<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/NCT01663714</url>
  </required_header>
  <id_info>
    <org_study_id>104514</org_study_id>
    <nct_id>NCT01663714</nct_id>
  </id_info>
  <brief_title>Open Label Multicenter Study of CVP Followed by Iodine-131 Anti-B1 Antibody for Subjects With Untreated Low-Grade Non Hodgkin's Lymphoma.</brief_title>
  <official_title>Phase II Multicenter Study of Cyclophosphamide, Vincristine, and Prednisone (CVP) Followed by Iodine-131 Anti-B1 Antibody for Patients With Untreated Low-grade Non-Hodgkin's Lymphoma (NHL).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase II, open-label, multicenter study of the efficacy and safety of sequential&#xD;
      administration of CVP x 6 followed by tositumomab and iodine I 131 tositumomab (formerly&#xD;
      referred to as tositumomab and iodine I 131 tositumomab). All patients who complete three&#xD;
      cycles of CVP, regardless of response, will be eligible for treatment with tositumomab and&#xD;
      iodine I 131 tositumomab. Subjects who have rapidly progressive disease prior to completing&#xD;
      three cycles of CVP may be removed from study.&#xD;
&#xD;
      In order to proceed to tositumomab and iodine I 131 tositumomab therapy, patients must have&#xD;
      completed six cycles of CVP within 20 weeks as described. Patients may proceed to Iodine-131&#xD;
      Anti-B1 Antibody if they have progressive disease documented at the response evaluation&#xD;
      following 6 cycles of CVP. In addition, patients must still meet the eligibility inclusion&#xD;
      exclusion criteria based upon the week 20 assessments, as applicable. Patients must also have&#xD;
      an average of ≤25% bone marrow involved by NHL to receive treatment with tositumomab and&#xD;
      iodine I 131 tositumomab. The dosimetric dose of tositumomab and iodine I 131 tositumomab&#xD;
      must be given within 28 days of the response evaluation following CVP and no later than 56&#xD;
      days from the first day of the sixth cycle of CVP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase II, open-label, multicenter study of the efficacy and safety sequential&#xD;
      administration of cycolophosphamide, vacristine, and prednisone (CVP) x6 cycles followed by&#xD;
      tositumomab and iodine I 131 tositumomab for previously untreated subjects with low-grade&#xD;
      Non-Hodgkin's Lymphoma (NHL). CVP will be repeated every 21 days for a total of six cycles.&#xD;
      tositumomab and iodine I 131 tositumomab will begin within 56 days following the first day of&#xD;
      the sixth cycle of CVP. Subjects will undergo two dosing phase for the tositumomab and iodine&#xD;
      I 131 tositumomab therapy. In the first phase, &quot;dosimetric dose&quot;, patients will receive an&#xD;
      infusion of unlabeled Anti-B1 Antibody (450mg) over 60 minutes followed by a 30 minute&#xD;
      infusion (including a 10-minutes flush) of Anti-B1 (35mg) containing 5mCi of Iodine-131.&#xD;
      Whole body gamma camera scans will be obtained on Day 0; Day 2, 3, or 4 and Day 6 or 7&#xD;
      following the dosimetric dose. Using the dosimetric data from three time points, a&#xD;
      patient-specific dose of Iodine-131 will be calculated to deliver the desired total body dose&#xD;
      of radiotherapy. In the second phase, termed the &quot;therapeutic dose&quot;, patients will receive&#xD;
      60-minute infusion of unlabeled Anti-B1 Antibody (450 mg) followed by a 30-minute infusion&#xD;
      (including a 10-minute flush) of 35 mg Anti-B1 Antibody labeled with the subjects -specific&#xD;
      dose of Iodine-131 calculate to deliver a 75cGy total body radiation dose. Subjects who have&#xD;
      platelet counts of 100,000-149,999 cells/mm3 will receive 65 cGy; obese patients will be&#xD;
      dosed base upon 137% of their lean body mass. Subjects will be treated with saturated&#xD;
      solution potassium iodide (SSKI), Lugol's solution, or potassium iodide tablets starting at&#xD;
      least 24 hours prior to the first infusion of the tositumomab and iodine I 131 tositumomab&#xD;
      (i.e., the dosimetric dose) and continuing for 14 days following the least infusion of&#xD;
      tositumomab and iodine I 131 tositumomab (i.e., the therapeutic dose).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2000</start_date>
  <completion_date type="Actual">February 2012</completion_date>
  <primary_completion_date type="Actual">February 2012</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants (Par.) With Unconfirmed Response (Complete Response, Complete Response/Unconfirmed, or Partial Response), as Assessed by the Investigator</measure>
    <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
    <description>Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Complete Response/unconfirmed (CRu: complete resolution of all disease-related symptoms; residual lymph node mass &gt;1.5 centimeters in the greatest transverse diameter that has regressed by &gt;75%, indeterminate bone marrow, are present), or Partial Response (PR: &gt;=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants (Par.) With Confirmed Response (Complete Response [CR], Complete Response/Unconfirmed [CRu], or Partial Response [PR]), as Assessed by the Investigator</measure>
    <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
    <description>CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. CRu: complete resolution of all disease-related symptoms; residual lymph node mass &gt;1.5 centimeters in the greatest transverse diameter that has regressed by &gt;75%, indeterminate bone marrow, are present. PR: &gt;=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. Confirmed response required CR, CRu, or PR, which were confirmed by 2 separate response evaluations &gt;=4 weeks apart.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Unconfirmed Complete Response (CR), as Assessed by the Investigator</measure>
    <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
    <description>CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease, if present before therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Confirmed Complete Response (CR), as Assessed by the Investigator</measure>
    <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
    <description>CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease, if present before therapy. Confirmed response required CR, which was confirmed by 2 separate response evaluations &gt;=4 weeks apart.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR), as Assessed by the Investigator</measure>
    <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
    <description>DOR=the time from the first documented response (for par. with CR, CRu, or PR) until disease progression (DP). DP=a &gt;=50% increase from the nadir value (lowest laboratory value recorded following administration of study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be &gt;1.5 centimeters (cm) in diameter by radiographic evaluation or &gt;1 cm in diameter by physical examination. Responses had to be confirmed by 2 separate evaluations occurring &gt;=4 weeks apart.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DOR for Unconfirmed and Confirmed Complete Response, as Assessed by the Investigator</measure>
    <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
    <description>DOR=the time from the first documented response (for par. with CR) until disease progression (DP). DP=a &gt;=50% increase from the nadir value (lowest laboratory value recorded following administration of study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be &gt;1.5 centimeters (cm) in diameter by radiographic evaluation or &gt;1 cm in diameter by physical examination. Responses had to be confirmed by 2 separate evaluations occurring &gt;=4 weeks apart.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Progression of Disease or Death, as Assessed by the Investigator</measure>
    <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
    <description>Time to progression or progression-free survival is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. Disease progression is defined as a &gt;=50% increase from the nadir value (lowest laboratory value recorded following administration of the study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be &gt;1.5 cm in diameter by radiographic evaluation or &gt;1 cm in diameter by physical examination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Treatment Failure, as Assessed by the Investigator</measure>
    <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
    <description>Time to treatment failure is defined as the time from the start of treatment to the first occurrence of study withdrawal, progression, or death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Body Residence Time (TBRT; Average Amount of Time TST Spends in the Body, Calculated From the Rate of TB Clearance of Radioactivity During the Dosimetric Dose [DD]) of Iodine 131 TST Antibody Following the DD</measure>
    <time_frame>Day (D) 0; D 2, 3, or 4; and D 6 or 7</time_frame>
    <description>To determine TBRT, the percent-injected activity (PIA) is calculated from the background-corrected (BC) total body count (TBC) at D 0; D 2/3/4; and D 7. The time from the DD to the acquisition of whole body count (WBC) is then determined. The PIA remaining at each time point (TP) is then calculated by dividing the BC WBC for that TP by the BC WBC from the first TP (D 0) * 100. To determine RT, a best-fit line from 100% (pre-plotted D 0 value) through 2 plotted points (other TPs) is made. TBRT=the x-axis value at the point where the line intersects the horizontal 37% injected activity line.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Nadir for Hematological Parameters: Absolute Neutrophil Count (ANC), Hemoglobin, Platelets, and White Blood Cell (WBC) Count</measure>
    <time_frame>Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)</time_frame>
    <description>Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Recovery (TTR) to Baseline (BL) for Hematologic Laboratory (Lab.) Evaluations</measure>
    <time_frame>Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)</time_frame>
    <description>TTR to BL grade (gr.) for par. with a Gr. 0 toxicity (tox.=lab. value outside the normal range) at BL=time from the last administration of study drug (SD) to the first post-nadir (PN) date with Gr. 0 toxicity with no other Gr. 1-4 toxicities recorded within the next week. For par. with a higher gr. tox. at BL, TTR=time from the last administration of SD to the first PN date with the BL gr. or better with no other higher gr. toxicities recorded during the next week. Each lab. established its own reference range using data from its own equipment/methods; there is no standard reference range.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nadir Values for Absolute Neutrophil Count (ANC)</measure>
    <time_frame>Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)</time_frame>
    <description>Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nadir Values for Hemoglobin</measure>
    <time_frame>Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)</time_frame>
    <description>Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nadir Values for Platelet Count</measure>
