<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/NCT01728805</url>
  </required_header>
  <id_info>
    <org_study_id>0761-010</org_study_id>
    <nct_id>NCT01728805</nct_id>
  </id_info>
  <brief_title>Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL</brief_title>
  <official_title>Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 (Mogamulizumab) Versus Vorinostat in Subjects With Previously Treated Cutaneous T-Cell Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kyowa Kirin, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kyowa Kirin, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the progression free survival of KW-0761 versus&#xD;
      vorinostat for subjects with relapsed or refractory CTCL.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase 3 randomized study to compare the progression free survival of subjects with&#xD;
      relapsed/refractory CTCL who receive KW-0761 versus those who receive vorinostat. Subjects&#xD;
      who progress on vorinostat will be allowed to cross over to KW-0761 upon progression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2012</start_date>
  <completion_date type="Actual">February 17, 2021</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>From date of randomization at every visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months</time_frame>
    <description>Progression was defined as follows, based on Olsen (2011):&#xD;
Lymph nodes: ≥ 50% increase in SPD from baseline of lymph nodes, any new node &gt; 1.5 cm in the long axis or &gt; 1 cm in the short axis if 1-1.5 cm in the long axis that is proven to be N3 histologically, or &gt; 50% increase from nadir in SPD of lymph nodes in those with PR&#xD;
Skin: ≥ 25% increase in skin disease from baseline, new tumors (T3) in patients with T1, T2 or T4 only skin disease, or in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score&#xD;
Blood: B0 to B2, &gt; 50% increase from baseline and at least 5,000 neoplastic cells/μL36, or &gt; 50% increase from nadir and at least 5,000 neoplastic cells/μL&#xD;
Viscera: &gt; 50% increase in size (SPD) of any organs involved at baseline, new organ involvement, or &gt; 50% increase from nadir in the size (SPD) of any previous organ involvement in those with PR</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate</measure>
    <time_frame>at the end of cycle 1 (26-28 days), and then every other cycle in Year 1 (cycle 3, 5, 7, 9, 11, 13), and every 16 weeks (cycle 17, 21, etc.) in Year 2 and beyond until progression up to 36 months</time_frame>
    <description>The ORR was defined as the count of subjects who had a confirmed CR or PR, defined as documented CR or PR per Global Composite Response Score that was confirmed by a subsequent observation at least 4 weeks later. Overall Response Rate was determined based on the response in all compartments (lymph nodes, skin, peripheral blood, and viscera), referencing Olsen, 2011 as follows: Complete Response (CR) = complete disappearance of all clinical evidence of disease; Partial Response (PR) = regression of measurable disease; Stable Disease (SD) = failure to attain CR, PR, or PD; Progressive Disease (PD) = PD in any compartment; Relapse = recurrence of disease in prior CR in any compartment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life (QoL) Assessment - Skindex-29 Symptoms Scale Score</measure>
    <time_frame>Cycle 1, 3, and 5</time_frame>
    <description>Skindex-29 rates 29 items assessing 3 domains (emotions, symptoms, &amp; functioning) on a linear scale from 0 (never) to all the time (100). Higher scores = higher impact of skin disease.&#xD;
FACT-G rates 27 items in 4 domains (physical well-being, social/family well-being, emotional well-being, functional well-being) on a 5-point scale from 0 (not at all) to 4 (very much). Higher scores = better QoL.&#xD;
EuroQoL lvl 3 (Eq-5D-3L) rates mobility, self-care, usual activities, pain/discomfort and anxiety/depression on 3 levels - no problems, some problems, extreme problems. Score is calculated using a set of item weights to derive a single score ranging from -0.109 to 1, with 1 representing full health.&#xD;
LS mean (and 95% CI) of the overall change from baseline across time points through 6-month assessment (including End of Cycles 1, 3, and 5 time points only) are calculated from MMRM with treatment, disease type, disease stage, and region as fixed effects and baseline score as a covariate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pruritis Evaluation</measure>
    <time_frame>Cycle 1, 3, and 5</time_frame>
    <description>The Itchy QoL is a validated pruritus specific quality of life instrument. It includes 22 pruritus-specific questions covering three major domains: symptoms, functioning, and emotions. The scale ranges from Never (1) to All The Time (5). The subscale scores consist of the average of the responses to the items in a given subscale. The overall score is the average of the responses to all items. Higher Itchy QoL scores indicate worse quality of life.&#xD;
LS mean (and 95% CI) of the overall change from baseline across time points through 6-month assessment (including End of Cycles 1, 3, and 5 time points only) are calculated from MMRM with treatment, disease type, disease stage, and region as fixed effects and baseline score as a covariate.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">372</enrollment>
  <condition>Cutaneous T-Cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>KW-0761</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vorinostat</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>vorinostat 400 mg once daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>KW-0761</intervention_name>
    <description>1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression</description>
    <arm_group_label>KW-0761</arm_group_label>
    <other_name>mogamulizumab</other_name>
    <other_name>POTELIGEO®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vorinostat</intervention_name>
    <arm_group_label>Vorinostat</arm_group_label>
    <other_name>400 mg orally daily</other_name>
    <other_name>ZOLINZA®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female subjects ≥ 18 years of age at the time of enrollment, except in Japan&#xD;
             where subjects must be ≥ 20 years of age at the time of enrollment&#xD;
&#xD;
          -  Histologically confirmed diagnosis of mycosis fungoides (MF) or Sezary Syndrome (SS)&#xD;
&#xD;
          -  Stage IB, II-A, II-B, III and IV&#xD;
&#xD;
          -  Subjects who had failed at least one prior course of systemic therapy. Psoralen plus&#xD;
             ultraviolet light therapy (PUVA) is not considered to be a systemic therapy&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1 at study&#xD;
             entry&#xD;
&#xD;
          -  Resolution of all clinically significant toxic effects of prior cancer therapy to&#xD;
             grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse&#xD;
             Events, version 4.0 (NCI-CTCAE, v.4.0)&#xD;
&#xD;
          -  Adequate hematological, renal and hepatic function&#xD;
&#xD;
          -  Subjects previously treated with anti-CD4 antibody or alemtuzumab were eligible&#xD;
             provided their CD4+ cell counts were ≥ 200/mm3&#xD;
&#xD;
          -  Subjects with mycosis fungoides (MF) and a known history of non-complicated&#xD;
             staphylococcus infection/colonization were eligible provided they continued to receive&#xD;
             stable doses of prophylactic antibiotics&#xD;
&#xD;
          -  Women of childbearing potential (WOCBP) must have had a negative pregnancy test within&#xD;
             7 days of receiving study medication&#xD;
&#xD;
          -  WOCBP and male subjects as well as their female partners of childbearing potential&#xD;
             must have agreed to use effective contraception throughout the study and for 3 months&#xD;
             after the last dose of KW-0761&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with KW-0761 or vorinostat.&#xD;
&#xD;
          -  Large cell transformation. However, subjects with a history of LCT but without current&#xD;
             aggressive disease and no current evidence of LCT on pathology in skin and lymph nodes&#xD;
