<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/NCT03247816</url>
  </required_header>
  <id_info>
    <org_study_id>ST10-01-401</org_study_id>
    <nct_id>NCT03247816</nct_id>
  </id_info>
  <brief_title>Feraccru® Real World Effectiveness Study in Hospital Practice ( FRESH )</brief_title>
  <acronym>FRESH</acronym>
  <official_title>Feraccru® Real World Effectiveness Study in Hospital Practice (FRESH): A Real World Study to Describe the Outcomes Associated With the Use of Ferric Maltol (Feraccru) for the Management of Iron Deficiency Anaemia in Patients With Inflammatory Bowel Disease in the UK.</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>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to understand the early experiences of Feraccru® in patients with&#xD;
      inflammatory bowel disease (IBD) and iron deficiency anaemia (IDA) in the UK, including&#xD;
      treatment effectiveness, patterns of use and tolerability.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study is to understand the early experiences of Feraccru® in patients with&#xD;
      inflammatory bowel disease (IBD) and iron deficiency anaemia (IDA) in the UK, including&#xD;
      treatment effectiveness, patterns of use and tolerability. By describing the characteristics&#xD;
      of patients treated with Feraccru® and their outcomes, this study will provide the medical&#xD;
      community with important information to support treatment decisions for their patients. This&#xD;
      will ultimately support improvements to patient care, including the long-term outcomes of&#xD;
      patients with IBD and IDA&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2017</start_date>
  <completion_date type="Actual">October 1, 2018</completion_date>
  <primary_completion_date type="Actual">March 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The Percentage of Patients With Normalised Hb Levels at 12 Weeks After Initiation of Feraccru®.</measure>
    <time_frame>12 weeks (permitting 10-16 weeks)</time_frame>
    <description>Normalised haemoglobin is defined in this study as Hb ≥12.0 g/dL for females and and (≥13.0 g/dL for males.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Hb Levels at Week 4</measure>
    <time_frame>Baseline to Week 4 (permitting 3 to 5 weeks)</time_frame>
    <description>Change in Haemoglobin levels from baseline to Week 4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hb Levels at 12 Weeks</measure>
    <time_frame>Baseline to Week 12 (permitting 10-16 weeks)</time_frame>
    <description>Change in Haemoglobin levels from baseline to Week 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Normalisation of Hb Levels</measure>
    <time_frame>Baseline to 12 weeks (permitting 10-16 weeks)</time_frame>
    <description>Normalised haemoglobin is defined in this study as Hb ≥12.0 g/dL for females and ≥13.0 g/dL for males.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Serum Ferritin Levels at Week 4</measure>
    <time_frame>Baseline to Week 4 (permitting 3 to 5 weeks)</time_frame>
    <description>Change in serum ferritin levels from baseline to week 4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Serum Ferritin Levels at Week 12</measure>
    <time_frame>Baseline to Week 12 (permitting 10-16 weeks)</time_frame>
    <description>Change in serum ferritin levels from baseline to week 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Normalised Ferritin Levels at 12 Weeks</measure>
    <time_frame>Baseline to Week 12 (permitting 10-16 weeks)</time_frame>
    <description>Normalised serum ferritin is defined in this study as serum ferritin concentration ≥30 microgram/L and ≤300 microgram/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Correction of Serum Ferritin Levels</measure>
    <time_frame>Baseline to Week 12 (permitting 10 to 16 weeks)</time_frame>
    <description>Normalised serum ferritin is defined in this study as serum ferritin concentration ≥30 microgram/L and ≤300 microgram/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Transferrin Saturation at Week 4</measure>
    <time_frame>Baseline to Week 4 (permitting 3 to 5 weeks)</time_frame>
    <description>Change in transferrin saturation (TSAT) at Week 4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Transferrin Saturation at Week 12</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Change in transferrin saturation (TSAT) at Week 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Normalised Transferrin Saturation at 12 Weeks After Initiation of Feraccru®</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Normalised transferrin saturation is defined in this study as transferrin saturation between 20% and 50%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Correction of Transferrin Saturation</measure>
    <time_frame>Baseline to Week 12</time_frame>
    <description>Normalised transferrin saturation is defined in this study as transferrin saturation between 20% and 50%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time From Diagnosis of IBD to Initiation of Feraccru</measure>
    <time_frame>Baseline</time_frame>
    <description>Time from diagnosis of Inflammatory Bowel Disease to initiation of Feraccru.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time From Diagnosis of IDA to Initiation of Feraccru®</measure>
    <time_frame>Baseline</time_frame>
    <description>Time from diagnosis of Iron Deficiency Anaemia to initiation of Feraccru®</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prior IV Treatment History</measure>
    <time_frame>Baseline</time_frame>