    <time_frame>Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)</time_frame>
    <description>Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nadir Values for WBC Count</measure>
    <time_frame>Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)</time_frame>
    <description>Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs)</measure>
    <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
    <description>AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug</measure>
    <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
    <description>AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE. The Investigator assessed whether the AE was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities (values outside the normal range) were assumed to be possibly or probably related to study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Any Treatment-related Serious Adverse Event (SAE)</measure>
    <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
    <description>An SAE is defined as any event occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience (at immediate risk of death from the experience as it occurred), inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious adverse drug experience when based upon appropriate medical judgment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With the Indicated Primary Cause of Death</measure>
    <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
    <description>The primary cause of death of the participants was assessed by the Investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Received Any Supportive Care</measure>
    <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
    <description>Supportive care is defined as interventions that help the participants achieve comfort but do not affect the course of a disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Were Negative for Human Anti-murine Antibodies (HAMA) at Baseline (Study Entry) But Positive or Negative at Month 24</measure>
    <time_frame>Day 1 to Day 730 (24 months) after receiving the dosimetric dose</time_frame>
    <description>The administration of murine antibodies may form HAMA. A HAMA assay was performed using the ImmunoSTRIP HAMA IgG enzyme-linked immune absorbent assay by a central laboratory (Covance Classic Laboratory Services, Indianapolis, IN). To be &quot;positive,&quot; a participant had to have a positive HAMA assessment during the first 24 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
    <description>Overall survival is defined as the time from the treatment start date to the date of death from any cause.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Lymphoma, Non-Hodgkin</condition>
  <arm_group>
    <arm_group_label>open-label, single arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>cycolophosphamide, vacristine, and pednisone (CVP) x6 cycles followed by tositumomab and iodine I 131 tositumomab. CVP will be repeated every 21 days for a total of six cycles. tositumomab and iodine I 131 tositumomab will begin within 56 days following the first day of the sixth cycle of CVP. Patient will undergo two dosing phase for the tositumomab and iodine I 131 tositumomab therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>cycolophosphamide, vacristine, and pednisone (CVP) x6 cycles followed by tositumomab and iodine I 131 tositumomab.</intervention_name>
    <description>cycolophosphamide, vacristine, and pednisone (CVP) x6 cycles followed by tositumomab and iodine I 131 tositumomab. CVP will be repeated every 21 days for a total of six cycles. tositumomab and iodine I 131 tositumomab will begin within 56 days following the first day of the sixth cycle of CVP. Patient will undergo two dosing phase for the tositumomab and iodine I 131 tositumomab therapy.</description>
    <arm_group_label>open-label, single arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must have a histologically confirmed initial diagnosis of low-grade&#xD;
             non-Hodgkin's B-cell lymphoma according to the International Working Formulation (IWF)&#xD;
             (32) (i.e., small lymphocytic with or without plasmacytoid differentiation; follicular&#xD;
             small cleaved cell; or follicular, mixed small cleaved and large cell).&#xD;
&#xD;
          -  Subjects must have Ann Arbor Stage III, Stage IV, or bulky Stage II disease at&#xD;
             diagnosis. Bulky Stage II is defined as a mediastinal mass greater than one-third of&#xD;
             the maximum chest diameter, or any other mass greater than or equal to 10 cm in&#xD;
             maximum diameter.&#xD;
&#xD;
          -  Subjects must have evidence that their tumor tissue expresses the CD20 antigen.&#xD;
             Immunoperoxidase stains of paraffin-embedded tissue showing positive reactivity with&#xD;
             L26 antibody or immunoperoxidase stains of frozen tissue showing positive reactivity&#xD;
             with Anti B1 Antibody (Coulter Clone®) or similar commercially available CD20 antibody&#xD;
             or evidence of CD20 positivity by flow cytometry are acceptable evidence of CD20&#xD;
             positivity. Testing of tumor tissue from any time in the course of the patient's&#xD;
             disease is acceptable.&#xD;
&#xD;
          -  Subjects must have a performance status of at least 60% on the Karnofsky Performance&#xD;
             Scale and an anticipated survival of at least 3 months.&#xD;
&#xD;
          -  Subjects must have an ANC≥1500 cells/mm3 and a platelet count ≥100,000 cells/mm3&#xD;
             within 14 days of study enrollment. These blood counts must be sustained without&#xD;
             support of hematopoietic cytokines or transfusion of blood products.&#xD;
&#xD;
          -  Subjects must have adequate renal function (defined as serum creatinine &lt;1.5 times the&#xD;
             upper limit of normal) and hepatic function (defined as total bilirubin &lt;1.5 times the&#xD;
             upper limit of normal and AST &lt;5 times the upper limit of normal) within 14 days of&#xD;
             study enrollment.&#xD;
&#xD;
          -  Subjects must have bi-dimensionally measurable disease. At least one lesion must be&#xD;
             ≥2.0x2.0 cm by computerized tomography scan.&#xD;
&#xD;
          -  Subjects must be at least 18 years of age.&#xD;
&#xD;
          -  Subjects of childbearing potential must have a negative serum pregnancy test within 7&#xD;
             days prior to study enrollment.&#xD;
&#xD;
          -  Subjects must give written informed consent and sign an IRB-approved informed consent&#xD;
             form prior to study enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have received prior chemotherapy, biologic therapy, steroids, or&#xD;
             radiation therapy as treatment for their NHL.&#xD;
&#xD;
          -  Subjects with active obstructive hydronephrosis.&#xD;
&#xD;
          -  Subjects with New York Heart Association class III or IV heart disease or other&#xD;
             serious illness that would preclude evaluation.&#xD;
&#xD;
          -  Subjects with prior malignancy other than lymphoma, except for adequately treated skin&#xD;
             cancer, in situ cervical cancer, or other cancer for which the patient has been&#xD;
             disease-free for 5 years. Patients who have been disease-free of another cancer for&#xD;
             greater than 5 years must be carefully assessed at the time of study entry to rule out&#xD;
             recurrent disease.&#xD;
&#xD;
          -  Subjects with known HIV infection.&#xD;
&#xD;
          -  Subjects who are HAMA positive.&#xD;
&#xD;
          -  Subjects with known brain or leptomeningeal metastases.&#xD;
&#xD;
          -  Subjects who are pregnant or breastfeeding. Males and females must agree to use a&#xD;
             contraceptive method from enrollment to 6 months after receiving Iodine 131 Anti B1&#xD;
             Antibody.&#xD;
&#xD;
          -  Subjects with active infection requiring IV anti-infectives at the time of study&#xD;
             enrollment.&#xD;
&#xD;
          -  Subjects with intermediate- or high-grade NHL.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <link>
    <url>https://www.clinicalstudydatarequest.com</url>
    <description>Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.</description>
  </link>
  <reference>
    <citation>Link BK, Martin P, Kaminski MS, Goldsmith SJ, Coleman M, Leonard JP. Cyclophosphamide, vincristine, and prednisone followed by tositumomab and iodine-131-tositumomab in patients with untreated low-grade follicular lymphoma: eight-year follow-up of a multicenter phase II study. J Clin Oncol. 2010 Jun 20;28(18):3035-41. doi: 10.1200/JCO.2009.27.8325. Epub 2010 May 10.</citation>
    <PMID>20458031</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2012</study_first_posted>
  <results_first_submitted>September 20, 2012</results_first_submitted>
  <results_first_submitted_qc>March 14, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 25, 2013</results_first_posted>
  <last_update_submitted>November 21, 2016</last_update_submitted>
  <last_update_submitted_qc>November 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Non-Hodgkin's Lymphoma</keyword>
  <keyword>tositumomab and iodine I 131 tositumomab</keyword>
  <keyword>Bexxar</keyword>
  <keyword>cycolophosphamide, vacristine, and pednisone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tositumomab I-131</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.</ipd_description>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>104514</doc_id>
      <doc_type>Informed Consent Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>104514</doc_id>
      <doc_type>Annotated Case Report Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>104514</doc_id>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>104514</doc_id>
      <doc_type>Dataset Specification</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>104514</doc_id>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>104514</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>104514</doc_id>
      <doc_type>Statistical Analysis Plan</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
  </study_docs>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Participants (par.) received cyclophosphamide (C), vincristine (V), prednisone (P) in the first study phase (P). Upon completion of this P, par. began the first of 2 phases of radio immunotherapy: P1, dosimetric dose (DD); P2, therapeutic dose. Par. completing 2 years of the study could enter a long-term follow-up study (BEX104528; NCT00240578).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Chemotherapy; TST and Iodine I 131 TST</title>
          <description>Par. received 6 cycles of chemotherapy (chemo.): oral Cyclophosphamide (400 milligrams/meters squared [mg/m^2]/day) for 1-5 days; intravenous (IV) Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled tositumomab (TST) (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) Iodine 131. Par. received 4 drops by mouth (DBM) 3 times a day (TID) of potassium iodide (KI) and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the therapeutic dose (TD: a 1 hour IV infusion of 450 mg TST), followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Dosimetric and Therapeutic Treatment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive Disease</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Rolled Over to Study BEX104528</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Long-Term Follow-Up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22">22 of the30 participants withdrawing from Study BEX104514 enrolled in the LTFU study.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Chemotherapy; TST and Iodine I 131 TST</title>
