<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/NCT02213263</url>
  </required_header>
  <id_info>
    <org_study_id>B3281006</org_study_id>
    <secondary_id>2014-000132-41</secondary_id>
    <secondary_id>REFLECTIONS</secondary_id>
    <nct_id>NCT02213263</nct_id>
  </id_info>
  <brief_title>A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment Of Patients With CD20-Positive, Low Tumor Burden, Follicular Lymphoma (REFLECTIONS B328-06)</brief_title>
  <official_title>A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280586 VERSUS RITUXIMAB FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH CD20-POSITIVE, LOW TUMOR BURDEN, FOLLICULAR LYMPHOMA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare the safety and effectiveness of PF-05280586 versus rituximab-EU in&#xD;
      patients with CD20-positive, low tumor burden follicular lymphoma. The primary hypothesis to&#xD;
      be tested in this study is that the effectiveness of PF-05280586, as measured by the Overall&#xD;
      Response Rate, is similar to that of rituximab-EU.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 30, 2014</start_date>
  <completion_date type="Actual">April 19, 2018</completion_date>
  <primary_completion_date type="Actual">October 23, 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Response Rate (ORR): Percentage of Participants With Overall Response (OR) at Week 26</measure>
    <time_frame>Week 26</time_frame>
    <description>ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) in accordance with the revised response criteria for malignant lymphoma (Cheson 2007). CR was defined as disappearance of all evidence of disease. PR was defined as regression of measureable disease and no new sites.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Baseline up to Week 52</time_frame>
    <description>An AE was any untoward medical occurrence in participants who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Baseline up to Week 52</time_frame>
    <description>Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state. Relatedness to treatment was assessed by investigator. AEs included both serious and non-serious AEs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Grade 3 or Higher Treatment-Emergent Adverse Events (AEs) as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03</measure>
    <time_frame>Baseline up to Week 52</time_frame>
    <description>An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 1=Mild, asymptomatic or mild symptoms, Grade 2=Moderate; minimal, local or noninvasive intervention indicated, Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life threatening) events caused participant to be in imminent danger of death. Grade 5 = death. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Grade 3 or Higher Treatment-Related Treatment-Emergent Adverse Events (AEs) as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03</measure>
    <time_frame>Baseline up to Week 52</time_frame>
    <description>Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Grade 1=Mild, asymptomatic or mild symptoms, Grade 2=Moderate; minimal, local or noninvasive intervention indicated; Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 = death. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Laboratory Abnormalities</measure>
    <time_frame>Baseline up to Week 52</time_frame>
    <description>Criteria for clinically significant laboratory abnormalities included total bilirubin (TB) less than (&lt;) 2*upper limit of normal (ULN), alanine aminotransferase (ALT)&lt;3*ULN; TB&lt;2*ULN, ALT more than (&gt;) 3 equal to (=) *ULN; TB&lt;2*ULN, aspartate aminotransferase (AST)&lt;3*ULN; TB&lt;2*ULN, AST&gt;=3*ULN. Data for only those categories are reported for which at least one participant had clinically significant laboratory abnormality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Treatment Failure (TTF)</measure>
    <time_frame>From randomization until disease progression, death or permanent discontinuation from treatment/study due to any reason, or up to Week 52</time_frame>
    <description>TTF was defined as the time (in months) from date of randomization to first progression of disease based on central review, death due to any cause, or permanent discontinuation from treatment, or discontinuation from study for any reason, whichever came first. Progression was defined as any new lesion or increase by greater than or equal to (&gt;=) 50% of previously involved sites from nadir. TTF was calculated using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>From randomization until disease progression or death due to any cause or up to Week 52</time_frame>
    <description>PFS was defined as the time (in months) from date of randomization to first progression of disease (PD) based on central review or death due to any cause in the absence of documented PD. PD was defined as any new lesion or increase by &gt;=50% of previously involved sites from nadir. PFS was calculated using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Complete Remission (CR) at Week 26</measure>
    <time_frame>Week 26</time_frame>
    <description>Complete Remission (CR) was defined as disappearance of all evidence of disease. CR was assessed by central review based on scans done at Week 26.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>From date of first documentation of overall response to first documentation of PD or to death due to any cause in absence of PD or up to Week 52</time_frame>
    <description>DOR was defined as the time (in months) from date of the first documentation of overall response (CR or PR) to the first documentation of progressive disease (PD) based on central review or to death due to any cause in the absence of documented PD. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measureable disease and no new sites. PD was defined as any new lesion or increase by &gt;=50% of previously involved sites from nadir. DOR was calculated using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>From randomization until death due to any cause or up to Week 52</time_frame>
    <description>Overall survival was defined as the time (in months) from date of randomization to death due to any cause. For participants who were alive, overall survival was censored at the last contact. Overall survival was calculated using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Serum Concentration (Cmax) of PF-05280586 and Rituximab-EU</measure>
    <time_frame>Predose (within 4 hours prior to start of infusion) on Days 1, 8, 15 and 22; within 15 minutes prior to end of infusion on Days 1 and 22</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimum Observed (Trough) Serum Concentration (Ctrough) of PF-05280586 and Rituximab-EU</measure>
    <time_frame>Predose (within 4 hours prior to the start of dosing) on Day 1, 8, 15, and 22</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cluster of Differentiation (CD) 19-Positive B-Cell Counts</measure>
    <time_frame>Baseline, Week 2, 3, 4, 5, 13, 26, 39, 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)</measure>
    <time_frame>Baseline up to Week 52</time_frame>
    <description>Human serum ADA samples were analyzed for the presence or absence of anti-rituximab antibodies or anti-PF-05280586 antibodies using the validated drug-specific assay with a tiered approach using screening, confirmation and titer/quantitation. Human NAb serum samples testing ADA positive were analyzed for the presence or absence of neutralizing anti-rituximab antibody and neutralizing anti-PF-05280586 antibody using the validated drug-specific assay with a tiered approach using screening, confirmation and titer/quantitation. Participants with their ADA titer &gt;= 1.88 were considered to be ADA positive. Only participants with a positive ADA result were further tested for NAb.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Immune-Based Adverse Effects</measure>
    <time_frame>Baseline up to Week 52</time_frame>
    <description>Immune-based adverse effects included infusion related reaction (IRR), adverse events which fulfill Sampson's criteria, and adverse events which belong to the Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) anaphylaxis or hypersensitivity reactions. Potential allergic and anaphylactic reactions were identified programmatically based on the criteria of Sampson et al, (2006).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">394</enrollment>
  <condition>Follicular Lymphoma</condition>
  <arm_group>
    <arm_group_label>PF-05280586</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>MabThera®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>PF-05280586</intervention_name>
    <description>PF-05280586 (rituximab-Pfizer) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22</description>
    <arm_group_label>PF-05280586</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MabThera®</intervention_name>
    <description>MabThera® (rituximab-EU) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22</description>
    <arm_group_label>MabThera®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed diagnosis of low tumor burden, CD20-positive follicular lymphoma&#xD;
&#xD;
          -  Ann Arbor Stage II, III, or IV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not a candidate for treatment with rituximab as a single-agent&#xD;
&#xD;
          -  Evidence of transformation to a high grade or diffuse large B-cell lymphoma&#xD;
&#xD;
          -  Any previous systemic therapy for B-cell NHL, including chemotherapy, immunotherapy,&#xD;
             or steroids&#xD;
&#xD;
          -  Any prior treatment with rituximab&#xD;
&#xD;
          -  Active, uncontrolled infection&#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>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pacific Cancer Medical Center, Inc.</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Oncology Institute of Hope and Innovation</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.</name>
      <address>
        <city>Corona</city>
        <state>California</state>
        <zip>92879</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Oncology Institute of Hope and Innovation</name>
      <address>
        <city>Downey</city>
        <state>California</state>
        <zip>90241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.</name>
      <address>
        <city>Fountain Valley</city>
        <state>California</state>
        <zip>92708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Global Cancer Research Institute (GCRI), Inc</name>
      <address>
        <city>Gilroy</city>
        <state>California</state>
        <zip>95020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Louise Regional Hospital Radiology Department (Radiology Only)</name>
      <address>
        <city>Gilroy</city>
        <state>California</state>
        <zip>95020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Valley Imaging Center (Imaging Only)</name>
      <address>
        <city>Gilroy</city>
        <state>California</state>
        <zip>95020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Los Angeles Hematology Oncology Medical Group</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Oncology Institute of Hope and Innovation</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Los Angeles Hematology Oncology Medical Group</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Oncology Institute of Hope and Innovation</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Los Angeles Hematology Oncology Medical Group</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Los Angeles Hematology Oncology Medical Group</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Oncology Institute of Hope and Innovation</name>
      <address>
        <city>Lynwood</city>
        <state>California</state>
        <zip>90262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Oncology Institute of Hope and Innovation</name>
      <address>
        <city>Montebello</city>
        <state>California</state>
        <zip>90640</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Center at Desert Regional Medical Center</name>
      <address>
        <city>Palm Springs</city>
        <state>California</state>
        <zip>92262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Torrance Health Association DBA, Torrance Memorial Physician, Network/Cancer Care Associates</name>
      <address>
        <city>Redondo Beach</city>
        <state>California</state>
        <zip>90277</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Compassionate Care Research Group, Inc., at Compassionate Cancer Care Medical Group, Inc.</name>
      <address>
        <city>Riverside</city>
        <state>California</state>
        <zip>92501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Global Cancer Research Institute, Inc.</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>O'Connor Hospital</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PET Imaging of San Jose (Imaging Only)</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Oncology Institute of Hope and Innovation</name>
      <address>
        <city>Santa Ana</city>
        <state>California</state>
        <zip>92705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Torrance Memorial Medical Center</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Oncology Institute of Hope and Innovation</name>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Innovative Clinical Research Institute (ICRI)</name>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers</name>
      <address>
        <city>Boulder</city>
        <state>Colorado</state>
        <zip>80303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Center-Lakewood (Laboratory)</name>
      <address>
        <city>Lakewood</city>
        <state>Colorado</state>
        <zip>80228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers (RMCC) - Lakewood - St Anthony</name>
      <address>
        <city>Lakewood</city>
        <state>Colorado</state>
        <zip>80228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers</name>
      <address>
        <city>Lone Tree</city>
        <state>Colorado</state>
        <zip>80124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Center Pueblo</name>
      <address>
        <city>Pueblo</city>
        <state>Colorado</state>
        <zip>81008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John D. Archbold Memorial Hospital</name>
      <address>
        <city>Thomasville</city>
        <state>Georgia</state>
        <zip>31792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lewis Hall Singletary Oncology Center At John D. Archbold Memorial Hospital</name>
      <address>
        <city>Thomasville</city>
        <state>Georgia</state>
        <zip>31792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern Medicine West Region</name>
      <address>
        <city>DeKalb</city>
        <state>Illinois</state>
        <zip>60115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center,Northwestern Medicine, West Region</name>
      <address>
        <city>Geneva</city>
        <state>Illinois</state>
        <zip>60134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas</name>
      <address>
        <city>Chanute</city>
        <state>Kansas</state>
        <zip>66720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas</name>
      <address>
        <city>Dodge City</city>
        <state>Kansas</state>
        <zip>67801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas</name>
      <address>
        <city>El Dorado</city>
        <state>Kansas</state>
        <zip>67042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas</name>
      <address>
        <city>Independence</city>
        <state>Kansas</state>
        <zip>67301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas</name>
      <address>
        <city>Kingman</city>
        <state>Kansas</state>
        <zip>67068</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas</name>
      <address>
        <city>Liberal</city>
        <state>Kansas</state>
        <zip>67905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas</name>
      <address>
        <city>McPherson</city>
        <state>Kansas</state>
        <zip>67460</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas</name>
      <address>
        <city>Newton</city>
        <state>Kansas</state>
        <zip>67114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Kansas Cancer Center</name>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas</name>
      <address>
        <city>Parsons</city>
        <state>Kansas</state>
        <zip>67357</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas</name>
