<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/NCT01688830</url>
  </required_header>
  <id_info>
    <org_study_id>1321.1</org_study_id>
    <secondary_id>2012-003611-66</secondary_id>
    <nct_id>NCT01688830</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 Administered Alone or With Dabigatran Etexilate</brief_title>
  <official_title>Randomised, Double-blind, Placebo-controlled Phase I Study in Healthy Male Volunteers. to Investigate Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BI 655075 (Part 1) and to Explore the Dose of BI 655075 Effective to Reverse Dabigatran Anticoagulant Activity (Part 2)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      The primary objective is to investigate the safety, tolerability and pharmacokinetics of BI&#xD;
      655075 following intravenous administration of single rising doses of BI 655075 when&#xD;
      administered alone and after administration of dabigatran.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Subjects With Drug Related Adverse Events (AE)</measure>
    <time_frame>AEs occurring until end of follow-up (Up to 3 months after last drug administration)</time_frame>
    <description>Frequency of subjects with related adverse events (AE) by treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax (Maximum Measured Concentration) for Idarucizumab</measure>
    <time_frame>-2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h</time_frame>
    <description>Cmax (maximum measured concentration) for idarucizumab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax (Time From Dosing to Maximum Measured Concentration) for Idarucizumab</measure>
    <time_frame>-2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h</time_frame>
    <description>tmax (time from dosing to maximum measured concentration) for idarucizumab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-inf (Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity) for Idarucizumab</measure>
    <time_frame>-2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h</time_frame>
    <description>AUC0-inf (area under the concentration-time curve from time 0 extrapolated to infinity) for idarucizumab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aet1-t2 (Amount of Idarucizumab Eliminated in Urine From Time Point t1 to Time Point t2)</measure>
    <time_frame>Up to 7 hours</time_frame>
    <description>Aet1-t2 (amount of idarucizumab eliminated in urine from time point t1 to time point t2)&#xD;
Ae(0-7h) is presented for dose groups with 1 h infusion and Ae(0-4h) is presented for dose groups with 5 min infusion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aet1-t2,ss (Amount of Dabigatran Etexilate Eliminated in Urine From Time Point t1 to Time Point t2, at Steady State) on Day 3 and Day 4 for Sum Dabigatran</measure>
    <time_frame>Intervals 0-2, 2-6, 6-10, 10-12 hours on Day 3 post dabigatran treatment and -2 to -0:05, -0:05 to 4, 4-8, 8-10, 10-12, 12-24, 24-48, 48-72 on Day 4 post Idarucizumab treatment</time_frame>
    <description>Aet1-t2,ss (amount of dabigatran etexilate eliminated in urine from time point t1 to time point t2, at steady state) on Day 3 and Day 4&#xD;
Ae(0-12h,ss) of sum dabigatran</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C1.92,ss, C2,ss, C2.5,ss, C6,ss, and C12,ss (Concentration of the Unbound Sum Dabigatran in Plasma at Steady State)</measure>
    <time_frame>1.92 hours (h), 2 h, 2.5 h, 6 h and 12 h on Day 4</time_frame>
    <description>Concentrations of unbound sum dabigatran in plasma after 1.92 to 12 h, at steady state of dabigatran, on Day 4 are presented.&#xD;
The endpoint refers to unbound sum dabigatran at several time points. The intended pharmacodynamic effect of idarucizumab is to reduce the concentration of this measure to levels below the lower limit of quantification (BLQ). &quot;BLQ&quot; values are not considered in the calculation of descriptive statistics; and therefore bias the result. This is the reason for applying the 2/3 rule to obtain reliable results. 2/3 rule states that, Statistics of PK parameters are only estimated when at least 2/3 of the data are evaluable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCt1-t2,ss (Area Under the Concentration-time Curve for the Unbound Sum Dabigatran in Plasma From Time Point t1 to Time Point t2, at Steady State) on Day 3 and Day 4</measure>
    <time_frame>2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h</time_frame>
    <description>AUC(2-12),ss ((area under the concentration-time curve for the idarucizumab in plasma from time point 2 to 12 h )) on Day 3 and Day 4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 2 of the Study</measure>
    <time_frame>2hours-12 hours</time_frame>
    <description>AUECt1-t2 (area under the effect curve from time point t1=2 hours to time point t2=12 hours) on Day 3 and Day 4 (determined under consideration of the baseline value).&#xD;
Ratio of above baseline AUEC(2-12) on Day 4 to above baseline AUEC(2-12) on Day 3 is presented.&#xD;
This endpoint was determined for Activated Partial Thromboplastin time (aPTT), Dithiothreitol (dTT), Thrombin time (TT) and Ecarin clotting time (ECT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 3 of the Study</measure>
    <time_frame>2hours-12 hours</time_frame>
    <description>AUECt1-t2 (area under the effect curve from time point t1=2 hours to time point t2=12 hours) on Day 3 and Day 4 (determined under consideration of the baseline value).&#xD;
Ratio of above baseline AUEC(2-12) on Day 4 to above baseline AUEC(2-12) on Day 3 is presented.&#xD;
This endpoint was determined for Activated Partial Thromboplastin time (aPTT) and Dithiothreitol (dTT)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">157</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BI 655075</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BI 655075 with dabigatran</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dabigatran</intervention_name>
    <arm_group_label>BI 655075 with dabigatran</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BI 655075</intervention_name>
    <arm_group_label>BI 655075</arm_group_label>
    <arm_group_label>BI 655075 with dabigatran</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        1. Healthy male subjects&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        1. Any relevant deviation from healthy conditions&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Boehringer Ingelheim</last_name>
    <role>Study Chair</role>
    <affiliation>Boehringer Ingelheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>1321.1.1 Boehringer Ingelheim Investigational Site</name>
      <address>
        <city>Antwerpen</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 20, 2012</study_first_posted>
  <results_first_submitted>November 13, 2015</results_first_submitted>
  <results_first_submitted_qc>January 15, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 15, 2016</results_first_posted>
  <last_update_submitted>May 20, 2016</last_update_submitted>
  <last_update_submitted_qc>May 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dabigatran</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study is conducted in two parts:&#xD;
Parts 1 and 2 had a single rising dose design; subjects in Part 3 received 2 single doses 1 h apart.&#xD;
Part 1: 8 subjects per dose group Part 2: 12 subjects per dose group Part 3: 12 subjects per dose group</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo 1 h</title>
          <description>One single intravenous long infusion (1 h) of Idarucizumab Placebo&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="P2">
          <title>20 mg Idarucizumab 1h</title>
          <description>Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="P3">
          <title>60 mg Idarucizumab 1h</title>
          <description>Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="P4">
          <title>200 mg Idarucizumab 1h</title>
          <description>Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="P5">
          <title>600 mg Idarucizumab 1h</title>
          <description>Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="P6">
          <title>1.2 g Idarucizumab 1h</title>
          <description>Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="P7">
          <title>2 g Idarucizumab 1h</title>
          <description>Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="P8">
          <title>3 g Idarucizumab 1h</title>
          <description>Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="P9">
          <title>4 g Idarucizumab 1h</title>
          <description>Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="P10">
          <title>6 g Idarucizumab 1h</title>
          <description>Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="P11">
          <title>8 g Idarucizumab 1h</title>
          <description>Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="P12">
          <title>Placebo 5min</title>
          <description>One single intravenous short infusion (5 min) of Idarucizumab Placebo&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="P13">
          <title>1 g Idarucizumab 5min</title>
          <description>Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="P14">
          <title>2 g Idarucizumab 5min</title>
          <description>Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="P15">
          <title>4 g Idarucizumab 5min</title>
          <description>Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="P16">
          <title>DE+ Placebo 5min</title>
          <description>One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
        </group>
        <group group_id="P17">
          <title>DE+ 1 g Idarucizumab 5min</title>
          <description>Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
        </group>
        <group group_id="P18">
          <title>DE+ 2 g Idarucizumab 5min</title>
          <description>Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
        </group>
        <group group_id="P19">
          <title>DE+ 4 g Idarucizumab 5min</title>
          <description>Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
        </group>
        <group group_id="P20">