          <description>Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.6" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</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="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants (Par.) With Unconfirmed Response (Complete Response, Complete Response/Unconfirmed, or Partial Response), as Assessed by the Investigator</title>
        <description>Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Complete Response/unconfirmed (CRu: complete resolution of all disease-related symptoms; residual lymph node mass &gt;1.5 centimeters in the greatest transverse diameter that has regressed by &gt;75%, indeterminate bone marrow, are present), or Partial Response (PR: &gt;=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).</description>
        <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
        <population>Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for response were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy; TST and Iodine I 131 TST</title>
            <description>Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants (Par.) With Unconfirmed Response (Complete Response, Complete Response/Unconfirmed, or Partial Response), as Assessed by the Investigator</title>
          <description>Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Complete Response/unconfirmed (CRu: complete resolution of all disease-related symptoms; residual lymph node mass &gt;1.5 centimeters in the greatest transverse diameter that has regressed by &gt;75%, indeterminate bone marrow, are present), or Partial Response (PR: &gt;=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).</description>
          <population>Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for response were analyzed.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>percentage of participants</param_type>
            <param_value>100</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>100</ci_lower_limit>
            <ci_upper_limit>100</ci_upper_limit>
            <estimate_desc>The estimated value represents the percentage of participants with unconfirmed response.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants (Par.) With Confirmed Response (Complete Response [CR], Complete Response/Unconfirmed [CRu], or Partial Response [PR]), as Assessed by the Investigator</title>
        <description>CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. CRu: complete resolution of all disease-related symptoms; residual lymph node mass &gt;1.5 centimeters in the greatest transverse diameter that has regressed by &gt;75%, indeterminate bone marrow, are present. PR: &gt;=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. Confirmed response required CR, CRu, or PR, which were confirmed by 2 separate response evaluations &gt;=4 weeks apart.</description>
        <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
        <population>Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for response were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy; TST and Iodine I 131 TST</title>
            <description>Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants (Par.) With Confirmed Response (Complete Response [CR], Complete Response/Unconfirmed [CRu], or Partial Response [PR]), as Assessed by the Investigator</title>
          <description>CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. CRu: complete resolution of all disease-related symptoms; residual lymph node mass &gt;1.5 centimeters in the greatest transverse diameter that has regressed by &gt;75%, indeterminate bone marrow, are present. PR: &gt;=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. Confirmed response required CR, CRu, or PR, which were confirmed by 2 separate response evaluations &gt;=4 weeks apart.</description>
          <population>Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for response were analyzed.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>percentage of participants</param_type>
            <param_value>100</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>100</ci_lower_limit>
            <ci_upper_limit>100</ci_upper_limit>
            <estimate_desc>The estimated value represents the percentage of participants with confirmed response.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Unconfirmed Complete Response (CR), as Assessed by the Investigator</title>
        <description>CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease, if present before therapy.</description>
        <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
        <population>ITT Exposed Population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy; TST and Iodine I 131 TST</title>
            <description>Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Unconfirmed Complete Response (CR), as Assessed by the Investigator</title>
          <description>CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease, if present before therapy.</description>
          <population>ITT Exposed Population</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Confirmed Complete Response (CR), as Assessed by the Investigator</title>
        <description>CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease, if present before therapy. Confirmed response required CR, which was confirmed by 2 separate response evaluations &gt;=4 weeks apart.</description>
        <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
        <population>ITT Exposed Population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy; TST and Iodine I 131 TST</title>
            <description>Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Confirmed Complete Response (CR), as Assessed by the Investigator</title>
          <description>CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease, if present before therapy. Confirmed response required CR, which was confirmed by 2 separate response evaluations &gt;=4 weeks apart.</description>
          <population>ITT Exposed Population</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR), as Assessed by the Investigator</title>
        <description>DOR=the time from the first documented response (for par. with CR, CRu, or PR) until disease progression (DP). DP=a &gt;=50% increase from the nadir value (lowest laboratory value recorded following administration of study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be &gt;1.5 centimeters (cm) in diameter by radiographic evaluation or &gt;1 cm in diameter by physical examination. Responses had to be confirmed by 2 separate evaluations occurring &gt;=4 weeks apart.</description>
        <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
        <population>ITT Exposed Population. Only those participants with response were analyzed. Participants who did not experience progression were censored.</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy; TST and Iodine I 131 TST</title>
            <description>Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DOR), as Assessed by the Investigator</title>
          <description>DOR=the time from the first documented response (for par. with CR, CRu, or PR) until disease progression (DP). DP=a &gt;=50% increase from the nadir value (lowest laboratory value recorded following administration of study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be &gt;1.5 centimeters (cm) in diameter by radiographic evaluation or &gt;1 cm in diameter by physical examination. Responses had to be confirmed by 2 separate evaluations occurring &gt;=4 weeks apart.</description>
          <population>ITT Exposed Population. Only those participants with response were analyzed. Participants who did not experience progression were censored.</population>
          <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="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Unconfirmed Responders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="129.6" lower_limit="42.1" upper_limit="NA">There were not enough events of progression to be able to determine/calculate the upper limit of the 95% confidence interval (CI).</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Confirmed Responders</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="129.6" lower_limit="42.1" upper_limit="NA">There were not enough events of progression to be able to determine/calculate the upper limit of the 95% CI.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>DOR for Unconfirmed and Confirmed Complete Response, as Assessed by the Investigator</title>
        <description>DOR=the time from the first documented response (for par. with CR) until disease progression (DP). DP=a &gt;=50% increase from the nadir value (lowest laboratory value recorded following administration of study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be &gt;1.5 centimeters (cm) in diameter by radiographic evaluation or &gt;1 cm in diameter by physical examination. Responses had to be confirmed by 2 separate evaluations occurring &gt;=4 weeks apart.</description>
        <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
        <population>ITT Exposed Population. Only those participants with response were analyzed. Participants who did not experience progression were censored.</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy; TST and Iodine I 131 TST</title>
            <description>Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.</description>
          </group>
        </group_list>
        <measure>
          <title>DOR for Unconfirmed and Confirmed Complete Response, as Assessed by the Investigator</title>
          <description>DOR=the time from the first documented response (for par. with CR) until disease progression (DP). DP=a &gt;=50% increase from the nadir value (lowest laboratory value recorded following administration of study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be &gt;1.5 centimeters (cm) in diameter by radiographic evaluation or &gt;1 cm in diameter by physical examination. Responses had to be confirmed by 2 separate evaluations occurring &gt;=4 weeks apart.</description>
          <population>ITT Exposed Population. Only those participants with response were analyzed. Participants who did not experience progression were censored.</population>
          <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="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Unconfirmed Responders with CR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="129.6" lower_limit="74.8" upper_limit="NA">There were not enough events of progression to be able to determine/calculate the upper limit of the 95% CI.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Confirmed Responders with CR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="129.6" lower_limit="74.8" upper_limit="NA">There were not enough events of progression to be able to determine/calculate the upper limit of the 95% CI.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Progression of Disease or Death, as Assessed by the Investigator</title>
