<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/NCT03034044</url>
  </required_header>
  <id_info>
    <org_study_id>B1831086</org_study_id>
    <nct_id>NCT03034044</nct_id>
  </id_info>
  <brief_title>Post-Marketing Surveillance To Observe Safety And Efficacy Of Xyntha Solofuse Prefilled Syringe</brief_title>
  <official_title>POST-MARKETING SURVEILLANCE TO OBSERVE SAFETY AND EFFICACY OF XYNTHA SOLOFUSE PREFILLED SYRINGE</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <brief_summary>
    <textblock>
      This study aims to observe the safety and efficacy of the Xyntha Solofuse prefilled syringe&#xD;
      in the setting of routine practice. The primary objective is to detect medically significant&#xD;
      events (factor VIII inhibitor). The secondary objective is to observe the overall efficacy&#xD;
      and safety of the Xyntha Solofuse prefilled syringe including serious adverse events. In this&#xD;
      open-label, non-comparative, observational, non-interventional, retrospective and&#xD;
      multi-center study, post-marketing surveillance data will be collected retrospectively for up&#xD;
      to 6 months from the initial administration day of the Xyntha Solofuse prefilled syringe&#xD;
      injected into patients who have been administered the Xyntha Solofuse prefilled syringe.&#xD;
&#xD;
      As specified in the product approval issued by the Ministry of Food and Drug Safety, the&#xD;
      study will be conducted for 4 years from the approval date. At least 600 study subjects will&#xD;
      be enrolled in this study to meet the MFDS requirements. Although 600 is the assigned number&#xD;
      of study subjects, the number of cases will be adjusted considering the actual number of&#xD;
      enrolled subjects after the study start day.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">January 17, 2018</completion_date>
  <primary_completion_date type="Actual">January 17, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
    <description>An AE was any untoward medical occurrence in participants who received Xyntha without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment Emergent Adverse Event (TEAE) was adverse event that started or worsened in severity after first administration of Xyntha Solofuse up to 6 months. AEs included both serious and non-serious adverse event.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) by Severity</measure>
    <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
    <description>An AE was any untoward medical occurrence in participants who received Xyntha without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function, and was determined based on investigator's discretion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Discontinued Due to Adverse Events</measure>
    <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
    <description>An AE was any untoward medical occurrence in participants who received study drug without regard to possibility of causal relationship.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events</measure>
    <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
    <description>Treatment-related AE was any untoward medical occurrence attributed to Xyntha in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to treatment was assessed by investigator. AEs included both serious and non-serious AEs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Who Died Due to Adverse Events</measure>
    <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
    <description>An AE was any untoward medical occurrence in participants who received Xyntha without regard to possibility of causal relationship.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Overall Responses on a 4-Point Scale to the Injections Used to Treat Bleeding: On-Demand Treatment According to Surgery</measure>
    <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
    <description>On-demand treatment according to surgery: treatment to increase factor in preparation for surgery. Overall responses to all injection of Xyntha Solofuse prefilled syringe used to treat bleeding in on-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) according to surgery was assessed on 4 point scale of 1=excellent, 2=good, 3=moderate and 4=no response, higher score = better response. Excellent= Definite pain relief and/or improvement in signs of bleeding within 8 hours after an infusion, with no additional infusion, good= Definite pain relief and/or improvement in signs of bleeding within 8 hours after an infusion, with 1 additional infusion, moderate= Probable/slight improvement starting after 8 hours following infusion, with &gt;=1 additional infusion administered for complete resolution of bleeding episode and no response= No improvement at all between infusions/during 24 hour interval following an infusion/condition worsens</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Overall Responses on a 4-Point Scale to the Injections Used to Treat Bleeding: On-Demand Treatment According to Bleeding</measure>
    <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
    <description>On-demand treatment according to bleeding: treatment administered for spontaneous bleeding/abrasion; not requiring surgery. Overall responses to all injection of Xyntha used to treat bleeding in on-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) according to bleeding was assessed on 4 point scale of 1=excellent, 2=good, 3=moderate,4=no response, higher score=better response. Excellent= Definite pain relief and/or improvement in signs of bleeding within 8 hours after an infusion, with no additional infusion, good= Definite pain relief and/or improvement in signs of bleeding within 8 hours after an infusion, with 1 additional infusion, moderate= Probable/slight improvement after 8 hours following infusion, with &gt;=1 additional infusion administered for complete resolution of bleeding episode and no response= No improvement at all between infusions/during 24 hour interval following an infusion, or condition worsens.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Less Than Expected Therapeutic Effect (LETE): On-Demand Treatment According to Surgery</measure>
    <time_frame>Within 24 hours of on-demand treatment (anytime within the observation period of 6 months)</time_frame>
    <description>LETE for on-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) was defined as &quot;no response&quot; rated after each infusion of 2 consecutive infusions within 24 hours after on-demand treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Less Than Expected Therapeutic Effect (LETE): On-Demand Treatment According to Bleeding</measure>
    <time_frame>Within 24 hours of on-demand treatment (anytime within the observation period of up to 6 months)</time_frame>
    <description>LETE for on-demand treatment ((administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) was defined as &quot;no response&quot; rated after each infusion of 2 consecutive infusions within 24 hours after on-demand treatment) was defined as &quot;no response&quot; rated after each infusion of 2 consecutive infusions within 24 hours after on-demand treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Infusions Required to Treat Each New Bleeding Episode</measure>
    <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