          <title>DE+ Placebo+ Placebo</title>
          <description>Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 3 of the study&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
        </group>
        <group group_id="P21">
          <title>DE+ 5 g + 2.5 g Idarucizumab</title>
          <description>Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 3 of the study&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="12"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="6"/>
                <participants group_id="P11" count="6"/>
                <participants group_id="P12" count="6"/>
                <participants group_id="P13" count="6"/>
                <participants group_id="P14" count="6"/>
                <participants group_id="P15" count="6"/>
                <participants group_id="P16" count="9"/>
                <participants group_id="P17" count="9"/>
                <participants group_id="P18" count="9"/>
                <participants group_id="P19" count="8"/>
                <participants group_id="P20" count="3"/>
                <participants group_id="P21" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="6"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="6"/>
                <participants group_id="P7" count="12"/>
                <participants group_id="P8" count="6"/>
                <participants group_id="P9" count="6"/>
                <participants group_id="P10" count="6"/>
                <participants group_id="P11" count="5"/>
                <participants group_id="P12" count="6"/>
                <participants group_id="P13" count="6"/>
                <participants group_id="P14" count="6"/>
                <participants group_id="P15" count="6"/>
                <participants group_id="P16" count="9"/>
                <participants group_id="P17" count="9"/>
                <participants group_id="P18" count="9"/>
                <participants group_id="P19" count="8"/>
                <participants group_id="P20" count="3"/>
                <participants group_id="P21" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
                <participants group_id="P21" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
                <participants group_id="P7" count="0"/>
                <participants group_id="P8" count="0"/>
                <participants group_id="P9" count="0"/>
                <participants group_id="P10" count="0"/>
                <participants group_id="P11" count="1"/>
                <participants group_id="P12" count="0"/>
                <participants group_id="P13" count="0"/>
                <participants group_id="P14" count="0"/>
                <participants group_id="P15" count="0"/>
                <participants group_id="P16" count="0"/>
                <participants group_id="P17" count="0"/>
                <participants group_id="P18" count="0"/>
                <participants group_id="P19" count="0"/>
                <participants group_id="P20" count="0"/>
                <participants group_id="P21" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Treated Set (TS): All randomised subjects who received 1 dose of trial medication were included in the treated set</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo 1 h</title>
          <description>One single intravenous long infusion (1 h) of Idarucizumab Placebo&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="B2">
          <title>20 mg Idarucizumab 1h</title>
          <description>Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="B3">
          <title>60 mg Idarucizumab 1h</title>
          <description>Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="B4">
          <title>200 mg Idarucizumab 1h</title>
          <description>Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="B5">
          <title>600 mg Idarucizumab 1h</title>
          <description>Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="B6">
          <title>1.2 g Idarucizumab 1h</title>
          <description>Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="B7">
          <title>2 g Idarucizumab 1h</title>
          <description>Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="B8">
          <title>3 g Idarucizumab 1h</title>
          <description>Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="B9">
          <title>4 g Idarucizumab 1h</title>
          <description>Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="B10">
          <title>6 g Idarucizumab 1h</title>
          <description>Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="B11">
          <title>8 g Idarucizumab 1h</title>
          <description>Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="B12">
          <title>Placebo 5min</title>
          <description>One single intravenous short infusion (5 min) of Idarucizumab Placebo&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="B13">
          <title>1 g Idarucizumab 5min</title>
          <description>Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="B14">
          <title>2 g Idarucizumab 5min</title>
          <description>Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="B15">
          <title>4 g Idarucizumab 5min</title>
          <description>Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
        </group>
        <group group_id="B16">
          <title>DE+ Placebo 5min</title>
          <description>One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
        </group>
        <group group_id="B17">
          <title>DE+ 1 g Idarucizumab 5min</title>
          <description>Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
        </group>
        <group group_id="B18">
          <title>DE+ 2 g Idarucizumab 5min</title>
          <description>Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
        </group>
        <group group_id="B19">
          <title>DE+ 4 g Idarucizumab 5min</title>
          <description>Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
        </group>
        <group group_id="B20">
          <title>DE+ Placebo+ Placebo</title>
          <description>Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 3 of the study&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
        </group>
        <group group_id="B21">
          <title>DE+ 5 g + 2.5 g Idarucizumab</title>
          <description>Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 3 of the study&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
        </group>
        <group group_id="B22">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="6"/>
            <count group_id="B4" value="6"/>
            <count group_id="B5" value="5"/>
            <count group_id="B6" value="6"/>
            <count group_id="B7" value="12"/>
            <count group_id="B8" value="6"/>
            <count group_id="B9" value="6"/>
            <count group_id="B10" value="6"/>
            <count group_id="B11" value="6"/>
            <count group_id="B12" value="6"/>
            <count group_id="B13" value="6"/>
            <count group_id="B14" value="6"/>
            <count group_id="B15" value="6"/>
            <count group_id="B16" value="9"/>
            <count group_id="B17" value="9"/>
            <count group_id="B18" value="9"/>
            <count group_id="B19" value="8"/>
            <count group_id="B20" value="3"/>
            <count group_id="B21" value="9"/>
            <count group_id="B22" value="157"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.3" spread="7.8"/>
                    <measurement group_id="B2" value="29.8" spread="6.6"/>
                    <measurement group_id="B3" value="35.2" spread="5.5"/>
                    <measurement group_id="B4" value="36.2" spread="8.8"/>
                    <measurement group_id="B5" value="36.6" spread="4.5"/>
                    <measurement group_id="B6" value="32.0" spread="8.9"/>
                    <measurement group_id="B7" value="30.3" spread="8.5"/>
                    <measurement group_id="B8" value="32.7" spread="4.2"/>
                    <measurement group_id="B9" value="35.3" spread="9.5"/>
                    <measurement group_id="B10" value="34.5" spread="8.8"/>
                    <measurement group_id="B11" value="35.2" spread="9.1"/>
                    <measurement group_id="B12" value="34.5" spread="11.2"/>
                    <measurement group_id="B13" value="34.7" spread="8.5"/>
                    <measurement group_id="B14" value="31.8" spread="5.4"/>
                    <measurement group_id="B15" value="36.0" spread="8.3"/>
                    <measurement group_id="B16" value="30.9" spread="8.9"/>
                    <measurement group_id="B17" value="31.3" spread="7.0"/>
                    <measurement group_id="B18" value="31.1" spread="8.3"/>
                    <measurement group_id="B19" value="31.9" spread="9.1"/>
                    <measurement group_id="B20" value="30.0" spread="2.6"/>
                    <measurement group_id="B21" value="29.9" spread="9.0"/>
                    <measurement group_id="B22" value="32.4" spread="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                    <measurement group_id="B8" value="0"/>
                    <measurement group_id="B9" value="0"/>
                    <measurement group_id="B10" value="0"/>
                    <measurement group_id="B11" value="0"/>
                    <measurement group_id="B12" value="0"/>
                    <measurement group_id="B13" value="0"/>
                    <measurement group_id="B14" value="0"/>
                    <measurement group_id="B15" value="0"/>
                    <measurement group_id="B16" value="0"/>
                    <measurement group_id="B17" value="0"/>
                    <measurement group_id="B18" value="0"/>
                    <measurement group_id="B19" value="0"/>
                    <measurement group_id="B20" value="0"/>
                    <measurement group_id="B21" value="0"/>
                    <measurement group_id="B22" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="6"/>
                    <measurement group_id="B7" value="12"/>
                    <measurement group_id="B8" value="6"/>
                    <measurement group_id="B9" value="6"/>