        <description>Time to progression or progression-free survival is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. Disease progression is defined as a &gt;=50% increase from the nadir value (lowest laboratory value recorded following administration of the study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be &gt;1.5 cm in diameter by radiographic evaluation or &gt;1 cm in diameter by physical examination.</description>
        <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
        <population>ITT Exposed Population. If a participant did not have progression or did not die, that participant was censored in the survival analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy; TST and Iodine I 131 TST</title>
            <description>Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Progression of Disease or Death, as Assessed by the Investigator</title>
          <description>Time to progression or progression-free survival is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. Disease progression is defined as a &gt;=50% increase from the nadir value (lowest laboratory value recorded following administration of the study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be &gt;1.5 cm in diameter by radiographic evaluation or &gt;1 cm in diameter by physical examination.</description>
          <population>ITT Exposed Population. If a participant did not have progression or did not die, that participant was censored in the survival analysis.</population>
          <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="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110.2" lower_limit="38.3" upper_limit="NA">There were not enough events of progression to be able to determine/calculate the upper limit of the 95% CI.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Treatment Failure, as Assessed by the Investigator</title>
        <description>Time to treatment failure is defined as the time from the start of treatment to the first occurrence of study withdrawal, progression, or death.</description>
        <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
        <population>ITT Exposed Population. If a participant did not have treatment failure, that participant was censored in the survival analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy; TST and Iodine I 131 TST</title>
            <description>Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Treatment Failure, as Assessed by the Investigator</title>
          <description>Time to treatment failure is defined as the time from the start of treatment to the first occurrence of study withdrawal, progression, or death.</description>
          <population>ITT Exposed Population. If a participant did not have treatment failure, that participant was censored in the survival analysis.</population>
          <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="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.9" lower_limit="36.5" upper_limit="NA">There were not enough events to be able to determine/calculate the upper limit of the 95% CI.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Body Residence Time (TBRT; Average Amount of Time TST Spends in the Body, Calculated From the Rate of TB Clearance of Radioactivity During the Dosimetric Dose [DD]) of Iodine 131 TST Antibody Following the DD</title>
        <description>To determine TBRT, the percent-injected activity (PIA) is calculated from the background-corrected (BC) total body count (TBC) at D 0; D 2/3/4; and D 7. The time from the DD to the acquisition of whole body count (WBC) is then determined. The PIA remaining at each time point (TP) is then calculated by dividing the BC WBC for that TP by the BC WBC from the first TP (D 0) * 100. To determine RT, a best-fit line from 100% (pre-plotted D 0 value) through 2 plotted points (other TPs) is made. TBRT=the x-axis value at the point where the line intersects the horizontal 37% injected activity line.</description>
        <time_frame>Day (D) 0; D 2, 3, or 4; and D 6 or 7</time_frame>
        <population>ITT Exposed Population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy; TST and Iodine I 131 TST</title>
            <description>Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Body Residence Time (TBRT; Average Amount of Time TST Spends in the Body, Calculated From the Rate of TB Clearance of Radioactivity During the Dosimetric Dose [DD]) of Iodine 131 TST Antibody Following the DD</title>
          <description>To determine TBRT, the percent-injected activity (PIA) is calculated from the background-corrected (BC) total body count (TBC) at D 0; D 2/3/4; and D 7. The time from the DD to the acquisition of whole body count (WBC) is then determined. The PIA remaining at each time point (TP) is then calculated by dividing the BC WBC for that TP by the BC WBC from the first TP (D 0) * 100. To determine RT, a best-fit line from 100% (pre-plotted D 0 value) through 2 plotted points (other TPs) is made. TBRT=the x-axis value at the point where the line intersects the horizontal 37% injected activity line.</description>
          <population>ITT Exposed Population</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103.7" spread="8.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Nadir for Hematological Parameters: Absolute Neutrophil Count (ANC), Hemoglobin, Platelets, and White Blood Cell (WBC) Count</title>
        <description>Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).</description>
        <time_frame>Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)</time_frame>
        <population>ITT Exposed Population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy; TST and Iodine I 131 TST</title>
            <description>Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Nadir for Hematological Parameters: Absolute Neutrophil Count (ANC), Hemoglobin, Platelets, and White Blood Cell (WBC) Count</title>
          <description>Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).</description>
          <population>ITT Exposed Population</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ANC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.0" lower_limit="15" upper_limit="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.0" lower_limit="34" upper_limit="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.5" lower_limit="26" upper_limit="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBC count</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.0" lower_limit="15" upper_limit="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Recovery (TTR) to Baseline (BL) for Hematologic Laboratory (Lab.) Evaluations</title>
        <description>TTR to BL grade (gr.) for par. with a Gr. 0 toxicity (tox.=lab. value outside the normal range) at BL=time from the last administration of study drug (SD) to the first post-nadir (PN) date with Gr. 0 toxicity with no other Gr. 1-4 toxicities recorded within the next week. For par. with a higher gr. tox. at BL, TTR=time from the last administration of SD to the first PN date with the BL gr. or better with no other higher gr. toxicities recorded during the next week. Each lab. established its own reference range using data from its own equipment/methods; there is no standard reference range.</description>
        <time_frame>Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)</time_frame>
        <population>ITT Exposed Population. Only those participants with hematologic toxicity were evaluated for time to recovery to baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy; TST and Iodine I 131 TST</title>
            <description>Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Recovery (TTR) to Baseline (BL) for Hematologic Laboratory (Lab.) Evaluations</title>
          <description>TTR to BL grade (gr.) for par. with a Gr. 0 toxicity (tox.=lab. value outside the normal range) at BL=time from the last administration of study drug (SD) to the first post-nadir (PN) date with Gr. 0 toxicity with no other Gr. 1-4 toxicities recorded within the next week. For par. with a higher gr. tox. at BL, TTR=time from the last administration of SD to the first PN date with the BL gr. or better with no other higher gr. toxicities recorded during the next week. Each lab. established its own reference range using data from its own equipment/methods; there is no standard reference range.</description>
          <population>ITT Exposed Population. Only those participants with hematologic toxicity were evaluated for time to recovery to baseline.</population>
          <units>days</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="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Time to recovery to baseline ANC, n=30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.0" lower_limit="70.0" upper_limit="91.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time to recovery to baseline hemoglobin, n=28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.5" lower_limit="62.0" upper_limit="168.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time to recovery to baseline platelets, n=30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.5" lower_limit="50.0" upper_limit="75.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Time to recovery to baseline WBC count, n=29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126.5" lower_limit="75.0" upper_limit="170.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nadir Values for Absolute Neutrophil Count (ANC)</title>
        <description>Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).</description>
        <time_frame>Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)</time_frame>
        <population>ITT Exposed Population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy; TST and Iodine I 131 TST</title>
            <description>Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.</description>
          </group>
        </group_list>
        <measure>
          <title>Nadir Values for Absolute Neutrophil Count (ANC)</title>
          <description>Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).</description>
          <population>ITT Exposed Population</population>
          <units>10^3 cells/cubic millimeters (mm^3)</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nadir Values for Hemoglobin</title>
        <description>Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).</description>
        <time_frame>Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)</time_frame>
        <population>ITT Exposed Population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy; TST and Iodine I 131 TST</title>
            <description>Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.</description>
          </group>
        </group_list>
        <measure>
          <title>Nadir Values for Hemoglobin</title>
          <description>Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).</description>
          <population>ITT Exposed Population</population>
