<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/NCT01681433</url>
  </required_header>
  <id_info>
    <org_study_id>GU12-159</org_study_id>
    <nct_id>NCT01681433</nct_id>
  </id_info>
  <brief_title>OGX-427 in Metastatic Castrate-Resistant Prostate Cancer With Prostate-Specific Antigen Progression While Receiving Abiraterone</brief_title>
  <official_title>The Pacific Clinical Trial: A Randomized Phase II Study Evaluating OGX-427 in Patients With Metastatic Castrate-Resistant Prostate Cancer (MCRPC)Who Have Prostate-Specific Antigen (PSA) Progression While Receiving Abiraterone: Hoosier Oncology Group GU12-159</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Costantine Albany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hoosier Cancer Research Network</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Achieve Life Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hoosier Cancer Research Network</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Phase II study has been designed to evaluate the anti-tumor effects of adding OGX-427 to&#xD;
      continuing abiraterone acetate and prednisone treatment in men with metastatic&#xD;
      castrate-resistant prostate cancer (MCRPC) who have prostate-specific antigen (PSA)&#xD;
      progression&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OUTLINE: This is a multi-center study.&#xD;
&#xD;
      This is an open-label, randomized, Phase II clinical trial designed to evaluate the&#xD;
      anti-tumor effects of OGX-427 and continuing abiraterone acetate and prednisone versus&#xD;
      continuing abiraterone acetate and prednisone alone in men with MCRPC who have evidence of&#xD;
      PSA progression but no evidence of symptomatic or radiographic progression that would require&#xD;
      alternative therapy (e.g., needing radiation therapy for pain or significant progression of&#xD;
      visceral metastases).&#xD;
&#xD;
      Patients on the control arm will be allowed to cross-over to receive OGX-427 following&#xD;
      documented disease progression. Patients will be randomized with equal probability to one of&#xD;
      the following arms:&#xD;
&#xD;
      EXPERIMENTAL ARM (Arm A):&#xD;
&#xD;
      OGX-427 Starting within 7 days of randomization, three loading doses of 600 mg intravenously&#xD;
      (IV) within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly&#xD;
      doses of 800 mg IV&#xD;
&#xD;
      Continuation of standard therapy with abiraterone acetate 1000 mg by mouth (PO) daily and&#xD;
      prednisone 10-20 mg PO daily&#xD;
&#xD;
      CONTROL ARM (Arm B):&#xD;
&#xD;
      Continuation of standard therapy with abiraterone acetate 1000 mg PO daily and prednisone&#xD;
      10-20 mg PO daily&#xD;
&#xD;
      After documented disease progression, patients on Arm B may opt to receive OGX-427 treatment&#xD;
      (according to the Arm A schedule) following a screening evaluation (i.e., all inclusion and&#xD;
      exclusion criteria have been met)&#xD;
&#xD;
      Both Arms:&#xD;
&#xD;
      Evaluations at 4 week-intervals. Disease assessments required at the milestone Day 60&#xD;
      assessment (expected to occur after 8 weeks of treatment and prior to Day 1, Week 9) and at&#xD;
      16, 24, 32, 40, and 48 weeks (if applicable) or until documented disease progression.&#xD;
      Patients who are withdrawn from the study for a reason other than documented disease&#xD;
      progression or patient withdrawal of consent will be followed every 4 weeks in the&#xD;
      Off-Treatment Follow-up Period until documented disease progression.&#xD;
&#xD;
      Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1&#xD;
&#xD;
      Life Expectancy: Not Specified&#xD;
&#xD;
      Hematopoietic:&#xD;
&#xD;
        -  Absolute neutrophil count (ANC) ≥ 1.5 x 109 cells /L, platelet count ≥ 100 x 109 /L, and&#xD;
           hemoglobin ≥ 9 g/dL without transfusion&#xD;
&#xD;
      Hepatic:&#xD;
&#xD;
        -  Total bilirubin ≤ 1.1 x upper limit of normal (ULN) unless elevated secondary to&#xD;
           conditions such as Gilbert's disease, in which case a direct bilirubin ≤ ULN is required&#xD;
&#xD;
        -  Serum glutamic pyruvic transaminase (SGPT), alanine transaminase (ALT) and alanine&#xD;
           transaminase (SGOT) aspartate transaminase (AST) ≤ 3.0 x ULN&#xD;
&#xD;
      Renal:&#xD;
&#xD;
        -  Creatinine ≤ 1.3 x ULN&#xD;
&#xD;
      Cardiac:&#xD;
&#xD;
        -  Known left ventricular ejection fraction (LVEF) &lt;50% or New York Heart Association&#xD;
           (NYHA) Functional Classification Class III or IV heart failure&#xD;
&#xD;
      Other:&#xD;
&#xD;
        -  Castrate serum testosterone level (&lt; 50 ng/dL or &lt; 1.7 nmol/L)&#xD;
&#xD;
        -  Potassium within normal limits&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    lack of accrual&#xD;
  </why_stopped>
  <start_date type="Actual">December 2012</start_date>
  <completion_date type="Actual">June 21, 2017</completion_date>
  <primary_completion_date type="Actual">June 21, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover 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>60 days</time_frame>
    <description>To ascertain whether Arm A has a greater proportion of patients observed to be alive without progression at Day 60 (±7 days) as compared to Arm B.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PSA Response</measure>
    <time_frame>60 days</time_frame>
    <description>Compare arms to determine the proportion of patients who have a PSA response (≥ 30% decline) and any PSA decline post-randomization.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Objective Response</measure>
    <time_frame>60 days</time_frame>
    <description>Compare arms to determine the objective response of study patients, per RECIST 1.1</description>
  </other_outcome>
  <other_outcome>
    <measure>Time to Disease Progression</measure>
    <time_frame>60 days</time_frame>
    <description>Compare arms to determine the time to disease progression of study patients</description>
  </other_outcome>
  <other_outcome>
    <measure>Circulating Tumor Cell (CTC) Counts</measure>
    <time_frame>Every 4 weeks</time_frame>
    <description>Compare arms to determine circulating tumor cell (CTC) counts for patients at baseline and while on study</description>
  </other_outcome>
  <other_outcome>
    <measure>Protein Levels</measure>
    <time_frame>Every 4 weeks</time_frame>
    <description>Compare arms to determine levels of heat shock protein 27 (Hsp27), clusterin, and other relevant proteins of patients at baseline and during study</description>
  </other_outcome>
  <other_outcome>
    <measure>Phosphatase and Tensin Homolog (PTEN) Deletion Status</measure>