                    <measurement group_id="B10" value="6"/>
                    <measurement group_id="B11" value="6"/>
                    <measurement group_id="B12" value="6"/>
                    <measurement group_id="B13" value="6"/>
                    <measurement group_id="B14" value="6"/>
                    <measurement group_id="B15" value="6"/>
                    <measurement group_id="B16" value="9"/>
                    <measurement group_id="B17" value="9"/>
                    <measurement group_id="B18" value="9"/>
                    <measurement group_id="B19" value="8"/>
                    <measurement group_id="B20" value="3"/>
                    <measurement group_id="B21" value="9"/>
                    <measurement group_id="B22" value="157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Secondary</type>
        <title>Cmax (Maximum Measured Concentration) for Idarucizumab</title>
        <description>Cmax (maximum measured concentration) for idarucizumab</description>
        <time_frame>-2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h</time_frame>
        <population>Pharmacokinetic set (PKS) comprises of all subjects (with evaluable observations) in the TS who provided at least 1 PK endpoint and had no important protocol violations relevant to the evaluation of PK and additionally for Part 2 and 3 had no emesis with onset at or before twice the median tmax of dabigatran.</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Idarucizumab 1h</title>
            <description>Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O2">
            <title>60 mg Idarucizumab 1h</title>
            <description>Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O3">
            <title>200 mg Idarucizumab 1h</title>
            <description>Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O4">
            <title>600 mg Idarucizumab 1h</title>
            <description>Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O5">
            <title>1.2 g Idarucizumab 1h</title>
            <description>Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O6">
            <title>2 g Idarucizumab 1h</title>
            <description>Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O7">
            <title>3 g Idarucizumab 1h</title>
            <description>Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O8">
            <title>4 g Idarucizumab 1h</title>
            <description>Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O9">
            <title>6 g Idarucizumab 1h</title>
            <description>Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O10">
            <title>8 g Idarucizumab 1h</title>
            <description>Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O11">
            <title>1 g Idarucizumab 5min</title>
            <description>Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O12">
            <title>2 g Idarucizumab 5min</title>
            <description>Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O13">
            <title>4 g Idarucizumab 5min</title>
            <description>Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O14">
            <title>DE+ 1 g Idarucizumab 5min</title>
            <description>Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O15">
            <title>DE+ 2 g Idarucizumab 5min</title>
            <description>Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O16">
            <title>DE+ 4 g Idarucizumab 5min</title>
            <description>Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O17">
            <title>DE+ 5 g + 2.5 g Idarucizumab</title>
            <description>Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 3 of the study&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Cmax (Maximum Measured Concentration) for Idarucizumab</title>
          <description>Cmax (maximum measured concentration) for idarucizumab</description>
          <population>Pharmacokinetic set (PKS) comprises of all subjects (with evaluable observations) in the TS who provided at least 1 PK endpoint and had no important protocol violations relevant to the evaluation of PK and additionally for Part 2 and 3 had no emesis with onset at or before twice the median tmax of dabigatran.</population>
          <units>nmol/L</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="12"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="5"/>
                <count group_id="O11" value="6"/>
                <count group_id="O12" value="6"/>
                <count group_id="O13" value="6"/>
                <count group_id="O14" value="9"/>
                <count group_id="O15" value="9"/>
                <count group_id="O16" value="8"/>
                <count group_id="O17" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.9" spread="15.1"/>
                    <measurement group_id="O2" value="257" spread="11.1"/>
                    <measurement group_id="O3" value="809" spread="13.9"/>
                    <measurement group_id="O4" value="2440" spread="13.1"/>
                    <measurement group_id="O5" value="4520" spread="9.72"/>
                    <measurement group_id="O6" value="7420" spread="15.1"/>
                    <measurement group_id="O7" value="11700" spread="10.4"/>
                    <measurement group_id="O8" value="15700" spread="15.6"/>
                    <measurement group_id="O9" value="22100" spread="12.0"/>
                    <measurement group_id="O10" value="33900" spread="13.2"/>
                    <measurement group_id="O11" value="6360" spread="16.7"/>
                    <measurement group_id="O12" value="13600" spread="23.4"/>
                    <measurement group_id="O13" value="21400" spread="13.1"/>
                    <measurement group_id="O14" value="5410" spread="13.5"/>
                    <measurement group_id="O15" value="12500" spread="21.5"/>
                    <measurement group_id="O16" value="25800" spread="25.1"/>
                    <measurement group_id="O17" value="35300" spread="24.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Tmax (Time From Dosing to Maximum Measured Concentration) for Idarucizumab</title>
        <description>tmax (time from dosing to maximum measured concentration) for idarucizumab</description>
        <time_frame>-2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h</time_frame>
        <population>PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Idarucizumab 1h</title>
            <description>Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O2">
            <title>60 mg Idarucizumab 1h</title>
            <description>Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O3">
            <title>200 mg Idarucizumab 1h</title>
            <description>Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O4">
            <title>600 mg Idarucizumab 1h</title>
            <description>Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O5">
            <title>1.2 g Idarucizumab 1h</title>
            <description>Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O6">
            <title>2 g Idarucizumab 1h</title>
            <description>Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O7">
            <title>3 g Idarucizumab 1h</title>
            <description>Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O8">
            <title>4 g Idarucizumab 1h</title>
            <description>Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O9">
            <title>6 g Idarucizumab 1h</title>
            <description>Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O10">
            <title>8 g Idarucizumab 1h</title>
            <description>Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O11">
            <title>1 g Idarucizumab 5min</title>
            <description>Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O12">
            <title>2 g Idarucizumab 5min</title>
            <description>Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O13">
            <title>4 g Idarucizumab 5min</title>
            <description>Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O14">
            <title>DE+ 1 g Idarucizumab 5min</title>
            <description>Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O15">
            <title>DE+ 2 g Idarucizumab 5min</title>
            <description>Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O16">
            <title>DE+ 4 g Idarucizumab 5min</title>
            <description>Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O17">
            <title>DE+ 5 g + 2.5 g Idarucizumab</title>
            <description>Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 3 of the study&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Tmax (Time From Dosing to Maximum Measured Concentration) for Idarucizumab</title>
          <description>tmax (time from dosing to maximum measured concentration) for idarucizumab</description>
          <population>PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="12"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="5"/>
                <count group_id="O11" value="6"/>
                <count group_id="O12" value="6"/>
                <count group_id="O13" value="6"/>
                <count group_id="O14" value="9"/>
                <count group_id="O15" value="9"/>
                <count group_id="O16" value="8"/>
                <count group_id="O17" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="0.967" upper_limit="1.17"/>
                    <measurement group_id="O2" value="1.03" lower_limit="0.967" upper_limit="1.17"/>
                    <measurement group_id="O3" value="1.03" lower_limit="0.967" upper_limit="1.08"/>
                    <measurement group_id="O4" value="1.10" lower_limit="1.03" upper_limit="1.18"/>
                    <measurement group_id="O5" value="0.967" lower_limit="0.967" upper_limit="1.08"/>
                    <measurement group_id="O6" value="0.984" lower_limit="0.967" upper_limit="1.17"/>
                    <measurement group_id="O7" value="1.00" lower_limit="0.967" upper_limit="1.05"/>
                    <measurement group_id="O8" value="1.06" lower_limit="0.967" upper_limit="1.17"/>