    <description>It was calculated as total number of injections given throughout the study divided by total number of bleeding events.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Dose of Infusions Per Bleeding Event: On-Demand Treatment According to Surgery</measure>
    <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
    <description>The average dose of Xyntha per bleeding event according to surgery in on-demand treatment was calculated as total dose of Xyntha (in IU) throughout the study divided by total number of bleeding event. On-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) according to surgery means treatment to increase factor in preparation for surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Dose of Infusions Per Bleeding Event: On-Demand Treatment According to Bleeding</measure>
    <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
    <description>The average dose of Xyntha per bleeding event was calculated as total dose of Xyntha throughout the study (in International Units [IU]) divided by total number of bleeding incidence. On-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) according to bleeding means treatment administered due to spontaneous bleeding or abrasion.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants With Bleeding Event</measure>
    <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Annualized Bleeding Rates (ABRs)</measure>
    <time_frame>Within 48 hours after the prophylactic administration of Xyntha (within the duration of 6 months)</time_frame>
    <description>Annualized bleeding rate defined as number of bleeds under prophylactic setting (defined as bleeding occurred after 48 hours of prophylactic therapy [administration of Xyntha not for the treatment of a bleed but for the prevention of bleeding]) divided by (/) [(number of prophylactic therapy participants)*0.5)]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Less Than Expected Therapeutic Effect (LETE): Prophylactic Therapy</measure>
    <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
    <description>Less than expected therapeutic effect for prophylaxis therapy defined as breakthrough (spontaneous/non-traumatic) bleeding occurred within 48 hours of prophylaxis infusion (defined as: administration of Xyntha not for the treatment of a bleed but for the prevention of bleeding).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average Dose of Infusions Per Bleeding Event: Prophylactic Therapy</measure>
    <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
    <description>The average dose of Xyntha per bleeding event according to prophylaxis therapy treatment was calculated as total dose of Xyntha (in IU) throughout the study divided by total number of bleeding event. Prophylaxis therapy defined as breakthrough (spontaneous/non-traumatic) bleeding occurred within 48 hours of prophylaxis infusion (defined as administration of Xyntha not for the treatment of a bleed but for the prevention of bleeding).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Factor VIII Consumption</measure>
    <time_frame>6 months</time_frame>
    <description>Total factor VIII consumption for each participant was calculated by sum of the total amount of Xyntha Solofuse (in IU) infused for each Xyntha Solofuse infusion.</description>
  </primary_outcome>
  <enrollment type="Actual">106</enrollment>
  <condition>Factor VIII Deficiency, Congenital</condition>
  <condition>Factor 8 Deficiency, Congenital</condition>
  <condition>Autosomal Hemophilia A</condition>
  <condition>Classic Hemophilia</condition>
  <condition>Hemophilia A, Congenital</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The study population is Hemophilia A (congenital factor VIII deficiency) patients who have&#xD;
        been administered the Xyntha Solofuse prefilled syringe (as part of routine treatment at&#xD;
        the Korean health care canter which has certified investigators).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -. Inclusion criteria&#xD;
&#xD;
        To be eligible to enroll in this study, the study subjects will have to meet all the&#xD;
        following inclusion criteria:&#xD;
&#xD;
          1. Hemophilia A (congenital factor VIII deficiency) patients who have been administered&#xD;
             according to the indication of the product 1) Control and prevention of bleeding&#xD;
             episodes and for routine and surgical prophylaxis in patients with hemophilia A&#xD;
             (congenital factor VIII deficiency) 2) This drug does not contain von Willebrand&#xD;
             factor and, therefore, is not indicated in von Willebrand's disease&#xD;
&#xD;
          2. Those who have been administered the Xyntha Solofuse prefilled syringe at least once -&#xD;
             Exclusion criteria&#xD;
&#xD;
        Patients who satisfy the following criteria are not included in the study according to the&#xD;
        local labeling:&#xD;
&#xD;
          1. Patients who have a history of hypersensitivity to the Xyntha Solofuse prefilled&#xD;
             syringe or the ingredients of this drug.&#xD;
&#xD;
          2. Patients who have a history of hypersensitivity to hamster proteins.&#xD;
&#xD;
          3. Patients who have bleeding disorders other than hemophilia A.&#xD;
&#xD;
          4. Patients who have a history of FVIII inhibitors, or currently have or are suspected of&#xD;
             having FVIII inhibitors. In case inhibitor titers quantified in Bethesda Units in the&#xD;
             laboratory test results are within the normal laboratory range or at least 0.6 BU/mL.&#xD;
             If laboratory tests cannot be performed, the investigator will determine whether or&#xD;
             not inhibitors exist based on the clinical assessment results that show a decrease in&#xD;
             efficacy of the replacement of FVIII (e.g. bleeding at least once, if the replacement&#xD;
             of anti-bleeding agents is needed to be administered, and if frequency or dosage of&#xD;
             replacement FVIII therapy needs to be increased).&#xD;
&#xD;
          5. Use of immunomodulatory therapy. (e.g. intravenous injection of immunoglobulin, use of&#xD;
             regular systemic corticosteroids, cyclosporine, and mediators of anti-TNF-α)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1831086&amp;StudyName=Post+Marketing+Surveillance+To+Observe+Safety+And+Efficacy+Of+Xyntha+%28registered%29+Solofuse</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1831086&amp;StudyName=Post-marketing+Surveillance+To+Observe+Safety+And+Efficacy+Of+Xyntha+Solofuse+Prefilled+Syringe</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <results_first_submitted>January 7, 2019</results_first_submitted>
  <results_first_submitted_qc>January 7, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 5, 2019</results_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2019</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>Hemophilia A</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 17, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03034044/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 20, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03034044/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Xyntha</title>