    <time_frame>Every 4 weeks</time_frame>
    <description>Compare arms to determine PTEN deletion status in original pathology specimens correlated with clinical outcomes</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Metastatic Castrate-Resistant Prostate Cancer</condition>
  <condition>PSA</condition>
  <arm_group>
    <arm_group_label>Experimental: Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm: Arm B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Continuation of standard therapy with abiraterone acetate and prednisone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>OGX-427</intervention_name>
    <description>OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV</description>
    <arm_group_label>Experimental: Arm A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abiraterone Acetate</intervention_name>
    <description>Standard therapy: Abiraterone Acetate 1000 mg PO daily</description>
    <arm_group_label>Control Arm: Arm B</arm_group_label>
    <arm_group_label>Experimental: Arm A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone</intervention_name>
    <description>Standard therapy: Prednisone 10-20 mg PO daily</description>
    <arm_group_label>Control Arm: Arm B</arm_group_label>
    <arm_group_label>Experimental: Arm A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects must meet ALL of the following criteria to be eligible for inclusion into the&#xD;
        study.&#xD;
&#xD;
          -  Histological or cytological diagnosis of adenocarcinoma of the prostate&#xD;
&#xD;
          -  Metastatic disease on chest, abdominal, or pelvic computed tomography (CT) scan and/or&#xD;
             bone scan&#xD;
&#xD;
          -  Currently receiving abiraterone acetate and prednisone and meeting the following&#xD;
             criteria:&#xD;
&#xD;
               -  Any PSA decline within 12 weeks from initiation of abiraterone acetate&#xD;
&#xD;
               -  Currently tolerating abiraterone acetate (1000 mg oral daily) and prednisone&#xD;
                  (10-20 mg oral daily)&#xD;
&#xD;
               -  PSA progression, defined as an increase in PSA which is ≥25% above the nadir and&#xD;
                  an absolute value of ≥2 ng/mL, which is confirmed by a second value ≥2 weeks&#xD;
                  later.&#xD;
&#xD;
               -  No evidence of symptomatic or radiographic progression that would require&#xD;
                  alternative therapy (e.g., needing radiation therapy for pain or significant&#xD;
                  progression of visceral metastases or &gt;33% increase in daily opioid use within 2&#xD;
                  weeks prior to randomization).&#xD;
&#xD;
          -  All patients who have not had a surgical orchiectomy must continue treatment with a&#xD;
             luteinizing hormone-releasing hormone (LHRH) agonist or antagonist to maintain a&#xD;
             castrate level of testosterone.&#xD;
&#xD;
          -  Patient must fulfill &quot;Prior Therapy&quot; criteria as follows:&#xD;
&#xD;
               -  Chemotherapy: no more than 1 prior chemotherapy regimen for castrate-resistant&#xD;
                  prostate cancer (CRPC) is permitted; a minimum of at least 28 days must have&#xD;
                  passed since the last dose of chemotherapy.&#xD;
&#xD;
               -  Hormone therapy: hormonal androgen ablation therapy prior to abiraterone is&#xD;
                  required.&#xD;
&#xD;
               -  Experimental therapy: prior non-cytotoxic experimental therapy is permitted&#xD;
                  provided a minimum of at least 14 days has passed since completing therapy. Prior&#xD;
                  treatment with enzalutamide (MDV3100) is allowed.&#xD;
&#xD;
               -  Radiation: prior external beam radiation is permitted provided a minimum of at&#xD;
                  least 14 days have passed since completing radiotherapy (exception for&#xD;
                  radiotherapy: at least 7 days since completing a single fraction of ≤800 cGy to a&#xD;
                  restricted field or limited-field radiotherapy to non-marrow bearing area such as&#xD;
                  an extremity or orbit) at the time of randomization&#xD;
&#xD;
          -  Must be willing to use effective contraception throughout study treatment and for 3&#xD;
             months after completion of study treatment if able to father a child.&#xD;
&#xD;
          -  Must be willing not to change (add or subtract) bone protecting therapy&#xD;
             (bisphosphonates and/or denosumab) during the study unless changed for toxicity.&#xD;
&#xD;
          -  Written informed consent must be obtained prior to any protocol-specific procedures&#xD;
             being performed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects meeting ANY of the following exclusion criteria will NOT be eligible for inclusion&#xD;
        into the study:&#xD;
&#xD;
          -  Currently receiving abiraterone acetate in combination with any other anti-cancer&#xD;
             agent (except prednisone)&#xD;
&#xD;
          -  Documented brain metastases, or carcinomatous meningitis, treated or untreated (Brain&#xD;
             imaging for asymptomatic patients is not required.)&#xD;
&#xD;
          -  Cord compression requiring surgery or radiation therapy while on abiraterone treatment&#xD;
&#xD;
          -  Active second malignancy (including lymphoid malignancies such as chronic lymphocytic&#xD;
             leukemia or low grade lymphoma) defined, in general, as requiring anticancer therapy&#xD;
             or at high risk of recurrence during the study; not including adequately treated non&#xD;
             melanomatous skin cancer or other solid tumors curatively treated with no evidence of&#xD;
             disease in &gt; 3 years&#xD;
&#xD;
          -  History of allergic reactions to therapeutic antisense oligonucleotides&#xD;
&#xD;
          -  Active autoimmune disease requiring treatment&#xD;
&#xD;
          -  Participated in a prior Phase 3 clinical study evaluating custirsen regardless of&#xD;
             study arm assignment (i.e., either control or investigational arm), or prior exposure&#xD;
             to OGX-427&#xD;
&#xD;
          -  Uncontrolled medical conditions such as myocardial infarction, uncontrolled&#xD;
             hypertension, stroke or treatment of a major active infection within 3 months of&#xD;
             randomization, as well as any significant concurrent medical illness that in the&#xD;
             opinion of the Investigator would preclude protocol therapy&#xD;
&#xD;
          -  Planned concomitant participation in another clinical trial of an experimental agent,&#xD;