                    <measurement group_id="O9" value="1.03" lower_limit="0.967" upper_limit="1.08"/>
                    <measurement group_id="O10" value="1.08" lower_limit="0.967" upper_limit="1.17"/>
                    <measurement group_id="O11" value="0.117" lower_limit="0.0830" upper_limit="0.167"/>
                    <measurement group_id="O12" value="0.142" lower_limit="0.117" upper_limit="0.250"/>
                    <measurement group_id="O13" value="0.167" lower_limit="0.117" upper_limit="0.250"/>
                    <measurement group_id="O14" value="0.117" lower_limit="0.0830" upper_limit="0.167"/>
                    <measurement group_id="O15" value="0.200" lower_limit="0.167" upper_limit="0.333"/>
                    <measurement group_id="O16" value="0.117" lower_limit="0.0830" upper_limit="0.167"/>
                    <measurement group_id="O17" value="0.117" lower_limit="0.0830" upper_limit="1.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUC0-inf (Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity) for Idarucizumab</title>
        <description>AUC0-inf (area under the concentration-time curve from time 0 extrapolated to infinity) for idarucizumab</description>
        <time_frame>-2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h</time_frame>
        <population>PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Idarucizumab 1h</title>
            <description>Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O2">
            <title>60 mg Idarucizumab 1h</title>
            <description>Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O3">
            <title>200 mg Idarucizumab 1h</title>
            <description>Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O4">
            <title>600 mg Idarucizumab 1h</title>
            <description>Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O5">
            <title>1.2 g Idarucizumab 1h</title>
            <description>Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O6">
            <title>2 g Idarucizumab 1h</title>
            <description>Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O7">
            <title>3 g Idarucizumab 1h</title>
            <description>Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O8">
            <title>4 g Idarucizumab 1h</title>
            <description>Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O9">
            <title>6 g Idarucizumab 1h</title>
            <description>Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O10">
            <title>8 g Idarucizumab 1h</title>
            <description>Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O11">
            <title>1 g Idarucizumab 5min</title>
            <description>Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O12">
            <title>2 g Idarucizumab 5min</title>
            <description>Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O13">
            <title>4 g Idarucizumab 5min</title>
            <description>Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O14">
            <title>DE+ 1 g Idarucizumab 5min</title>
            <description>Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O15">
            <title>DE+ 2 g Idarucizumab 5min</title>
            <description>Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O16">
            <title>DE+ 4 g Idarucizumab 5min</title>
            <description>Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O17">
            <title>DE+ 5 g + 2.5 g Idarucizumab</title>
            <description>Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 3 of the study&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
        </group_list>
        <measure>
          <title>AUC0-inf (Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity) for Idarucizumab</title>
          <description>AUC0-inf (area under the concentration-time curve from time 0 extrapolated to infinity) for idarucizumab</description>
          <population>PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)</population>
          <units>nmol*h/L</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="12"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="5"/>
                <count group_id="O11" value="6"/>
                <count group_id="O12" value="6"/>
                <count group_id="O13" value="6"/>
                <count group_id="O14" value="9"/>
                <count group_id="O15" value="9"/>
                <count group_id="O16" value="8"/>
                <count group_id="O17" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146" spread="19.8"/>
                    <measurement group_id="O2" value="426" spread="11.6"/>
                    <measurement group_id="O3" value="1950" spread="129"/>
                    <measurement group_id="O4" value="6970" spread="75.4"/>
                    <measurement group_id="O5" value="8780" spread="4.92"/>
                    <measurement group_id="O6" value="14500" spread="15.9"/>
                    <measurement group_id="O7" value="22600" spread="17.6"/>
                    <measurement group_id="O8" value="31000" spread="12.9"/>
                    <measurement group_id="O9" value="41200" spread="11.8"/>
                    <measurement group_id="O10" value="63800" spread="15.6"/>
                    <measurement group_id="O11" value="7790" spread="13.1"/>
                    <measurement group_id="O12" value="16400" spread="16.8"/>
                    <measurement group_id="O13" value="25800" spread="22.1"/>
                    <measurement group_id="O14" value="6480" spread="17.1"/>
                    <measurement group_id="O15" value="16600" spread="10.7"/>
                    <measurement group_id="O16" value="30900" spread="14.1"/>
                    <measurement group_id="O17" value="62300" spread="8.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Aet1-t2 (Amount of Idarucizumab Eliminated in Urine From Time Point t1 to Time Point t2)</title>
        <description>Aet1-t2 (amount of idarucizumab eliminated in urine from time point t1 to time point t2)&#xD;
Ae(0-7h) is presented for dose groups with 1 h infusion and Ae(0-4h) is presented for dose groups with 5 min infusion.</description>
        <time_frame>Up to 7 hours</time_frame>
        <population>PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)</population>
        <group_list>
          <group group_id="O1">
            <title>20 mg Idarucizumab 1h</title>
            <description>Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O2">
            <title>60 mg Idarucizumab 1h</title>
            <description>Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O3">
            <title>200 mg Idarucizumab 1h</title>
            <description>Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O4">
            <title>600 mg Idarucizumab 1h</title>
            <description>Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O5">
            <title>1.2 g Idarucizumab 1h</title>
            <description>Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O6">
            <title>2 g Idarucizumab 1h</title>
            <description>Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O7">
            <title>3 g Idarucizumab 1h</title>
            <description>Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O8">
            <title>4 g Idarucizumab 1h</title>
            <description>Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O9">
            <title>6 g Idarucizumab 1h</title>
            <description>Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O10">
            <title>8 g Idarucizumab 1h</title>
            <description>Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O11">
            <title>1 g Idarucizumab 5min</title>
            <description>Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O12">
            <title>2 g Idarucizumab 5min</title>
            <description>Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O13">
            <title>4 g Idarucizumab 5min</title>
            <description>Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O14">
            <title>DE+ 1 g Idarucizumab 5min</title>
            <description>Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O15">
            <title>DE+ 2 g Idarucizumab 5min</title>
            <description>Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O16">
            <title>DE+ 4 g Idarucizumab 5min</title>
            <description>Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O17">
            <title>DE+ 5 g + 2.5 g Idarucizumab</title>
            <description>Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 3 of the study&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Aet1-t2 (Amount of Idarucizumab Eliminated in Urine From Time Point t1 to Time Point t2)</title>
          <description>Aet1-t2 (amount of idarucizumab eliminated in urine from time point t1 to time point t2)&#xD;
Ae(0-7h) is presented for dose groups with 1 h infusion and Ae(0-4h) is presented for dose groups with 5 min infusion.</description>
          <population>PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)</population>
          <units>μmol</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="5"/>
                <count group_id="O5" value="6"/>
                <count group_id="O6" value="12"/>
                <count group_id="O7" value="6"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="5"/>
                <count group_id="O11" value="6"/>
                <count group_id="O12" value="6"/>
                <count group_id="O13" value="6"/>
                <count group_id="O14" value="9"/>
                <count group_id="O15" value="9"/>
                <count group_id="O16" value="8"/>
                <count group_id="O17" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Missing values (denoted with 'NA') were not measured for the respective dose groups.</measurement>
                    <measurement group_id="O2" value="NA" spread="NA">Missing values (denoted with 'NA') were not measured for the respective dose groups.</measurement>
                    <measurement group_id="O3" value="NA" spread="NA">Missing values (denoted with 'NA') were not measured for the respective dose groups.</measurement>