    <description>Prior intravenous iron treatment history</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reason for Initiating Feraccru®</measure>
    <time_frame>Baseline</time_frame>
    <description>Reason(s) for initiation of Feraccru®</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients Who Discontinue Feraccru®</measure>
    <time_frame>Baseline to week 12</time_frame>
    <description>Percentage of patients who discontinue Feraccru® during the 12 weeks period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reason for Discontinuing Feraccru®</measure>
    <time_frame>Baseline to week 12</time_frame>
    <description>Reasons for stopping will be collected as predefined common options and a free text field.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events That Are Related to and Caused by Feraccru®</measure>
    <time_frame>For the duration of study, average of 12 weeks.</time_frame>
    <description>Type, severity and time of adverse events that are related to and caused by Feraccru®, from initiation of Feraccru®</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reason for Discontinuing Each Prior Oral Ferrous Product</measure>
    <time_frame>Baseline</time_frame>
    <description>Reason(s) for discontinuing each prior Oral Ferrous Product (OFP). Patients could have multiple reasons for discontinuation of previous OFP.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Sex of Patient at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Sex of patient at Baseline - Male or Female</description>
  </other_outcome>
  <other_outcome>
    <measure>Type of IBD at Baseline (Crohn's Disease or Ulcerative Colitis)</measure>
    <time_frame>Baseline</time_frame>
    <description>Type of Inflammatory Bowel Disease at baseline (Crohn's Disease or Ulcerative Colitis)</description>
  </other_outcome>
  <other_outcome>
    <measure>Platelets Count at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean platelets count at baseline</description>
  </other_outcome>
  <other_outcome>
    <measure>Vitamin B12 Value at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Vitamin B12 mean value at baseline</description>
  </other_outcome>
  <other_outcome>
    <measure>Mean Corpuscular Volume at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean value of C-reactive protein (CRP) at Baseline</description>
  </other_outcome>
  <other_outcome>
    <measure>Mean Corpuscular Hb at Baseline</measure>
    <time_frame>Baseline</time_frame>
    <description>Mean corpuscular haemoglobin (MCH) at Baseline</description>
  </other_outcome>
  <enrollment type="Actual">59</enrollment>
  <condition>Anemia, Iron Deficiency</condition>
  <condition>Inflammatory Bowel Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Real World subjects with IBD (Crohn's disease or ulcerative colitis) who are also diagnosed&#xD;
        with mild-moderate IDA.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients aged ≥ 18 years at the time of initiation .&#xD;
&#xD;
          -  Patient presenting with mild to moderate IDA that is secondary to either Crohn's&#xD;
             disease (CD) or ulcerative colitis (UC) defined as Hb ≥9.5 g/dL and &lt;13.0 g/dL in&#xD;
             males, or Hb ≥9.5 g/dL and &lt;12.0 g/dL in females&#xD;
&#xD;
          -  Serum ferritin concentration &lt;30 microgram/L or transferrin saturation of &lt;20% .&#xD;
&#xD;
          -  Patient receiving Feraccru® since the time of UK launch in June 2016.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient receiving Feraccru® as part of an interventional clinical trial.&#xD;
&#xD;
          -  Patients with severely active IBD or requiring corticosteroids at the time of&#xD;
             initiation on Feraccru®.&#xD;
&#xD;
          -  Patient with an IBD flare, as determined by the clinician.&#xD;
&#xD;
          -  Patient with medical records that are not available for review.&#xD;
&#xD;
          -  Patient not willing or unable to consent to study participation, or patient is&#xD;
             deceased at the start of data collection period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Southampton General Hospital</name>
      <address>
        <city>Southampton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>March 12, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <results_first_submitted>September 2, 2020</results_first_submitted>
  <results_first_submitted_qc>September 2, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 25, 2020</results_first_posted>
  <last_update_submitted>September 29, 2020</last_update_submitted>
  <last_update_submitted_qc>September 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 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>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    <mesh_term>Anemia</mesh_term>
    <mesh_term>Anemia, Iron-Deficiency</mesh_term>
    <mesh_term>Iron Deficiencies</mesh_term>
  </condition_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>March 2, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT03247816/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Number of Eligible Subjects</title>
          <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missing Feraccru stop date</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Number of Eligible Subjects</title>
          <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="59"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>18 &lt; 25</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>25 &lt; 35</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>35 &lt; 45</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>45 &lt; 55</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>55 &lt; 65</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;65</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Haemoglobin</title>