             would be eligible.&#xD;
&#xD;
          -  Diagnosed with a malignancy in the past two years. However, subjects with non-melanoma&#xD;
             skin cancers, melanoma in situ, localized cancer of the prostate with current PSA of&#xD;
             &lt;0.1 ng/mL, treated thyroid cancer or cervical carcinoma in situ or ductal/lobular&#xD;
             carcinoma in situ of the breast within the past two years could enroll as long as&#xD;
             there was no current evidence of disease.&#xD;
&#xD;
          -  Clinical evidence of central nervous system (CNS) metastasis.&#xD;
&#xD;
          -  Psychiatric illness, disability or social situation that would have compromised the&#xD;
             subject's safety or ability to provide consent, or limited compliance with study&#xD;
             requirements.&#xD;
&#xD;
          -  Significant uncontrolled intercurrent illness&#xD;
&#xD;
          -  Known or tested positive for human immunodeficiency virus (HIV), human T-cell leukemia&#xD;
             virus (HTLV-1), hepatitis B or hepatitis C.&#xD;
&#xD;
          -  Active herpes simplex or herpes zoster. Subjects on prophylaxis for herpes who started&#xD;
             taking medication at least 30 days prior to study entry, and had no active signs of&#xD;
             active infection, and whose last active infection was more than 6 months ago, could&#xD;
             enter the study, and should have continued to take the prescribed medication for the&#xD;
             duration of the study.&#xD;
&#xD;
          -  Experienced allergic reactions to monoclonal antibodies or other therapeutic proteins.&#xD;
&#xD;
          -  Known active autoimmune disease were excluded. (For example, Grave's disease; systemic&#xD;
             lupus erythematosus; rheumatoid arthritis; Crohn's disease; psoriasis).&#xD;
&#xD;
          -  Was pregnant (confirmed by beta human chorionic gonadotrophin [β-HCG]) or lactating.&#xD;
&#xD;
          -  History of allogeneic transplant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dmitri O. Grebennik, MD</last_name>
    <role>Study Director</role>
    <affiliation>Kyowa Kirin, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama - Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Banner MD Anderson</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City of Hope National Medical Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Medical Center</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yale University School of Medicine - Yale Cancer Center</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Lee Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Winship Cancer Institute (Emory University)</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Cancer Center</name>
      <address>
        <city>Westwood</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulane University Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Medical Center, Department of Medicine, Section of Hem/Onc</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universal Dermatology, PLLC</name>
      <address>
        <city>Fairport</city>
        <state>New York</state>
        <zip>14450</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia Presbyterian</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester School of Medicine</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh School of Medicine</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M.D.Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53266</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westmead Hospital</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Adelaide Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Flinders Medical Centre</name>
      <address>
        <city>Bedford Park</city>
        <state>South Australia</state>
        <zip>5042</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkville Cancer Clinical Trials Unit</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Louis</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bordeaux - Hopital Haut-Leveque</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Lyon Sud</name>
      <address>
        <city>Pierre-Benite Cedex</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Centre Mannheim</name>
      <address>
        <city>Mannheim</city>
        <zip>D-68167</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Muenster</name>
      <address>
        <city>Muenster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Hematology and Oncology Lorenzo e Ariosto Seràgnoli, University of Bologna</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universita degli Studi di Torino</name>
      <address>
        <city>Turin</city>
        <zip>10124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagoya City University Hospital</name>
      <address>
        <city>Nagoya-shi</city>
        <state>Aichi</state>
        <zip>467-8602</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukushima Medical University Hospital</name>
      <address>
        <city>Fukushima-shi</city>
        <state>Fukushima</state>
        <zip>960-1295</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gunma University Hospital</name>
      <address>
        <city>Maebashi-shi</city>
        <state>Gunma</state>
        <zip>371-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hiroshima University Hospital</name>
      <address>
        <city>Hiroshima-shi</city>
        <state>Hiroshima</state>
        <zip>734-8551</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asahikawa Medical University Hospital</name>
      <address>
        <city>Asahikawa</city>
        <state>Hokkaido</state>
        <zip>078-8510</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imamura Bun-in Hospital</name>
      <address>
        <city>Kagoshima-shi</city>
        <state>Kagoshima</state>
        <zip>890-0064</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yokohama City University Hospital</name>
      <address>
        <city>Yokohama-shi</city>
        <state>Kanagawa</state>
        <zip>236-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kochi Medical School Hospital</name>
      <address>
        <city>Nankoku-shi</city>
        <state>Kochi</state>
        <zip>783-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mie University Hospital</name>
      <address>
        <city>Tsu-shi</city>
        <state>Mie</state>
        <zip>514-8507</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital</name>
      <address>
        <city>Sendai-shi</city>
        <state>Miyagi</state>
        <zip>980-8574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shinshu University Hospital</name>
      <address>
        <city>Matsumoto-shi</city>
        <state>Nagano</state>
        <zip>390-8621</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okayama University Hospital</name>
      <address>
        <city>Okayama-shi</city>
        <state>Okayama</state>
        <zip>700-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansai Medical University Hospital</name>
      <address>
        <city>Hirakata-shi</city>
        <state>Osaka</state>
        <zip>571-1191</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka University Hospital</name>
      <address>
        <city>Suita-shi</city>
        <state>Osaka</state>
        <zip>565-0871</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamamatsu University Hospital</name>
      <address>
        <city>Hamamatsu-shi</city>
        <state>Shizuoka</state>
        <zip>431-3192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Tokyo Hospital</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>113-8655</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Metropolitan Tama Medical Center</name>
      <address>
        <city>Fuchu-shi</city>
        <state>Tokyo</state>
        <zip>183-8524</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Japanese Foundation for Cancer Research</name>
      <address>
        <city>Koto-ku</city>
        <state>Tokyo</state>
        <zip>135-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leiden University Medical Center - Leids Universitair Medisch Centrum (LUMC)</name>
      <address>
        <city>Leiden</city>