          <description>Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="106"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Xyntha</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Enrolled, but not received Xyntha</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis was performed on all participants who received at least 1 dose of Xyntha solofuse prefilled syringe.</population>
      <group_list>
        <group group_id="B1">
          <title>Xyntha</title>
          <description>Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="105"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt; 30 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30- 39 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40- 49 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50- 59 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;= 60 years</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </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="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <description>Race and Ethnicity were not collected from any participant.</description>
          <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>Duration of the disease, Continuous</title>
          <description>Duration of Hemophilia A in the study participants is provided in this baseline measure.</description>
          <units>Years</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="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.4" spread="16.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Genetic mutation of factor VIII</title>
          <description>Presence of Genetic mutation of factor VIII was analyzed and provided in the categories of Yes (Present), No (not present) and Unknown.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Previous exposure to plasma-derived factor VIII</title>
          <description>Previous exposure of participants (before enrollment into the study) to plasma-derived factor VIII was determined and provided by using the categories as Yes (had exposure), No (did not have exposure) and Unknown.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Previous used factor VIII therapy</title>
          <description>Previous (before enrollment into the study) use of factor VIII therapy by participants was determined and provided by using the categories as Yes (had exposure) and No (did not have exposure).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Personal history of allergic reactions to factor VIII products</title>
          <description>Personal history of allergic reactions to factor VIII products was analyzed and provided as in the categories of 'Yes' (had allergy) and 'No (did not have allergy)'.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Family history of hemophilia A</title>
          <description>History of hemophilia A in the family of participants was determined and provided as in the categories of 'Yes' (had history of hemophilia disease) and 'No' (did not have history of hemophilia disease).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Family history of factor VIII inhibitors</title>
          <description>History of factor VIII inhibitors in the family of participants was determined and provided as in the categories of 'Yes' (had history of factor VIII inhibitors) and 'No' (did not have history of factor VIII inhibitors).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Family history of allergic reactions to factor VIII products</title>
          <description>History of allergic reactions to factor VIII products in the family of participants was determined and provided as in the categories of 'Yes' (had history of allergy) and 'No' (did not have allergy).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Disease severity</title>
          <description>Disease Severity was determined based on activity of coagulation factor and was categorized into different level of categories which included as Mild (5 percent [%] to 40%), Moderate (1 to 5%) and Severe (less than [&lt;] 1%).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Mild</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Medical history</title>
          <description>Medical history of hemophilia A in the family of participants was determined and provided as in the categories of 'Yes' (had history of hemophilia A) and 'No' (did not have history of hemophilia A).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Renal Disorder</title>
          <description>Participants with renal disorder was determined and provided as in the categories of 'Yes' (had renal disorder besides Haemophilia A) and 'No'(did not have renal disorder).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hepatic Disorder</title>
          <description>Participants with hepatic disorder was determined and provided as in the categories of 'Yes' (had hepatic disorder besides Haemophilia A) and 'No' (did not have hepatic disorder).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Personal History of Allergic Reactions to Factor VIII Products (within 12 months)</title>
          <description>Personal history of allergic reactions of participants to factor VIII products was analyzed and provided as in the categories of 'Yes' (had allergy) and 'No (did not had allergy)</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Concomitant treatments</title>
          <description>Concomitant treatments usage was determined in participants and provided here in the categories of 'Yes' (participants who had concomitant medication) and 'No (participants who did not have concomitant medication)'. Concomitant treatment included any other medicine/drug, which participants received other than Xyntha.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Concomitant therapy</title>
          <description>Concomitant therapy was determined in participants and provided here in the categories of 'Yes' (participants who had receive concomitant therapy) and 'No (participants who did not have received concomitant therapy)'. Concomitant therapy included any other therapy which participants were received other than study therapy.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="105"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
        <description>An AE was any untoward medical occurrence in participants who received Xyntha without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment Emergent Adverse Event (TEAE) was adverse event that started or worsened in severity after first administration of Xyntha Solofuse up to 6 months. AEs included both serious and non-serious adverse event.</description>
        <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
        <population>The safety population included all participants who received at least one dose of Xyntha Solofuse prefilled syringe.</population>
        <group_list>
          <group group_id="O1">
            <title>Xyntha</title>
            <description>Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
          <description>An AE was any untoward medical occurrence in participants who received Xyntha without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment Emergent Adverse Event (TEAE) was adverse event that started or worsened in severity after first administration of Xyntha Solofuse up to 6 months. AEs included both serious and non-serious adverse event.</description>