             vaccine, or device. Concomitant participation in observational studies is acceptable.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Constantine Albany, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hoosier Cancer Research Network</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Prostate Oncology Specialists, Inc.</name>
      <address>
        <city>Marina Del Rey</city>
        <state>California</state>
        <zip>90292</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IU Health Bloomington Hospital</name>
      <address>
        <city>Bloomington</city>
        <state>Indiana</state>
        <zip>47403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IU Health Goshen Hospital</name>
      <address>
        <city>Goshen</city>
        <state>Indiana</state>
        <zip>46527</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University Melvin and Bren Simon Cancer Center</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IU Health Central Indiana Cancer Centers</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern Indiana Cancer Research Consortium</name>
      <address>
        <city>South Bend</city>
        <state>Indiana</state>
        <zip>46601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of New Mexico Cancer Center: Albuquerque</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Oncology Associates</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alberta Health Services: Tom Baker Cancer Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BC Cancer Agency</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Care Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3E 0V9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juravinski Cancer Centre</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de l'Université de Montréal</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2L 4M1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://hoosiercancer.org/</url>
    <description>Hoosier Cancer Research Network Website</description>
  </link>
  <reference>
    <citation>Kim N. Chi, Christopher Sweeney, Cindy Jacobs, Patricia S. Stewart, Noah M. Hahn. The Pacific trial: A randomized phase II study of OGX-427 in men with metastatic castration-resistant prostate cancer (mCRPC) and PSA progression while receiving abiraterone acetate (AA). J Clin Oncol 31, 2013 (suppl; abstr TPS5101) http://abstracts2.asco.org/AbstView_132_115104.html</citation>
  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <results_first_submitted>September 20, 2018</results_first_submitted>
  <results_first_submitted_qc>September 20, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 18, 2018</results_first_posted>
  <last_update_submitted>July 7, 2022</last_update_submitted>
  <last_update_submitted_qc>July 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hoosier Cancer Research Network</investigator_affiliation>
    <investigator_full_name>Costantine Albany</investigator_full_name>
    <investigator_title>Sponsor-Investigator</investigator_title>
  </responsible_party>
  <keyword>OGX-427</keyword>
  <keyword>Abiraterone Acetate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Abiraterone Acetate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 21, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT01681433/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Experimental: Arm A</title>
          <description>OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone&#xD;
OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV&#xD;
Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily&#xD;
Prednisone: Standard therapy: Prednisone 10-20 mg PO daily</description>
        </group>
        <group group_id="P2">
          <title>Control Arm: Arm B</title>
          <description>Continuation of standard therapy with abiraterone acetate and prednisone&#xD;
Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily&#xD;
Prednisone: Standard therapy: Prednisone 10-20 mg PO daily</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="33"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Experimental: Arm A</title>
          <description>OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone&#xD;
OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV&#xD;
Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily&#xD;
Prednisone: Standard therapy: Prednisone 10-20 mg PO daily</description>
        </group>
        <group group_id="B2">
          <title>Control Arm: Arm B</title>
          <description>Continuation of standard therapy with abiraterone acetate and prednisone&#xD;
Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily&#xD;
Prednisone: Standard therapy: Prednisone 10-20 mg PO daily</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="36"/>
            <count group_id="B2" value="36"/>
            <count group_id="B3" value="72"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71" lower_limit="53" upper_limit="85"/>
                    <measurement group_id="B2" value="72" lower_limit="57" upper_limit="89"/>
                    <measurement group_id="B3" value="72" lower_limit="53" upper_limit="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</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>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </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>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ECOG Status</title>
          <description>Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) from 0-5 that describes a patient's level of functioning where 0=Fully active, able to carry on all pre-disease performance without restriction and 5=Dead:</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>ECOG 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ECOG 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Median PSA</title>
          <units>ug/L</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.19" lower_limit="2.51" upper_limit="387.60"/>
                    <measurement group_id="B2" value="18.17" lower_limit="4.24" upper_limit="302.15"/>
                    <measurement group_id="B3" value="23" lower_limit="2.51" upper_limit="387.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Progression-Free Survival</title>
        <description>To ascertain whether Arm A has a greater proportion of patients observed to be alive without progression at Day 60 (±7 days) as compared to Arm B.</description>
        <time_frame>60 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental: Arm A</title>
            <description>OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone&#xD;
OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV&#xD;
Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily&#xD;