        <zip>2300RC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Christie Hospital Foundation NHS Trust</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Birmingham</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guys &amp; St. Thomas NHS Trust</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <results_first_submitted>October 11, 2018</results_first_submitted>
  <results_first_submitted_qc>March 20, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">April 11, 2019</results_first_posted>
  <disposition_first_submitted>February 9, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>February 9, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">February 14, 2018</disposition_first_posted>
  <last_update_submitted>July 22, 2022</last_update_submitted>
  <last_update_submitted_qc>July 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cutaneous T-Cell Lymphoma (CTCL)</keyword>
  <keyword>myocis fungoides (MF)</keyword>
  <keyword>Sezary Syndrome (SS)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, T-Cell</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Peripheral</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Cutaneous</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vorinostat</mesh_term>
    <mesh_term>Mogamulizumab</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 31, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT01728805/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 22, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT01728805/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>KW-0761</title>
          <description>anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)&#xD;
KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression</description>
        </group>
        <group group_id="P2">
          <title>Vorinostat</title>
          <description>vorinostat 400 mg once daily&#xD;
Vorinostat</description>
        </group>
        <group group_id="P3">
          <title>Vorinostat Original Then Crossover to KW-0761</title>
          <description>Subjects who were randomized to vorinostat could be crossed over to receive mogamulizumab upon disease progression and with permission from the Medical Monitor.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Randomization Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="186"/>
                <participants group_id="P2" count="186"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="186"/>
                <participants group_id="P2" count="186"/>
                <participants group_id="P3" count="0"/>
              </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_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Crossover Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="136"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="136"/>
              </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_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>KW-0761</title>
          <description>anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)&#xD;
KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression</description>
        </group>
        <group group_id="B2">
          <title>Vorinostat</title>
          <description>vorinostat 400 mg once daily&#xD;
Vorinostat</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="186"/>
            <count group_id="B2" value="186"/>
            <count group_id="B3" value="372"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="99"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="188"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="97"/>
                    <measurement group_id="B3" value="184"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.8" lower_limit="25" upper_limit="101"/>
                    <measurement group_id="B2" value="63.3" lower_limit="25" upper_limit="89"/>
                    <measurement group_id="B3" value="63.0" lower_limit="25" upper_limit="101"/>
                  </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="77"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="156"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="109"/>
                    <measurement group_id="B2" value="107"/>
                    <measurement group_id="B3" value="216"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race/Ethnicity</title>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="125"/>
                    <measurement group_id="B2" value="135"/>
                    <measurement group_id="B3" value="260"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="98"/>
                    <measurement group_id="B2" value="103"/>
                    <measurement group_id="B3" value="201"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Denmark</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Switzerland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Progression Free Survival</title>
        <description>Progression was defined as follows, based on Olsen (2011):&#xD;
Lymph nodes: ≥ 50% increase in SPD from baseline of lymph nodes, any new node &gt; 1.5 cm in the long axis or &gt; 1 cm in the short axis if 1-1.5 cm in the long axis that is proven to be N3 histologically, or &gt; 50% increase from nadir in SPD of lymph nodes in those with PR&#xD;
Skin: ≥ 25% increase in skin disease from baseline, new tumors (T3) in patients with T1, T2 or T4 only skin disease, or in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score&#xD;
Blood: B0 to B2, &gt; 50% increase from baseline and at least 5,000 neoplastic cells/μL36, or &gt; 50% increase from nadir and at least 5,000 neoplastic cells/μL&#xD;
Viscera: &gt; 50% increase in size (SPD) of any organs involved at baseline, new organ involvement, or &gt; 50% increase from nadir in the size (SPD) of any previous organ involvement in those with PR</description>
        <time_frame>From date of randomization at every visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>KW-0761</title>
            <description>anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)&#xD;
KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression</description>
          </group>
          <group group_id="O2">
            <title>Vorinostat</title>
            <description>vorinostat 400 mg once daily&#xD;
Vorinostat</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival</title>
          <description>Progression was defined as follows, based on Olsen (2011):&#xD;
Lymph nodes: ≥ 50% increase in SPD from baseline of lymph nodes, any new node &gt; 1.5 cm in the long axis or &gt; 1 cm in the short axis if 1-1.5 cm in the long axis that is proven to be N3 histologically, or &gt; 50% increase from nadir in SPD of lymph nodes in those with PR&#xD;
Skin: ≥ 25% increase in skin disease from baseline, new tumors (T3) in patients with T1, T2 or T4 only skin disease, or in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score&#xD;
Blood: B0 to B2, &gt; 50% increase from baseline and at least 5,000 neoplastic cells/μL36, or &gt; 50% increase from nadir and at least 5,000 neoplastic cells/μL&#xD;
Viscera: &gt; 50% increase in size (SPD) of any organs involved at baseline, new organ involvement, or &gt; 50% increase from nadir in the size (SPD) of any previous organ involvement in those with PR</description>
          <units>percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="186"/>
                <count group_id="O2" value="186"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Rate (%) of Being Alive w/o Progression at 6 mos.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.3" lower_limit="47.1" upper_limit="62.6"/>
                    <measurement group_id="O2" value="28.8" lower_limit="21.6" upper_limit="36.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rate (%) of Being Alive w/o Progression at 12 mos.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.3" lower_limit="30.2" upper_limit="46.4"/>
                    <measurement group_id="O2" value="15.3" lower_limit="9.5" upper_limit="22.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rate (%) of Being Alive w/o Progression at 18 mos.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.0" lower_limit="19.8" upper_limit="36.8"/>