          <population>The safety population included all participants who received at least one dose of Xyntha Solofuse prefilled syringe.</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="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Adverse Events (AEs) by Severity</title>
        <description>An AE was any untoward medical occurrence in participants who received Xyntha without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function, and was determined based on investigator's discretion.</description>
        <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
        <population>The safety population included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Xyntha</title>
            <description>Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events (AEs) by Severity</title>
          <description>An AE was any untoward medical occurrence in participants who received Xyntha without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function, and was determined based on investigator's discretion.</description>
          <population>The safety population included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</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="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Mild</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Discontinued Due to Adverse Events</title>
        <description>An AE was any untoward medical occurrence in participants who received study drug without regard to possibility of causal relationship.</description>
        <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
        <population>The safety population included all participants who received at least one dose of Xyntha Solofuse prefilled syringe.</population>
        <group_list>
          <group group_id="O1">
            <title>Xyntha</title>
            <description>Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Discontinued Due to Adverse Events</title>
          <description>An AE was any untoward medical occurrence in participants who received study drug without regard to possibility of causal relationship.</description>
          <population>The safety population included all participants who received at least one dose of Xyntha Solofuse prefilled syringe.</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="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events</title>
        <description>Treatment-related AE was any untoward medical occurrence attributed to Xyntha in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to treatment was assessed by investigator. AEs included both serious and non-serious AEs.</description>
        <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
        <population>The safety population included all participants who received at least one dose of Xyntha Solofuse prefilled syringe.</population>
        <group_list>
          <group group_id="O1">
            <title>Xyntha</title>
            <description>Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events</title>
          <description>Treatment-related AE was any untoward medical occurrence attributed to Xyntha in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to treatment was assessed by investigator. AEs included both serious and non-serious AEs.</description>
          <population>The safety population included all participants who received at least one dose of Xyntha Solofuse prefilled syringe.</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="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Died Due to Adverse Events</title>
        <description>An AE was any untoward medical occurrence in participants who received Xyntha without regard to possibility of causal relationship.</description>
        <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
        <population>The safety population included all participants who received at least one dose of Xyntha Solofuse prefilled syringe.</population>
        <group_list>
          <group group_id="O1">
            <title>Xyntha</title>
            <description>Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Died Due to Adverse Events</title>
          <description>An AE was any untoward medical occurrence in participants who received Xyntha without regard to possibility of causal relationship.</description>
          <population>The safety population included all participants who received at least one dose of Xyntha Solofuse prefilled syringe.</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="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Overall Responses on a 4-Point Scale to the Injections Used to Treat Bleeding: On-Demand Treatment According to Surgery</title>
        <description>On-demand treatment according to surgery: treatment to increase factor in preparation for surgery. Overall responses to all injection of Xyntha Solofuse prefilled syringe used to treat bleeding in on-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) according to surgery was assessed on 4 point scale of 1=excellent, 2=good, 3=moderate and 4=no response, higher score = better response. Excellent= Definite pain relief and/or improvement in signs of bleeding within 8 hours after an infusion, with no additional infusion, good= Definite pain relief and/or improvement in signs of bleeding within 8 hours after an infusion, with 1 additional infusion, moderate= Probable/slight improvement starting after 8 hours following infusion, with &gt;=1 additional infusion administered for complete resolution of bleeding episode and no response= No improvement at all between infusions/during 24 hour interval following an infusion/condition worsens</description>
        <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
        <population>The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Xyntha</title>
            <description>Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Overall Responses on a 4-Point Scale to the Injections Used to Treat Bleeding: On-Demand Treatment According to Surgery</title>
          <description>On-demand treatment according to surgery: treatment to increase factor in preparation for surgery. Overall responses to all injection of Xyntha Solofuse prefilled syringe used to treat bleeding in on-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) according to surgery was assessed on 4 point scale of 1=excellent, 2=good, 3=moderate and 4=no response, higher score = better response. Excellent= Definite pain relief and/or improvement in signs of bleeding within 8 hours after an infusion, with no additional infusion, good= Definite pain relief and/or improvement in signs of bleeding within 8 hours after an infusion, with 1 additional infusion, moderate= Probable/slight improvement starting after 8 hours following infusion, with &gt;=1 additional infusion administered for complete resolution of bleeding episode and no response= No improvement at all between infusions/during 24 hour interval following an infusion/condition worsens</description>
          <population>The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</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="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Excellent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Overall Responses on a 4-Point Scale to the Injections Used to Treat Bleeding: On-Demand Treatment According to Bleeding</title>