          <units>Grams/deciliter (g/dL)</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6" lower_limit="6" upper_limit="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nadir Values for Platelet Count</title>
        <description>Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).</description>
        <time_frame>Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)</time_frame>
        <population>ITT Exposed Population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy; TST and Iodine I 131 TST</title>
            <description>Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.</description>
          </group>
        </group_list>
        <measure>
          <title>Nadir Values for Platelet Count</title>
          <description>Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).</description>
          <population>ITT Exposed Population</population>
          <units>10^3 cells/microliter (µL)</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.0" lower_limit="4" upper_limit="145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Nadir Values for WBC Count</title>
        <description>Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).</description>
        <time_frame>Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)</time_frame>
        <population>ITT Exposed Population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy; TST and Iodine I 131 TST</title>
            <description>Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.</description>
          </group>
        </group_list>
        <measure>
          <title>Nadir Values for WBC Count</title>
          <description>Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).</description>
          <population>ITT Exposed Population</population>
          <units>10^3 cells/µL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" lower_limit="0" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs)</title>
        <description>AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.</description>
        <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
        <population>ITT Exposed Population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy; TST and Iodine I 131 TST</title>
            <description>Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs)</title>
          <description>AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.</description>
          <population>ITT Exposed Population</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ANC &lt;1000 cells/mm^3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBC &lt;2000 cells/mm^3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets &lt;50000 cells/mm^3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin &lt;8.0 g/dL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutropenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukopenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Febrile neutropenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thrombocytopenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Granulocytopenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphopenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alopecia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Night sweats</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acute myeloid leukaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basal cell carcinoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myelodysplastic syndrome</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prostate cancer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Squamous cell carcinoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Perirectal abscess</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urinary tract infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cystitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutropenic infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Otitis media</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Periorbital cellulitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aphasia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cerebrovascular accident</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypoaesthesia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VIIth nerve paralysis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asthenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pyrexia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain in extremity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Depression</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insomnia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Amenorrhoea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breast mass</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Conjunctivitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Constipation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drug hypersensitivity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate aminotransferase increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cystitis hemorrhagic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Epistaxis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug</title>
        <description>AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE. The Investigator assessed whether the AE was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities (values outside the normal range) were assumed to be possibly or probably related to study drug.</description>
        <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
        <population>ITT Exposed Population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy; TST and Iodine I 131 TST</title>
            <description>Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug</title>
          <description>AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE. The Investigator assessed whether the AE was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities (values outside the normal range) were assumed to be possibly or probably related to study drug.</description>
          <population>ITT Exposed Population</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ANC &lt;1000 cells/mm^3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBC &lt;2000 cells/mm^3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets &lt;50000 cells/mm^3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin &lt;8.0 g/dL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutropenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukopenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Febrile neutropenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thrombocytopenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Granulocytopenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphopenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alopecia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Night sweats</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Perirectal abscess</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Urinary tract infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cystitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutropenic infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Otitis media</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Periorbital cellulitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acute myeloid leukaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basal cell carcinoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myelodysplastic syndrome</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Squamous cell carcinoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VIIth nerve paralysis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Depression</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Insomnia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Conjunctivitis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Constipation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pyrexia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aspartate aminotransferase increased</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cystitis hemorrhagic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Amenorrhoea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Epistaxis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Any Treatment-related Serious Adverse Event (SAE)</title>
        <description>An SAE is defined as any event occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience (at immediate risk of death from the experience as it occurred), inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious adverse drug experience when based upon appropriate medical judgment.</description>
        <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
        <population>ITT-Exposed Population. All participants who experienced a treatment-related SAE were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy; TST and Iodine I 131 TST</title>
            <description>Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Treatment-related Serious Adverse Event (SAE)</title>
          <description>An SAE is defined as any event occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience (at immediate risk of death from the experience as it occurred), inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious adverse drug experience when based upon appropriate medical judgment.</description>
          <population>ITT-Exposed Population. All participants who experienced a treatment-related SAE were analyzed.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Febrile neutropenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutropenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Thrombocytopenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Granulocytopenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukopenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Acute myeloid leukaemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basal cell carcinoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myelodysplastic syndrome</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Squamous cell carcinoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Perirectal abscess</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutropenic infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pyrexia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cystitis hemorrhagic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With the Indicated Primary Cause of Death</title>
        <description>The primary cause of death of the participants was assessed by the Investigator.</description>
        <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
        <population>ITT Exposed Population. All participants who died during the study were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy; TST and Iodine I 131 TST</title>
            <description>Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With the Indicated Primary Cause of Death</title>
          <description>The primary cause of death of the participants was assessed by the Investigator.</description>
          <population>ITT Exposed Population. All participants who died during the study were analyzed.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Progression of lymphoma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Complications related to study drug</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Received Any Supportive Care</title>