                    <measurement group_id="O4" value="NA" spread="NA">Missing values (denoted with 'NA') were not measured for the respective dose groups.</measurement>
                    <measurement group_id="O5" value="NA" spread="NA">Missing values (denoted with 'NA') were not measured for the respective dose groups.</measurement>
                    <measurement group_id="O6" value="NA" spread="NA">Missing values (denoted with 'NA') were not measured for the respective dose groups.</measurement>
                    <measurement group_id="O7" value="NA" spread="NA">Missing values (denoted with 'NA') were not measured for the respective dose groups.</measurement>
                    <measurement group_id="O8" value="NA" spread="NA">Missing values (denoted with 'NA') were not measured for the respective dose groups.</measurement>
                    <measurement group_id="O9" value="36.1" spread="50.1"/>
                    <measurement group_id="O10" value="39.5" spread="395"/>
                    <measurement group_id="O11" value="2.23" spread="76.3"/>
                    <measurement group_id="O12" value="8.00" spread="73.1"/>
                    <measurement group_id="O13" value="32.6" spread="23.6"/>
                    <measurement group_id="O14" value="1.71" spread="90.6"/>
                    <measurement group_id="O15" value="11.0" spread="23.4"/>
                    <measurement group_id="O16" value="33.6" spread="30.5"/>
                    <measurement group_id="O17" value="73.5" spread="24.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects With Drug Related Adverse Events (AE)</title>
        <description>Frequency of subjects with related adverse events (AE) by treatment</description>
        <time_frame>AEs occurring until end of follow-up (Up to 3 months after last drug administration)</time_frame>
        <population>Treated set</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo 1 h</title>
            <description>One single intravenous long infusion (1 h) of Idarucizumab Placebo&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O2">
            <title>20 mg Idarucizumab 1h</title>
            <description>Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O3">
            <title>60 mg Idarucizumab 1h</title>
            <description>Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O4">
            <title>200 mg Idarucizumab 1h</title>
            <description>Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O5">
            <title>600 mg Idarucizumab 1h</title>
            <description>Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O6">
            <title>1.2 g Idarucizumab 1h</title>
            <description>Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O7">
            <title>2 g Idarucizumab 1h</title>
            <description>Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O8">
            <title>3 g Idarucizumab 1h</title>
            <description>Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O9">
            <title>4 g Idarucizumab 1h</title>
            <description>Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O10">
            <title>6 g Idarucizumab 1h</title>
            <description>Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O11">
            <title>8 g Idarucizumab 1h</title>
            <description>Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O12">
            <title>Placebo 5min</title>
            <description>One single intravenous short infusion (5 min) of Idarucizumab Placebo&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O13">
            <title>1 g Idarucizumab 5min</title>
            <description>Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O14">
            <title>2 g Idarucizumab 5min</title>
            <description>Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O15">
            <title>4 g Idarucizumab 5min</title>
            <description>Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum&#xD;
This is administered during Part 1 of the study</description>
          </group>
          <group group_id="O16">
            <title>DE+ Placebo 5min</title>
            <description>One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O17">
            <title>DE+ 1 g Idarucizumab 5min</title>
            <description>Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O18">
            <title>DE+ 2 g Idarucizumab 5min</title>
            <description>Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O19">
            <title>DE+ 4 g Idarucizumab 5min</title>
            <description>Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O20">
            <title>DE+ Placebo+ Placebo</title>
            <description>Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 3 of the study&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O21">
            <title>DE+ 5 g + 2.5 g Idarucizumab</title>
            <description>Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 3 of the study&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Drug Related Adverse Events (AE)</title>
          <description>Frequency of subjects with related adverse events (AE) by treatment</description>
          <population>Treated set</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="6"/>
                <count group_id="O4" value="6"/>
                <count group_id="O5" value="5"/>
                <count group_id="O6" value="6"/>
                <count group_id="O7" value="12"/>
                <count group_id="O8" value="6"/>
                <count group_id="O9" value="6"/>
                <count group_id="O10" value="6"/>
                <count group_id="O11" value="6"/>
                <count group_id="O12" value="6"/>
                <count group_id="O13" value="6"/>
                <count group_id="O14" value="6"/>
                <count group_id="O15" value="6"/>
                <count group_id="O16" value="9"/>
                <count group_id="O17" value="9"/>
                <count group_id="O18" value="9"/>
                <count group_id="O19" value="8"/>
                <count group_id="O20" value="3"/>
                <count group_id="O21" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                    <measurement group_id="O7" value="2"/>
                    <measurement group_id="O8" value="0"/>
                    <measurement group_id="O9" value="0"/>
                    <measurement group_id="O10" value="0"/>
                    <measurement group_id="O11" value="1"/>
                    <measurement group_id="O12" value="0"/>
                    <measurement group_id="O13" value="0"/>
                    <measurement group_id="O14" value="0"/>
                    <measurement group_id="O15" value="0"/>
                    <measurement group_id="O16" value="0"/>
                    <measurement group_id="O17" value="1"/>
                    <measurement group_id="O18" value="0"/>
                    <measurement group_id="O19" value="0"/>
                    <measurement group_id="O20" value="1"/>
                    <measurement group_id="O21" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Aet1-t2,ss (Amount of Dabigatran Etexilate Eliminated in Urine From Time Point t1 to Time Point t2, at Steady State) on Day 3 and Day 4 for Sum Dabigatran</title>
        <description>Aet1-t2,ss (amount of dabigatran etexilate eliminated in urine from time point t1 to time point t2, at steady state) on Day 3 and Day 4&#xD;
Ae(0-12h,ss) of sum dabigatran</description>
        <time_frame>Intervals 0-2, 2-6, 6-10, 10-12 hours on Day 3 post dabigatran treatment and -2 to -0:05, -0:05 to 4, 4-8, 8-10, 10-12, 12-24, 24-48, 48-72 on Day 4 post Idarucizumab treatment</time_frame>
        <population>PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)</population>
        <group_list>
          <group group_id="O1">
            <title>DE (Dose Groups 14-16: Day 3)</title>
            <description>Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 in dose groups 14-16</description>
          </group>
          <group group_id="O2">
            <title>DE+ Placebo 5min</title>
            <description>One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O3">
            <title>DE+ 1 g Idarucizumab 5min</title>
            <description>One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O4">
            <title>DE+ 2 g Idarucizumab 5min</title>
            <description>One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O5">
            <title>DE+ 4 g Idarucizumab 5min</title>
            <description>One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O6">
            <title>DE (Dose Groups 17: Day 3)</title>
            <description>Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 in dose group 17</description>
          </group>
          <group group_id="O7">
            <title>DE+ Placebo+ Placebo</title>
            <description>Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 3 of the study&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O8">
            <title>DE+ 5 g + 2.5 g Idarucizumab</title>
            <description>Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 3 of the study&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
        </group_list>
        <measure>
          <title>Aet1-t2,ss (Amount of Dabigatran Etexilate Eliminated in Urine From Time Point t1 to Time Point t2, at Steady State) on Day 3 and Day 4 for Sum Dabigatran</title>
          <description>Aet1-t2,ss (amount of dabigatran etexilate eliminated in urine from time point t1 to time point t2, at steady state) on Day 3 and Day 4&#xD;
Ae(0-12h,ss) of sum dabigatran</description>
          <population>PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)</population>
          <units>μg</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="12"/>
                <count group_id="O7" value="2"/>
                <count group_id="O8" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6600" spread="54.4"/>
                    <measurement group_id="O2" value="6870" spread="37.8"/>
                    <measurement group_id="O3" value="5160" spread="57.1"/>