          <units>g/dl</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.1" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of Inflammatory Bowel Disease</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="59"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Crohn's Disease (CD)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ulcerative Colitis (UC)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unspecified</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Percentage of Patients With Normalised Hb Levels at 12 Weeks After Initiation of Feraccru®.</title>
        <description>Normalised haemoglobin is defined in this study as Hb ≥12.0 g/dL for females and and (≥13.0 g/dL for males.</description>
        <time_frame>12 weeks (permitting 10-16 weeks)</time_frame>
        <population>Number of subjects with Hb measurement at 12 weeks (permitting 10-16 weeks) following initiation with Feraccru.</population>
        <group_list>
          <group group_id="O1">
            <title>Normalised Hb at 12 Weeks</title>
            <description>Normalisation of haemoglobin at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.</description>
          </group>
          <group group_id="O2">
            <title>Not Normalised Hb at 12 Weeks</title>
            <description>Not normalised haemoglobin result at 12 weeks (permitting 10-16 weeks) after initiation of Feraccru.</description>
          </group>
        </group_list>
        <measure>
          <title>The Percentage of Patients With Normalised Hb Levels at 12 Weeks After Initiation of Feraccru®.</title>
          <description>Normalised haemoglobin is defined in this study as Hb ≥12.0 g/dL for females and and (≥13.0 g/dL for males.</description>
          <population>Number of subjects with Hb measurement at 12 weeks (permitting 10-16 weeks) following initiation with Feraccru.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Hb Levels at Week 4</title>
        <description>Change in Haemoglobin levels from baseline to Week 4</description>
        <time_frame>Baseline to Week 4 (permitting 3 to 5 weeks)</time_frame>
        <population>Subjects with available Hb at Week 4 (permitting 3 to 5 weeks).</population>
        <group_list>
          <group group_id="O1">
            <title>Number of Eligible Subjects</title>
            <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Hb Levels at Week 4</title>
          <description>Change in Haemoglobin levels from baseline to Week 4</description>
          <population>Subjects with available Hb at Week 4 (permitting 3 to 5 weeks).</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="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Hb Levels at 12 Weeks</title>
        <description>Change in Haemoglobin levels from baseline to Week 12</description>
        <time_frame>Baseline to Week 12 (permitting 10-16 weeks)</time_frame>
        <population>Subjects with available Hb at Week 12 (permitting 10-16 weeks).</population>
        <group_list>
          <group group_id="O1">
            <title>Number of Eligible Subjects</title>
            <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Hb Levels at 12 Weeks</title>
          <description>Change in Haemoglobin levels from baseline to Week 12</description>
          <population>Subjects with available Hb at Week 12 (permitting 10-16 weeks).</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="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Normalisation of Hb Levels</title>
        <description>Normalised haemoglobin is defined in this study as Hb ≥12.0 g/dL for females and ≥13.0 g/dL for males.</description>
        <time_frame>Baseline to 12 weeks (permitting 10-16 weeks)</time_frame>
        <population>Subjects with available Hb at Week 12 (permitting 10-16 weeks)</population>
        <group_list>
          <group group_id="O1">
            <title>Number of Eligible Subjects</title>
            <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Normalisation of Hb Levels</title>
          <description>Normalised haemoglobin is defined in this study as Hb ≥12.0 g/dL for females and ≥13.0 g/dL for males.</description>
          <population>Subjects with available Hb at Week 12 (permitting 10-16 weeks)</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.5" spread="25.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Serum Ferritin Levels at Week 4</title>
        <description>Change in serum ferritin levels from baseline to week 4</description>
        <time_frame>Baseline to Week 4 (permitting 3 to 5 weeks)</time_frame>
        <population>Subjects with available ferritin measurements at Week 4 (permitting 3 to 5 weeks).</population>
        <group_list>
          <group group_id="O1">
            <title>Number of Eligible Subjects</title>
            <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Serum Ferritin Levels at Week 4</title>
          <description>Change in serum ferritin levels from baseline to week 4</description>
          <population>Subjects with available ferritin measurements at Week 4 (permitting 3 to 5 weeks).</population>
          <units>ug/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.9" spread="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Serum Ferritin Levels at Week 12</title>
        <description>Change in serum ferritin levels from baseline to week 12</description>
        <time_frame>Baseline to Week 12 (permitting 10-16 weeks)</time_frame>
