<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/NCT01716559</url>
  </required_header>
  <id_info>
    <org_study_id>ML25362</org_study_id>
    <nct_id>NCT01716559</nct_id>
  </id_info>
  <brief_title>An Observational Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Non-myeloid Malignancy</brief_title>
  <official_title>Multicenter, Observational Study to Evaluate NeoRecormon Treatment in Anemic Patients Suffering From Non-myeloid Malignancy Receiving Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This observational, prospective, multicenter study will evaluate the treatment response rate&#xD;
      and the safety of NeoRecormon (epoetin beta) in anemic patients with non-myeloid malignancy.&#xD;
      In addition to NeoRecormon, patients receive chemotherapy for their malignancy. Data will be&#xD;
      collected for 16 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2010</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">March 2012</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With an Increase of Greater Than or Equal to 1 Gram Per Decilitre in Hemoglobin Level at Week 8</measure>
    <time_frame>Baseline to Week 8</time_frame>
    <description>Therapeutic response was defined as an increase of greater than or equal to (&gt;=) 1 gram per decilitre (g/dL) in hemoglobin (Hb) level as compared to baseline, following 8 weeks of Epoetin beta treatment. The Therapeutic response rate was summarized as percentage of participants with an increase of &gt;= 1 g/dL in Hb level at Week 8 as compared to baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change From Baseline in Hemoglobin Level up to Week 16</measure>
    <time_frame>Baseline, Week 4, Week 8, Week 12, and Week 16</time_frame>
    <description>The mean change in Hb concentration was calculated by subtracting the baseline Hb concentration from the Weekly Hb concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Red Blood Cell Transfusion-free Participants</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>Percentage of participants who have not received red blood cell (RBC) transfusion (packed RBC or whole blood) during the study were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With or With no Response on Efficacy of Treatment With or Without Iron Replacement Therapy</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>Effect of individual iron supplementation on the efficacy of Epoetin beta treatment was described by percentage of participants with or with no response on efficacy of treatment due iron replacement therapy. Response was determined by calculating the difference in Hb level at H3 (Week 8) as compared to H1 (baseline). If H3-H1 is greater than (&gt;) 1, there is a response (response value =1), otherwise there was no response (response value=0). If both were missing, then response was also missing. Response value as &quot;1&quot; denotes an effect on the response of treatment with or without iron replacement therapy. Response value as &quot;0&quot; denotes no effect on the response of treatment with or without iron replacement therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events and Serious Adverse Events</measure>
    <time_frame>Up to Week 16</time_frame>
    <description>An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">160</enrollment>
  <condition>Anemia</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Anemic patients with non-myeloid malignancy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients, &gt;/=18 years of age&#xD;
&#xD;
          -  Presence of solid-tumor or non-myeloid malignancy&#xD;
&#xD;
          -  Patients receiving chemotherapy&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance status 0-2&#xD;
&#xD;
          -  Patients require NeoRecormon&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity to the drug&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Female patients if pregnant and/or lactating&#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>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Budapest</city>
        <zip>1088</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Budapest</city>
        <zip>1125</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Budapest</city>
        <zip>1441</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Budapest</city>
        <zip>1529</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kaposvár</city>
        <zip>7400</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Szolnok</city>
        <zip>5000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <results_first_submitted>January 11, 2016</results_first_submitted>
  <results_first_submitted_qc>January 11, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 9, 2016</results_first_posted>
  <last_update_submitted>August 16, 2016</last_update_submitted>
  <last_update_submitted_qc>August 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 18, 2016</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>Neoplasms</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This is an observational study. A total of 160 participants were enrolled across 8 study centers in Hungary from 03 August 2010 to 28 March 2012.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Epoetin Beta</title>
          <description>Participants receiving 30,000 International units (IU) of Epoetin beta (NeoRecormon) subcutaneously by prefilled pen injection once a week for 16 weeks were observed.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="160"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="111"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other withdrawal reason</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Total population included all participants who met the inclusion and exclusion criteria and received at least one dose of study medication.</population>
      <group_list>
        <group group_id="B1">
          <title>Epoetin Beta</title>
          <description>Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="160"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="63" spread="9.97"/>
                  </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="87"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With an Increase of Greater Than or Equal to 1 Gram Per Decilitre in Hemoglobin Level at Week 8</title>