        <description>Supportive care is defined as interventions that help the participants achieve comfort but do not affect the course of a disease.</description>
        <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
        <population>ITT-Exposed Population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy; TST and Iodine I 131 TST</title>
            <description>Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received Any Supportive Care</title>
          <description>Supportive care is defined as interventions that help the participants achieve comfort but do not affect the course of a disease.</description>
          <population>ITT-Exposed Population</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Were Negative for Human Anti-murine Antibodies (HAMA) at Baseline (Study Entry) But Positive or Negative at Month 24</title>
        <description>The administration of murine antibodies may form HAMA. A HAMA assay was performed using the ImmunoSTRIP HAMA IgG enzyme-linked immune absorbent assay by a central laboratory (Covance Classic Laboratory Services, Indianapolis, IN). To be &quot;positive,&quot; a participant had to have a positive HAMA assessment during the first 24 months.</description>
        <time_frame>Day 1 to Day 730 (24 months) after receiving the dosimetric dose</time_frame>
        <population>ITT Exposed Population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy; TST and Iodine I 131 TST</title>
            <description>Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Were Negative for Human Anti-murine Antibodies (HAMA) at Baseline (Study Entry) But Positive or Negative at Month 24</title>
          <description>The administration of murine antibodies may form HAMA. A HAMA assay was performed using the ImmunoSTRIP HAMA IgG enzyme-linked immune absorbent assay by a central laboratory (Covance Classic Laboratory Services, Indianapolis, IN). To be &quot;positive,&quot; a participant had to have a positive HAMA assessment during the first 24 months.</description>
          <population>ITT Exposed Population</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Positive</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Negative</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival</title>
        <description>Overall survival is defined as the time from the treatment start date to the date of death from any cause.</description>
        <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.</time_frame>
        <population>ITT Exposed Population</population>
        <group_list>
          <group group_id="O1">
            <title>Chemotherapy; TST and Iodine I 131 TST</title>
            <description>Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</title>
          <description>Overall survival is defined as the time from the treatment start date to the date of death from any cause.</description>
          <population>ITT Exposed Population</population>
          <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="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">There were not enough events to be able to calculate the median or the confidence interval.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from both Study BEX104514 and Study BEX104528.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Period After CVP</title>
          <description>Par. received 6 cycles of chemotherapy as follows: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; intravenous Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days</description>
        </group>
        <group group_id="E2">
          <title>Period After Dosimetric and Therapeutic Dose</title>
          <description>After receiving Cyclophosphamide, Vincristine, and Prednisone, par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled tositumomab (TST) (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) Iodine 131. Par. received 4 drops by mouth (DBM) 3 times a day (TID) of potassium iodide (KI) and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the therapeutic dose (TD: a 1 hour IV infusion of 450 mg TST), followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose.</description>
        </group>
        <group group_id="E3">
          <title>Combined Regimen Period</title>
          <description>Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) &gt;=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Granulocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Perirectal abscess</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Neutropenic infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute myeloid leukaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Myelodysplastic syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Cystitis hemorrhagic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="30" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Granulocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Vertigo positional</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Cushingoid</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Keratitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Gingival bleeding</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Oral pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Tooth disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Anal pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Epigastric discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Oral disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Paraesthesia oral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Parotid gland enlargement</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Salivary gland disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Swollen tongue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Tongue discolouration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Tongue ulceration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="23" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Edema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Crepitations</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Facial pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Ill-defined disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Nodule</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Suprapubic pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Xerosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatomegaly</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hypogammaglobulinaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Periorbital cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Tinea pedis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ANC &lt;1000 cells/mm^3</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="29" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>WBC &lt;2000 cells/mm^3</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="23" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Platelets &lt;50000 cells/mm^3</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hemoglobin &lt;8.0 g/dL</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Blood bicarbonate decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Blood potassium increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Blood sodium decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Body temperature decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Body temperature increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Cardiac murmur</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Heart rate increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Heart rate irregular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Glucose tolerance impaired</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pain in jaw</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Musculoskeletal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Joint stiffness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Muscle hypertrophy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Muscle rigidity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Sensation of heaviness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Trismus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Adenoma benign</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Depressed level of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hyporeflexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Sinus headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>VIIth nerve paralysis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Abnormal dreams</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Emotional distress</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hypervigilance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Mood altered</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Mood swings</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Nervousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Bladder irritation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Bladder pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Nocturia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Amenorrhea</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Breast mass</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Breast pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Vulvovaginal dryness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dyspnea exertional</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Rhinorrhea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Nasal mucosal hypertrophy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Oropharyngeal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Paranasal sinus hypersecretion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Tonsillar disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dermal cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Increased tendency to bruise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Scab</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Skin tightness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Varicose vein</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Hematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Phlebitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
              </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>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
    </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/NCT01663714
org study id: 104514
nct id: NCT01663714
lead sponsor: 
has dmc: Yes
This is a phase II, open-label, multicenter study of the efficacy and safety of sequential
      administration of CVP x 6 followed by tositumomab and iodine I 131 tositumomab (formerly
      referred to as tositumomab and iodine I 131 tositumomab). All patients who complete three
      cycles of CVP, regardless of response, will be eligible for treatment with tositumomab and
      iodine I 131 tositumomab. Subjects who have rapidly progressive disease prior to completing
      three cycles of CVP may be removed from study.