        <description>On-demand treatment according to bleeding: treatment administered for spontaneous bleeding/abrasion; not requiring surgery. Overall responses to all injection of Xyntha used to treat bleeding in on-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) according to bleeding was assessed on 4 point scale of 1=excellent, 2=good, 3=moderate,4=no response, higher score=better response. Excellent= Definite pain relief and/or improvement in signs of bleeding within 8 hours after an infusion, with no additional infusion, good= Definite pain relief and/or improvement in signs of bleeding within 8 hours after an infusion, with 1 additional infusion, moderate= Probable/slight improvement after 8 hours following infusion, with &gt;=1 additional infusion administered for complete resolution of bleeding episode and no response= No improvement at all between infusions/during 24 hour interval following an infusion, or condition worsens.</description>
        <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
        <population>The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Xyntha</title>
            <description>Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Overall Responses on a 4-Point Scale to the Injections Used to Treat Bleeding: On-Demand Treatment According to Bleeding</title>
          <description>On-demand treatment according to bleeding: treatment administered for spontaneous bleeding/abrasion; not requiring surgery. Overall responses to all injection of Xyntha used to treat bleeding in on-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) according to bleeding was assessed on 4 point scale of 1=excellent, 2=good, 3=moderate,4=no response, higher score=better response. Excellent= Definite pain relief and/or improvement in signs of bleeding within 8 hours after an infusion, with no additional infusion, good= Definite pain relief and/or improvement in signs of bleeding within 8 hours after an infusion, with 1 additional infusion, moderate= Probable/slight improvement after 8 hours following infusion, with &gt;=1 additional infusion administered for complete resolution of bleeding episode and no response= No improvement at all between infusions/during 24 hour interval following an infusion, or condition worsens.</description>
          <population>The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</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="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Excellent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Less Than Expected Therapeutic Effect (LETE): On-Demand Treatment According to Surgery</title>
        <description>LETE for on-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) was defined as &quot;no response&quot; rated after each infusion of 2 consecutive infusions within 24 hours after on-demand treatment.</description>
        <time_frame>Within 24 hours of on-demand treatment (anytime within the observation period of 6 months)</time_frame>
        <population>The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Xyntha</title>
            <description>Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Less Than Expected Therapeutic Effect (LETE): On-Demand Treatment According to Surgery</title>
          <description>LETE for on-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) was defined as &quot;no response&quot; rated after each infusion of 2 consecutive infusions within 24 hours after on-demand treatment.</description>
          <population>The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</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="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Less Than Expected Therapeutic Effect (LETE): On-Demand Treatment According to Bleeding</title>
        <description>LETE for on-demand treatment ((administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) was defined as &quot;no response&quot; rated after each infusion of 2 consecutive infusions within 24 hours after on-demand treatment) was defined as &quot;no response&quot; rated after each infusion of 2 consecutive infusions within 24 hours after on-demand treatment.</description>
        <time_frame>Within 24 hours of on-demand treatment (anytime within the observation period of up to 6 months)</time_frame>
        <population>The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Xyntha</title>
            <description>Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Less Than Expected Therapeutic Effect (LETE): On-Demand Treatment According to Bleeding</title>
          <description>LETE for on-demand treatment ((administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) was defined as &quot;no response&quot; rated after each infusion of 2 consecutive infusions within 24 hours after on-demand treatment) was defined as &quot;no response&quot; rated after each infusion of 2 consecutive infusions within 24 hours after on-demand treatment.</description>
          <population>The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</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="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Infusions Required to Treat Each New Bleeding Episode</title>
        <description>It was calculated as total number of injections given throughout the study divided by total number of bleeding events.</description>
        <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
        <population>The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Xyntha</title>
            <description>Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Infusions Required to Treat Each New Bleeding Episode</title>
          <description>It was calculated as total number of injections given throughout the study divided by total number of bleeding events.</description>
          <population>The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>Infusions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.22" spread="0.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Average Dose of Infusions Per Bleeding Event: On-Demand Treatment According to Surgery</title>
        <description>The average dose of Xyntha per bleeding event according to surgery in on-demand treatment was calculated as total dose of Xyntha (in IU) throughout the study divided by total number of bleeding event. On-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) according to surgery means treatment to increase factor in preparation for surgery.</description>
        <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
        <population>The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Xyntha</title>
            <description>Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Dose of Infusions Per Bleeding Event: On-Demand Treatment According to Surgery</title>
          <description>The average dose of Xyntha per bleeding event according to surgery in on-demand treatment was calculated as total dose of Xyntha (in IU) throughout the study divided by total number of bleeding event. On-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) according to surgery means treatment to increase factor in preparation for surgery.</description>