      <address>
        <city>Salina</city>
        <state>Kansas</state>
        <zip>67401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas</name>
      <address>
        <city>Wellington</city>
        <state>Kansas</state>
        <zip>67152</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center Of Kansas</name>
      <address>
        <city>Winfield</city>
        <state>Kansas</state>
        <zip>67156</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PET/CT facility Seton Imaging Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Agnes Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rcca Md Llc</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holy Cross Hospital Resource Center</name>
      <address>
        <city>Silver Spring</city>
        <state>Maryland</state>
        <zip>20902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holy Cross Hospital Hospital Pharmacy</name>
      <address>
        <city>Silver Spring</city>
        <state>Maryland</state>
        <zip>20910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holy Cross Hospital</name>
      <address>
        <city>Silver Spring</city>
        <state>Maryland</state>
        <zip>20910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maryland Oncology Hematology, P.A.</name>
      <address>
        <city>Wheaton</city>
        <state>Maryland</state>
        <zip>20902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Kansas Cancer Center</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Kansas Cancer Center</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Kansas Cancer Center</name>
      <address>
        <city>Lee's Summit</city>
        <state>Missouri</state>
        <zip>64064</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Francis Medical Center, Saint Francis Cancer Treatment Center</name>
      <address>
        <city>Grand Island</city>
        <state>Nebraska</state>
        <zip>68803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Francis Medical Center</name>
      <address>
        <city>Grand Island</city>
        <state>Nebraska</state>
        <zip>68803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Francis Medical Center, Saint Francis Cancer Treatment Center</name>
      <address>
        <city>Hastings</city>
        <state>Nebraska</state>
        <zip>68901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89074</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brody School of Medicine at East Carolina University</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vidant Medical Center Pharmacy</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vidant Medical Center</name>
      <address>
        <city>Greenville</city>
        <state>North Carolina</state>
        <zip>27834</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toledo Clinic Cancer Center - Maumee</name>
      <address>
        <city>Maumee</city>
        <state>Ohio</state>
        <zip>43537</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toledo Clinic Cancer Center - Toledo</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43623</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toledo Clinic, Inc.</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43623</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Willamette Valley Cancer Institute and Research Center</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Tennessee Medical Center</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Antonio Military Medical Center- Department of Pharmacy</name>
      <address>
        <city>Fort Sam Houston</city>
        <state>Texas</state>
        <zip>78234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Antonio Military Medical Center- Department of Radiology</name>
      <address>
        <city>Fort Sam Houston</city>
        <state>Texas</state>
        <zip>78234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>San Antonio Military Medical Center</name>
      <address>
        <city>Fort Sam Houston</city>
        <state>Texas</state>
        <zip>78234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Products Center (I PC)</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76177</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Products Center (IPC)</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76177</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Millennium Oncology</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>US Oncology Investigational Products Center (IPC)</name>
      <address>
        <city>Irving</city>
        <state>Texas</state>
        <zip>75063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Millennium Oncology</name>
      <address>
        <city>Kingwood</city>
        <state>Texas</state>
        <zip>77339</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Longview Cancer Center</name>
      <address>
        <city>Longview</city>
        <state>Texas</state>
        <zip>75601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Millennium Oncology</name>
      <address>
        <city>Shenandoah</city>
        <state>Texas</state>
        <zip>77384</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Millennium Oncology</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77380</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology-Tyler</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yakima Valley Memorial Hospital/North Star Lodge Cancer Center</name>
      <address>
        <city>Yakima</city>
        <state>Washington</state>
        <zip>98902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Krankenhaus der Barmherzigen Schwestern Linz</name>
      <address>
        <city>Linz</city>
        <zip>4010</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kepler Universitaetsklinikum GmbH</name>
      <address>
        <city>Linz</city>
        <zip>4020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kepler Universitaetsklinikum GmbH</name>
      <address>
        <city>Linz</city>
        <zip>4021</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SI 'Republican Research and Practice Centre of Oncology and Medical Radiology n.a. N.N. Alexandrov'</name>
      <address>
        <city>Lesnoy</city>
        <state>Minsk Region</state>
        <zip>220013</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SI 'Republican Research and Practice Centre of Oncology and Medical Radiology n.a. N.N. Alexandrov'</name>
      <address>
        <city>Lesnoy</city>
        <state>Minsk Region</state>
        <zip>223040</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Healthcare Institution &quot;Brest Regional Oncologic Dispensary&quot;</name>
      <address>
        <city>Brest</city>
        <zip>224027</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Healthcare Institution 'Minsk City Clinical Oncology Dispensary'</name>
      <address>
        <city>Minsk</city>
        <zip>220013</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SI Republican Research and Practice Centre of oncology and medical radiology n.a N.N Alexandrov</name>
      <address>
        <city>Republic Of Belarus</city>
        <zip>223040</zip>
        <country>Belarus</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Erasme</name>
      <address>
        <city>Brussels</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nuclear Medicine Department</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grand Hopital de Charleroi-Site Notre-Dame</name>
      <address>
        <city>Charleroi</city>
        <zip>6000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PET/CT facility: Grand Hopital de Charleroi (GHdC) - site Notre-Dame</name>
      <address>
        <city>Charleroi</city>
        <zip>6000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacy Department: Grand Hopital de Charleroi (GHdC) - site Notre-Dame</name>
      <address>
        <city>Charleroi</city>
        <zip>6000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacy Department, Centre Hospitalier De Jolimont - Lobbes</name>
      <address>
        <city>La Louviere (Haine-Saint Paul)</city>
        <zip>7100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Jolimont - Lobbes</name>
      <address>
        <city>La Louviere (Haine-Saint-Paul)</city>
        <zip>7100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiology Department</name>
      <address>
        <city>La Louviere (Haine-Saint-Paul)</city>
        <zip>7100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C.H.U. Ambroise Pare</name>
      <address>
        <city>Mons</city>
        <zip>7000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacy Department, CHU Ambroise Pare</name>
      <address>
        <city>Mons</city>
        <zip>7000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Izabel - Setor de Bioimagem</name>
      <address>
        <city>Salvador</city>
        <state>Bahia</state>
        <zip>40050-410</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Santa Izabel / Santa Casa de Misericordia da Bahia</name>
      <address>
        <city>Salvador</city>
        <state>Bahia</state>
        <zip>40050-410</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Multimagem</name>
      <address>
        <city>Goiania</city>
        <state>GO</state>
        <zip>74175-150</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital das Clinicas da Universidade Federal de Goias \ Centro de Pesquisa Clinica</name>
      <address>
        <city>Goiania</city>
        <state>GO</state>
        <zip>74605-020</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro de Imagens da Faculdade de Medicina - INCT Medicina Nuclear - PET/CT</name>
      <address>
        <city>Belo Horizonte</city>
        <state>MG</state>
        <zip>30130-100</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidade Funcional Apoio Diagnostico e terapeutica por Imagem do HC/UFMG - CT Scan</name>
      <address>
        <city>Belo Horizonte</city>
        <state>MG</state>
        <zip>30130-100</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital das Clinicas Universidade Federal de Minas Gerais</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <zip>30130-100</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central de Misturas Intravenosas do Hospital de Clinicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>RIO Grande DO SUL</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Clinicas de Porto Alegre - Centro de Pesquisa Clinica</name>
      <address>
        <city>Porto Alegre</city>
        <state>RIO Grande DO SUL</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Clinicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>RIO Grande DO SUL</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Servico de Radiologia do Hospital de Clinicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>RIO Grande DO SUL</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CDI - Centro de Diagnostico por Imagem do Hospital Sao Lucas da PUCRS</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90610-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>InsCer - Instituto do Cerebro do Rio Grande do Sul - PUCRS</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90610-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniao Brasileira de Educacao e Assistencia (UBEA) - Hospital Sao Lucas da PUCRS -</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90610-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacao Amaral Carvalho / Fundacao Dr. Amaral Carvalho</name>
      <address>
        <city>Jau</city>
        <state>SAO Paulo</state>
        <zip>17210-080</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacao Amaral Carvalho / Fundacao Dr. Amaral Carvalho</name>
      <address>
        <city>Jau</city>
        <state>SAO Paulo</state>
        <zip>17210-120</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unidade de Quimioterapia</name>
      <address>
        <city>Jaú</city>
        <state>SAO Paulo</state>
        <zip>17210-120</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Casa da Esperanca</name>
      <address>
        <city>Santo Andre</city>
        <state>SAO Paulo</state>
        <zip>09030-340</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tecnolab</name>
      <address>
        <city>Sao Bernardo do Campo</city>
        <state>SAO Paulo</state>
        <zip>09750-670</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CEMEDI</name>
      <address>
        <city>Campinas</city>
        <state>SP</state>
        <zip>13075-460</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Radium</name>
      <address>
        <city>Campinas</city>
        <state>SP</state>
        <zip>13075-460</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAEP - Centro Avancado de Estudos e Pesquisas LTDA</name>
      <address>
        <city>Campinas</city>
        <state>SP</state>
        <zip>13087-567</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital e Maternidade Madre Theodora LTDA</name>
      <address>
        <city>Campinas</city>
        <state>SP</state>
        <zip>13087-567</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CENNI Oncologia</name>
      <address>
        <city>Campinas</city>
        <state>SP</state>
        <zip>13092-132</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacao do ABC - FMABC/ Faculdade de Medicina ABC ( CEPHO - Centro de Estudos e Pesquisas de</name>
      <address>
        <city>Santo Andre</city>
        <state>SP</state>
        <zip>09060-650</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Bandeirantes</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>01506-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital das Clinicas da Faculdade de Medicina da USP / Fundacao Faculdade de Medicina MEC MPAS</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>05403-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Casa de Saude Santa Marcelina (Centro de Pesquisa Santa Marcelina)</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>08270-070</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IEP São Lucas (Pharmacy)</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>01242-020</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IEP Sao Lucas - Instituto de Ensino e Pesquisa Sao Lucas / HEMOMED - Instituto de Oncologia e</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01236-030</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fleury</name>
      <address>
        <city>Sao Paulo</city>
        <zip>01333-910</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Center Zagreb, Department of Nuclear Medicine and Radiation Protection</name>
      <address>
        <city>Zagreb</city>
        <zip>10 000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Center Zagreb, Department of Pathology and Cytology</name>
      <address>
        <city>Zagreb</city>
        <zip>10 000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Center Zagreb, Department of Radiology</name>
      <address>
        <city>Zagreb</city>
        <zip>10 000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Centre &quot;Sestre Milosrdnice&quot;</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Centre Zagreb</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Marseille Hopital de La Conception</name>
      <address>
        <city>Marseille</city>
        <state>Marseille Cedex 05</state>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH de Mulhouse, Hopital Emile Muller</name>
      <address>
        <city>Mulhouse</city>
        <state>Mulhouse Cedex</state>
        <zip>68100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Duchenne Chu - Boulogne Sur Mer</name>
      <address>
        <city>Boulogne Sur Mer</city>
        <state>NAP</state>
        <zip>62321</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Duchenne Chu - Boulogne Sur Mer</name>
      <address>
        <city>Boulogne Sur Mer</city>
        <zip>62321</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier De Bourg En Bresse</name>
      <address>
        <city>Bourg En Bresse Cedex</city>
        <zip>01012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Morvan-CHU Brest- Service Hematologie Clinique</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Cote de Nacre</name>
      <address>
        <city>Caen</city>
        <zip>14033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier du Mans</name>
      <address>
        <city>Le Mans</city>
        <zip>72037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique de la Sauvegarde</name>
      <address>
        <city>Lyon</city>
        <zip>69009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;LTD &quot;&quot;M. Zodelava's Hematology Centre&quot;&quot;&quot;</name>