        <description>Therapeutic response was defined as an increase of greater than or equal to (&gt;=) 1 gram per decilitre (g/dL) in hemoglobin (Hb) level as compared to baseline, following 8 weeks of Epoetin beta treatment. The Therapeutic response rate was summarized as percentage of participants with an increase of &gt;= 1 g/dL in Hb level at Week 8 as compared to baseline.</description>
        <time_frame>Baseline to Week 8</time_frame>
        <population>The analysis was performed on total population. At the end of the Week 8, data allowing the evaluation of the therapeutic response was available for 103 participants out of total population of 160.</population>
        <group_list>
          <group group_id="O1">
            <title>Epoetin Beta</title>
            <description>Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With an Increase of Greater Than or Equal to 1 Gram Per Decilitre in Hemoglobin Level at Week 8</title>
          <description>Therapeutic response was defined as an increase of greater than or equal to (&gt;=) 1 gram per decilitre (g/dL) in hemoglobin (Hb) level as compared to baseline, following 8 weeks of Epoetin beta treatment. The Therapeutic response rate was summarized as percentage of participants with an increase of &gt;= 1 g/dL in Hb level at Week 8 as compared to baseline.</description>
          <population>The analysis was performed on total population. At the end of the Week 8, data allowing the evaluation of the therapeutic response was available for 103 participants out of total population of 160.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.96" lower_limit="58.95" upper_limit="76.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Change From Baseline in Hemoglobin Level up to Week 16</title>
        <description>The mean change in Hb concentration was calculated by subtracting the baseline Hb concentration from the Weekly Hb concentration.</description>
        <time_frame>Baseline, Week 4, Week 8, Week 12, and Week 16</time_frame>
        <population>The analysis was performed on Total population. The &quot;n&quot; signifies the number of participants assessed for mean change in hemoglobin level for specified time point.</population>
        <group_list>
          <group group_id="O1">
            <title>Epoetin Beta</title>
            <description>Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Change From Baseline in Hemoglobin Level up to Week 16</title>
          <description>The mean change in Hb concentration was calculated by subtracting the baseline Hb concentration from the Weekly Hb concentration.</description>
          <population>The analysis was performed on Total population. The &quot;n&quot; signifies the number of participants assessed for mean change in hemoglobin level for specified time point.</population>
          <units>g/dL</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 4; n = 149</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.194" spread="0.133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 8, n = 103</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.641" spread="0.169"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 12, n = 70</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.970" spread="0.198"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 16, n = 50</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.789" spread="0.227"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Red Blood Cell Transfusion-free Participants</title>
        <description>Percentage of participants who have not received red blood cell (RBC) transfusion (packed RBC or whole blood) during the study were reported.</description>
        <time_frame>Up to Week 16</time_frame>
        <population>The analysis was performed on Total population.</population>
        <group_list>
          <group group_id="O1">
            <title>Epoetin Beta</title>
            <description>Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Red Blood Cell Transfusion-free Participants</title>
          <description>Percentage of participants who have not received red blood cell (RBC) transfusion (packed RBC or whole blood) during the study were reported.</description>
          <population>The analysis was performed on Total population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.25" lower_limit="69.66" upper_limit="82.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With or With no Response on Efficacy of Treatment With or Without Iron Replacement Therapy</title>
        <description>Effect of individual iron supplementation on the efficacy of Epoetin beta treatment was described by percentage of participants with or with no response on efficacy of treatment due iron replacement therapy. Response was determined by calculating the difference in Hb level at H3 (Week 8) as compared to H1 (baseline). If H3-H1 is greater than (&gt;) 1, there is a response (response value =1), otherwise there was no response (response value=0). If both were missing, then response was also missing. Response value as &quot;1&quot; denotes an effect on the response of treatment with or without iron replacement therapy. Response value as &quot;0&quot; denotes no effect on the response of treatment with or without iron replacement therapy.</description>
        <time_frame>Up to Week 16</time_frame>
        <population>The analysis was performed on total population. At the end of the study, data allowing the evaluation of effect of individual iron supplementation on the efficacy of Epoetin beta treatment were available for 103 participants out of total population of 160.</population>
        <group_list>
          <group group_id="O1">
            <title>Epoetin Beta</title>
            <description>Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With or With no Response on Efficacy of Treatment With or Without Iron Replacement Therapy</title>