          <population>The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>IU/event</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2619.29" spread="1089.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Average Dose of Infusions Per Bleeding Event: On-Demand Treatment According to Bleeding</title>
        <description>The average dose of Xyntha per bleeding event was calculated as total dose of Xyntha throughout the study (in International Units [IU]) divided by total number of bleeding incidence. On-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) according to bleeding means treatment administered due to spontaneous bleeding or abrasion.</description>
        <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
        <population>The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Xyntha</title>
            <description>Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Dose of Infusions Per Bleeding Event: On-Demand Treatment According to Bleeding</title>
          <description>The average dose of Xyntha per bleeding event was calculated as total dose of Xyntha throughout the study (in International Units [IU]) divided by total number of bleeding incidence. On-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) according to bleeding means treatment administered due to spontaneous bleeding or abrasion.</description>
          <population>The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>IU/event</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2140.08" spread="640.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Bleeding Event</title>
        <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
        <population>The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Xyntha</title>
            <description>Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Bleeding Event</title>
          <population>The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</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="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Annualized Bleeding Rates (ABRs)</title>
        <description>Annualized bleeding rate defined as number of bleeds under prophylactic setting (defined as bleeding occurred after 48 hours of prophylactic therapy [administration of Xyntha not for the treatment of a bleed but for the prevention of bleeding]) divided by (/) [(number of prophylactic therapy participants)*0.5)]</description>
        <time_frame>Within 48 hours after the prophylactic administration of Xyntha (within the duration of 6 months)</time_frame>
        <population>The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Xyntha</title>
            <description>Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.</description>
          </group>
        </group_list>
        <measure>
          <title>Annualized Bleeding Rates (ABRs)</title>
          <description>Annualized bleeding rate defined as number of bleeds under prophylactic setting (defined as bleeding occurred after 48 hours of prophylactic therapy [administration of Xyntha not for the treatment of a bleed but for the prevention of bleeding]) divided by (/) [(number of prophylactic therapy participants)*0.5)]</description>
          <population>The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>bleeds per participant</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Less Than Expected Therapeutic Effect (LETE): Prophylactic Therapy</title>
        <description>Less than expected therapeutic effect for prophylaxis therapy defined as breakthrough (spontaneous/non-traumatic) bleeding occurred within 48 hours of prophylaxis infusion (defined as: administration of Xyntha not for the treatment of a bleed but for the prevention of bleeding).</description>
        <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
        <population>The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Xyntha</title>
            <description>Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Less Than Expected Therapeutic Effect (LETE): Prophylactic Therapy</title>
          <description>Less than expected therapeutic effect for prophylaxis therapy defined as breakthrough (spontaneous/non-traumatic) bleeding occurred within 48 hours of prophylaxis infusion (defined as: administration of Xyntha not for the treatment of a bleed but for the prevention of bleeding).</description>
          <population>The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</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="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Average Dose of Infusions Per Bleeding Event: Prophylactic Therapy</title>
        <description>The average dose of Xyntha per bleeding event according to prophylaxis therapy treatment was calculated as total dose of Xyntha (in IU) throughout the study divided by total number of bleeding event. Prophylaxis therapy defined as breakthrough (spontaneous/non-traumatic) bleeding occurred within 48 hours of prophylaxis infusion (defined as administration of Xyntha not for the treatment of a bleed but for the prevention of bleeding).</description>
        <time_frame>From the first administration of Xyntha up to 6 months</time_frame>
        <population>The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Xyntha</title>
            <description>Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Dose of Infusions Per Bleeding Event: Prophylactic Therapy</title>
          <description>The average dose of Xyntha per bleeding event according to prophylaxis therapy treatment was calculated as total dose of Xyntha (in IU) throughout the study divided by total number of bleeding event. Prophylaxis therapy defined as breakthrough (spontaneous/non-traumatic) bleeding occurred within 48 hours of prophylaxis infusion (defined as administration of Xyntha not for the treatment of a bleed but for the prevention of bleeding).</description>
          <population>The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>IU/event</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1881.33" spread="531.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Factor VIII Consumption</title>
        <description>Total factor VIII consumption for each participant was calculated by sum of the total amount of Xyntha Solofuse (in IU) infused for each Xyntha Solofuse infusion.</description>
        <time_frame>6 months</time_frame>
        <population>The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Xyntha</title>
            <description>Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Factor VIII Consumption</title>
          <description>Total factor VIII consumption for each participant was calculated by sum of the total amount of Xyntha Solofuse (in IU) infused for each Xyntha Solofuse infusion.</description>
          <population>The efficacy analysis set included all participants who received at least one dose of Xyntha Solofuse prefilled syringe. Here, &quot;Overall Number of Participants Analyzed&quot; signifies those participants who were evaluable for this outcome measure.</population>
          <units>IU</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106116.16" spread="55747.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the first administration of Xyntha Solofuse prefilled syringe up to 6 months</time_frame>
      <desc>Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety analysis set.</desc>
      <group_list>