                    <measurement group_id="O2" value="7.2" lower_limit="2.7" upper_limit="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rate (%) of Being Alive w/o Progression at 24 mos.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.1" lower_limit="6.4" upper_limit="24.8"/>
                    <measurement group_id="O2" value="7.2" lower_limit="2.7" upper_limit="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rate (%) of Being Alive w/o Progression at 30 mos.</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" lower_limit="0.5" upper_limit="17.7"/>
                    <measurement group_id="O2" value="7.2" lower_limit="2.7" upper_limit="14.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Response Rate</title>
        <description>The ORR was defined as the count of subjects who had a confirmed CR or PR, defined as documented CR or PR per Global Composite Response Score that was confirmed by a subsequent observation at least 4 weeks later. Overall Response Rate was determined based on the response in all compartments (lymph nodes, skin, peripheral blood, and viscera), referencing Olsen, 2011 as follows: Complete Response (CR) = complete disappearance of all clinical evidence of disease; Partial Response (PR) = regression of measurable disease; Stable Disease (SD) = failure to attain CR, PR, or PD; Progressive Disease (PD) = PD in any compartment; Relapse = recurrence of disease in prior CR in any compartment.</description>
        <time_frame>at the end of cycle 1 (26-28 days), and then every other cycle in Year 1 (cycle 3, 5, 7, 9, 11, 13), and every 16 weeks (cycle 17, 21, etc.) in Year 2 and beyond until progression up to 36 months</time_frame>
        <population>The total number of patients analyzed are further broken out by disease type [mycosis fungoides (MF) and Sezary Syndrome (SS)]</population>
        <group_list>
          <group group_id="O1">
            <title>KW-0761</title>
            <description>anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)&#xD;
KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression</description>
          </group>
          <group group_id="O2">
            <title>Vorinostat</title>
            <description>vorinostat 400 mg once daily&#xD;
Vorinostat</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate</title>
          <description>The ORR was defined as the count of subjects who had a confirmed CR or PR, defined as documented CR or PR per Global Composite Response Score that was confirmed by a subsequent observation at least 4 weeks later. Overall Response Rate was determined based on the response in all compartments (lymph nodes, skin, peripheral blood, and viscera), referencing Olsen, 2011 as follows: Complete Response (CR) = complete disappearance of all clinical evidence of disease; Partial Response (PR) = regression of measurable disease; Stable Disease (SD) = failure to attain CR, PR, or PD; Progressive Disease (PD) = PD in any compartment; Relapse = recurrence of disease in prior CR in any compartment.</description>
          <population>The total number of patients analyzed are further broken out by disease type [mycosis fungoides (MF) and Sezary Syndrome (SS)]</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="186"/>
                <count group_id="O2" value="186"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>All Subjects ORR (confirmed CR + PR)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="186"/>
                    <count group_id="O2" value="186"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Disease Type = MF ORR (confirmed CR + PR)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Disease Type = SS ORR (confirmed CR + PR)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="81"/>
                    <count group_id="O2" value="87"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Quality of Life (QoL) Assessment - Skindex-29 Symptoms Scale Score</title>
        <description>Skindex-29 rates 29 items assessing 3 domains (emotions, symptoms, &amp; functioning) on a linear scale from 0 (never) to all the time (100). Higher scores = higher impact of skin disease.&#xD;
FACT-G rates 27 items in 4 domains (physical well-being, social/family well-being, emotional well-being, functional well-being) on a 5-point scale from 0 (not at all) to 4 (very much). Higher scores = better QoL.&#xD;
EuroQoL lvl 3 (Eq-5D-3L) rates mobility, self-care, usual activities, pain/discomfort and anxiety/depression on 3 levels - no problems, some problems, extreme problems. Score is calculated using a set of item weights to derive a single score ranging from -0.109 to 1, with 1 representing full health.&#xD;
LS mean (and 95% CI) of the overall change from baseline across time points through 6-month assessment (including End of Cycles 1, 3, and 5 time points only) are calculated from MMRM with treatment, disease type, disease stage, and region as fixed effects and baseline score as a covariate.</description>
        <time_frame>Cycle 1, 3, and 5</time_frame>
        <population>The number of subjects analyzed in each row is the number of subjects with values at baseline and the specified post-baseline timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>KW-0761</title>
            <description>anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)&#xD;
KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression</description>
          </group>
          <group group_id="O2">
            <title>Vorinostat</title>
            <description>vorinostat 400 mg once daily&#xD;
Vorinostat</description>
          </group>
        </group_list>
        <measure>
          <title>Quality of Life (QoL) Assessment - Skindex-29 Symptoms Scale Score</title>
          <description>Skindex-29 rates 29 items assessing 3 domains (emotions, symptoms, &amp; functioning) on a linear scale from 0 (never) to all the time (100). Higher scores = higher impact of skin disease.&#xD;
FACT-G rates 27 items in 4 domains (physical well-being, social/family well-being, emotional well-being, functional well-being) on a 5-point scale from 0 (not at all) to 4 (very much). Higher scores = better QoL.&#xD;
EuroQoL lvl 3 (Eq-5D-3L) rates mobility, self-care, usual activities, pain/discomfort and anxiety/depression on 3 levels - no problems, some problems, extreme problems. Score is calculated using a set of item weights to derive a single score ranging from -0.109 to 1, with 1 representing full health.&#xD;
LS mean (and 95% CI) of the overall change from baseline across time points through 6-month assessment (including End of Cycles 1, 3, and 5 time points only) are calculated from MMRM with treatment, disease type, disease stage, and region as fixed effects and baseline score as a covariate.</description>
          <population>The number of subjects analyzed in each row is the number of subjects with values at baseline and the specified post-baseline timepoint.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="186"/>
                <count group_id="O2" value="186"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Skindex-29 Across 6-month Assessment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="162"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.6" lower_limit="-15.94" upper_limit="-9.29"/>
                    <measurement group_id="O2" value="-6.0" lower_limit="-9.39" upper_limit="-2.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>FACT-G Across 6-month Assessment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="167"/>
                    <count group_id="O2" value="177"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" lower_limit="2.14" upper_limit="7.04"/>
                    <measurement group_id="O2" value="-2.3" lower_limit="-4.84" upper_limit="0.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>EQ-5D-3L Across 6-month Assessment</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="169"/>
                    <count group_id="O2" value="174"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.06" lower_limit="0.028" upper_limit="0.085"/>
                    <measurement group_id="O2" value="0.02" lower_limit="-0.008" upper_limit="0.052"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pruritis Evaluation</title>