Prednisone: Standard therapy: Prednisone 10-20 mg PO daily</description>
          </group>
          <group group_id="O2">
            <title>Control Arm: Arm B</title>
            <description>Continuation of standard therapy with abiraterone acetate and prednisone&#xD;
Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily&#xD;
Prednisone: Standard therapy: Prednisone 10-20 mg PO daily</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-Free Survival</title>
          <description>To ascertain whether Arm A has a greater proportion of patients observed to be alive without progression at Day 60 (±7 days) as compared to Arm B.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PSA Response</title>
        <description>Compare arms to determine the proportion of patients who have a PSA response (≥ 30% decline) and any PSA decline post-randomization.</description>
        <time_frame>60 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental: Arm A</title>
            <description>OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone&#xD;
OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV&#xD;
Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily&#xD;
Prednisone: Standard therapy: Prednisone 10-20 mg PO daily</description>
          </group>
          <group group_id="O2">
            <title>Control Arm: Arm B</title>
            <description>Continuation of standard therapy with abiraterone acetate and prednisone&#xD;
Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily&#xD;
Prednisone: Standard therapy: Prednisone 10-20 mg PO daily</description>
          </group>
        </group_list>
        <measure>
          <title>PSA Response</title>
          <description>Compare arms to determine the proportion of patients who have a PSA response (≥ 30% decline) and any PSA decline post-randomization.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PSA DECLINE &gt;= 30%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PSA DELCINE &gt;=50 %</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ANY DECLINE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Objective Response</title>
        <description>Compare arms to determine the objective response of study patients, per RECIST 1.1</description>
        <time_frame>60 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental: Arm A</title>
            <description>OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone&#xD;
OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV&#xD;
Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily&#xD;
Prednisone: Standard therapy: Prednisone 10-20 mg PO daily</description>
          </group>
          <group group_id="O2">
            <title>Control Arm: Arm B</title>
            <description>Continuation of standard therapy with abiraterone acetate and prednisone&#xD;
Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily&#xD;
Prednisone: Standard therapy: Prednisone 10-20 mg PO daily</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response</title>
          <description>Compare arms to determine the objective response of study patients, per RECIST 1.1</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Partial Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stable Disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Progressive Disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Time to Disease Progression</title>
        <description>Compare arms to determine the time to disease progression of study patients</description>
        <time_frame>60 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental: Arm A</title>
            <description>OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone&#xD;
OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV&#xD;
Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily&#xD;
Prednisone: Standard therapy: Prednisone 10-20 mg PO daily</description>
          </group>
          <group group_id="O2">
            <title>Control Arm: Arm B</title>
            <description>Continuation of standard therapy with abiraterone acetate and prednisone&#xD;
Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily&#xD;
Prednisone: Standard therapy: Prednisone 10-20 mg PO daily</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Disease Progression</title>
          <description>Compare arms to determine the time to disease progression of study patients</description>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9055" lower_limit="1.0842" upper_limit="2.32341"/>
                    <measurement group_id="O2" value="1.0842" lower_limit=".9856" upper_limit="1.8398"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Circulating Tumor Cell (CTC) Counts</title>
        <description>Compare arms to determine circulating tumor cell (CTC) counts for patients at baseline and while on study</description>
        <time_frame>Every 4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental: Arm A</title>
            <description>OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone&#xD;
OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV&#xD;
Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily&#xD;
Prednisone: Standard therapy: Prednisone 10-20 mg PO daily</description>
          </group>
          <group group_id="O2">
            <title>Control Arm: Arm B</title>
            <description>Continuation of standard therapy with abiraterone acetate and prednisone&#xD;
Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily&#xD;
Prednisone: Standard therapy: Prednisone 10-20 mg PO daily</description>
          </group>
        </group_list>
        <measure>
          <title>Circulating Tumor Cell (CTC) Counts</title>
          <description>Compare arms to determine circulating tumor cell (CTC) counts for patients at baseline and while on study</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Best CTC Change from Baseline &gt;=5 to &lt;5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Best CTC Change from Baseline &lt;5 to &lt;5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Best CTC Change from Baseline &gt;=5 to &gt;=5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Best CTC Change from Baseline&lt;5 to &gt;=5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Protein Levels</title>
        <description>Compare arms to determine levels of heat shock protein 27 (Hsp27), clusterin, and other relevant proteins of patients at baseline and during study</description>
        <time_frame>Every 4 weeks</time_frame>
        <population>Data for this secondary objective was not collected or analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental: Arm A</title>