      <address>
        <city>Tbilisi</city>
        <zip>0112</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LTD &quot;Research Institute of Clinical Medicine&quot;</name>
      <address>
        <city>Tbilisi</city>
        <zip>0112</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>High Technology Medical Center, University Clinic</name>
      <address>
        <city>Tbilisi</city>
        <zip>0144</zip>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite - Universitaetsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>12200</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite - Universitatsmedizin Berlin - Campus Benjamin Franklin</name>
      <address>
        <city>Berlin</city>
        <zip>12200</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite - Universitaetsmedizin Berlin, Campus Virchow-Klinikum</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite - Universitatsmedizin Berlin, Campus Virchow-Klinikum</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charite - Universitatsmedizin Berlin</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Chemnitz gGmbH - Institut fuer Interventionelle Radiologie und Neuroradiologie</name>
      <address>
        <city>Chemnitz</city>
        <zip>09113</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Chemnitz gGmbH</name>
      <address>
        <city>Chemnitz</city>
        <zip>09113</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Chemnitz gGmbH - Klinik fuer Nuklearmedizin</name>
      <address>
        <city>Chemnitz</city>
        <zip>09116</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Chemnitz gGmbH - Zentralapotheke</name>
      <address>
        <city>Chemnitz</city>
        <zip>09116</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Essen (AoeR)</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Essen (AoR)</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DokuSan Gesellschaft fuer Medizinische Studien mbH &amp; Co. KG</name>
      <address>
        <city>Herne</city>
        <zip>44623</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apotheke des St. Anna Hospital</name>
      <address>
        <city>Herne</city>
        <zip>44649</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EVK Eickel</name>
      <address>
        <city>Herne</city>
        <zip>44651</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis im Koeln Triangle</name>
      <address>
        <city>Koeln</city>
        <zip>50679</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftspraxis fuer Diagnostische Radiologie und Nuklearmedizin</name>
      <address>
        <city>Mutlangen</city>
        <zip>73557</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kliniken Ostalb, Stauferklinikum Schwaebisch Gmuend, Zentrum fuer Innere Medizin</name>
      <address>
        <city>Mutlangen</city>
        <zip>73557</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stauferklinikum Schwaebisch Gmuend, Apotheke</name>
      <address>
        <city>Mutlangen</city>
        <zip>73557</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsmedizin Rostock</name>
      <address>
        <city>Rostock</city>
        <zip>18057</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum Stuttgart, Klinik fuer Nuklearmedizin</name>
      <address>
        <city>Stuttgart</city>
        <zip>70174</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vinzenz von Paul Kliniken gGmbH</name>
      <address>
        <city>Stuttgart</city>
        <zip>70199</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiologie Rhein-Sieg</name>
      <address>
        <city>Troisdorf</city>
        <zip>53840</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ueberoertliche Berufsausuebungsgemeinschaft Drs. med. Helmut Forstbauer</name>
      <address>
        <city>Troisdorf</city>
        <zip>53840</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zentralapotheke</name>
      <address>
        <city>Troisdorf</city>
        <zip>53842</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gen. Hosp. of Athens &quot;Evangelismos - Eye Hosp.- Polikliniki&quot;</name>
      <address>
        <city>Athens</city>
        <zip>10676</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gen. Hosp. of Athens &quot;Evangelismos-Eye Hosp. - Polikliniki&quot;</name>
      <address>
        <city>Athens</city>
        <zip>10676</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gen. Hosp. of Athens &quot;Evangelismos-Eye Hosp.-Polikliniki&quot;</name>
      <address>
        <city>Athens</city>
        <zip>10676</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gen.Hosp.of Athens &quot;Evangelismos-Eye Hosp.-polikiliniki&quot;</name>
      <address>
        <city>Athens</city>
        <zip>10676</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens &quot;Evangelismos - Eye Hosp. - Polikliniki&quot;</name>
      <address>
        <city>Athens</city>
        <zip>10676</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bioiatriki S.A.</name>
      <address>
        <city>Athens</city>
        <zip>11526</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bioiatriki</name>
      <address>
        <city>Athens</city>
        <zip>11526</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens 'Laiko'</name>
      <address>
        <city>Athens</city>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;&quot;&quot;ATTIKON&quot;&quot; Gen. Univ. Hosp&quot;</name>
      <address>
        <city>Athens</city>
        <zip>12462</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;ATTIKON'' Gen. Univ. Hosp.</name>
      <address>
        <city>Chaidari, Athens</city>
        <zip>12462</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Magnitiki Patron</name>
      <address>
        <city>Patras</city>
        <zip>26222</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University General Hospital of Patras</name>
      <address>
        <city>Patras</city>
        <zip>26504</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Super Scan Imaging Centre</name>
      <address>
        <city>Surat</city>
        <state>Gujarat</state>
        <zip>395001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pathology Department, Unique Hospital Multispeciality &amp; Research Institute</name>
      <address>
        <city>Surat</city>
        <state>Gujarat</state>
        <zip>395002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zircon- BIC Imaging Centre</name>
      <address>
        <city>Surat</city>
        <state>Gujarat</state>
        <zip>395002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mangalore Institute of Oncology</name>
      <address>
        <city>Mangalore</city>
        <state>Karanataka</state>
        <zip>575002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HealthCare Global Enterprises Limited</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560027</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kasturba Medical College and Hospital</name>
      <address>
        <city>Manipal</city>
        <state>Karnataka</state>
        <zip>576104</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Curie Manavata Cancer Centre</name>
      <address>
        <city>Nashik</city>
        <state>Maharashtra</state>
        <zip>422004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Radiology, Curie Manavata Cancer Centre</name>
      <address>
        <city>Nashik</city>
        <state>Maharashtra</state>
        <zip>422004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Radiology</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jehangir Clinical Development Centre Pvt. Ltd.</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruby Hall clinic</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>R.K. Birla Cancer Center, Sawai Man Singh Hospital</name>
      <address>
        <city>Jaipur</city>
        <state>Rajasthan</state>
        <zip>302004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apollo Speciality Hospital</name>
      <address>
        <city>Chennai</city>
        <state>Tamilnadu</state>
        <zip>600035</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Radiology</name>
      <address>
        <city>Chennai</city>
        <state>Tamilnadu</state>
        <zip>600035</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Global Hospitals</name>
      <address>
        <city>Hyderabad</city>
        <state>Telangana</state>
        <zip>500 004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vijaya Diagnostic Centre</name>
      <address>
        <city>Hyderabad</city>
        <state>Telangana</state>
        <zip>500029</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>N.R.S Medical College and Hospital</name>
      <address>
        <city>Kolkata</city>
        <state>WEST Bengal</state>
        <zip>700014</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spandan PET-CT Unit</name>
      <address>
        <city>Kolkata</city>
        <state>WEST Bengal</state>
        <zip>700014</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rajiv Gandhi Cancer Institute &amp; Research Center (RGCIRC)</name>
      <address>
        <city>New Delhi</city>
        <zip>110 085</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>U.O. di Ematologia e CTMO - Istituti Ospedalieri di Cremona</name>
      <address>
        <city>Cremona</city>
        <state>CR</state>
        <zip>26100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRST - IRCCS U. O. Oncologia Medica</name>
      <address>
        <city>Meldola</city>
        <state>FC</state>
        <zip>47014</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>U.O. Ematologia 1 - IRCCS AOU San Martino-IST</name>
      <address>
        <city>Genova</city>
        <state>GE</state>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unita di Ricerca Clinica</name>
      <address>
        <city>Monza</city>
        <state>MB</state>
        <zip>20900</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Europeo di Oncologia</name>
      <address>
        <city>Milano</city>
        <state>MI</state>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unità semplice di Medicina Nucleare</name>
      <address>
        <city>Latina</city>
        <state>NAP</state>
        <zip>04100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Ematologica - A.O.U. Ospedali Riuniti di Ancona</name>
      <address>
        <city>Torrette Ancona</city>
        <state>Palermo</state>
        <zip>60121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Az Ospedaliera Santa Maria</name>
      <address>
        <city>Terni</city>
        <state>PG</state>
        <zip>05100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medicina nucleare</name>
      <address>
        <city>Reggio Emilia</city>
        <state>Reggio</state>
        <zip>42123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiologia</name>
      <address>
        <city>Reggio Emilia</city>
        <state>Reggio</state>
        <zip>42123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SC Ematologia - SC Ematologia - Arcispedale Santa Maria Nuova - IRCCS</name>
      <address>
        <city>Reggio Emilia</city>
        <state>Reggio</state>
        <zip>42123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Dipartimento di Biotecnologie Cellulari ed Ematologia, Universita &quot;&quot;Sapienza&quot;&quot;</name>
      <address>
        <city>Rome</city>
        <state>Rome Rm</state>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCSS A.O.U. San Martino - IST - UO Clinica Ematologica</name>
      <address>
        <city>Genova</city>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SC Ematologia, Fondazione IRCCS Ist Nazionale dei Tumori</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Padiglione 1, Torre delle medicine, 6 piano</name>
      <address>
        <city>Parma</city>
        <zip>43100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ematologia e Centro Trapianti - AZ Osp. Ospedali Riuniti Marche Nord (AORMN) - Presidio S. Salvatore</name>
      <address>
        <city>Pesaro</city>
        <zip>61122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>U.O. Ematologia Universitaria - Dip. Di Oncologia dei Trapianti - AOU Pisana</name>
      <address>
        <city>Pisa</city>
        <zip>56126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Universitario Campus Bio- Medico-U.O.C. di Ematologia Trapianto Cellule Staminali</name>
      <address>
        <city>Roma</city>
        <zip>00128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Nagoya Imaging Diagnosis Center</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>464-0044</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagoya Daini Red Cross Hospital</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <zip>466-8650</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Akita University Hospital</name>
      <address>
        <city>Akita City</city>
        <state>Akita</state>
        <zip>010-8543</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiba Cancer Center</name>
      <address>
        <city>Chiba-shi</city>
        <state>Chiba</state>
        <zip>260-8717</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kyushu Medical Center</name>
      <address>
        <city>Fukuoka-shi</city>
        <state>Fukuoka</state>
        <zip>810-8563</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kyushu Cancer Center</name>
      <address>
        <city>Fukuoka-Shi</city>
        <state>Fukuoka</state>
        <zip>811-1395</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kobe City Medical Center General Hospital</name>
      <address>
        <city>Kobe-City</city>
        <state>Hyogo</state>
        <zip>650-0047</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kanazawa Medical Center</name>
      <address>
        <city>Kanazawa</city>
        <state>Ishikawa</state>
        <zip>920-8650</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanazawa Advanced Medical Center</name>
      <address>
        <city>Kanazawa</city>
        <state>Ishikawa</state>
        <zip>9200934</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Showa University Northern Yokohama Hospital</name>
      <address>
        <city>Yokohama-shi</city>
        <state>Kanagawa-ken</state>
        <zip>224-8503</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kochi Medical School Hospital</name>
      <address>
        <city>Okocho, Nankoku</city>
        <state>Kochi</state>
        <zip>783-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kumamoto Medical Center</name>
      <address>
        <city>Kumamoto-shi</city>
        <state>Kumamoto-ken</state>
        <zip>860-0008</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uozumi Clinic</name>
      <address>
        <city>Kumamoto-shi</city>
        <state>Kumamoto-ken</state>
        <zip>862-0941</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sendai Kousei Hospital</name>
      <address>
        <city>Sendai-shi</city>
        <state>Miyagi</state>
        <zip>980-0873</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Sendai Medical Center</name>
      <address>
        <city>Sendai-shi</city>
        <state>Miyagi</state>
        <zip>983-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aizawa Hospital</name>
      <address>
        <city>Matsumoto-shi</city>
        <state>Nagano</state>
        <zip>390-8510</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagano Red Cross Hospital</name>
      <address>
        <city>Nagano-shi</city>
        <state>Nagano</state>
        <zip>380-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Nagasaki Medical Center</name>
      <address>
        <city>Omura</city>
        <state>Nagasaki</state>
        <zip>856-8562</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Osaka Minami Medical Center</name>
      <address>
        <city>Kawachinagano</city>
        <state>Osaka</state>
        <zip>586-8521</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hanwa Dai 2 Senboku Hospital</name>
      <address>
        <city>Naka-ku Sakai</city>
        <state>Osaka</state>
        <zip>599-8271</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka City University Hospital</name>
      <address>
        <city>Osaka-City</city>
        <state>Osaka</state>
        <zip>545-8586</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokushima University Hospital</name>
      <address>
        <city>Tokushima-Shi</city>
        <state>Tokushima</state>
        <zip>770-8503</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Tokyo Medical Center</name>
      <address>
        <city>Meguro-Ku</city>
        <state>Tokyo</state>