        <description>The Itchy QoL is a validated pruritus specific quality of life instrument. It includes 22 pruritus-specific questions covering three major domains: symptoms, functioning, and emotions. The scale ranges from Never (1) to All The Time (5). The subscale scores consist of the average of the responses to the items in a given subscale. The overall score is the average of the responses to all items. Higher Itchy QoL scores indicate worse quality of life.&#xD;
LS mean (and 95% CI) of the overall change from baseline across time points through 6-month assessment (including End of Cycles 1, 3, and 5 time points only) are calculated from MMRM with treatment, disease type, disease stage, and region as fixed effects and baseline score as a covariate.</description>
        <time_frame>Cycle 1, 3, and 5</time_frame>
        <population>The number of participants analyzed were subjects with values at baseline and post-baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>KW-0761</title>
            <description>anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)&#xD;
KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression</description>
          </group>
          <group group_id="O2">
            <title>Vorinostat</title>
            <description>vorinostat 400 mg once daily&#xD;
Vorinostat</description>
          </group>
        </group_list>
        <measure>
          <title>Pruritis Evaluation</title>
          <description>The Itchy QoL is a validated pruritus specific quality of life instrument. It includes 22 pruritus-specific questions covering three major domains: symptoms, functioning, and emotions. The scale ranges from Never (1) to All The Time (5). The subscale scores consist of the average of the responses to the items in a given subscale. The overall score is the average of the responses to all items. Higher Itchy QoL scores indicate worse quality of life.&#xD;
LS mean (and 95% CI) of the overall change from baseline across time points through 6-month assessment (including End of Cycles 1, 3, and 5 time points only) are calculated from MMRM with treatment, disease type, disease stage, and region as fixed effects and baseline score as a covariate.</description>
          <population>The number of participants analyzed were subjects with values at baseline and post-baseline.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="166"/>
                <count group_id="O2" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" lower_limit="-0.66" upper_limit="-0.39"/>
                    <measurement group_id="O2" value="-0.4" lower_limit="-0.52" upper_limit="-0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All subjects were assessed regularly for potential occurrence of adverse events from the time of signing the informed consent until 90 days after the last dose or initiation of alternative therapy, whichever came first, assessed up to 36 months.</time_frame>
      <desc>The following tables are based on the safety analysis set (all subjects who received at least one dose, even a partial dose, of the assigned study agent). Two subjects randomized to the mogamulizumab arm withdrew consent prior to receiving the first dose subsequently did not receive study treatment, bringing the number from 186 to 184.&#xD;
One subject crossed over from vorinostat to mogamulizumab but discontinued before receiving treatment, bringing the number from 136 to 135.</desc>
      <group_list>
        <group group_id="E1">
          <title>KW-0761</title>
          <description>anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)&#xD;
KW-0761: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression</description>
        </group>
        <group group_id="E2">
          <title>Vorinostat</title>
          <description>vorinostat 400 mg once daily&#xD;
Vorinostat</description>
        </group>
        <group group_id="E3">
          <title>Vorinostat Original Then Crossover to KW-0761</title>
          <description>Subjects who were randomized to vorinostat could be crossed over to receive mogamulizumab upon disease progression and with permission from the Medical Monitor.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (20.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="40" subjects_at_risk="184"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="186"/>
                <counts group_id="E3" subjects_affected="32" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="69" subjects_at_risk="184"/>
                <counts group_id="E2" subjects_affected="46" subjects_at_risk="186"/>
                <counts group_id="E3" subjects_affected="40" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Anaemia Haemolytic Autoimmune</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Febrile Neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Haemolytic Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Myocardial Infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Angina Unstable</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Left Ventricular Hypertrophy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Myocarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Supraventricular Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Lens Dislocation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Retinal Vein Occlusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Anal Fistula</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Gastric Haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Ileitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Inguinal Hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Intestinal Obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Large Intestinal Ulcer Haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Lip Swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Chest Discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Chest Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Device Failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Disease Progression</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Facial Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>General Physical Health Deterioration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Hypothermia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Localised Oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="5" subjects_affected="2" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Autoimmune Hepatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Cholecystitis Acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Hepatic Failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Hepatitis Acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Hepatocellular Injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Contrast Media Allergy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Drug Hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess Limb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Arthritis Bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Atypical Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Bronchopneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="184"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="186"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Device Related Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Enterovirus Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Epstein-Barr Virus Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Herpes Simplex</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Herpes Zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Lower Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Meningitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Otitis Externa</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Periorbital Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Pneumocystis Jiroveci Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="184"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="186"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Pneumonia Influenzal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Pneumonia Legionella</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Pneumonia Pneumococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Postoperative