            <description>OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone&#xD;
OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV&#xD;
Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily&#xD;
Prednisone: Standard therapy: Prednisone 10-20 mg PO daily</description>
          </group>
          <group group_id="O2">
            <title>Control Arm: Arm B</title>
            <description>Continuation of standard therapy with abiraterone acetate and prednisone&#xD;
Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily&#xD;
Prednisone: Standard therapy: Prednisone 10-20 mg PO daily</description>
          </group>
        </group_list>
        <measure>
          <title>Protein Levels</title>
          <description>Compare arms to determine levels of heat shock protein 27 (Hsp27), clusterin, and other relevant proteins of patients at baseline and during study</description>
          <population>Data for this secondary objective was not collected or analyzed</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Phosphatase and Tensin Homolog (PTEN) Deletion Status</title>
        <description>Compare arms to determine PTEN deletion status in original pathology specimens correlated with clinical outcomes</description>
        <time_frame>Every 4 weeks</time_frame>
        <population>Data for this objective was not collected or analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental: Arm A</title>
            <description>OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone&#xD;
OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV&#xD;
Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily&#xD;
Prednisone: Standard therapy: Prednisone 10-20 mg PO daily</description>
          </group>
          <group group_id="O2">
            <title>Control Arm: Arm B</title>
            <description>Continuation of standard therapy with abiraterone acetate and prednisone&#xD;
Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily&#xD;
Prednisone: Standard therapy: Prednisone 10-20 mg PO daily</description>
          </group>
        </group_list>
        <measure>
          <title>Phosphatase and Tensin Homolog (PTEN) Deletion Status</title>
          <description>Compare arms to determine PTEN deletion status in original pathology specimens correlated with clinical outcomes</description>
          <population>Data for this objective was not collected or analyzed</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Every four weeks, up to 48 weeks or disease progression.</time_frame>
      <desc>All adverse events for all subjects who were both randomized to arm A and crossed over to Arm A. 20 subjects crossed over to arm A after disease progression and their adverse events are reported from the date of crossover.</desc>
      <group_list>
        <group group_id="E1">
          <title>Experimental: Arm A</title>
          <description>OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone&#xD;
OGX-427: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV&#xD;
Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily&#xD;
Prednisone: Standard therapy: Prednisone 10-20 mg PO daily</description>
        </group>
        <group group_id="E2">
          <title>Control Arm: Arm B</title>
          <description>Continuation of standard therapy with abiraterone acetate and prednisone&#xD;
Abiraterone Acetate: Standard therapy: Abiraterone Acetate 1000 mg PO daily&#xD;
Prednisone: Standard therapy: Prednisone 10-20 mg PO daily</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>CTCAEv4</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>ANEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>GASTROINTESTINAL DISORDERS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>EDEMA LIMBS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>INFECTIONS AND INFESTATIONS</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>DEHYDRATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>GENERALIZED MUSCLE WEAKNESS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>NERVOUS SYSTEM DISORDERS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>CONFUSION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE KIDNEY INJURY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>CYSTITIS NONINFECTIVE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>HEMATURIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>RENAL AND URINARY DISORDERS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>URINARY RETENTION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>URINARY TRACT OBSTRUCTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>DYSPNEA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>PNEUMONITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>CTCAEv4</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="51" subjects_at_risk="56"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>ANEMIA</sub_title>
                <counts group_id="E1" events="25" subjects_affected="13" subjects_at_risk="56"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>LEUKOCYTOSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>FEBRILE NEUTROPENIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>ATRIAL FLUTTER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>CARDIAC DISORDERS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>EXTERNAL EAR PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>VERTIGO</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>HEARING IMPAIRED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>CUSHINGOID</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>HYPOTHYROIDISM</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>ENDOCRINE DISORDERS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>HYPERPARATHYROIDISM</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>EYE DISORDERS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>GLAUCOMA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>VITREOUS HEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>NIGHT BLINDNESS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>RETINAL VASCULAR DISORDER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>ABDOMINAL PAIN</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="56"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>DIARRHEA</sub_title>
                <counts group_id="E1" events="14" subjects_affected="11" subjects_at_risk="56"/>