        <population>Subjects with available ferritin measurement at Week 12 (permitting 10-16 weeks)</population>
        <group_list>
          <group group_id="O1">
            <title>Number of Eligible Subjects</title>
            <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Serum Ferritin Levels at Week 12</title>
          <description>Change in serum ferritin levels from baseline to week 12</description>
          <population>Subjects with available ferritin measurement at Week 12 (permitting 10-16 weeks)</population>
          <units>ug/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.1" spread="36.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Normalised Ferritin Levels at 12 Weeks</title>
        <description>Normalised serum ferritin is defined in this study as serum ferritin concentration ≥30 microgram/L and ≤300 microgram/L.</description>
        <time_frame>Baseline to Week 12 (permitting 10-16 weeks)</time_frame>
        <population>Subjects with available ferritin measurements at Week 12 (permitting 10-16 weeks).</population>
        <group_list>
          <group group_id="O1">
            <title>Number of Eligible Subjects</title>
            <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Normalised Ferritin Levels at 12 Weeks</title>
          <description>Normalised serum ferritin is defined in this study as serum ferritin concentration ≥30 microgram/L and ≤300 microgram/L.</description>
          <population>Subjects with available ferritin measurements at Week 12 (permitting 10-16 weeks).</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="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Correction of Serum Ferritin Levels</title>
        <description>Normalised serum ferritin is defined in this study as serum ferritin concentration ≥30 microgram/L and ≤300 microgram/L.</description>
        <time_frame>Baseline to Week 12 (permitting 10 to 16 weeks)</time_frame>
        <population>Subjects with available ferritin measurement at Week 12 (permitting 10 to 16 weeks).</population>
        <group_list>
          <group group_id="O1">
            <title>Number of Eligible Subjects</title>
            <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Correction of Serum Ferritin Levels</title>
          <description>Normalised serum ferritin is defined in this study as serum ferritin concentration ≥30 microgram/L and ≤300 microgram/L.</description>
          <population>Subjects with available ferritin measurement at Week 12 (permitting 10 to 16 weeks).</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.0" spread="25.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Transferrin Saturation at Week 4</title>
        <description>Change in transferrin saturation (TSAT) at Week 4</description>
        <time_frame>Baseline to Week 4 (permitting 3 to 5 weeks)</time_frame>
        <population>Due to insufficient data, this outcome could not be measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Number of Eligible Subjects</title>
            <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Transferrin Saturation at Week 4</title>
          <description>Change in transferrin saturation (TSAT) at Week 4</description>
          <population>Due to insufficient data, this outcome could not be measured.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Transferrin Saturation at Week 12</title>
        <description>Change in transferrin saturation (TSAT) at Week 12</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>Due to insufficient data, this outcome could not be measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Number of Eligible Subjects</title>
            <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Transferrin Saturation at Week 12</title>
          <description>Change in transferrin saturation (TSAT) at Week 12</description>
          <population>Due to insufficient data, this outcome could not be measured.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Normalised Transferrin Saturation at 12 Weeks After Initiation of Feraccru®</title>
        <description>Normalised transferrin saturation is defined in this study as transferrin saturation between 20% and 50%.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>Due to insufficient data, this outcome could not be measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Number of Eligible Subjects</title>
            <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Normalised Transferrin Saturation at 12 Weeks After Initiation of Feraccru®</title>
          <description>Normalised transferrin saturation is defined in this study as transferrin saturation between 20% and 50%.</description>
          <population>Due to insufficient data, this outcome could not be measured.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Correction of Transferrin Saturation</title>
        <description>Normalised transferrin saturation is defined in this study as transferrin saturation between 20% and 50%.</description>
        <time_frame>Baseline to Week 12</time_frame>
        <population>Due to insufficient data, this outcome could not be measured.</population>
        <group_list>
          <group group_id="O1">
            <title>Number of Eligible Subjects</title>
            <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Correction of Transferrin Saturation</title>
          <description>Normalised transferrin saturation is defined in this study as transferrin saturation between 20% and 50%.</description>