Wound Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Rhinovirus Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="184"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="186"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Sepsis Syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Septic Embolus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Septic Shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Skin Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Staphylococcal Abscess</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Staphylococcal Bacteraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Staphylococcal Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Staphylococcal Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Superinfection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection Bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Viral Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Wound Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Femur Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Infusion Related Reaction</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Lower Limb Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Pelvic Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Subdural Haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Subdural Haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Vascular Access Complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Aspartate Aminotransferase Increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Blood Alkaline Phospatase Increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Blood Creatinine Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Metabolic Acidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Monarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Muscular Weakness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Musculoskeletal Chest Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Polymyositis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Basal Cell Carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Bladder Transitional Cell Carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Bowen's Disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Colon Cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Infected Neoplasm</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Malignant Melanoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Malignant Pleural Effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Metastases to Lymph Nodes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Mycosis Fungoides</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Ovarian Cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Squamous Cell Carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Depressed Level of Consciousness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Haemorrhage Intracranial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Hepatic Encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Metabolic Encephalopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Miller Fisher Syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Monoparesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Motor Dysfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional State</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Mental Status Changes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Renal Failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Renal Failure Acute</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Renal Impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema Genital</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Respiratory Distress Syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Bronchitis Chronic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Chronic Obstructive Pulmonary Disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Dyspnoea Exertional</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Interstitial Lung Disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Pleural Effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis Exfoliative</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Drug Eruption</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Photosensitivity Reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Pruritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Skin Disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Social Stay Hospitalization</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Cardiac Pacemaker Replacement</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Air Embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Aortic Stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Peripheral Arterial Occlusive Disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (20.0)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="178" subjects_at_risk="184"/>
                <counts group_id="E2" subjects_affected="182" subjects_at_risk="186"/>
                <counts group_id="E3" subjects_affected="128" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="35" subjects_affected="20" subjects_at_risk="184"/>
                <counts group_id="E2" events="20" subjects_affected="18" subjects_at_risk="186"/>
                <counts group_id="E3" events="10" subjects_affected="9" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="34" subjects_affected="21" subjects_at_risk="184"/>
                <counts group_id="E2" events="83" subjects_affected="56" subjects_at_risk="186"/>
                <counts group_id="E3" events="48" subjects_affected="11" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Dry Eye</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="184"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Vision Blurred</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="184"/>
                <counts group_id="E2" events="14" subjects_affected="12" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="184"/>
                <counts group_id="E2" events="24" subjects_affected="21" subjects_at_risk="186"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Abdominal Pain Upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="27" subjects_affected="23" subjects_at_risk="184"/>
                <counts group_id="E2" events="37" subjects_affected="34" subjects_at_risk="186"/>
                <counts group_id="E3" events="15" subjects_affected="15" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="62" subjects_affected="45" subjects_at_risk="184"/>
                <counts group_id="E2" events="180" subjects_affected="114" subjects_at_risk="186"/>
                <counts group_id="E3" events="33" subjects_affected="22" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Dry Mouth</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="184"/>
                <counts group_id="E2" events="17" subjects_affected="17" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="184"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="38" subjects_affected="29" subjects_at_risk="184"/>
                <counts group_id="E2" events="99" subjects_affected="78" subjects_at_risk="186"/>
                <counts group_id="E3" events="13" subjects_affected="10" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="16" subjects_affected="10" subjects_at_risk="184"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="184"/>
                <counts group_id="E2" events="33" subjects_affected="23" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="12" subjects_affected="10" subjects_at_risk="184"/>
                <counts group_id="E2" events="32" subjects_affected="25" subjects_at_risk="186"/>
                <counts group_id="E3" events="18" subjects_affected="11" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="17" subjects_affected="13" subjects_at_risk="184"/>
                <counts group_id="E2" events="15" subjects_affected="14" subjects_at_risk="186"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="55" subjects_affected="44" subjects_at_risk="184"/>
                <counts group_id="E2" events="75" subjects_affected="69" subjects_at_risk="186"/>