                <counts group_id="E2" events="14" subjects_affected="8" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>DYSPEPSIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>GASTRITIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>GASTROESOPHAGEAL REFLUX DISEASE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>GASTROINTESTINAL DISORDERS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>HEMORRHOIDS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>MUCOSITIS ORAL</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" events="28" subjects_affected="25" subjects_at_risk="56"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>TOOTHACHE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" events="18" subjects_affected="15" subjects_at_risk="56"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>DRY MOUTH</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>DYSPHAGIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>GASTRIC ULCER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>ILEAL ULCER</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>PROCTITIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>STOMACH PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>CHILLS</sub_title>
                <counts group_id="E1" events="23" subjects_affected="16" subjects_at_risk="56"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>EDEMA LIMBS</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="56"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>EDEMA TRUNK</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>FACIAL PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" events="40" subjects_affected="26" subjects_at_risk="56"/>
                <counts group_id="E2" events="32" subjects_affected="22" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>FEVER</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>FLU LIKE SYMPTOMS</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="56"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>LOCALIZED EDEMA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>MALAISE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>NON-CARDIAC CHEST PAIN</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>PAIN</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="56"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>HEPATOBILIARY DISORDERS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>BLADDER INFECTION</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>BRONCHIAL INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>HEPATITIS VIRAL</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>INFECTIONS AND INFESTATIONS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>PAPULOPUSTULAR RASH</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>SINUSITIS</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>UPPER RESPIRATORY INFECTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>RHINITIS INFECTIVE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>SKIN INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>TOOTH INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>ANKLE FRACTURE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>BRUISING</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>FALL</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>FRACTURE</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>INFUSION RELATED REACTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>INJURY, POISONING AND PROCEDURAL COMPLICATIONS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>VASCULAR ACCESS COMPLICATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ALANINE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="17" subjects_affected="9" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>ALKALINE PHOSPHATASE INCREASED</sub_title>
                <counts group_id="E1" events="7" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>ASPARTATE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" events="18" subjects_affected="8" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>CHOLESTEROL HIGH</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>CREATININE INCREASED</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>INVESTIGATIONS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>NEUTROPHIL COUNT DECREASED</sub_title>
                <counts group_id="E1" events="8" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>PLATELET COUNT DECREASED</sub_title>
                <counts group_id="E1" events="11" subjects_affected="5" subjects_at_risk="56"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>URINE OUTPUT DECREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>WEIGHT LOSS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>WHITE BLOOD CELL DECREASED</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>BLOOD BILIRUBIN INCREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="6" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>CARDIAC TROPONIN I INCREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>LYMPHOCYTE COUNT INCREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>WEIGHT GAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>ACIDOSIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>ANOREXIA</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="56"/>
                <counts group_id="E2" events="15" subjects_affected="9" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>DEHYDRATION</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>HYPERGLYCEMIA</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E2" events="8" subjects_affected="5" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>HYPOCALCEMIA</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>HYPOKALEMIA</sub_title>
                <counts group_id="E1" events="16" subjects_affected="11" subjects_at_risk="56"/>
                <counts group_id="E2" events="13" subjects_affected="5" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>HYPONATREMIA</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>HYPOPHOSPHATEMIA</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>HYPOALBUMINEMIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>METABOLISM AND NUTRITION DISORDERS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </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="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>ARTHRITIS</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>BACK PAIN</sub_title>
                <counts group_id="E1" events="21" subjects_affected="15" subjects_at_risk="56"/>
                <counts group_id="E2" events="15" subjects_affected="12" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>BONE PAIN</sub_title>
                <counts group_id="E1" events="11" subjects_affected="6" subjects_at_risk="56"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>BUTTOCK PAIN</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>FLANK PAIN</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>GENERALIZED MUSCLE WEAKNESS</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>MUSCLE WEAKNESS LOWER LIMB</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>MYALGIA</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>NECK PAIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>PAIN IN EXTREMITY</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="56"/>