                    <measurement group_id="O4" value="3820" spread="86.9"/>
                    <measurement group_id="O5" value="3860" spread="39.1"/>
                    <measurement group_id="O6" value="6420" spread="38.7"/>
                    <measurement group_id="O7" value="5060" spread="55.1"/>
                    <measurement group_id="O8" value="4290" spread="35.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>C1.92,ss, C2,ss, C2.5,ss, C6,ss, and C12,ss (Concentration of the Unbound Sum Dabigatran in Plasma at Steady State)</title>
        <description>Concentrations of unbound sum dabigatran in plasma after 1.92 to 12 h, at steady state of dabigatran, on Day 4 are presented.&#xD;
The endpoint refers to unbound sum dabigatran at several time points. The intended pharmacodynamic effect of idarucizumab is to reduce the concentration of this measure to levels below the lower limit of quantification (BLQ). &quot;BLQ&quot; values are not considered in the calculation of descriptive statistics; and therefore bias the result. This is the reason for applying the 2/3 rule to obtain reliable results. 2/3 rule states that, Statistics of PK parameters are only estimated when at least 2/3 of the data are evaluable.</description>
        <time_frame>1.92 hours (h), 2 h, 2.5 h, 6 h and 12 h on Day 4</time_frame>
        <population>Pharmadynamic set (PDS) : The PDS was used for all PD analyses and comprised all subjects in the TS who provided at least 1 evaluable predose and&#xD;
1 on-treatment observation for calculating ratio (PD endpoint) and who had no important protocol violations relevant to the evaluation of PD.</population>
        <group_list>
          <group group_id="O1">
            <title>DE+ Placebo 5min</title>
            <description>One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O2">
            <title>DE+ 1 g Idarucizumab 5min</title>
            <description>One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O3">
            <title>DE+ 2 g Idarucizumab 5min</title>
            <description>One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O4">
            <title>DE+ 4 g Idarucizumab 5min</title>
            <description>One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O5">
            <title>DE+ Placebo+ Placebo</title>
            <description>Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 3 of the study&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O6">
            <title>DE+ 5 g + 2.5 g Idarucizumab</title>
            <description>Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 3 of the study&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
        </group_list>
        <measure>
          <title>C1.92,ss, C2,ss, C2.5,ss, C6,ss, and C12,ss (Concentration of the Unbound Sum Dabigatran in Plasma at Steady State)</title>
          <description>Concentrations of unbound sum dabigatran in plasma after 1.92 to 12 h, at steady state of dabigatran, on Day 4 are presented.&#xD;
The endpoint refers to unbound sum dabigatran at several time points. The intended pharmacodynamic effect of idarucizumab is to reduce the concentration of this measure to levels below the lower limit of quantification (BLQ). &quot;BLQ&quot; values are not considered in the calculation of descriptive statistics; and therefore bias the result. This is the reason for applying the 2/3 rule to obtain reliable results. 2/3 rule states that, Statistics of PK parameters are only estimated when at least 2/3 of the data are evaluable.</description>
          <population>Pharmadynamic set (PDS) : The PDS was used for all PD analyses and comprised all subjects in the TS who provided at least 1 evaluable predose and&#xD;
1 on-treatment observation for calculating ratio (PD endpoint) and who had no important protocol violations relevant to the evaluation of PD.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="8"/>
                <count group_id="O5" value="2"/>
                <count group_id="O6" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C1.92,ss (N= 9, 9, 9, 8, 2, 8)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119" spread="38.0"/>
                    <measurement group_id="O2" value="136" spread="51.8"/>
                    <measurement group_id="O3" value="96.2" spread="33.3"/>
                    <measurement group_id="O4" value="135" spread="47.6"/>
                    <measurement group_id="O5" value="101" spread="97.8"/>
                    <measurement group_id="O6" value="112" spread="34.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C2,ss (N= 9, 6, NA, NA, 2, NA)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="123" spread="40.8"/>
                    <measurement group_id="O2" value="1.59" spread="10.7"/>
                    <measurement group_id="O3" value="NA" spread="NA">NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules</measurement>
                    <measurement group_id="O4" value="NA" spread="NA">NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules</measurement>
                    <measurement group_id="O5" value="95.6" spread="109"/>
                    <measurement group_id="O6" value="NA" spread="NA">NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C2.5,ss (N= 9, NA, NA, NA, 2, NA )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130" spread="47.9"/>
                    <measurement group_id="O2" value="NA" spread="NA">NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules</measurement>
                    <measurement group_id="O3" value="NA" spread="NA">NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules</measurement>
                    <measurement group_id="O4" value="NA" spread="NA">NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules</measurement>
                    <measurement group_id="O5" value="92.9" spread="99.4"/>
                    <measurement group_id="O6" value="NA" spread="NA">NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C6,ss (N= 9, 9, NA, NA, 2, NA)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.2" spread="44.6"/>
                    <measurement group_id="O2" value="15.3" spread="296"/>
                    <measurement group_id="O3" value="NA" spread="NA">NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules</measurement>
                    <measurement group_id="O4" value="NA" spread="NA">NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules</measurement>
                    <measurement group_id="O5" value="54.8" spread="93.2"/>
                    <measurement group_id="O6" value="NA" spread="NA">NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C12,ss (N= 9, 9, NA, NA, 2, NA)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.5" spread="40.3"/>
                    <measurement group_id="O2" value="18.2" spread="71.1"/>
                    <measurement group_id="O3" value="NA" spread="NA">NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules</measurement>
                    <measurement group_id="O4" value="NA" spread="NA">NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules</measurement>
                    <measurement group_id="O5" value="28.9" spread="90.6"/>
                    <measurement group_id="O6" value="NA" spread="NA">NA: Not calculated, reliable estimation can only be performed when at least 2/3 of the data are available and thus not calculated according to internal rules</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUCt1-t2,ss (Area Under the Concentration-time Curve for the Unbound Sum Dabigatran in Plasma From Time Point t1 to Time Point t2, at Steady State) on Day 3 and Day 4</title>
        <description>AUC(2-12),ss ((area under the concentration-time curve for the idarucizumab in plasma from time point 2 to 12 h )) on Day 3 and Day 4</description>
        <time_frame>2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h</time_frame>
        <population>PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)</population>
        <group_list>
          <group group_id="O1">
            <title>DE (Dose Groups 14-16: Day 3)</title>
            <description>Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 in dose groups 14-16</description>
          </group>
          <group group_id="O2">
            <title>DE+ Placebo 5min</title>
            <description>One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O3">
            <title>DE+ 1 g Idarucizumab 5min</title>
            <description>One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O4">
            <title>DE+ 2 g Idarucizumab 5min</title>
            <description>One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O5">
            <title>DE+ 4 g Idarucizumab 5min</title>
            <description>One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O6">
            <title>DE (Dose Groups 17: Day 3)</title>
            <description>Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 in dose group 17</description>
          </group>
          <group group_id="O7">
            <title>DE+ Placebo+ Placebo</title>
            <description>Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 3 of the study&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O8">
            <title>DE+ 5 g + 2.5 g Idarucizumab</title>
            <description>Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 3 of the study&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
        </group_list>
        <measure>
          <title>AUCt1-t2,ss (Area Under the Concentration-time Curve for the Unbound Sum Dabigatran in Plasma From Time Point t1 to Time Point t2, at Steady State) on Day 3 and Day 4</title>
          <description>AUC(2-12),ss ((area under the concentration-time curve for the idarucizumab in plasma from time point 2 to 12 h )) on Day 3 and Day 4</description>
          <population>PKS (presented values are those subjects from the PKS with evaluable observations for this endpoint)</population>
          <units>ng*h/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="9"/>
                <count group_id="O5" value="8"/>
                <count group_id="O6" value="12"/>
                <count group_id="O7" value="2"/>
                <count group_id="O8" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="805" spread="57.4"/>