        <zip>152-8902</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Showa University Hospital</name>
      <address>
        <city>Shinagawa-ku</city>
        <state>Tokyo</state>
        <zip>142-8666</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Disaster Medical Center</name>
      <address>
        <city>Tachikawa</city>
        <state>Tokyo</state>
        <zip>190-0014</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yamagata University Hospital</name>
      <address>
        <city>Yamagata-Shi</city>
        <state>Yamagata</state>
        <zip>990-9585</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuoka Wajiro PET Diagnostic Imaging Clinic</name>
      <address>
        <city>Fukuoka</city>
        <zip>811-0213</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Matsumoto Medical Center</name>
      <address>
        <city>Nagano</city>
        <zip>399-8701</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Musashimurayama Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>2080022</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hallym University Sacred Heart Hospital</name>
      <address>
        <city>Anyang-si</city>
        <state>Gyeonggi-do</state>
        <zip>14068</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chonbuk National University Hospital</name>
      <address>
        <city>Jeonju-si</city>
        <state>Jeollabuk-do</state>
        <zip>54907</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ulsan University Hospital</name>
      <address>
        <city>Ulsan</city>
        <state>Korea</state>
        <zip>44033</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje University Busan Paik Hospital</name>
      <address>
        <city>Busan</city>
        <zip>47392</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hammoud Hospital, University Medical Center</name>
      <address>
        <city>Saida</city>
        <state>Southern Governate</state>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Doctors Center Radiology</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Lebanon Hospital</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Middle East Institute Of Health</name>
      <address>
        <city>El Metn</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ain Wazein Hospital</name>
      <address>
        <city>Mount Lebanon</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grupo Medico Camino S.C.</name>
      <address>
        <city>Mexico City</city>
        <state>Distrito Federal</state>
        <zip>03310</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imagenus</name>
      <address>
        <city>Mexico City</city>
        <state>Distrito Federal</state>
        <zip>03340</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Isos Pharmacorp, S.A. de C.V.</name>
      <address>
        <city>Mexico City</city>
        <state>Distrito Federal</state>
        <zip>06700</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vely Grupo Medico Quirurgico, S.A. de C.V.</name>
      <address>
        <city>Cuautitlan Izacalli</city>
        <state>Estado DE Mexico</state>
        <zip>54750</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Phylasis Clinicas Research S. de R.L. de C.V.</name>
      <address>
        <city>Cuautitlan Izcalli</city>
        <state>Estado DE Mexico</state>
        <zip>54769</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Universitario de Imagen Diagnostica, Radiologia e Imagen del Hospital Universitario</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo LEON</state>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario &quot;Dr. Jose Eleuterio Gonzalez&quot;</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo LEON</state>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cirurgia y Ginecobstetricia de Oaxaca, S.A de C.V.</name>
      <address>
        <city>Oaxaca</city>
        <zip>68000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oaxaca Site Management Organization S.C.</name>
      <address>
        <city>Oaxaca</city>
        <zip>68000</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Angeles Puebla</name>
      <address>
        <city>Puebla</city>
        <zip>72190</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancerologia de Queretaro S.C.</name>
      <address>
        <city>Queretaro</city>
        <zip>76090</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Infantil Teleton de Oncologia</name>
      <address>
        <city>Queretaro</city>
        <zip>76140</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital San Jose Norte</name>
      <address>
        <city>Queretaro</city>
        <zip>76158</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Nacional de Enfermedades Neoplasicas</name>
      <address>
        <city>Surquillo</city>
        <state>Lima</state>
        <zip>34</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pet Scan Peru</name>
      <address>
        <city>Lima</city>
        <zip>18</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Resocentro</name>
      <address>
        <city>Lima</city>
        <zip>18</zip>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Philippines Manila-Philippine General Hospital</name>
      <address>
        <city>Manila</city>
        <state>Metro Manila</state>
        <zip>1000</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Medical Center</name>
      <address>
        <city>Quezon City</city>
        <zip>1102</zip>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinika Nowotworow Ukladu Chlonnego Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie</name>
      <address>
        <city>Warszawa</city>
        <zip>02-781</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Euromedic Wroclawskie Centrum Medyczne II</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-420</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Euromedic Wroclawskie Centrum Medyczne III</name>
      <address>
        <city>Wroclaw</city>
        <zip>50-557</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku</name>
      <address>
        <city>Wroclaw</city>
        <zip>53-439</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Euromedic Wroclawskie Centrum Medyczne I</name>
      <address>
        <city>Wroclaw</city>
        <zip>53-439</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apteka Dolnoslaskiego Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku</name>
      <address>
        <city>Wroclaw</city>
        <zip>54-424</zip>
        <country>Poland</country>
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    </facility>
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  <location>
    <facility>
      <name>Unidade Local de Saude de Matosinhos E.P.E. - Hospital Pedro Hispano S.A.</name>
      <address>
        <city>Matosinhos</city>
        <state>Porto</state>
        <zip>4464-513</zip>
        <country>Portugal</country>
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    </facility>
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  <location>
    <facility>
      <name>Hospital de Braga</name>
      <address>
        <city>Braga</city>
        <zip>4710-243</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital CUF Descobertas</name>
      <address>
        <city>Lisboa</city>
        <zip>1998-018</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CIMC</name>
      <address>
        <city>Porto</city>
        <zip>4050-075</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Campos Costa Clinic</name>
      <address>
        <city>Porto</city>
        <zip>4050-075</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar do Porto-Hospital de Santo Antonio E.P.E.</name>
      <address>
        <city>Porto</city>
        <zip>4099 - 001</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto Portugues de Oncologia do Porto Francisco Gentil E.P.E</name>
      <address>
        <city>Porto</city>
        <zip>4200-072</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.</name>
      <address>
        <city>Vila Nova de Gaia</city>
        <zip>4434-502</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Modern Radiology, PSC</name>
      <address>
        <city>Coto Laurel</city>
        <zip>00780</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ad-Vance Medical Research, LLC</name>
      <address>
        <city>Ponce</city>
        <zip>00717</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Caribe MRI and CT</name>
      <address>
        <city>Ponce</city>
        <zip>00717</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinica de Diagnostic Rapid, Hematologie</name>
      <address>
        <city>Brasov</city>
        <zip>500152</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinica de Diagnostic Rapid SA</name>
      <address>
        <city>Brasov</city>
        <zip>500366</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic Colentina</name>
      <address>
        <city>Bucuresti</city>
        <zip>020125</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hiperdia Ritmului</name>
      <address>
        <city>Bucuresti</city>
        <zip>021675</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affidea Fundeni</name>
      <address>
        <city>Bucuresti</city>
        <zip>022328</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affidea Romania SRL</name>
      <address>
        <city>Bucuresti</city>
        <zip>022328</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic Coltea, Clinica de Hematologie</name>
      <address>
        <city>Bucuresti</city>
        <zip>030171</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institutul Oncologic Prof. Dr. Ion Chiricuta, Laborator Radiologie si Imagistica Medicala</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400015</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institutul Oncologic Prof. Dr. Ion Chiricuta, Sectia Oncologie Medicala</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400015</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica de Hematologie-Institutul Oncologic, Prof. Dr. Ion Chiricuta</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400124</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CT Clinic S.R.L.</name>
      <address>
        <city>Cluj-Napoca</city>
        <zip>400489</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.Tsyb Medical Radiological Research Centre -</name>
      <address>
        <city>Obninsk</city>
        <state>Kaluga Region</state>
        <zip>249036</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Healthcare Institution Republican Oncology Dispensary</name>
      <address>
        <city>Saransk</city>
        <state>Mordovian Republic</state>
        <zip>430032</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;SBHI of NNR &quot;&quot;Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko&quot;&quot;&quot;</name>
      <address>
        <city>Nizhniy Novgorod</city>
        <state>Nizhniy Novgorod Region</state>
        <zip>603126</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC MC &quot;MRT-Diagnostika&quot;</name>
      <address>
        <city>Nizhniy Novgorod</city>
        <state>Nizhniy Novgorod Region</state>
        <zip>603126</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSBI &quot;Russian Research Centre of Radiology and Surgical Technologies&quot; of MoH of RF</name>
      <address>
        <city>Saint-Petersburg</city>
        <state>Pesochniy TOWN</state>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSBI &quot;Russian Research Centre of Radiology and Surgical Technologies&quot;</name>
      <address>
        <city>Saint-Petersburg</city>
        <state>Pesochniy TOWN</state>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSBI &quot;Russian Research Centre of Radiology and Surgical Technologies</name>
      <address>
        <city>Saint-Petersburg</city>
        <state>Pesochniy TOWN</state>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSBI 'Russian Research Centre of Radiology and Surgical Technologies</name>
      <address>
        <city>Saint-Petersburg</city>
        <state>Pesochniy TOWN</state>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSBI &quot;Russian Research Centre of Radiology and Surgical Technologies n.a. A.M. Granov&quot; of MoH of RF</name>
      <address>
        <city>Saint-Petersburg</city>
        <state>Pesochniy</state>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSBI &quot;Russian Research Centre of Radiology and Surgical Technologies named after academician</name>
      <address>
        <city>Saint-Petersburg</city>
        <state>Pesochniy</state>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSBI &quot;Russian Research Centre of Radiology and Surgical Technologies</name>
      <address>
        <city>Saint-Petersburg</city>
        <state>Pesochniy</state>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSBI 'National Medical Oncology Research Centre n.a. N.N.Petrov'</name>
      <address>
        <city>Saint-Petersburg</city>
        <state>Pos.pesochny</state>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Branch office of LLC 'PET-Technology' at Ufa city</name>
      <address>
        <city>Ufa</city>
        <state>Republic Bashkortostan</state>
        <zip>450054</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Healthcare Institution &quot;Republican Clinical Oncology Dispensary of the Ministry</name>
      <address>
        <city>Ufa</city>
        <state>Republic Bashkortostan</state>
        <zip>450054</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private medical institution &quot;Euromedservice&quot;</name>
      <address>
        <city>Pushkin</city>
        <state>Saint Petersburg</state>
        <zip>196603</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSBI &quot;Russian Research Centre of Radiology and Surgical Technologies&quot; of MoH of RF</name>
      <address>
        <city>Pesochniy Town</city>
        <state>Saint-petersburg</state>
        <zip>197758</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Federal State-Financed Institution 'North-Caucasian Research and Clinical Center'</name>
      <address>
        <city>Lermontov</city>
        <state>Stavropol Region</state>
        <zip>357340</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SBHI of Stavropol Region &quot;Pyatigorsk Interdistrict Oncology Dispensary</name>
      <address>
        <city>Pyatigorsk</city>
        <state>Stavropol Region</state>
        <zip>357502</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;State Budget Healthcare Institution &quot;&quot;Chelyabinsk Regional Clinical Center of Oncology</name>
      <address>
        <city>Chelyabinsk</city>
        <zip>454087</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FSBSI 'N.N.Blokhin Russian Cancer Research Center' of MoH of RF</name>
      <address>
        <city>Moscow</city>
        <zip>115478</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Russian Cancer Research Centre them N.N. Blokhin</name>
      <address>
        <city>Moscow</city>
        <zip>115478</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC &quot;VitaMed&quot;</name>
      <address>
        <city>Moscow</city>
        <zip>121309</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SBHI of Moscow City Clinical Hospital n.a. S.P.Botkin of Healthcare Department of Moscow</name>
      <address>
        <city>Moscow</city>
        <zip>125284</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ramsay Diagnostics</name>
      <address>
        <city>Moscow</city>
        <zip>127473</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Institution of Healthcare &quot;Leningrad Regional Clinical Hospital&quot;</name>
      <address>
        <city>Saint Petersburg</city>
        <zip>194291</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Berezin Medical Institute</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>194214</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>N.P. Bechtereva Institute of Human Brain of the Russian Academy of Sciences</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>197376</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>N.P. Bechtereva Institute of the Human Brain of the Russian Academy of Sciences</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>197376</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
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  <location>
    <facility>
      <name>Non-state healthcare institution &quot;Road Clinical Hospital of Joint Stock Company &quot;Russian Railways&quot;</name>
      <address>
        <city>Saint-Petersurg</city>
