week 16</time_frame>
        <population>safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Ferric Maltol</title>
            <description>30mg capsules BID&#xD;
Ferric maltol</description>
          </group>
          <group group_id="O2">
            <title>Oral Placebo</title>
            <description>Matching placebo capsules BID&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)</title>
          <description>Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the double blind phase</description>
          <population>safety population</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="111"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in TSAT From Baseline to Week 16</title>
        <description>Changes in iron parameters - TSAT - from baseline to week 16</description>
        <time_frame>baseline to week 16</time_frame>
        <population>ITT OC</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Ferric Maltol</title>
            <description>30mg capsules BID&#xD;
Ferric maltol</description>
          </group>
          <group group_id="O2">
            <title>Oral Placebo</title>
            <description>Matching placebo capsules BID&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in TSAT From Baseline to Week 16</title>
          <description>Changes in iron parameters - TSAT - from baseline to week 16</description>
          <population>ITT OC</population>
          <units>TSAT (%)</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.32" spread="0.719"/>
                    <measurement group_id="O2" value="-0.15" spread="1.060"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0007</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>4.46</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.282</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.928</ci_lower_limit>
            <ci_upper_limit>7.001</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Iron Parameter From Baseline to Week 16</title>
        <description>Changes in iron parameters - serum iron - from baseline to week 16</description>
        <time_frame>from baseline to week 16</time_frame>
        <population>ITT OC</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Ferric Maltol</title>
            <description>30mg capsules BID&#xD;
Ferric maltol</description>
          </group>
          <group group_id="O2">
            <title>Oral Placebo</title>
            <description>Matching placebo capsules BID&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Iron Parameter From Baseline to Week 16</title>
          <description>Changes in iron parameters - serum iron - from baseline to week 16</description>
          <population>ITT OC</population>
          <units>umol/l</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="111"/>
                <count group_id="O2" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.87" spread="0.397"/>
                    <measurement group_id="O2" value="0.01" spread="0.586"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0098</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.86</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.708</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.457</ci_lower_limit>
            <ci_upper_limit>3.261</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</title>
        <description>Number of Participants with Treatment-Emergent Adverse Events (TEAEs) during the open label phase</description>
        <time_frame>Week 52</time_frame>
        <population>safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Ferric Maltol</title>
            <description>30mg capsules BID&#xD;
Ferric maltol</description>
          </group>
          <group group_id="O2">
            <title>Oral Placebo</title>
            <description>Matching placebo capsules BID&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</title>
          <description>Number of Participants with Treatment-Emergent Adverse Events (TEAEs) during the open label phase</description>
          <population>safety population</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="86"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)</title>
        <description>Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the open label phase</description>
        <time_frame>Week 52</time_frame>
        <population>safety population</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Ferric Maltol</title>
            <description>30mg capsules BID&#xD;
Ferric maltol</description>
          </group>
          <group group_id="O2">
            <title>Oral Placebo</title>
            <description>Matching placebo capsules BID&#xD;
Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)</title>
          <description>Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the open label phase</description>
          <population>safety population</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="86"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>16 week double blind phase</time_frame>
      <desc>167 subjects. Definitions of AEs and SAEs in line with clintrials.gov definitions</desc>
      <group_list>
        <group group_id="E1">
          <title>Oral Ferric Maltol DB</title>
          <description>30mg capsules BID&#xD;
Ferric maltol&#xD;
double blind phase</description>
        </group>
        <group group_id="E2">
          <title>Oral Placebo DB</title>
          <description>Matching placebo capsules BID&#xD;
Placebo&#xD;
double blind phase</description>
        </group>
        <group group_id="E3">
          <title>Oral Ferric Maltol OL</title>
          <description>30mg capsules BID&#xD;
Ferric maltol&#xD;
open label phase</description>
        </group>
        <group group_id="E4">
          <title>Oral Placebo OL</title>
          <description>Matching placebo capsules BID&#xD;
Placebo&#xD;
open label phase</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.1</default_vocab>
        <default_assessment>Non-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="75" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="42" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="76" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="35" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="27" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Hemorrhagic anemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Iron deficiency anemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Coagulopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Normochromic normocytic anemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Atrioventricular block complete</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Cardiac failure acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Cardiomyopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diverticulum intestinal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Duodenal polyp</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Gastritis erosive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Gastrointestinal hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Gastrointestinal wall thickening</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Gastroesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Oesophageal ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Necrotizing fasciitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Streptococcal bacteremia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Toxicity to various agents</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Wound dehiscence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Hemoglobin decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Hyperglycemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Joint contracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Pathological fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Metastatic squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Rectosigmoid cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebellar infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Lacunar stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Renal tubular necrosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Vaginal hemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertensive emergency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Hypovolemic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Malignant hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 18.1</default_vocab>
        <default_assessment>Non-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="75" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="42" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="76" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="35" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Blood and lymphatic system disorders</sub_title>
                <description>TEAEs in &lt;5% of Subjects Overall by SOC</description>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Feces discolored</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders</sub_title>
                <counts group_id="E1" subjects_affected="45" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="48" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="18" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>General disorders and administration site conditions</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Edema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infections and infestations</sub_title>
                <description>TEAEs in &lt;5% of Subjects Overall by SOC</description>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="39" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="19" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Injury, poisoning, and procedural complications</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Metabolism and nutrition disorders</sub_title>
                <description>TEAEs in &lt;5% of Subjects Overall by SOC</description>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="25" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal and urinary disorders</sub_title>
                <description>TEAEs in &lt;5% of Subjects Overall by SOC</description>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory, thoracic, and mediastinal disorders</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="39"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Vascular disorders</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="39"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="86"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="39"/>
              </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>
    <point_of_contact>
      <name_or_title>Jackie Mitchell MA DPhil</name_or_title>
      <organization>Shield Therapeutics</organization>
      <phone>+44 (0) 191 511 8515</phone>
      <email>jmitchell@shieldtx.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/NCT02968368
org study id: ST10-01-303
nct id: NCT02968368
lead sponsor: 
has dmc: Yes
To evaluate the efficacy of oral ferric maltol compared with placebo in the treatment of IDA
      in subjects with CKD
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in Hb Concentration From Baseline to Week 16
time frame: 16 weeks
description: Change in hemoglobin concentration from baseline to Week 16.
measure: Number of Subjects That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 16
time frame: 16 weeks
description: Number of subjects that achieve an increase in Hemoglobin concentration of ≥1 g/dL at Week 16
measure: Number of Subjects That Achieve a Hb Concentration of ≥11 g/dL at Week 16
time frame: 16 weeks
description: Number of subjects that achieve a Hemoglobin concentration of ≥11 g/dL at week 16
measure: Change in Hb Concentration From Baseline to Week 8
time frame: 8 weeks
description: Change in Hemoglobin concentration from baseline to Week 8
measure: Number of Subjects That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 16
time frame: 16 weeks
description: Number of subjects that achieve an increase in Hemoglobin concentration of ≥2 g/dL at Week 16
measure: Changes in Ferritin From Baseline to Week 16
time frame: baseline to week 16
description: Changes in iron parameter - ferritin - from baseline to week 16
measure: Number of Participants With (TEAEs)
time frame: Week 16
description: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
measure: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
time frame: Week 16
description: Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the double blind phase
measure: Changes in TSAT From Baseline to Week 16
time frame: baseline to week 16
description: Changes in iron parameters - TSAT - from baseline to week 16
measure: Changes in Iron Parameter From Baseline to Week 16
time frame: from baseline to week 16
description: Changes in iron parameters - serum iron - from baseline to week 16
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
time frame: Week 52
description: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) during the open label phase
measure: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)
time frame: Week 52
description: Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the open label phase
arm group label: Oral ferric maltol
arm group type: Experimental
description: 30mg capsules BID
arm group label: Oral placebo
arm group type: Placebo Comparator
description: Matching placebo capsules BID
intervention type: Drug
intervention name: Ferric maltol
arm group label: Oral ferric maltol
other name: Feraccru
intervention type: Other
intervention name: Placebo
arm group label: Oral placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark Sampson, MBChB
role: Study Director
affiliation: Shield Therapeutics
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country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Renal Insufficiency
mesh term: Anemia
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
mesh term: Deficiency Diseases
mesh term: Ferric maltol
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 