      In order to proceed to tositumomab and iodine I 131 tositumomab therapy, patients must have
      completed six cycles of CVP within 20 weeks as described. Patients may proceed to Iodine-131
      Anti-B1 Antibody if they have progressive disease documented at the response evaluation
      following 6 cycles of CVP. In addition, patients must still meet the eligibility inclusion
      exclusion criteria based upon the week 20 assessments, as applicable. Patients must also have
      an average of ≤25% bone marrow involved by NHL to receive treatment with tositumomab and
      iodine I 131 tositumomab. The dosimetric dose of tositumomab and iodine I 131 tositumomab
      must be given within 28 days of the response evaluation following CVP and no later than 56
      days from the first day of the sixth cycle of CVP.
This is a phase II, open-label, multicenter study of the efficacy and safety sequential
      administration of cycolophosphamide, vacristine, and prednisone (CVP) x6 cycles followed by
      tositumomab and iodine I 131 tositumomab for previously untreated subjects with low-grade
      Non-Hodgkin's Lymphoma (NHL). CVP will be repeated every 21 days for a total of six cycles.
      tositumomab and iodine I 131 tositumomab will begin within 56 days following the first day of
      the sixth cycle of CVP. Subjects will undergo two dosing phase for the tositumomab and iodine
      I 131 tositumomab therapy. In the first phase, "dosimetric dose", patients will receive an
      infusion of unlabeled Anti-B1 Antibody (450mg) over 60 minutes followed by a 30 minute
      infusion (including a 10-minutes flush) of Anti-B1 (35mg) containing 5mCi of Iodine-131.
      Whole body gamma camera scans will be obtained on Day 0; Day 2, 3, or 4 and Day 6 or 7
      following the dosimetric dose. Using the dosimetric data from three time points, a
      patient-specific dose of Iodine-131 will be calculated to deliver the desired total body dose
      of radiotherapy. In the second phase, termed the "therapeutic dose", patients will receive
      60-minute infusion of unlabeled Anti-B1 Antibody (450 mg) followed by a 30-minute infusion
      (including a 10-minute flush) of 35 mg Anti-B1 Antibody labeled with the subjects -specific
      dose of Iodine-131 calculate to deliver a 75cGy total body radiation dose. Subjects who have
      platelet counts of 100,000-149,999 cells/mm3 will receive 65 cGy; obese patients will be
      dosed base upon 137% of their lean body mass. Subjects will be treated with saturated
      solution potassium iodide (SSKI), Lugol's solution, or potassium iodide tablets starting at
      least 24 hours prior to the first infusion of the tositumomab and iodine I 131 tositumomab
      (i.e., the dosimetric dose) and continuing for 14 days following the least infusion of
      tositumomab and iodine I 131 tositumomab (i.e., the therapeutic dose).
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants (Par.) With Unconfirmed Response (Complete Response, Complete Response/Unconfirmed, or Partial Response), as Assessed by the Investigator
time frame: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
description: Par. with response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Complete Response/unconfirmed (CRu: complete resolution of all disease-related symptoms; residual lymph node mass >1.5 centimeters in the greatest transverse diameter that has regressed by >75%, indeterminate bone marrow, are present), or Partial Response (PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).
measure: Number of Participants (Par.) With Confirmed Response (Complete Response [CR], Complete Response/Unconfirmed [CRu], or Partial Response [PR]), as Assessed by the Investigator
time frame: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
description: CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. CRu: complete resolution of all disease-related symptoms; residual lymph node mass >1.5 centimeters in the greatest transverse diameter that has regressed by >75%, indeterminate bone marrow, are present. PR: >=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions. Confirmed response required CR, CRu, or PR, which were confirmed by 2 separate response evaluations >=4 weeks apart.
measure: Number of Participants With Unconfirmed Complete Response (CR), as Assessed by the Investigator
time frame: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
description: CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease, if present before therapy.
measure: Number of Participants With Confirmed Complete Response (CR), as Assessed by the Investigator
time frame: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
description: CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease, if present before therapy. Confirmed response required CR, which was confirmed by 2 separate response evaluations >=4 weeks apart.
measure: Duration of Response (DOR), as Assessed by the Investigator
time frame: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
description: DOR=the time from the first documented response (for par. with CR, CRu, or PR) until disease progression (DP). DP=a >=50% increase from the nadir value (lowest laboratory value recorded following administration of study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >1.5 centimeters (cm) in diameter by radiographic evaluation or >1 cm in diameter by physical examination. Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart.
measure: DOR for Unconfirmed and Confirmed Complete Response, as Assessed by the Investigator
time frame: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
description: DOR=the time from the first documented response (for par. with CR) until disease progression (DP). DP=a >=50% increase from the nadir value (lowest laboratory value recorded following administration of study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >1.5 centimeters (cm) in diameter by radiographic evaluation or >1 cm in diameter by physical examination. Responses had to be confirmed by 2 separate evaluations occurring >=4 weeks apart.