                <counts group_id="E2" events="21" subjects_affected="14" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>OSTEONECROSIS OF JAW</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>OSTEOPOROSIS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>NEOPLASMS BENIGN, MALIGNANT AND UNSPECIFIED (INCL CYSTS AND POLYPS)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>DYSARTHRIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>DYSGEUSIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>DYSPHASIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="56"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>NERVOUS SYSTEM DISORDERS</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>PARESTHESIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>PERIPHERAL MOTOR NEUROPATHY</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>PERIPHERAL SENSORY NEUROPATHY</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="56"/>
                <counts group_id="E2" events="9" subjects_affected="7" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>PRESYNCOPE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>SPASTICITY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>SYNCOPE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>TREMOR</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>VASOVAGAL REACTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>SEIZURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>AGITATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>ANXIETY</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>CONFUSION</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>DEPRESSION</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>INSOMNIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>RESTLESSNESS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>LIBIDO DECREASED</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>ACUTE KIDNEY INJURY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>BLADDER SPASM</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>CHRONIC KIDNEY DISEASE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>HEMATURIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>RENAL AND URINARY DISORDERS</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>URINARY FREQUENCY</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" events="9" subjects_affected="8" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>URINARY INCONTINENCE</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>URINARY RETENTION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>URINARY TRACT PAIN</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>URINARY URGENCY</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>CYSTITIS NONINFECTIVE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>RENAL CALCULI</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>ERECTILE DYSFUNCTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>GYNECOMASTIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>PELVIC PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>PROSTATIC OBSTRUCTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>SCROTAL PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>ALLERGIC RHINITIS</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>COUGH</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="56"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>DYSPNEA</sub_title>
                <counts group_id="E1" events="20" subjects_affected="8" subjects_at_risk="56"/>
                <counts group_id="E2" events="9" subjects_affected="6" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>EPISTAXIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>LARYNGEAL HEMORRHAGE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>PRODUCTIVE COUGH</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>SLEEP APNEA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>WHEEZING</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>HYPOXIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>NASAL CONGESTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>SORE THROAT</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>VOICE ALTERATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </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="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>ERYTHEMA MULTIFORME</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>PAIN OF SKIN</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>PRURITUS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>PURPURA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>RASH MACULO-PAPULAR</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>SKIN AND SUBCUTANEOUS TISSUE DISORDERS</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>URTICARIA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>DRY SKIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>TELANGIECTASIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>SURGICAL AND MEDICAL PROCEDURES</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>FLUSHING</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>HOT FLASHES</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="56"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" events="17" subjects_affected="12" subjects_at_risk="56"/>
                <counts group_id="E2" events="19" subjects_affected="18" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>HYPOTENSION</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>VASCULAR DISORDERS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="56"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>THROMBOEMBOLIC EVENT</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="56"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </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>Clinical Data Coordinator</name_or_title>
      <organization>Hoosier Cancer Research Network</organization>
      <phone>317-921-2050</phone>
      <email>jsmith@hoosiercancer.org</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/NCT01681433
org study id: GU12-159
nct id: NCT01681433
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This Phase II study has been designed to evaluate the anti-tumor effects of adding OGX-427 to
      continuing abiraterone acetate and prednisone treatment in men with metastatic
      castrate-resistant prostate cancer (MCRPC) who have prostate-specific antigen (PSA)
      progression
OUTLINE: This is a multi-center study.