          <population>Due to insufficient data, this outcome could not be measured.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From Diagnosis of IBD to Initiation of Feraccru</title>
        <description>Time from diagnosis of Inflammatory Bowel Disease to initiation of Feraccru.</description>
        <time_frame>Baseline</time_frame>
        <population>Subjects with available medical history on IBD prior to Feraccru.</population>
        <group_list>
          <group group_id="O1">
            <title>Number of Eligible Subjects</title>
            <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Diagnosis of IBD to Initiation of Feraccru</title>
          <description>Time from diagnosis of Inflammatory Bowel Disease to initiation of Feraccru.</description>
          <population>Subjects with available medical history on IBD prior to Feraccru.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.4" spread="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time From Diagnosis of IDA to Initiation of Feraccru®</title>
        <description>Time from diagnosis of Iron Deficiency Anaemia to initiation of Feraccru®</description>
        <time_frame>Baseline</time_frame>
        <population>Subjects with available medical history on IDA prior to Feraccru.</population>
        <group_list>
          <group group_id="O1">
            <title>Number of Eligible Subjects</title>
            <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Diagnosis of IDA to Initiation of Feraccru®</title>
          <description>Time from diagnosis of Iron Deficiency Anaemia to initiation of Feraccru®</description>
          <population>Subjects with available medical history on IDA prior to Feraccru.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.8" spread="110.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Prior IV Treatment History</title>
        <description>Prior intravenous iron treatment history</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Number of Eligible Subjects</title>
            <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
          </group>
        </group_list>
        <measure>
          <title>Prior IV Treatment History</title>
          <description>Prior intravenous iron treatment history</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>≥1 course of intravenous iron</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>not received previous IV</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>unkown</title>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reason for Initiating Feraccru®</title>
        <description>Reason(s) for initiation of Feraccru®</description>
        <time_frame>Baseline</time_frame>
        <population>The initiation reasons are not exclusive per patient. Some subjects had multiple reasons for initiating Feraccru®.</population>
        <group_list>
          <group group_id="O1">
            <title>Number of Eligible Subjects</title>
            <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
          </group>
        </group_list>
        <measure>
          <title>Reason for Initiating Feraccru®</title>
          <description>Reason(s) for initiation of Feraccru®</description>
          <population>The initiation reasons are not exclusive per patient. Some subjects had multiple reasons for initiating Feraccru®.</population>
          <units>initiation reasons</units>
          <param>Count of Units</param>
          <units_analyzed>initiation reasons</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>initiation reasons</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Intolerance to ferrous sulphate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intolerance to ferrous fumarate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intolerance to ferrous gluconate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intolerance to oral iron</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinician decision</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not recorded</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients Who Discontinue Feraccru®</title>
        <description>Percentage of patients who discontinue Feraccru® during the 12 weeks period</description>
        <time_frame>Baseline to week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Number of Eligible Subjects</title>
            <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Who Discontinue Feraccru®</title>
          <description>Percentage of patients who discontinue Feraccru® during the 12 weeks period</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reason for Discontinuing Feraccru®</title>
        <description>Reasons for stopping will be collected as predefined common options and a free text field.</description>
        <time_frame>Baseline to week 12</time_frame>
        <population>The categories are not mutually exclusive so a single subject could have multiple reasons listed.</population>
        <group_list>
          <group group_id="O1">
            <title>Number of Eligible Subjects</title>
            <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
          </group>
        </group_list>
        <measure>
          <title>Reason for Discontinuing Feraccru®</title>
          <description>Reasons for stopping will be collected as predefined common options and a free text field.</description>