        <zip>195271</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yaroslavl State Medical Academy</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150010</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GBUZ of Yaroslavl Region &quot;Regional Clinical Hospital&quot;</name>
      <address>
        <city>Yaroslavl</city>
        <zip>150062</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NIKSCH &amp; PARTNERS t/a CAPITAL RADIOLOGY</name>
      <address>
        <city>Groenkloof</city>
        <state>Gauteng</state>
        <zip>0181</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Medical Oncology Centre of Rosebank</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>2196</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Medical Oncology, University of Pretoria, Steve Biko Academic Hospitals Complex</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0002</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albert Alberts Stem Cell Transplant Centre</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0044</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr JN De Jong and Partners t/a East Rad</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0044</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NIKSCH &amp; PARTNERS t/a CAPITAL RADIOLOGY</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0181</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drs Sulman &amp; Partners Specialist Radiologists</name>
      <address>
        <city>Rosebank</city>
        <state>Gauteng</state>
        <zip>2196</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drs Bloch &amp; Partners Incorporated</name>
      <address>
        <city>Sandton</city>
        <state>Gauteng</state>
        <zip>2191</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Parc Tauli</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onkologikoa</name>
      <address>
        <city>San Sebastian</city>
        <state>Guipuzcoa</state>
        <zip>20014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Sanitas La Zarzuela</name>
      <address>
        <city>Aravaca</city>
        <state>Madrid</state>
        <zip>28023</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Rey Juan Carlos</name>
      <address>
        <city>Mostoles</city>
        <state>Madrid</state>
        <zip>28933</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario Virgen de la Arrixaca</name>
      <address>
        <city>El Palmar</city>
        <state>Murcia</state>
        <zip>30120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario Virgen de la Arrixaca</name>
      <address>
        <city>El Palmar</city>
        <state>Murcia</state>
        <zip>30120</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital do Meixoeiro Complejo Hospitalario Universitario de Vigo</name>
      <address>
        <city>Vigo</city>
        <state>Pontevedra</state>
        <zip>36200</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario A Coruna</name>
      <address>
        <city>A Coruna</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Modelo</name>
      <address>
        <city>A Coruna</city>
        <zip>15011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Quiron de Barcelona, IEC</name>
      <address>
        <city>Barcelona</city>
        <zip>08012</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CETIR, Centre Medic</name>
      <address>
        <city>Barcelona</city>
        <zip>08029</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiodiagnostic CETIR - Clinica del Pilar</name>
      <address>
        <city>Barcelona</city>
        <zip>08029</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta del Mar</name>
      <address>
        <city>Cadiz</city>
        <zip>11009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Fundacion Jimenez Diaz</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Sanitas La Moraleja</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro CIMES</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital universitario Virgen de la Victoria</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Mario Gallegos</name>
      <address>
        <city>Malaga</city>
        <zip>29016</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Ourense. Hematología</name>
      <address>
        <city>Ourense</city>
        <zip>32005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocio</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H. Quiron Zaragoza</name>
      <address>
        <city>Zaragoza</city>
        <zip>50006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Dia Quiron Zaragoza</name>
      <address>
        <city>Zaragoza</city>
        <zip>50012</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsspital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inselspital Bern</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apotheke, Spital STS AG</name>
      <address>
        <city>Thun</city>
        <zip>3600</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onkologiezentrum Thun-Berner Oberland Spital Sts Ag</name>
      <address>
        <city>Thun</city>
        <zip>3600</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsapotheke Zuerich</name>
      <address>
        <city>Zuerich</city>
        <zip>8006</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UniversitaetsSpital Zuerich</name>
      <address>
        <city>Zuerich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiology Unit,Department of Medicine, Faculty of Medicine, Ramathibodi Hospital,</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Radiology, Ramathibodi Hospital</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Institute</name>
      <address>
        <city>Bangkok</city>
        <zip>10400</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hacettepe Universitesi Tip Fakultesi Onkoloji Hastanesi</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Abdurrahman Yurtaslan Ankara Onkoloji Eg. ve Aras.</name>
      <address>
        <city>Ankara</city>
        <zip>06200</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ultramar Tibbi Gorunteleme Merkezi</name>
      <address>
        <city>Ankara</city>
        <zip>06420</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ultramar Tibbi Goruntuleme Merkezi</name>
      <address>
        <city>Ankara</city>
        <zip>06420</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Integra Gurses Teshis Tedavi ve Saglik Hizmetleri A.S.</name>
      <address>
        <city>Ankara</city>
        <zip>06540</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adnan Menderes University Medical Faculty</name>
      <address>
        <city>Aydin</city>
        <zip>09010</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi</name>
      <address>
        <city>Gaziantep</city>
        <zip>27310</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gaziantep Universitesi Sahinbey Arastirma ve Uygulama</name>
      <address>
        <city>Gaziantep</city>
        <zip>27310</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bezmialem Vakif Universitesi Tip Fakultesi Hastanesi</name>
      <address>
        <city>Istanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ege Universitesi Tip Fakultesi Ic Hastaliklari Anabilim Dali</name>
      <address>
        <city>Izmir</city>
        <zip>35040</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>EGE-RAD Bilgisayarli Tomografi Ozel Saglik Hizmetleri ve Malzemeleri Tic.Ltd.Sti.</name>
      <address>
        <city>Izmir</city>
        <zip>35040</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erciyes Universitesi Tip Fakultesi Nukleer Tip Laboratuvari</name>
      <address>
        <city>Kayseri</city>
        <zip>38100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erciyes Universitesi Tip Fakultesi Radyoloji Laboratuvari</name>
      <address>
        <city>Kayseri</city>
        <zip>38100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erciyes Universitesi Tip Fakultesi</name>
      <address>
        <city>Kayseri</city>
        <zip>38100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inonu Universitesi Tip Fakultesi Turgut Ozal Tip Merkezi</name>
      <address>
        <city>Malatya</city>
        <zip>44280</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Celal Bayar University Medical Faculty</name>
      <address>
        <city>Manisa</city>
        <zip>45000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ondokuz Mayis Universitesi Tip Fakultesi</name>
      <address>
        <city>Samsun</city>
        <zip>55139</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Mediks-rey International Group&quot; LLC</name>
      <address>
        <city>Obukhiv District</city>
        <state>KYIV Region</state>
        <zip>08720</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;MedX-rey International Group&quot; LLC</name>
      <address>
        <city>Obukhiv District</city>
        <state>KYIV Region</state>
        <zip>08720</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;MedX-Ray International Group&quot; LLC</name>
      <address>
        <city>Obukhiv</city>
        <state>KYIV Region</state>
        <zip>08720</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Municipal Institution &quot;&quot;Chernivtsi Regional Clinical Oncology Center&quot;&quot;,</name>
      <address>
        <city>Chernivtsi</city>
        <zip>58013</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MI 'City Dnipropetrovsk Multi-field Clin. Hospital #4 of DRC',</name>
      <address>
        <city>Dnipropetrovsk</city>
        <zip>49102</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Non-Profit Enterprise &quot;Regional Oncology Centre&quot;</name>
      <address>
        <city>Kharkiv</city>
        <zip>61070</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Institute</name>
      <address>
        <city>Kyiv</city>
        <zip>03022</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>&quot;Central City Clinical Hospital, City Oncology Center, SHEI &quot;&quot;Uzhhorod National University&quot;&quot;, Chair</name>
      <address>
        <city>Uzhhorod</city>
        <zip>88017</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Podilskyy Regional Oncology Center, Chemotherapy Department</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21029</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Municipal Establishment 'Zaporizhzhia Regional Clinical Oncology Dispensary'</name>
      <address>
        <city>Zaporizhzhia</city>
        <zip>69040</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LLC &quot;Diaservis&quot;</name>
      <address>
        <city>Zaporizhzhia</city>
        <zip>69076</zip>
        <country>Ukraine</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southend University Hospital NHS Foundation Trust</name>
      <address>
        <city>Westcliff-On-Sea</city>
        <state>Essex</state>
        <zip>SS0 0RY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cobalt Diagnostic Imaging</name>
      <address>
        <city>Cheltenham</city>
        <state>Glos.</state>
        <zip>GL53 7AS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal United Hospitals Bath NHS Foundation Trust</name>
      <address>
        <city>Bath</city>
        <zip>BA1 3NG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barts Health NHS Trust</name>
      <address>
        <city>London</city>
        <zip>EC1A 7BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Positron Emission Tomography (PET) Centre</name>
      <address>
        <city>Newcastle upon Tyne</city>
        <zip>NE4 6BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City Hospitals Sunderland NHS Foundation Trust-Sunderland Royal Hospital</name>
      <address>
        <city>Sunderland</city>
        <zip>SR4 7TP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Diagnostic Imaging</name>
      <address>
        <city>Sunderland</city>
        <zip>SR4 7TP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belarus</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Croatia</country>
    <country>France</country>
    <country>Georgia</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>India</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Lebanon</country>
    <country>Mexico</country>
    <country>Peru</country>
    <country>Philippines</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Puerto Rico</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>Thailand</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3281006</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <results_first_submitted>October 2, 2018</results_first_submitted>
  <results_first_submitted_qc>October 2, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 30, 2018</results_first_posted>
  <last_update_submitted>June 18, 2019</last_update_submitted>
  <last_update_submitted_qc>June 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>rituximab</keyword>
  <keyword>follicular lymphoma</keyword>
  <keyword>Non-Hodgkin lymphoma</keyword>
  <keyword>Non-Hodgkin's lymphoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Follicular</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rituximab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
    <ipd_url>https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 19, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT02213263/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 13, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT02213263/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>A total of 394 participants were enrolled and randomized in 1:1 ratio to 1 of the 2 study treatment arms: PF-05280586 (Rituximab-Pfizer) and Rituximab-EU (MabThera®).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Rituximab-EU</title>
          <description>Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
        </group>
        <group group_id="P2">
          <title>PF-05280586</title>
          <description>Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="198"/>
                <participants group_id="P2" count="196"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="197"/>
                <participants group_id="P2" count="196"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="170"/>
                <participants group_id="P2" count="170"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="26"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Insufficient clinical response</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>No longer willing to participate</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive disease</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-treat (ITT) population included all participants who were randomized.</population>
      <group_list>
        <group group_id="B1">
          <title>Rituximab-EU</title>
          <description>Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
        </group>
        <group group_id="B2">
          <title>PF-05280586</title>
          <description>Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="198"/>
            <count group_id="B2" value="196"/>
            <count group_id="B3" value="394"/>
          </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="58.3" spread="12.8"/>
                    <measurement group_id="B2" value="58.7" spread="12.1"/>
                    <measurement group_id="B3" value="58.5" spread="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="106"/>
                    <measurement group_id="B2" value="110"/>
                    <measurement group_id="B3" value="216"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="92"/>
                    <measurement group_id="B2" value="86"/>
                    <measurement group_id="B3" value="178"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="172"/>
                    <measurement group_id="B2" value="165"/>
                    <measurement group_id="B3" value="337"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="146"/>
                    <measurement group_id="B2" value="158"/>
                    <measurement group_id="B3" value="304"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Response Rate (ORR): Percentage of Participants With Overall Response (OR) at Week 26</title>
        <description>ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) in accordance with the revised response criteria for malignant lymphoma (Cheson 2007). CR was defined as disappearance of all evidence of disease. PR was defined as regression of measureable disease and no new sites.</description>
        <time_frame>Week 26</time_frame>
        <population>ITT population included all participants who were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab-EU</title>
            <description>Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