                    <measurement group_id="O2" value="754" spread="45.6"/>
                    <measurement group_id="O3" value="161" spread="148"/>
                    <measurement group_id="O4" value="20.9" spread="199"/>
                    <measurement group_id="O5" value="11.9" spread="44.3"/>
                    <measurement group_id="O6" value="786" spread="40.1"/>
                    <measurement group_id="O7" value="542" spread="98.9"/>
                    <measurement group_id="O8" value="10.0" spread="0.344"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 2 of the Study</title>
        <description>AUECt1-t2 (area under the effect curve from time point t1=2 hours to time point t2=12 hours) on Day 3 and Day 4 (determined under consideration of the baseline value).&#xD;
Ratio of above baseline AUEC(2-12) on Day 4 to above baseline AUEC(2-12) on Day 3 is presented.&#xD;
This endpoint was determined for Activated Partial Thromboplastin time (aPTT), Dithiothreitol (dTT), Thrombin time (TT) and Ecarin clotting time (ECT)</description>
        <time_frame>2hours-12 hours</time_frame>
        <population>Pharmacodynamic set (PDS) : The PDS was used for all PD analyses and comprised all subjects in the TS who provided at least 1 evaluable predose and&#xD;
1 on-treatment observation for calculating ratio (PD endpoint) and who had no important protocol violations relevant to the evaluation of PD.</population>
        <group_list>
          <group group_id="O1">
            <title>DE+ Placebo 5min</title>
            <description>One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O2">
            <title>DE+ 1 g Idarucizumab 5min</title>
            <description>Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O3">
            <title>DE+ 2 g Idarucizumab 5min</title>
            <description>Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O4">
            <title>DE+ 4 g Idarucizumab 5min</title>
            <description>Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 2 of the study.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
        </group_list>
        <measure>
          <title>AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 2 of the Study</title>
          <description>AUECt1-t2 (area under the effect curve from time point t1=2 hours to time point t2=12 hours) on Day 3 and Day 4 (determined under consideration of the baseline value).&#xD;
Ratio of above baseline AUEC(2-12) on Day 4 to above baseline AUEC(2-12) on Day 3 is presented.&#xD;
This endpoint was determined for Activated Partial Thromboplastin time (aPTT), Dithiothreitol (dTT), Thrombin time (TT) and Ecarin clotting time (ECT)</description>
          <population>Pharmacodynamic set (PDS) : The PDS was used for all PD analyses and comprised all subjects in the TS who provided at least 1 evaluable predose and&#xD;
1 on-treatment observation for calculating ratio (PD endpoint) and who had no important protocol violations relevant to the evaluation of PD.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="9"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>aPTT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.28" spread="0.399"/>
                    <measurement group_id="O2" value="0.46" spread="0.342"/>
                    <measurement group_id="O3" value="0.14" spread="0.135"/>
                    <measurement group_id="O4" value="0.07" spread="0.103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>dTT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.01" spread="0.484"/>
                    <measurement group_id="O2" value="0.26" spread="0.245"/>
                    <measurement group_id="O3" value="0.06" spread="0.094"/>
                    <measurement group_id="O4" value="0.02" spread="0.016"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.08" spread="0.361"/>
                    <measurement group_id="O2" value="0.32" spread="0.280"/>
                    <measurement group_id="O3" value="0.06" spread="0.124"/>
                    <measurement group_id="O4" value="0.00" spread="0.007"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.04" spread="0.493"/>
                    <measurement group_id="O2" value="0.28" spread="0.231"/>
                    <measurement group_id="O3" value="0.07" spread="0.080"/>
                    <measurement group_id="O4" value="0.03" spread="0.013"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 3 of the Study</title>
        <description>AUECt1-t2 (area under the effect curve from time point t1=2 hours to time point t2=12 hours) on Day 3 and Day 4 (determined under consideration of the baseline value).&#xD;
Ratio of above baseline AUEC(2-12) on Day 4 to above baseline AUEC(2-12) on Day 3 is presented.&#xD;
This endpoint was determined for Activated Partial Thromboplastin time (aPTT) and Dithiothreitol (dTT)</description>
        <time_frame>2hours-12 hours</time_frame>
        <population>Pharmacodynamic set (PDS) : The PDS was used for all PD analyses and comprised all subjects in the TS who provided at least 1 evaluable predose and&#xD;
1 on-treatment observation for calculating ratio (PD endpoint) and who had no important protocol violations relevant to the evaluation of PD.</population>
        <group_list>
          <group group_id="O1">
            <title>DE+ Placebo+ Placebo</title>
            <description>Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 3 of the study&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
          <group group_id="O2">
            <title>DE+ 5 g + 2.5 g Idarucizumab</title>
            <description>Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
This is administered during Part 3 of the study&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
          </group>
        </group_list>
        <measure>
          <title>AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 3 of the Study</title>
          <description>AUECt1-t2 (area under the effect curve from time point t1=2 hours to time point t2=12 hours) on Day 3 and Day 4 (determined under consideration of the baseline value).&#xD;
Ratio of above baseline AUEC(2-12) on Day 4 to above baseline AUEC(2-12) on Day 3 is presented.&#xD;
This endpoint was determined for Activated Partial Thromboplastin time (aPTT) and Dithiothreitol (dTT)</description>
          <population>Pharmacodynamic set (PDS) : The PDS was used for all PD analyses and comprised all subjects in the TS who provided at least 1 evaluable predose and&#xD;
1 on-treatment observation for calculating ratio (PD endpoint) and who had no important protocol violations relevant to the evaluation of PD.</population>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>aPTT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.68" spread="0.534"/>
                    <measurement group_id="O2" value="0.03" spread="0.045"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>dTT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.02" spread="1.036"/>
                    <measurement group_id="O2" value="0.01" spread="0.029"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>AEs occurring until end of follow-up (Up to 3 months after last drug administration)</time_frame>
      <desc>AEs occurring between first administration of BI 655075 (5g) and second administration of BI 655075 2.5g are presented separately (shown under &quot;DE + 5g&quot;), and AEs occurring between second administration of BI 655075 2.5g and date of day after trial completion at 0:00h from this group of subjects are presented separately shown under DE+5g+2.5g.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo 1 h</title>
          <description>One single intravenous long infusion (1 h) of Idarucizumab Placebo</description>
        </group>
        <group group_id="E2">
          <title>20 mg Idarucizumab 1h</title>
          <description>One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum</description>
        </group>
        <group group_id="E3">
          <title>60 mg Idarucizumab 1h</title>
          <description>One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum</description>
        </group>
        <group group_id="E4">
          <title>200 mg Idarucizumab 1h</title>
          <description>One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum</description>
        </group>
        <group group_id="E5">
          <title>600 mg Idarucizumab 1h</title>
          <description>One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum</description>
        </group>
        <group group_id="E6">
          <title>1.2 g Idarucizumab 1h</title>
          <description>One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum</description>
        </group>
        <group group_id="E7">
          <title>2 g Idarucizumab 1h</title>
          <description>One single intravenous long infusion (1 h) of 2 g Idarucizumab verum</description>
        </group>
        <group group_id="E8">
          <title>3 g Idarucizumab 1h</title>
          <description>One single intravenous long infusion (1 h) of 3 g Idarucizumab verum</description>
        </group>
        <group group_id="E9">
          <title>4 g Idarucizumab 1h</title>
          <description>One single intravenous long infusion (1 h) of 4 g Idarucizumab verum</description>
        </group>
        <group group_id="E10">
          <title>6 g Idarucizumab 1h</title>
          <description>One single intravenous long infusion (1 h) of 6 g Idarucizumab verum</description>
        </group>
        <group group_id="E11">
          <title>8 g Idarucizumab 1h</title>
          <description>One single intravenous long infusion (1 h) of 8 g Idarucizumab verum</description>
        </group>
        <group group_id="E12">
          <title>Placebo 5min</title>
          <description>One single intravenous short infusion (5 min) of Idarucizumab Placebo</description>
        </group>
        <group group_id="E13">
          <title>1 g Idarucizumab 5min</title>
          <description>One single intravenous short infusion (5 min) of 1 g Idarucizumab verum</description>
        </group>
        <group group_id="E14">
          <title>2 g Idarucizumab 5min</title>