          <population>The categories are not mutually exclusive so a single subject could have multiple reasons listed.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Abdominal pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Clinician decision</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhoea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Constipation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment complete</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lack of efficacy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not known</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Events That Are Related to and Caused by Feraccru®</title>
        <description>Type, severity and time of adverse events that are related to and caused by Feraccru®, from initiation of Feraccru®</description>
        <time_frame>For the duration of study, average of 12 weeks.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Number of Eligible Subjects</title>
            <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events That Are Related to and Caused by Feraccru®</title>
          <description>Type, severity and time of adverse events that are related to and caused by Feraccru®, from initiation of Feraccru®</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>definitely related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>probably related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>possibly related</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Reason for Discontinuing Each Prior Oral Ferrous Product</title>
        <description>Reason(s) for discontinuing each prior Oral Ferrous Product (OFP). Patients could have multiple reasons for discontinuation of previous OFP.</description>
        <time_frame>Baseline</time_frame>
        <population>Each discontinuation reason is exclusive per patient. Some patients had multiple reason for discontinuation.</population>
        <group_list>
          <group group_id="O1">
            <title>Number of Eligible Subjects</title>
            <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
          </group>
        </group_list>
        <measure>
          <title>Reason for Discontinuing Each Prior Oral Ferrous Product</title>
          <description>Reason(s) for discontinuing each prior Oral Ferrous Product (OFP). Patients could have multiple reasons for discontinuation of previous OFP.</description>
          <population>Each discontinuation reason is exclusive per patient. Some patients had multiple reason for discontinuation.</population>
          <units>individual reasons</units>
          <param>Number</param>
          <units_analyzed>individual reasons</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>individual reasons</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Diarrhoea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not known</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lack of efficacy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment completion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Constipation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Flatulence</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abdominal pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unable to tolerate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dramatically worsened GI symptoms</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Sex of Patient at Baseline</title>
        <description>Sex of patient at Baseline - Male or Female</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Number of Eligible Subjects</title>
            <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
          </group>
        </group_list>
        <measure>
          <title>Sex of Patient at Baseline</title>
          <description>Sex of patient at Baseline - Male or Female</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Type of IBD at Baseline (Crohn's Disease or Ulcerative Colitis)</title>
        <description>Type of Inflammatory Bowel Disease at baseline (Crohn's Disease or Ulcerative Colitis)</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Number of Eligible Subjects</title>
            <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
          </group>
        </group_list>
        <measure>
          <title>Type of IBD at Baseline (Crohn's Disease or Ulcerative Colitis)</title>
          <description>Type of Inflammatory Bowel Disease at baseline (Crohn's Disease or Ulcerative Colitis)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="59"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Chron's Disease</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ulcerative Colitis (UC)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unspecified IBD</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Platelets Count at Baseline</title>
        <description>Mean platelets count at baseline</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Number of Eligible Subjects</title>
            <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
          </group>
        </group_list>
        <measure>
          <title>Platelets Count at Baseline</title>
          <description>Mean platelets count at baseline</description>
          <units>cells*10^9/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="370.7" spread="131.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Vitamin B12 Value at Baseline</title>
        <description>Vitamin B12 mean value at baseline</description>
        <time_frame>Baseline</time_frame>
        <population>Subjects with available B12 measurement at Baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Number of Eligible Subjects</title>
            <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
          </group>
        </group_list>
        <measure>
          <title>Vitamin B12 Value at Baseline</title>
          <description>Vitamin B12 mean value at baseline</description>