        <group group_id="E1">
          <title>Xyntha</title>
          <description>Participants who were prescribed with Xyntha Solofuse prefilled syringe, as part of routine treatment, were observed in this study for up to 6 months from the initial administration of Xyntha Solofuse.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="105"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>WHO-ART v 92</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title vocab="WHO-ART 092">Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title vocab="WHO-ART 092">Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="105"/>
              </event>
              <event>
                <sub_title>Periodontal destruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title vocab="WHO-ART 092">Fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="105"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="105"/>
              </event>
              <event>
                <sub_title>Skeletal Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title vocab="WHO-ART 092">Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="105"/>
              </event>
              <event>
                <sub_title>Renal calculus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis fungal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="105"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="105"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title vocab="WHO-ART 092">Factor VIII antibody positive</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="105"/>
              </event>
              <event>
                <sub_title vocab="WHO-ART 092">Haemorrhage NOS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="105"/>
              </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>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.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/NCT03034044
org study id: B1831086
nct id: NCT03034044
lead sponsor: 
This study aims to observe the safety and efficacy of the Xyntha Solofuse prefilled syringe
      in the setting of routine practice. The primary objective is to detect medically significant
      events (factor VIII inhibitor). The secondary objective is to observe the overall efficacy
      and safety of the Xyntha Solofuse prefilled syringe including serious adverse events. In this
      open-label, non-comparative, observational, non-interventional, retrospective and
      multi-center study, post-marketing surveillance data will be collected retrospectively for up
      to 6 months from the initial administration day of the Xyntha Solofuse prefilled syringe
      injected into patients who have been administered the Xyntha Solofuse prefilled syringe.

      As specified in the product approval issued by the Ministry of Food and Drug Safety, the
      study will be conducted for 4 years from the approval date. At least 600 study subjects will
      be enrolled in this study to meet the MFDS requirements. Although 600 is the assigned number
      of study subjects, the number of cases will be adjusted considering the actual number of
      enrolled subjects after the study start day.
observational model: Case-Only
time perspective: Retrospective
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: From the first administration of Xyntha up to 6 months
description: An AE was any untoward medical occurrence in participants who received Xyntha without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment Emergent Adverse Event (TEAE) was adverse event that started or worsened in severity after first administration of Xyntha Solofuse up to 6 months. AEs included both serious and non-serious adverse event.
measure: Number of Participants With Adverse Events (AEs) by Severity
time frame: From the first administration of Xyntha up to 6 months
description: An AE was any untoward medical occurrence in participants who received Xyntha without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function, and was determined based on investigator's discretion.
measure: Number of Participants Who Discontinued Due to Adverse Events
time frame: From the first administration of Xyntha up to 6 months
description: An AE was any untoward medical occurrence in participants who received study drug without regard to possibility of causal relationship.
measure: Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events
time frame: From the first administration of Xyntha up to 6 months
description: Treatment-related AE was any untoward medical occurrence attributed to Xyntha in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to treatment was assessed by investigator. AEs included both serious and non-serious AEs.
measure: Number of Participants Who Died Due to Adverse Events
time frame: From the first administration of Xyntha up to 6 months
description: An AE was any untoward medical occurrence in participants who received Xyntha without regard to possibility of causal relationship.
measure: Number of Participants With Overall Responses on a 4-Point Scale to the Injections Used to Treat Bleeding: On-Demand Treatment According to Surgery
time frame: From the first administration of Xyntha up to 6 months
description: On-demand treatment according to surgery: treatment to increase factor in preparation for surgery. Overall responses to all injection of Xyntha Solofuse prefilled syringe used to treat bleeding in on-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) according to surgery was assessed on 4 point scale of 1=excellent, 2=good, 3=moderate and 4=no response, higher score = better response. Excellent= Definite pain relief and/or improvement in signs of bleeding within 8 hours after an infusion, with no additional infusion, good= Definite pain relief and/or improvement in signs of bleeding within 8 hours after an infusion, with 1 additional infusion, moderate= Probable/slight improvement starting after 8 hours following infusion, with >=1 additional infusion administered for complete resolution of bleeding episode and no response= No improvement at all between infusions/during 24 hour interval following an infusion/condition worsens
measure: Number of Participants With Overall Responses on a 4-Point Scale to the Injections Used to Treat Bleeding: On-Demand Treatment According to Bleeding
time frame: From the first administration of Xyntha up to 6 months
description: On-demand treatment according to bleeding: treatment administered for spontaneous bleeding/abrasion; not requiring surgery. Overall responses to all injection of Xyntha used to treat bleeding in on-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) according to bleeding was assessed on 4 point scale of 1=excellent, 2=good, 3=moderate,4=no response, higher score=better response. Excellent= Definite pain relief and/or improvement in signs of bleeding within 8 hours after an infusion, with no additional infusion, good= Definite pain relief and/or improvement in signs of bleeding within 8 hours after an infusion, with 1 additional infusion, moderate= Probable/slight improvement after 8 hours following infusion, with >=1 additional infusion administered for complete resolution of bleeding episode and no response= No improvement at all between infusions/during 24 hour interval following an infusion, or condition worsens.