          <group group_id="O2">
            <title>PF-05280586</title>
            <description>Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate (ORR): Percentage of Participants With Overall Response (OR) at Week 26</title>
          <description>ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) in accordance with the revised response criteria for malignant lymphoma (Cheson 2007). CR was defined as disappearance of all evidence of disease. PR was defined as regression of measureable disease and no new sites.</description>
          <population>ITT population included all participants who were randomized.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="198"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.7" lower_limit="63.8" upper_limit="76.9"/>
                    <measurement group_id="O2" value="75.5" lower_limit="68.9" upper_limit="81.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference in ORR between PF-05280586 and rituximab-EU was computed using the stratified Mantel-Haenszel method. The 95% confidence interval for the difference was calculated using the asymptotic stratified method proposed by Miettinen and Nurminen.</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Equivalence was tested within the pre-specified margins of (-16%, 16%) 95% confidence interval.</non_inferiority_desc>
            <param_type>Difference in ORR</param_type>
            <param_value>4.66</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.16</ci_lower_limit>
            <ci_upper_limit>13.47</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
        <description>An AE was any untoward medical occurrence in participants who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious.</description>
        <time_frame>Baseline up to Week 52</time_frame>
        <population>Safety population included all participants who received at least 1 dose of any study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab-EU</title>
            <description>Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
          <group group_id="O2">
            <title>PF-05280586</title>
            <description>Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
          <description>An AE was any untoward medical occurrence in participants who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious.</description>
          <population>Safety population included all participants who received at least 1 dose of any study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="197"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="145"/>
                    <measurement group_id="O2" value="156"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
        <description>Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state. Relatedness to treatment was assessed by investigator. AEs included both serious and non-serious AEs.</description>
        <time_frame>Baseline up to Week 52</time_frame>
        <population>Safety population included all participants who received at least 1 dose of any study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab-EU</title>
            <description>Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
          <group group_id="O2">
            <title>PF-05280586</title>
            <description>Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)</title>
          <description>Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state. Relatedness to treatment was assessed by investigator. AEs included both serious and non-serious AEs.</description>
          <population>Safety population included all participants who received at least 1 dose of any study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="197"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94"/>
                    <measurement group_id="O2" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Grade 3 or Higher Treatment-Emergent Adverse Events (AEs) as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03</title>
        <description>An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 1=Mild, asymptomatic or mild symptoms, Grade 2=Moderate; minimal, local or noninvasive intervention indicated, Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life threatening) events caused participant to be in imminent danger of death. Grade 5 = death. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state.</description>
        <time_frame>Baseline up to Week 52</time_frame>
        <population>Safety population included all participants who received at least 1 dose of any study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab-EU</title>
            <description>Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
          <group group_id="O2">
            <title>PF-05280586</title>
            <description>Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Grade 3 or Higher Treatment-Emergent Adverse Events (AEs) as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03</title>
          <description>An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 1=Mild, asymptomatic or mild symptoms, Grade 2=Moderate; minimal, local or noninvasive intervention indicated, Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life threatening) events caused participant to be in imminent danger of death. Grade 5 = death. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state.</description>
          <population>Safety population included all participants who received at least 1 dose of any study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="197"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Grade 3 or Higher Treatment-Related Treatment-Emergent Adverse Events (AEs) as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03</title>
        <description>Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Grade 1=Mild, asymptomatic or mild symptoms, Grade 2=Moderate; minimal, local or noninvasive intervention indicated; Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 = death. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state.</description>
        <time_frame>Baseline up to Week 52</time_frame>
        <population>Safety population included all participants who received at least 1 dose of any study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab-EU</title>
            <description>Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
          <group group_id="O2">
            <title>PF-05280586</title>
            <description>Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Grade 3 or Higher Treatment-Related Treatment-Emergent Adverse Events (AEs) as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03</title>
          <description>Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Grade 1=Mild, asymptomatic or mild symptoms, Grade 2=Moderate; minimal, local or noninvasive intervention indicated; Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 = death. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state.</description>
          <population>Safety population included all participants who received at least 1 dose of any study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="197"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Laboratory Abnormalities</title>
        <description>Criteria for clinically significant laboratory abnormalities included total bilirubin (TB) less than (&lt;) 2*upper limit of normal (ULN), alanine aminotransferase (ALT)&lt;3*ULN; TB&lt;2*ULN, ALT more than (&gt;) 3 equal to (=) *ULN; TB&lt;2*ULN, aspartate aminotransferase (AST)&lt;3*ULN; TB&lt;2*ULN, AST&gt;=3*ULN. Data for only those categories are reported for which at least one participant had clinically significant laboratory abnormality.</description>
        <time_frame>Baseline up to Week 52</time_frame>
        <population>Safety population included all participants who received at least 1 dose of any study drug. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab-EU</title>
            <description>Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
          <group group_id="O2">
            <title>PF-05280586</title>
            <description>Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Laboratory Abnormalities</title>
          <description>Criteria for clinically significant laboratory abnormalities included total bilirubin (TB) less than (&lt;) 2*upper limit of normal (ULN), alanine aminotransferase (ALT)&lt;3*ULN; TB&lt;2*ULN, ALT more than (&gt;) 3 equal to (=) *ULN; TB&lt;2*ULN, aspartate aminotransferase (AST)&lt;3*ULN; TB&lt;2*ULN, AST&gt;=3*ULN. Data for only those categories are reported for which at least one participant had clinically significant laboratory abnormality.</description>
          <population>Safety population included all participants who received at least 1 dose of any study drug. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="197"/>
                <count group_id="O2" value="195"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TB&lt;2*ULN, ALT&lt;3*ULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="194"/>
                    <measurement group_id="O2" value="192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TB&lt;2*ULN, ALT&gt;=3*ULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TB&lt;2*ULN, AST&lt;3*ULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="196"/>
                    <measurement group_id="O2" value="195"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>TB&lt;2*ULN, AST&gt;=3*ULN</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Treatment Failure (TTF)</title>
        <description>TTF was defined as the time (in months) from date of randomization to first progression of disease based on central review, death due to any cause, or permanent discontinuation from treatment, or discontinuation from study for any reason, whichever came first. Progression was defined as any new lesion or increase by greater than or equal to (&gt;=) 50% of previously involved sites from nadir. TTF was calculated using Kaplan-Meier method.</description>
        <time_frame>From randomization until disease progression, death or permanent discontinuation from treatment/study due to any reason, or up to Week 52</time_frame>
        <population>ITT population included all participants who were randomized. Here. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab-EU</title>
            <description>Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
          <group group_id="O2">
            <title>PF-05280586</title>
            <description>Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Treatment Failure (TTF)</title>
          <description>TTF was defined as the time (in months) from date of randomization to first progression of disease based on central review, death due to any cause, or permanent discontinuation from treatment, or discontinuation from study for any reason, whichever came first. Progression was defined as any new lesion or increase by greater than or equal to (&gt;=) 50% of previously involved sites from nadir. TTF was calculated using Kaplan-Meier method.</description>
          <population>ITT population included all participants who were randomized. Here. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.</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="48"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.9" lower_limit="12.6" upper_limit="18.9"/>
                    <measurement group_id="O2" value="NA" lower_limit="12.3" upper_limit="NA">Due to smaller number of participants with an event, median and upper limit of 95% CI could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.450</p_value>
            <p_value_desc>A log-rank test stratified by follicular lymphoma international prognostic index 2 (FLIPI2) risk was used to compare the treatment groups with respect to TTF at a 2-sided alpha level of 0.05.</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.163</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.786</ci_lower_limit>
            <ci_upper_limit>1.720</ci_upper_limit>
            <estimate_desc>Hazard ratio and its confidence intervals (CIs) were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-Free Survival (PFS)</title>
        <description>PFS was defined as the time (in months) from date of randomization to first progression of disease (PD) based on central review or death due to any cause in the absence of documented PD. PD was defined as any new lesion or increase by &gt;=50% of previously involved sites from nadir. PFS was calculated using Kaplan-Meier method.</description>
        <time_frame>From randomization until disease progression or death due to any cause or up to Week 52</time_frame>
        <population>ITT population included all participants who were randomized. Here. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab-EU</title>
            <description>Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
          <group group_id="O2">
            <title>PF-05280586</title>
            <description>Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-Free Survival (PFS)</title>
          <description>PFS was defined as the time (in months) from date of randomization to first progression of disease (PD) based on central review or death due to any cause in the absence of documented PD. PD was defined as any new lesion or increase by &gt;=50% of previously involved sites from nadir. PFS was calculated using Kaplan-Meier method.</description>
          <population>ITT population included all participants who were randomized. Here. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.</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="28"/>
                <count group_id="O2" value="37"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.9" lower_limit="12.6" upper_limit="18.9"/>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Due to smaller number of participants with an event, median and upper limit of 95% CI could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.189</p_value>
            <method>Log Rank</method>
            <method_desc>A log-rank test stratified by FLIPI2 risk was used to compare the treatment groups with respect to PFS at a 2-sided alpha level of 0.05.</method_desc>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.393</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.847</ci_lower_limit>
            <ci_upper_limit>2.291</ci_upper_limit>
            <estimate_desc>Hazard ratio and its CIs were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Complete Remission (CR) at Week 26</title>
        <description>Complete Remission (CR) was defined as disappearance of all evidence of disease. CR was assessed by central review based on scans done at Week 26.</description>
        <time_frame>Week 26</time_frame>
        <population>ITT population included all participants who were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab-EU</title>
            <description>Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
          <group group_id="O2">
            <title>PF-05280586</title>
            <description>Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Complete Remission (CR) at Week 26</title>
          <description>Complete Remission (CR) was defined as disappearance of all evidence of disease. CR was assessed by central review based on scans done at Week 26.</description>
          <population>ITT population included all participants who were randomized.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="198"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.3" lower_limit="22.1" upper_limit="35.1"/>
                    <measurement group_id="O2" value="26.0" lower_limit="20.0" upper_limit="32.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Difference in CR between PF-05280586 and rituximab-EU was computed using the stratified Mantel-Haenszel method. The 95% confidence interval for the difference was calculated using the asymptotic stratified method proposed by Miettinen and Nurminen.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-11.09</ci_lower_limit>
            <ci_upper_limit>6.50</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR)</title>
        <description>DOR was defined as the time (in months) from date of the first documentation of overall response (CR or PR) to the first documentation of progressive disease (PD) based on central review or to death due to any cause in the absence of documented PD. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measureable disease and no new sites. PD was defined as any new lesion or increase by &gt;=50% of previously involved sites from nadir. DOR was calculated using Kaplan-Meier method.</description>