          <population>Subjects with available B12 measurement at Baseline.</population>
          <units>pmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="354.6" spread="266.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Mean Corpuscular Volume at Baseline</title>
        <description>Mean value of C-reactive protein (CRP) at Baseline</description>
        <time_frame>Baseline</time_frame>
        <population>Subjects with available CRP value at Baseline</population>
        <group_list>
          <group group_id="O1">
            <title>Number of Eligible Subjects</title>
            <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Corpuscular Volume at Baseline</title>
          <description>Mean value of C-reactive protein (CRP) at Baseline</description>
          <population>Subjects with available CRP value at Baseline</population>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.9" spread="18.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Mean Corpuscular Hb at Baseline</title>
        <description>Mean corpuscular haemoglobin (MCH) at Baseline</description>
        <time_frame>Baseline</time_frame>
        <population>53 patients had MCH measured at Baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Number of Eligible Subjects</title>
            <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Corpuscular Hb at Baseline</title>
          <description>Mean corpuscular haemoglobin (MCH) at Baseline</description>
          <population>53 patients had MCH measured at Baseline.</population>
          <units>pg/cell</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="53"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.0" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline to approximately 12 weeks (permitting 10-16 weeks)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Number of Eligible Subjects</title>
          <description>Number of eligible subjects following the initial invitation to collect data on retrospective and prospective data.</description>
        </group>
      </group_list>
      <serious_events>
        <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="0" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Patient commenced with HB of 7.2</sub_title>
                <description>Patient commenced on Feraccru® with HB of 7.2</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Lower abdominal abscess</sub_title>
                <description>Lower abdominal abscess (secondary to CD)</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>gastritis and abdominal pain</sub_title>
                <description>Patient admitted overnight with gastritis and abdominal pain</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Right side buccal space abscess;</sub_title>
                <description>Right side buccal space abscess; admitted to hospital and treated.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <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="9" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <description>Diarrhoea</description>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <description>Constipation</description>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="59"/>
              </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>
    </certain_agreements>
    <limitations_and_caveats>Multiple patients lacked Hb (and other clinical parameters) at the 3-5- and 10-16-week time points, limiting the analysis that could be performed; due to this, overestimation or underestimation of the true normalisation rates may have been observed.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Jackie Mitchell MA DPhil</name_or_title>
      <organization>Shield TX (UK) Limited</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/NCT03247816
org study id: ST10-01-401
nct id: NCT03247816
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to understand the early experiences of Feraccru® in patients with
      inflammatory bowel disease (IBD) and iron deficiency anaemia (IDA) in the UK, including
      treatment effectiveness, patterns of use and tolerability.
The aim of the study is to understand the early experiences of Feraccru® in patients with
      inflammatory bowel disease (IBD) and iron deficiency anaemia (IDA) in the UK, including
      treatment effectiveness, patterns of use and tolerability. By describing the characteristics
      of patients treated with Feraccru® and their outcomes, this study will provide the medical
      community with important information to support treatment decisions for their patients. This
      will ultimately support improvements to patient care, including the long-term outcomes of
      patients with IBD and IDA
observational model: Cohort
time perspective: Cross-Sectional
measure: The Percentage of Patients With Normalised Hb Levels at 12 Weeks After Initiation of Feraccru®.
time frame: 12 weeks (permitting 10-16 weeks)
description: Normalised haemoglobin is defined in this study as Hb ≥12.0 g/dL for females and and (≥13.0 g/dL for males.
measure: Change in Hb Levels at Week 4
time frame: Baseline to Week 4 (permitting 3 to 5 weeks)
description: Change in Haemoglobin levels from baseline to Week 4
measure: Change in Hb Levels at 12 Weeks
time frame: Baseline to Week 12 (permitting 10-16 weeks)
description: Change in Haemoglobin levels from baseline to Week 12
measure: Time to Normalisation of Hb Levels
time frame: Baseline to 12 weeks (permitting 10-16 weeks)
description: Normalised haemoglobin is defined in this study as Hb ≥12.0 g/dL for females and ≥13.0 g/dL for males.