measure: Number of Participants With Less Than Expected Therapeutic Effect (LETE): On-Demand Treatment According to Surgery
time frame: Within 24 hours of on-demand treatment (anytime within the observation period of 6 months)
description: LETE for on-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) was defined as "no response" rated after each infusion of 2 consecutive infusions within 24 hours after on-demand treatment.
measure: Number of Participants With Less Than Expected Therapeutic Effect (LETE): On-Demand Treatment According to Bleeding
time frame: Within 24 hours of on-demand treatment (anytime within the observation period of up to 6 months)
description: LETE for on-demand treatment ((administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) was defined as "no response" rated after each infusion of 2 consecutive infusions within 24 hours after on-demand treatment) was defined as "no response" rated after each infusion of 2 consecutive infusions within 24 hours after on-demand treatment.
measure: Number of Infusions Required to Treat Each New Bleeding Episode
time frame: From the first administration of Xyntha up to 6 months
description: It was calculated as total number of injections given throughout the study divided by total number of bleeding events.
measure: Average Dose of Infusions Per Bleeding Event: On-Demand Treatment According to Surgery
time frame: From the first administration of Xyntha up to 6 months
description: The average dose of Xyntha per bleeding event according to surgery in on-demand treatment was calculated as total dose of Xyntha (in IU) throughout the study divided by total number of bleeding event. On-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) according to surgery means treatment to increase factor in preparation for surgery.
measure: Average Dose of Infusions Per Bleeding Event: On-Demand Treatment According to Bleeding
time frame: From the first administration of Xyntha up to 6 months
description: The average dose of Xyntha per bleeding event was calculated as total dose of Xyntha throughout the study (in International Units [IU]) divided by total number of bleeding incidence. On-demand treatment (administration of an unscheduled dose of Xyntha Solofuse prefilled syringe to stop bleeding) according to bleeding means treatment administered due to spontaneous bleeding or abrasion.
measure: Percentage of Participants With Bleeding Event
time frame: From the first administration of Xyntha up to 6 months
measure: Annualized Bleeding Rates (ABRs)
time frame: Within 48 hours after the prophylactic administration of Xyntha (within the duration of 6 months)
description: Annualized bleeding rate defined as number of bleeds under prophylactic setting (defined as bleeding occurred after 48 hours of prophylactic therapy [administration of Xyntha not for the treatment of a bleed but for the prevention of bleeding]) divided by (/) [(number of prophylactic therapy participants)*0.5)]
measure: Number of Participants With Less Than Expected Therapeutic Effect (LETE): Prophylactic Therapy
time frame: From the first administration of Xyntha up to 6 months
description: Less than expected therapeutic effect for prophylaxis therapy defined as breakthrough (spontaneous/non-traumatic) bleeding occurred within 48 hours of prophylaxis infusion (defined as: administration of Xyntha not for the treatment of a bleed but for the prevention of bleeding).
measure: Average Dose of Infusions Per Bleeding Event: Prophylactic Therapy
time frame: From the first administration of Xyntha up to 6 months
description: The average dose of Xyntha per bleeding event according to prophylaxis therapy treatment was calculated as total dose of Xyntha (in IU) throughout the study divided by total number of bleeding event. Prophylaxis therapy defined as breakthrough (spontaneous/non-traumatic) bleeding occurred within 48 hours of prophylaxis infusion (defined as administration of Xyntha not for the treatment of a bleed but for the prevention of bleeding).
measure: Total Factor VIII Consumption
time frame: 6 months
description: Total factor VIII consumption for each participant was calculated by sum of the total amount of Xyntha Solofuse (in IU) infused for each Xyntha Solofuse infusion.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1831086&StudyName=Post+Marketing+Surveillance+To+Observe+Safety+And+Efficacy+Of+Xyntha+%28registered%29+Solofuse
description: To obtain contact information for a study center near you, click here.
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1831086&StudyName=Post-marketing+Surveillance+To+Observe+Safety+And+Efficacy+Of+Xyntha+Solofuse+Prefilled+Syringe
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Hemophilia A
sharing ipd: No
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 