          <description>Effect of individual iron supplementation on the efficacy of Epoetin beta treatment was described by percentage of participants with or with no response on efficacy of treatment due iron replacement therapy. Response was determined by calculating the difference in Hb level at H3 (Week 8) as compared to H1 (baseline). If H3-H1 is greater than (&gt;) 1, there is a response (response value =1), otherwise there was no response (response value=0). If both were missing, then response was also missing. Response value as &quot;1&quot; denotes an effect on the response of treatment with or without iron replacement therapy. Response value as &quot;0&quot; denotes no effect on the response of treatment with or without iron replacement therapy.</description>
          <population>The analysis was performed on total population. At the end of the study, data allowing the evaluation of effect of individual iron supplementation on the efficacy of Epoetin beta treatment were available for 103 participants out of total population of 160.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>With IRT, Response value = 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>With IRT, Response value = 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without IRT, Response value = 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Without IRT, Response value = 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events and Serious Adverse Events</title>
        <description>An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.</description>
        <time_frame>Up to Week 16</time_frame>
        <population>The analysis was performed on total population.</population>
        <group_list>
          <group group_id="O1">
            <title>Epoetin Beta</title>
            <description>Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events and Serious Adverse Events</title>
          <description>An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.</description>
          <population>The analysis was performed on total population.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Week 16</time_frame>
      <desc>An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.</desc>
      <group_list>
        <group group_id="E1">
          <title>Epoetin Beta</title>
          <description>Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia haemolytic autoimmune</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Bone marrow failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Granulocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Idiopathic thrombocytopenic purpura</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiopulmonary failure</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Disease progression</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Brain abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </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="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Metastases to central nervous system</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Plasma cell myeloma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hemiparesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Circulatory collapse</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA 18.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Granulocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Granulocytosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Metastasis to Bone</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="160"/>
              </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>The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Roche Trial Information Hotline</name_or_title>
      <organization>F. Hoffmann-La Roche AG</organization>
      <phone>+41 61 6878333</phone>
      <email>global.trial_information@roche.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/NCT01716559
org study id: ML25362
nct id: NCT01716559
lead sponsor: 
This observational, prospective, multicenter study will evaluate the treatment response rate
      and the safety of NeoRecormon (epoetin beta) in anemic patients with non-myeloid malignancy.
      In addition to NeoRecormon, patients receive chemotherapy for their malignancy. Data will be
      collected for 16 weeks.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants With an Increase of Greater Than or Equal to 1 Gram Per Decilitre in Hemoglobin Level at Week 8
time frame: Baseline to Week 8
description: Therapeutic response was defined as an increase of greater than or equal to (>=) 1 gram per decilitre (g/dL) in hemoglobin (Hb) level as compared to baseline, following 8 weeks of Epoetin beta treatment. The Therapeutic response rate was summarized as percentage of participants with an increase of >= 1 g/dL in Hb level at Week 8 as compared to baseline.
measure: Mean Change From Baseline in Hemoglobin Level up to Week 16
time frame: Baseline, Week 4, Week 8, Week 12, and Week 16
description: The mean change in Hb concentration was calculated by subtracting the baseline Hb concentration from the Weekly Hb concentration.
measure: Percentage of Red Blood Cell Transfusion-free Participants
time frame: Up to Week 16
description: Percentage of participants who have not received red blood cell (RBC) transfusion (packed RBC or whole blood) during the study were reported.
measure: Number of Participants With or With no Response on Efficacy of Treatment With or Without Iron Replacement Therapy
time frame: Up to Week 16
description: Effect of individual iron supplementation on the efficacy of Epoetin beta treatment was described by percentage of participants with or with no response on efficacy of treatment due iron replacement therapy. Response was determined by calculating the difference in Hb level at H3 (Week 8) as compared to H1 (baseline). If H3-H1 is greater than (>) 1, there is a response (response value =1), otherwise there was no response (response value=0). If both were missing, then response was also missing. Response value as "1" denotes an effect on the response of treatment with or without iron replacement therapy. Response value as "0" denotes no effect on the response of treatment with or without iron replacement therapy.
measure: Number of Participants With Adverse Events and Serious Adverse Events
time frame: Up to Week 16
description: An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. Number of participants with at least one AE and SAE were reported.
arm group label: Cohort
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Hungary
responsible party type: Sponsor
mesh term: Neoplasms
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 