      This is an open-label, randomized, Phase II clinical trial designed to evaluate the
      anti-tumor effects of OGX-427 and continuing abiraterone acetate and prednisone versus
      continuing abiraterone acetate and prednisone alone in men with MCRPC who have evidence of
      PSA progression but no evidence of symptomatic or radiographic progression that would require
      alternative therapy (e.g., needing radiation therapy for pain or significant progression of
      visceral metastases).

      Patients on the control arm will be allowed to cross-over to receive OGX-427 following
      documented disease progression. Patients will be randomized with equal probability to one of
      the following arms:

      EXPERIMENTAL ARM (Arm A):

      OGX-427 Starting within 7 days of randomization, three loading doses of 600 mg intravenously
      (IV) within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly
      doses of 800 mg IV

      Continuation of standard therapy with abiraterone acetate 1000 mg by mouth (PO) daily and
      prednisone 10-20 mg PO daily

      CONTROL ARM (Arm B):

      Continuation of standard therapy with abiraterone acetate 1000 mg PO daily and prednisone
      10-20 mg PO daily

      After documented disease progression, patients on Arm B may opt to receive OGX-427 treatment
      (according to the Arm A schedule) following a screening evaluation (i.e., all inclusion and
      exclusion criteria have been met)

      Both Arms:

      Evaluations at 4 week-intervals. Disease assessments required at the milestone Day 60
      assessment (expected to occur after 8 weeks of treatment and prior to Day 1, Week 9) and at
      16, 24, 32, 40, and 48 weeks (if applicable) or until documented disease progression.
      Patients who are withdrawn from the study for a reason other than documented disease
      progression or patient withdrawal of consent will be followed every 4 weeks in the
      Off-Treatment Follow-up Period until documented disease progression.

      Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

      Life Expectancy: Not Specified

      Hematopoietic:

        -  Absolute neutrophil count (ANC) ≥ 1.5 x 109 cells /L, platelet count ≥ 100 x 109 /L, and
           hemoglobin ≥ 9 g/dL without transfusion

      Hepatic:

        -  Total bilirubin ≤ 1.1 x upper limit of normal (ULN) unless elevated secondary to
           conditions such as Gilbert's disease, in which case a direct bilirubin ≤ ULN is required

        -  Serum glutamic pyruvic transaminase (SGPT), alanine transaminase (ALT) and alanine
           transaminase (SGOT) aspartate transaminase (AST) ≤ 3.0 x ULN

      Renal:

        -  Creatinine ≤ 1.3 x ULN

      Cardiac:

        -  Known left ventricular ejection fraction (LVEF) <50% or New York Heart Association
           (NYHA) Functional Classification Class III or IV heart failure

      Other:

        -  Castrate serum testosterone level (< 50 ng/dL or < 1.7 nmol/L)

        -  Potassium within normal limits
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-Free Survival
time frame: 60 days
description: To ascertain whether Arm A has a greater proportion of patients observed to be alive without progression at Day 60 (±7 days) as compared to Arm B.
measure: PSA Response
time frame: 60 days
description: Compare arms to determine the proportion of patients who have a PSA response (≥ 30% decline) and any PSA decline post-randomization.
measure: Objective Response
time frame: 60 days
description: Compare arms to determine the objective response of study patients, per RECIST 1.1
measure: Time to Disease Progression
time frame: 60 days
description: Compare arms to determine the time to disease progression of study patients
measure: Circulating Tumor Cell (CTC) Counts
time frame: Every 4 weeks
description: Compare arms to determine circulating tumor cell (CTC) counts for patients at baseline and while on study
measure: Protein Levels
time frame: Every 4 weeks
description: Compare arms to determine levels of heat shock protein 27 (Hsp27), clusterin, and other relevant proteins of patients at baseline and during study
measure: Phosphatase and Tensin Homolog (PTEN) Deletion Status
time frame: Every 4 weeks
description: Compare arms to determine PTEN deletion status in original pathology specimens correlated with clinical outcomes
arm group label: Experimental: Arm A
arm group type: Experimental
description: OGX-427 + continuation of standard therapy with abiraterone acetate and prednisone
arm group label: Control Arm: Arm B
arm group type: Active Comparator
description: Continuation of standard therapy with abiraterone acetate and prednisone
intervention type: Drug
intervention name: OGX-427
description: OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV
arm group label: Experimental: Arm A
intervention type: Drug
intervention name: Abiraterone Acetate
description: Standard therapy: Abiraterone Acetate 1000 mg PO daily
arm group label: Control Arm: Arm B
arm group label: Experimental: Arm A
intervention type: Drug
intervention name: Prednisone
description: Standard therapy: Prednisone 10-20 mg PO daily
arm group label: Control Arm: Arm B
arm group label: Experimental: Arm A
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Constantine Albany, M.D.
role: Principal Investigator
affiliation: Hoosier Cancer Research Network
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
url: https://hoosiercancer.org/
description: Hoosier Cancer Research Network Website
citation: Kim N. Chi, Christopher Sweeney, Cindy Jacobs, Patricia S. Stewart, Noah M. Hahn. The Pacific trial: A randomized phase II study of OGX-427 in men with metastatic castration-resistant prostate cancer (mCRPC) and PSA progression while receiving abiraterone acetate (AA). J Clin Oncol 31, 2013 (suppl; abstr TPS5101) http://abstracts2.asco.org/AbstView_132_115104.html
responsible party type: Sponsor-Investigator
investigator affiliation: Hoosier Cancer Research Network
investigator full name: Costantine Albany
investigator title: Sponsor-Investigator
mesh term: Prostatic Neoplasms
mesh term: Prednisone
mesh term: Abiraterone Acetate
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 