measure: Change in Serum Ferritin Levels at Week 4
time frame: Baseline to Week 4 (permitting 3 to 5 weeks)
description: Change in serum ferritin levels from baseline to week 4
measure: Change in Serum Ferritin Levels at Week 12
time frame: Baseline to Week 12 (permitting 10-16 weeks)
description: Change in serum ferritin levels from baseline to week 12
measure: Percentage of Patients With Normalised Ferritin Levels at 12 Weeks
time frame: Baseline to Week 12 (permitting 10-16 weeks)
description: Normalised serum ferritin is defined in this study as serum ferritin concentration ≥30 microgram/L and ≤300 microgram/L.
measure: Time to Correction of Serum Ferritin Levels
time frame: Baseline to Week 12 (permitting 10 to 16 weeks)
description: Normalised serum ferritin is defined in this study as serum ferritin concentration ≥30 microgram/L and ≤300 microgram/L.
measure: Change in Transferrin Saturation at Week 4
time frame: Baseline to Week 4 (permitting 3 to 5 weeks)
description: Change in transferrin saturation (TSAT) at Week 4
measure: Change in Transferrin Saturation at Week 12
time frame: Baseline to Week 12
description: Change in transferrin saturation (TSAT) at Week 12
measure: Percentage of Patients With Normalised Transferrin Saturation at 12 Weeks After Initiation of Feraccru®
time frame: Baseline to Week 12
description: Normalised transferrin saturation is defined in this study as transferrin saturation between 20% and 50%.
measure: Time to Correction of Transferrin Saturation
time frame: Baseline to Week 12
description: Normalised transferrin saturation is defined in this study as transferrin saturation between 20% and 50%.
measure: Time From Diagnosis of IBD to Initiation of Feraccru
time frame: Baseline
description: Time from diagnosis of Inflammatory Bowel Disease to initiation of Feraccru.
measure: Time From Diagnosis of IDA to Initiation of Feraccru®
time frame: Baseline
description: Time from diagnosis of Iron Deficiency Anaemia to initiation of Feraccru®
measure: Prior IV Treatment History
time frame: Baseline
description: Prior intravenous iron treatment history
measure: Reason for Initiating Feraccru®
time frame: Baseline
description: Reason(s) for initiation of Feraccru®
measure: Percentage of Patients Who Discontinue Feraccru®
time frame: Baseline to week 12
description: Percentage of patients who discontinue Feraccru® during the 12 weeks period
measure: Reason for Discontinuing Feraccru®
time frame: Baseline to week 12
description: Reasons for stopping will be collected as predefined common options and a free text field.
measure: Adverse Events That Are Related to and Caused by Feraccru®
time frame: For the duration of study, average of 12 weeks.
description: Type, severity and time of adverse events that are related to and caused by Feraccru®, from initiation of Feraccru®
measure: Reason for Discontinuing Each Prior Oral Ferrous Product
time frame: Baseline
description: Reason(s) for discontinuing each prior Oral Ferrous Product (OFP). Patients could have multiple reasons for discontinuation of previous OFP.
measure: Sex of Patient at Baseline
time frame: Baseline
description: Sex of patient at Baseline - Male or Female
measure: Type of IBD at Baseline (Crohn's Disease or Ulcerative Colitis)
time frame: Baseline
description: Type of Inflammatory Bowel Disease at baseline (Crohn's Disease or Ulcerative Colitis)
measure: Platelets Count at Baseline
time frame: Baseline
description: Mean platelets count at baseline
measure: Vitamin B12 Value at Baseline
time frame: Baseline
description: Vitamin B12 mean value at baseline
measure: Mean Corpuscular Volume at Baseline
time frame: Baseline
description: Mean value of C-reactive protein (CRP) at Baseline
measure: Mean Corpuscular Hb at Baseline
time frame: Baseline
description: Mean corpuscular haemoglobin (MCH) at Baseline
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
mesh term: Anemia
mesh term: Anemia, Iron-Deficiency
mesh term: Iron Deficiencies
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Multiple patients lacked Hb (and other clinical parameters) at the 3-5- and 10-16-week time points, limiting the analysis that could be performed; due to this, overestimation or underestimation of the true normalisation rates may have been observed.
point of contact: 