                <counts group_id="E3" events="19" subjects_affected="14" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" events="32" subjects_affected="27" subjects_at_risk="184"/>
                <counts group_id="E2" events="37" subjects_affected="26" subjects_at_risk="186"/>
                <counts group_id="E3" events="16" subjects_affected="13" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="28" subjects_affected="26" subjects_at_risk="184"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="186"/>
                <counts group_id="E3" events="25" subjects_affected="17" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="12" subjects_affected="9" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="19" subjects_affected="14" subjects_at_risk="184"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="186"/>
                <counts group_id="E3" events="18" subjects_affected="13" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="19" subjects_affected="13" subjects_at_risk="184"/>
                <counts group_id="E2" events="23" subjects_affected="16" subjects_at_risk="186"/>
                <counts group_id="E3" events="12" subjects_affected="9" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Oral Candidasis</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="184"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Skin Infection</sub_title>
                <counts group_id="E1" events="28" subjects_affected="17" subjects_at_risk="184"/>
                <counts group_id="E2" events="15" subjects_affected="10" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="28" subjects_affected="20" subjects_at_risk="184"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="186"/>
                <counts group_id="E3" events="22" subjects_affected="12" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="17" subjects_affected="13" subjects_at_risk="184"/>
                <counts group_id="E2" events="20" subjects_affected="14" subjects_at_risk="186"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Infusion Related Reaction</sub_title>
                <counts group_id="E1" events="83" subjects_affected="59" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="55" subjects_affected="47" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="13" subjects_affected="12" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Aspartate Aminotransferase Increased</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="184"/>
                <counts group_id="E2" events="19" subjects_affected="12" subjects_at_risk="186"/>
                <counts group_id="E3" events="15" subjects_affected="13" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Blood Creatinine Increased</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="184"/>
                <counts group_id="E2" events="58" subjects_affected="52" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Platelet Count Decreased</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="184"/>
                <counts group_id="E2" events="22" subjects_affected="19" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Weight Decreased</sub_title>
                <counts group_id="E1" events="15" subjects_affected="11" subjects_at_risk="184"/>
                <counts group_id="E2" events="35" subjects_affected="32" subjects_at_risk="186"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Weight Increased</sub_title>
                <counts group_id="E1" events="17" subjects_affected="15" subjects_at_risk="184"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="184"/>
                <counts group_id="E2" events="49" subjects_affected="45" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="29" subjects_affected="15" subjects_at_risk="184"/>
                <counts group_id="E2" events="28" subjects_affected="13" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="15" subjects_affected="11" subjects_at_risk="184"/>
                <counts group_id="E2" events="16" subjects_affected="11" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="184"/>
                <counts group_id="E2" events="17" subjects_affected="11" subjects_at_risk="186"/>
                <counts group_id="E3" events="17" subjects_affected="15" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="20" subjects_affected="17" subjects_at_risk="184"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="186"/>
                <counts group_id="E3" events="13" subjects_affected="10" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Muscle Spasms</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="184"/>
                <counts group_id="E2" events="49" subjects_affected="29" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Muscular Weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="184"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Pain In Extremity</sub_title>
                <counts group_id="E1" events="17" subjects_affected="13" subjects_at_risk="184"/>
                <counts group_id="E2" events="16" subjects_affected="10" subjects_at_risk="186"/>
                <counts group_id="E3" events="13" subjects_affected="13" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="184"/>
                <counts group_id="E2" events="20" subjects_affected="19" subjects_at_risk="186"/>
                <counts group_id="E3" events="11" subjects_affected="8" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="184"/>
                <counts group_id="E2" events="59" subjects_affected="55" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="35" subjects_affected="23" subjects_at_risk="184"/>
                <counts group_id="E2" events="32" subjects_affected="27" subjects_at_risk="186"/>
                <counts group_id="E3" events="32" subjects_affected="17" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="184"/>
                <counts group_id="E2" events="16" subjects_affected="14" subjects_at_risk="186"/>
                <counts group_id="E3" events="10" subjects_affected="8" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="184"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="16" subjects_affected="16" subjects_at_risk="184"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="20" subjects_affected="18" subjects_at_risk="184"/>
                <counts group_id="E2" events="19" subjects_affected="16" subjects_at_risk="186"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="14" subjects_affected="10" subjects_at_risk="184"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="184"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="186"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="184"/>
                <counts group_id="E2" events="35" subjects_affected="35" subjects_at_risk="186"/>
                <counts group_id="E3" events="9" subjects_affected="9" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Drug Eruption</sub_title>
                <counts group_id="E1" events="77" subjects_affected="44" subjects_at_risk="184"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="186"/>
                <counts group_id="E3" events="54" subjects_affected="35" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Intertrigo</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="12" subjects_affected="7" subjects_at_risk="135"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="184"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="186"/>
                <counts group_id="E3" events="15" subjects_affected="11" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="38" subjects_affected="17" subjects_at_risk="184"/>
                <counts group_id="E2" events="28" subjects_affected="25" subjects_at_risk="186"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="135"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Fiona Herr, Associate Director, Medical Communications</name_or_title>
      <organization>Kyowa Kirin Inc</organization>
      <phone>1 (908) 234-1096</phone>
      <email>medinfo-US@kyowakirin.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/NCT01728805
org study id: 0761-010
nct id: NCT01728805
lead sponsor: 
has dmc: Yes
The purpose of this study is to compare the progression free survival of KW-0761 versus
      vorinostat for subjects with relapsed or refractory CTCL.