          <description>Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum</description>
        </group>
        <group group_id="E15">
          <title>4 g Idarucizumab 5min</title>
          <description>One single intravenous short infusion (5 min) of 4 g Idarucizumab verum</description>
        </group>
        <group group_id="E16">
          <title>DE (Dose Groups 14-16)</title>
          <description>Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 and in the morning of Day 4 in dose groups 14-16</description>
        </group>
        <group group_id="E17">
          <title>DE+ Placebo 5min</title>
          <description>One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
        </group>
        <group group_id="E18">
          <title>DE+ 1 g Idarucizumab 5min</title>
          <description>One single intravenous short infusion (5 min) of 1g of Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
        </group>
        <group group_id="E19">
          <title>DE+ 4 g Idarucizumab 5min</title>
          <description>One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
        </group>
        <group group_id="E20">
          <title>DE+ 2 g Idarucizumab 5min</title>
          <description>One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
        </group>
        <group group_id="E21">
          <title>DE (Dose Groups 17)</title>
          <description>Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 and in the morning of Day 4 in dose group 17</description>
        </group>
        <group group_id="E22">
          <title>DE+ Placebo</title>
          <description>One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
        </group>
        <group group_id="E23">
          <title>DE+ Placebo+ Placebo</title>
          <description>Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
        </group>
        <group group_id="E24">
          <title>DE+ 5 g</title>
          <description>One single intravenous short infusion (5 min) of 5 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
        </group>
        <group group_id="E25">
          <title>DE+ 5 g + 2.5 g Idarucizumab</title>
          <description>Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.&#xD;
DE is administered orally :&#xD;
Day 1 to 3: twice daily; Day 4: once daily</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MEDDRA 16.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="4" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="20" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="4" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="3" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Infusion site swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Injection site haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Application site irritation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="5" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Glycosuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="1" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin irritation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Skin reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E7" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E8" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E9" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E10" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E11" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E12" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E13" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E14" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E15" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E16" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E17" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E18" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E19" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E20" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E21" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E22" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E23" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E24" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E25" subjects_affected="0" subjects_at_risk="9"/>
              </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>Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>There is only one group of subjects in study part 3 receiving active treatment. However, AE table displays the AEs occurring in different phases separately.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Boehringer Ingelheim Call Center</name_or_title>
      <organization>Boehringer Ingelheim Pharmaceuticals</organization>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.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/NCT01688830
org study id: 1321.1
secondary id: 2012-003611-66
nct id: NCT01688830
lead sponsor: 
The primary objective is to investigate the safety, tolerability and pharmacokinetics of BI
      655075 following intravenous administration of single rising doses of BI 655075 when
      administered alone and after administration of dabigatran.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double
measure: Number of Subjects With Drug Related Adverse Events (AE)
time frame: AEs occurring until end of follow-up (Up to 3 months after last drug administration)
description: Frequency of subjects with related adverse events (AE) by treatment
measure: Cmax (Maximum Measured Concentration) for Idarucizumab
time frame: -2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h
description: Cmax (maximum measured concentration) for idarucizumab
measure: Tmax (Time From Dosing to Maximum Measured Concentration) for Idarucizumab
time frame: -2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h
description: tmax (time from dosing to maximum measured concentration) for idarucizumab
measure: AUC0-inf (Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity) for Idarucizumab
time frame: -2 hours(h), -0.5h, 0h, 2min(m), 5m, 10m, 15m,30m, 45m, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h
description: AUC0-inf (area under the concentration-time curve from time 0 extrapolated to infinity) for idarucizumab
measure: Aet1-t2 (Amount of Idarucizumab Eliminated in Urine From Time Point t1 to Time Point t2)
time frame: Up to 7 hours
description: Aet1-t2 (amount of idarucizumab eliminated in urine from time point t1 to time point t2)
Ae(0-7h) is presented for dose groups with 1 h infusion and Ae(0-4h) is presented for dose groups with 5 min infusion.
measure: Aet1-t2,ss (Amount of Dabigatran Etexilate Eliminated in Urine From Time Point t1 to Time Point t2, at Steady State) on Day 3 and Day 4 for Sum Dabigatran
time frame: Intervals 0-2, 2-6, 6-10, 10-12 hours on Day 3 post dabigatran treatment and -2 to -0:05, -0:05 to 4, 4-8, 8-10, 10-12, 12-24, 24-48, 48-72 on Day 4 post Idarucizumab treatment
description: Aet1-t2,ss (amount of dabigatran etexilate eliminated in urine from time point t1 to time point t2, at steady state) on Day 3 and Day 4
Ae(0-12h,ss) of sum dabigatran
measure: C1.92,ss, C2,ss, C2.5,ss, C6,ss, and C12,ss (Concentration of the Unbound Sum Dabigatran in Plasma at Steady State)
time frame: 1.92 hours (h), 2 h, 2.5 h, 6 h and 12 h on Day 4
description: Concentrations of unbound sum dabigatran in plasma after 1.92 to 12 h, at steady state of dabigatran, on Day 4 are presented.
The endpoint refers to unbound sum dabigatran at several time points. The intended pharmacodynamic effect of idarucizumab is to reduce the concentration of this measure to levels below the lower limit of quantification (BLQ). "BLQ" values are not considered in the calculation of descriptive statistics; and therefore bias the result. This is the reason for applying the 2/3 rule to obtain reliable results. 2/3 rule states that, Statistics of PK parameters are only estimated when at least 2/3 of the data are evaluable.
measure: AUCt1-t2,ss (Area Under the Concentration-time Curve for the Unbound Sum Dabigatran in Plasma From Time Point t1 to Time Point t2, at Steady State) on Day 3 and Day 4
time frame: 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h
description: AUC(2-12),ss ((area under the concentration-time curve for the idarucizumab in plasma from time point 2 to 12 h )) on Day 3 and Day 4
measure: AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 2 of the Study
time frame: 2hours-12 hours
description: AUECt1-t2 (area under the effect curve from time point t1=2 hours to time point t2=12 hours) on Day 3 and Day 4 (determined under consideration of the baseline value).
Ratio of above baseline AUEC(2-12) on Day 4 to above baseline AUEC(2-12) on Day 3 is presented.
This endpoint was determined for Activated Partial Thromboplastin time (aPTT), Dithiothreitol (dTT), Thrombin time (TT) and Ecarin clotting time (ECT)
measure: AUECt1-t2 (Area Under the Effect Curve From Time Point t1 to Time Point t2) on Day 3 and Day 4 (Determined Under Consideration of the Baseline Value) for Part 3 of the Study
time frame: 2hours-12 hours
description: AUECt1-t2 (area under the effect curve from time point t1=2 hours to time point t2=12 hours) on Day 3 and Day 4 (determined under consideration of the baseline value).
Ratio of above baseline AUEC(2-12) on Day 4 to above baseline AUEC(2-12) on Day 3 is presented.
This endpoint was determined for Activated Partial Thromboplastin time (aPTT) and Dithiothreitol (dTT)
arm group label: BI 655075
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: BI 655075 with dabigatran
arm group type: Experimental
intervention type: Drug
intervention name: Dabigatran
arm group label: BI 655075 with dabigatran
intervention type: Drug
intervention name: BI 655075
arm group label: BI 655075
arm group label: BI 655075 with dabigatran
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Boehringer Ingelheim
role: Study Chair
affiliation: Boehringer Ingelheim
facility: 
country: Belgium
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Dabigatran
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: There is only one group of subjects in study part 3 receiving active treatment. However, AE table displays the AEs occurring in different phases separately.
point of contact: 