        <time_frame>From date of first documentation of overall response to first documentation of PD or to death due to any cause in absence of PD or up to Week 52</time_frame>
        <population>The response-evaluable population was defined as all randomized participants who received at least 1 dose of study drug, had adequate disease assessment at baseline, and at least 1 post baseline response assessment. Here. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab-EU</title>
            <description>Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
          <group group_id="O2">
            <title>PF-05280586</title>
            <description>Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DOR)</title>
          <description>DOR was defined as the time (in months) from date of the first documentation of overall response (CR or PR) to the first documentation of progressive disease (PD) based on central review or to death due to any cause in the absence of documented PD. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measureable disease and no new sites. PD was defined as any new lesion or increase by &gt;=50% of previously involved sites from nadir. DOR was calculated using Kaplan-Meier method.</description>
          <population>The response-evaluable population was defined as all randomized participants who received at least 1 dose of study drug, had adequate disease assessment at baseline, and at least 1 post baseline response assessment. Here. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.</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="19"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.4" lower_limit="10.4" upper_limit="15.4"/>
                    <measurement group_id="O2" value="NA" lower_limit="9.6" upper_limit="NA">Due to smaller number of participants with an event, median and upper limit of 95% CI could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.185</p_value>
            <p_value_desc>A log-rank test stratified by FLIPI2 risk was used to compare the treatment groups with respect to DOR at a 2-sided alpha level of 0.05.</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.492</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.823</ci_lower_limit>
            <ci_upper_limit>2.704</ci_upper_limit>
            <estimate_desc>Hazard ratio and its CIs were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival</title>
        <description>Overall survival was defined as the time (in months) from date of randomization to death due to any cause. For participants who were alive, overall survival was censored at the last contact. Overall survival was calculated using Kaplan-Meier method.</description>
        <time_frame>From randomization until death due to any cause or up to Week 52</time_frame>
        <population>ITT population included all participants who were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab-EU</title>
            <description>Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
          <group group_id="O2">
            <title>PF-05280586</title>
            <description>Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival</title>
          <description>Overall survival was defined as the time (in months) from date of randomization to death due to any cause. For participants who were alive, overall survival was censored at the last contact. Overall survival was calculated using Kaplan-Meier method.</description>
          <population>ITT population included all participants who were randomized.</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="198"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.9" lower_limit="NA" upper_limit="NA">Due to single participant with an event, lower and upper limit of 95% CI could not be calculated.</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="NA" upper_limit="NA">Due to single participant with an event, median, lower and upper limit of 95% CI could not be calculated.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.319</p_value>
            <p_value_desc>A log-rank test stratified by FLIPI2 risk was used to compare the treatment groups with respect to overall survival at a 2-sided alpha level of 0.05.</p_value_desc>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>2.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.000</ci_lower_limit>
            <ci_upper_limit_na_comment>Due to smaller number of participants with an event, upper limit of 95% CI could not be calculated.</ci_upper_limit_na_comment>
            <estimate_desc>Hazard ratio and its CIs were estimated from Cox Proportional hazards model stratified by FLIPI2 risk categorization.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Serum Concentration (Cmax) of PF-05280586 and Rituximab-EU</title>
        <time_frame>Predose (within 4 hours prior to start of infusion) on Days 1, 8, 15 and 22; within 15 minutes prior to end of infusion on Days 1 and 22</time_frame>
        <population>The pharmacokinetic analysis set (PKAS) included participants who received at least 1 dose of any study drug and who provided at least one post-dose pharmacokinetic concentration. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab-EU</title>
            <description>Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
          <group group_id="O2">
            <title>PF-05280586</title>
            <description>Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Serum Concentration (Cmax) of PF-05280586 and Rituximab-EU</title>
          <population>The pharmacokinetic analysis set (PKAS) included participants who received at least 1 dose of any study drug and who provided at least one post-dose pharmacokinetic concentration. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.</population>
          <units>nanograms per milliliter (ng/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="132"/>
                <count group_id="O2" value="138"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="334848.88" spread="33"/>
                    <measurement group_id="O2" value="337708.05" spread="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Minimum Observed (Trough) Serum Concentration (Ctrough) of PF-05280586 and Rituximab-EU</title>
        <time_frame>Predose (within 4 hours prior to the start of dosing) on Day 1, 8, 15, and 22</time_frame>
        <population>The pharmacokinetic analysis set (PKAS) included participants who received at least 1 dose of any study drug and who provided at least one post-dose pharmacokinetic concentration. Here 'Number analyzed' signifies number of participants evaluable for this outcome measure at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab-EU</title>
            <description>Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
          <group group_id="O2">
            <title>PF-05280586</title>
            <description>Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Minimum Observed (Trough) Serum Concentration (Ctrough) of PF-05280586 and Rituximab-EU</title>
          <population>The pharmacokinetic analysis set (PKAS) included participants who received at least 1 dose of any study drug and who provided at least one post-dose pharmacokinetic concentration. Here 'Number analyzed' signifies number of participants evaluable for this outcome measure at specified time points.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="197"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="195"/>
                    <count group_id="O2" value="192"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="577"/>
                    <measurement group_id="O2" value="0.01" spread="1320"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="197"/>
                    <count group_id="O2" value="194"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62311.74" spread="47"/>
                    <measurement group_id="O2" value="66669.15" spread="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="194"/>
                    <count group_id="O2" value="193"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109619.73" spread="43"/>
                    <measurement group_id="O2" value="119026.91" spread="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="194"/>
                    <count group_id="O2" value="194"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144650.79" spread="68"/>
                    <measurement group_id="O2" value="158294.91" spread="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cluster of Differentiation (CD) 19-Positive B-Cell Counts</title>
        <time_frame>Baseline, Week 2, 3, 4, 5, 13, 26, 39, 52</time_frame>
        <population>The modified ITT (mITT) Population included all participants who were randomized and received at least 1 dose of any study drug. Here 'Number analyzed' signifies number of participants evaluable for this outcome measure at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab-EU</title>
            <description>Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
          <group group_id="O2">
            <title>PF-05280586</title>
            <description>Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Cluster of Differentiation (CD) 19-Positive B-Cell Counts</title>
          <population>The modified ITT (mITT) Population included all participants who were randomized and received at least 1 dose of any study drug. Here 'Number analyzed' signifies number of participants evaluable for this outcome measure at specified time points.</population>
          <units>Cells per microliter</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="197"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="173"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114.2" lower_limit="0.6" upper_limit="2313.1"/>
                    <measurement group_id="O2" value="119.9" lower_limit="10.9" upper_limit="1310.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="168"/>
                    <count group_id="O2" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.2" upper_limit="44.8"/>
                    <measurement group_id="O2" value="0.8" lower_limit="0.2" upper_limit="136.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="149"/>
                    <count group_id="O2" value="149"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="0.2" upper_limit="19.5"/>
                    <measurement group_id="O2" value="0.6" lower_limit="0.2" upper_limit="248.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="143"/>
                    <count group_id="O2" value="114"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0.2" upper_limit="8.7"/>
                    <measurement group_id="O2" value="0.4" lower_limit="0.2" upper_limit="144.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="118"/>
                    <count group_id="O2" value="128"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0.2" upper_limit="19.0"/>
                    <measurement group_id="O2" value="0.4" lower_limit="0.2" upper_limit="19.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 13</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="103"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0.2" upper_limit="130.7"/>
                    <measurement group_id="O2" value="0.5" lower_limit="0.2" upper_limit="183.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 26</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="142"/>
                    <count group_id="O2" value="123"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" lower_limit="0.2" upper_limit="496.5"/>
                    <measurement group_id="O2" value="0.9" lower_limit="0.2" upper_limit="329.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 39</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="157"/>
                    <count group_id="O2" value="135"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.7" lower_limit="0.3" upper_limit="341.0"/>
                    <measurement group_id="O2" value="10.7" lower_limit="0.2" upper_limit="442.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="151"/>
                    <count group_id="O2" value="147"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.8" lower_limit="1.4" upper_limit="413.0"/>
                    <measurement group_id="O2" value="51.6" lower_limit="0.3" upper_limit="597.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)</title>
        <description>Human serum ADA samples were analyzed for the presence or absence of anti-rituximab antibodies or anti-PF-05280586 antibodies using the validated drug-specific assay with a tiered approach using screening, confirmation and titer/quantitation. Human NAb serum samples testing ADA positive were analyzed for the presence or absence of neutralizing anti-rituximab antibody and neutralizing anti-PF-05280586 antibody using the validated drug-specific assay with a tiered approach using screening, confirmation and titer/quantitation. Participants with their ADA titer &gt;= 1.88 were considered to be ADA positive. Only participants with a positive ADA result were further tested for NAb.</description>
        <time_frame>Baseline up to Week 52</time_frame>
        <population>Safety population included all participants who received at least 1 dose of any study drug. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab-EU</title>
            <description>Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
          <group group_id="O2">
            <title>PF-05280586</title>
            <description>Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)</title>
          <description>Human serum ADA samples were analyzed for the presence or absence of anti-rituximab antibodies or anti-PF-05280586 antibodies using the validated drug-specific assay with a tiered approach using screening, confirmation and titer/quantitation. Human NAb serum samples testing ADA positive were analyzed for the presence or absence of neutralizing anti-rituximab antibody and neutralizing anti-PF-05280586 antibody using the validated drug-specific assay with a tiered approach using screening, confirmation and titer/quantitation. Participants with their ADA titer &gt;= 1.88 were considered to be ADA positive. Only participants with a positive ADA result were further tested for NAb.</description>
          <population>Safety population included all participants who received at least 1 dose of any study drug. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="197"/>
                <count group_id="O2" value="195"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ADA Positive</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="197"/>
                    <count group_id="O2" value="195"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NAB Positive</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="39"/>
                    <count group_id="O2" value="43"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting Immune-Based Adverse Effects</title>
        <description>Immune-based adverse effects included infusion related reaction (IRR), adverse events which fulfill Sampson's criteria, and adverse events which belong to the Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) anaphylaxis or hypersensitivity reactions. Potential allergic and anaphylactic reactions were identified programmatically based on the criteria of Sampson et al, (2006).</description>
        <time_frame>Baseline up to Week 52</time_frame>
        <population>The Safety analysis population include all participants who received at least 1 dose of any study treatment.</population>
        <group_list>
          <group group_id="O1">
            <title>Rituximab-EU</title>
            <description>Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
          <group group_id="O2">
            <title>PF-05280586</title>
            <description>Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Immune-Based Adverse Effects</title>
          <description>Immune-based adverse effects included infusion related reaction (IRR), adverse events which fulfill Sampson's criteria, and adverse events which belong to the Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) anaphylaxis or hypersensitivity reactions. Potential allergic and anaphylactic reactions were identified programmatically based on the criteria of Sampson et al, (2006).</description>
          <population>The Safety analysis population include all participants who received at least 1 dose of any study treatment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="197"/>