measure: Time to Progression of Disease or Death, as Assessed by the Investigator
time frame: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
description: Time to progression or progression-free survival is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death. Disease progression is defined as a >=50% increase from the nadir value (lowest laboratory value recorded following administration of the study medication) of the sum of the products of the longest perpendicular diameters of all measurable lesions or the appearance of any new lesion. Individual lesions must be >1.5 cm in diameter by radiographic evaluation or >1 cm in diameter by physical examination.
measure: Time to Treatment Failure, as Assessed by the Investigator
time frame: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
description: Time to treatment failure is defined as the time from the start of treatment to the first occurrence of study withdrawal, progression, or death.
measure: Total Body Residence Time (TBRT; Average Amount of Time TST Spends in the Body, Calculated From the Rate of TB Clearance of Radioactivity During the Dosimetric Dose [DD]) of Iodine 131 TST Antibody Following the DD
time frame: Day (D) 0; D 2, 3, or 4; and D 6 or 7
description: To determine TBRT, the percent-injected activity (PIA) is calculated from the background-corrected (BC) total body count (TBC) at D 0; D 2/3/4; and D 7. The time from the DD to the acquisition of whole body count (WBC) is then determined. The PIA remaining at each time point (TP) is then calculated by dividing the BC WBC for that TP by the BC WBC from the first TP (D 0) * 100. To determine RT, a best-fit line from 100% (pre-plotted D 0 value) through 2 plotted points (other TPs) is made. TBRT=the x-axis value at the point where the line intersects the horizontal 37% injected activity line.
measure: Time to Nadir for Hematological Parameters: Absolute Neutrophil Count (ANC), Hemoglobin, Platelets, and White Blood Cell (WBC) Count
time frame: Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)
description: Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).
measure: Time to Recovery (TTR) to Baseline (BL) for Hematologic Laboratory (Lab.) Evaluations
time frame: Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)
description: TTR to BL grade (gr.) for par. with a Gr. 0 toxicity (tox.=lab. value outside the normal range) at BL=time from the last administration of study drug (SD) to the first post-nadir (PN) date with Gr. 0 toxicity with no other Gr. 1-4 toxicities recorded within the next week. For par. with a higher gr. tox. at BL, TTR=time from the last administration of SD to the first PN date with the BL gr. or better with no other higher gr. toxicities recorded during the next week. Each lab. established its own reference range using data from its own equipment/methods; there is no standard reference range.
measure: Nadir Values for Absolute Neutrophil Count (ANC)
time frame: Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)
description: Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).
measure: Nadir Values for Hemoglobin
time frame: Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)
description: Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).
measure: Nadir Values for Platelet Count
time frame: Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)
description: Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).
measure: Nadir Values for WBC Count
time frame: Up to 120 days following the therapeutic dose (given on Study Day 7, following the dosimetric dose) (or the dosimetric dose for participants who did not receive the therapeutic dose)
description: Nadir is defined as the lowest laboratory value recorded up to 120 days following the therapeutic dose (or the dosimetric dose for participants who did not receive the therapeutic dose).
measure: Number of Participants With the Indicated Grade 3 or Grade 4 Adverse Events (AEs)
time frame: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
description: AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE.
measure: Number of Participants With the Indicated Grade 3 or Grade 4 AEs Possibly or Probably Related to Study Drug
time frame: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
description: AEs were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No AE or within normal limits; 1 = Mild AE; 2 = Moderate AE; 3 = Severe and undesirable AE; 4 = Life-threatening or disabling AE; 5 = Death related to AE. The Investigator assessed whether the AE was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities (values outside the normal range) were assumed to be possibly or probably related to study drug.
measure: Number of Participants With Any Treatment-related Serious Adverse Event (SAE)
time frame: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
description: An SAE is defined as any event occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience (at immediate risk of death from the experience as it occurred), inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life threatening, or require hospitalization may be considered to be a serious adverse drug experience when based upon appropriate medical judgment.
measure: Number of Participants With the Indicated Primary Cause of Death
time frame: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
description: The primary cause of death of the participants was assessed by the Investigator.
measure: Number of Participants Who Received Any Supportive Care
time frame: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
description: Supportive care is defined as interventions that help the participants achieve comfort but do not affect the course of a disease.
measure: Number of Participants Who Were Negative for Human Anti-murine Antibodies (HAMA) at Baseline (Study Entry) But Positive or Negative at Month 24
time frame: Day 1 to Day 730 (24 months) after receiving the dosimetric dose
description: The administration of murine antibodies may form HAMA. A HAMA assay was performed using the ImmunoSTRIP HAMA IgG enzyme-linked immune absorbent assay by a central laboratory (Covance Classic Laboratory Services, Indianapolis, IN). To be "positive," a participant had to have a positive HAMA assessment during the first 24 months.
measure: Overall Survival
time frame: Par. were evaluated until death/disease progression or for 2 years in Study BEX104514. Par. who completed 2 years in Study BEX104514 were followed in Study BEX104528 for up to 130 months. Data are included from Study BEX104514 and Study BEX104528.
description: Overall survival is defined as the time from the treatment start date to the date of death from any cause.
arm group label: open-label, single arm
arm group type: Experimental
description: cycolophosphamide, vacristine, and pednisone (CVP) x6 cycles followed by tositumomab and iodine I 131 tositumomab. CVP will be repeated every 21 days for a total of six cycles. tositumomab and iodine I 131 tositumomab will begin within 56 days following the first day of the sixth cycle of CVP. Patient will undergo two dosing phase for the tositumomab and iodine I 131 tositumomab therapy.
intervention type: Biological
intervention name: cycolophosphamide, vacristine, and pednisone (CVP) x6 cycles followed by tositumomab and iodine I 131 tositumomab.
description: cycolophosphamide, vacristine, and pednisone (CVP) x6 cycles followed by tositumomab and iodine I 131 tositumomab. CVP will be repeated every 21 days for a total of six cycles. tositumomab and iodine I 131 tositumomab will begin within 56 days following the first day of the sixth cycle of CVP. Patient will undergo two dosing phase for the tositumomab and iodine I 131 tositumomab therapy.
arm group label: open-label, single arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
url: https://www.clinicalstudydatarequest.com
description: Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
citation: Link BK, Martin P, Kaminski MS, Goldsmith SJ, Coleman M, Leonard JP. Cyclophosphamide, vincristine, and prednisone followed by tositumomab and iodine-131-tositumomab in patients with untreated low-grade follicular lymphoma: eight-year follow-up of a multicenter phase II study. J Clin Oncol. 2010 Jun 20;28(18):3035-41. doi: 10.1200/JCO.2009.27.8325. Epub 2010 May 10.
PMID: 20458031
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Tositumomab I-131
sharing ipd: Yes
ipd description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
study doc: 
study doc: 
study doc: 
study doc: 
study doc: 
study doc: 
study doc: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 