Phase 3 randomized study to compare the progression free survival of subjects with
      relapsed/refractory CTCL who receive KW-0761 versus those who receive vorinostat. Subjects
      who progress on vorinostat will be allowed to cross over to KW-0761 upon progression.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival
time frame: From date of randomization at every visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
description: Progression was defined as follows, based on Olsen (2011):
Lymph nodes: ≥ 50% increase in SPD from baseline of lymph nodes, any new node > 1.5 cm in the long axis or > 1 cm in the short axis if 1-1.5 cm in the long axis that is proven to be N3 histologically, or > 50% increase from nadir in SPD of lymph nodes in those with PR
Skin: ≥ 25% increase in skin disease from baseline, new tumors (T3) in patients with T1, T2 or T4 only skin disease, or in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score
Blood: B0 to B2, > 50% increase from baseline and at least 5,000 neoplastic cells/μL36, or > 50% increase from nadir and at least 5,000 neoplastic cells/μL
Viscera: > 50% increase in size (SPD) of any organs involved at baseline, new organ involvement, or > 50% increase from nadir in the size (SPD) of any previous organ involvement in those with PR
measure: Overall Response Rate
time frame: at the end of cycle 1 (26-28 days), and then every other cycle in Year 1 (cycle 3, 5, 7, 9, 11, 13), and every 16 weeks (cycle 17, 21, etc.) in Year 2 and beyond until progression up to 36 months
description: The ORR was defined as the count of subjects who had a confirmed CR or PR, defined as documented CR or PR per Global Composite Response Score that was confirmed by a subsequent observation at least 4 weeks later. Overall Response Rate was determined based on the response in all compartments (lymph nodes, skin, peripheral blood, and viscera), referencing Olsen, 2011 as follows: Complete Response (CR) = complete disappearance of all clinical evidence of disease; Partial Response (PR) = regression of measurable disease; Stable Disease (SD) = failure to attain CR, PR, or PD; Progressive Disease (PD) = PD in any compartment; Relapse = recurrence of disease in prior CR in any compartment.
measure: Quality of Life (QoL) Assessment - Skindex-29 Symptoms Scale Score
time frame: Cycle 1, 3, and 5
description: Skindex-29 rates 29 items assessing 3 domains (emotions, symptoms, & functioning) on a linear scale from 0 (never) to all the time (100). Higher scores = higher impact of skin disease.
FACT-G rates 27 items in 4 domains (physical well-being, social/family well-being, emotional well-being, functional well-being) on a 5-point scale from 0 (not at all) to 4 (very much). Higher scores = better QoL.
EuroQoL lvl 3 (Eq-5D-3L) rates mobility, self-care, usual activities, pain/discomfort and anxiety/depression on 3 levels - no problems, some problems, extreme problems. Score is calculated using a set of item weights to derive a single score ranging from -0.109 to 1, with 1 representing full health.
LS mean (and 95% CI) of the overall change from baseline across time points through 6-month assessment (including End of Cycles 1, 3, and 5 time points only) are calculated from MMRM with treatment, disease type, disease stage, and region as fixed effects and baseline score as a covariate.
measure: Pruritis Evaluation
time frame: Cycle 1, 3, and 5
description: The Itchy QoL is a validated pruritus specific quality of life instrument. It includes 22 pruritus-specific questions covering three major domains: symptoms, functioning, and emotions. The scale ranges from Never (1) to All The Time (5). The subscale scores consist of the average of the responses to the items in a given subscale. The overall score is the average of the responses to all items. Higher Itchy QoL scores indicate worse quality of life.
LS mean (and 95% CI) of the overall change from baseline across time points through 6-month assessment (including End of Cycles 1, 3, and 5 time points only) are calculated from MMRM with treatment, disease type, disease stage, and region as fixed effects and baseline score as a covariate.
arm group label: KW-0761
arm group type: Experimental
description: anti-CCR4 monoclonal antibody KW-0761 (mogamulizumab)
arm group label: Vorinostat
arm group type: Active Comparator
description: vorinostat 400 mg once daily
intervention type: Biological
intervention name: KW-0761
description: 1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression
arm group label: KW-0761
other name: mogamulizumab
other name: POTELIGEO®
intervention type: Drug
intervention name: Vorinostat
arm group label: Vorinostat
other name: 400 mg orally daily
other name: ZOLINZA®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dmitri O. Grebennik, MD
role: Study Director
affiliation: Kyowa Kirin, Inc.
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country: Australia
country: Denmark
country: France
country: Germany
country: Italy
country: Japan
country: Netherlands
country: Spain
country: Switzerland
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, T-Cell
mesh term: Lymphoma, T-Cell, Peripheral
mesh term: Lymphoma, T-Cell, Cutaneous
mesh term: Vorinostat
mesh term: Mogamulizumab
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