                <count group_id="O2" value="196"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>IRR reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                    <measurement group_id="O2" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AE based on Sampson's criteria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Anaphylaxis/Hypersensitivity (SMQ)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to end of study (up to 52 weeks)</time_frame>
      <desc>Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis was performed on safety population.</desc>
      <group_list>
        <group group_id="E1">
          <title>Rituximab-EU</title>
          <description>Participants received Rituximab-EU intravenous (IV) infusion at a dose of 375 milligrams per meter square (mg/m^2) on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
        </group>
        <group group_id="E2">
          <title>PF-05280586</title>
          <description>Participants received PF-05280586 IV infusion at a dose of 375 mg/m^2 on Day 1, 8, 15, and 22. The maximum dose that could be infused in 1 day was 1125 mg.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (v20.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Intracardiac thrombus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Mesenteric artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Disease progression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Serum sickness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Escherichia sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Hepatitis B</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Kidney infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Viral sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </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="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Intervertebral disc disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Polyarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Spinal column stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Bladder cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma stage I</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of lung</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Uterine cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Colon adenoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (v20.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="143" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="153" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Lymph node pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Sinus bradycardia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Ear disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Ear pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Hypoacusis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Vertigo positional</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Thyroid cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Accommodation disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Conjunctival disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Erythema of eyelid</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Eye pruritus</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Lacrimation increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Meibomianitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Entropion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Abdominal pain lower</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Cheilitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Chronic gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Faeces soft</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Functional gastrointestinal disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Gingival pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Gingival swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Lip oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Mouth swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Odynophagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Oral discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Oral mucosal erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Paraesthesia oral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Periodontal disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Salivary gland pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Swollen tongue</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Tooth disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Axillary pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Catheter site related reaction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Face oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Facial pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Feeling abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Feeling cold</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Infusion site bruising</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Infusion site erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Infusion site extravasation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Infusion site pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Suprapubic pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic steatosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Hepatocellular injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Contrast media allergy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Cytokine release syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Hypogammaglobulinaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Acarodermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Atypical mycobacterial infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Cystitis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Enteritis infectious</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Genital herpes</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Infected bite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Otitis externa fungal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Pertussis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Purulence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Sycosis barbae</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Systemic infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Tracheitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Trichophytosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Viral pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Bone contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Chest injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" subjects_affected="58" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="49" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Neck injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Suture related complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Suture rupture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Tendon rupture</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Wound complication</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Incision site pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Blood glucose increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Blood lactate dehydrogenase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Blood potassium increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Blood pressure decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Blood thyroid stimulating hormone increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Blood urine present</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Neutrophil count increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Serum ferritin decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Breath sounds abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </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="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Dyslipidaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Fluid retention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Hypertriglyceridaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </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="6" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Bone loss</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Costochondritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Haemarthrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Joint effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Joint stiffness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Muscle contracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Muscle twitching</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Musculoskeletal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Posture abnormal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Pubic pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Spondylolisthesis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Tendon calcification</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Periarthritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Infected neoplasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Lung adenocarcinoma stage I</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Meningioma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Non-Hodgkin's lymphoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Burning sensation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Head discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Hypotonia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Intercostal neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Lethargy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Nerve compression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Polyneuropathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Restless legs syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Speech disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Tension headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Affect lability</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Gastrointestinal somatic symptom disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Panic attack</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Restlessness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Bladder spasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Calculus bladder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Nocturia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Renal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Strangury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Urinary tract pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Breast pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Breast tenderness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Genital burning sensation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Menorrhagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Metrorrhagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Scrotal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Testicular pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Vulvovaginal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Vulvovaginal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Dry throat</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Emphysema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Hyperventilation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Laryngeal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Laryngeal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Laryngeal oedema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Laryngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Nasal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Nasal pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Oropharyngeal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Paranasal sinus mucosal hypertrophy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Pharyngeal erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Pharyngeal inflammation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Pharyngeal oedema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Pharyngeal paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Respiratory disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Rhinalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Sleep apnoea syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Suffocation feeling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Throat tightness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Tonsillar disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Tonsillar erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Tonsillar hypertrophy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract inflammation</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Upper-airway cough syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Sinus disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Angioedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Asteatosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Blister</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Drug eruption</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Hyperkeratosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Intertrigo</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Nail disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Neurodermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Pruritus allergic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Rash erythematous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Scab</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Seborrhoeic dermatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Skin burning sensation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Pruritus generalised</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Scar pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Menopause</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="110"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Lymphoedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="196"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02213263
org study id: B3281006
secondary id: 2014-000132-41
secondary id: REFLECTIONS
nct id: NCT02213263
lead sponsor: 
has dmc: Yes
This study will compare the safety and effectiveness of PF-05280586 versus rituximab-EU in
      patients with CD20-positive, low tumor burden follicular lymphoma. The primary hypothesis to
      be tested in this study is that the effectiveness of PF-05280586, as measured by the Overall
      Response Rate, is similar to that of rituximab-EU.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Overall Response Rate (ORR): Percentage of Participants With Overall Response (OR) at Week 26
time frame: Week 26
description: ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) in accordance with the revised response criteria for malignant lymphoma (Cheson 2007). CR was defined as disappearance of all evidence of disease. PR was defined as regression of measureable disease and no new sites.
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Baseline up to Week 52
description: An AE was any untoward medical occurrence in participants who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious.
measure: Number of Participants With Treatment Related Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
time frame: Baseline up to Week 52
description: Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state. Relatedness to treatment was assessed by investigator. AEs included both serious and non-serious AEs.
measure: Number of Participants With Grade 3 or Higher Treatment-Emergent Adverse Events (AEs) as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03
time frame: Baseline up to Week 52
description: An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Grade 1=Mild, asymptomatic or mild symptoms, Grade 2=Moderate; minimal, local or noninvasive intervention indicated, Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life threatening) events caused participant to be in imminent danger of death. Grade 5 = death. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state.
measure: Number of Participants With Grade 3 or Higher Treatment-Related Treatment-Emergent Adverse Events (AEs) as Graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03
time frame: Baseline up to Week 52
description: Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Grade 1=Mild, asymptomatic or mild symptoms, Grade 2=Moderate; minimal, local or noninvasive intervention indicated; Grade 3 (Severe) events=unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 = death. Treatment-emergent were events after first dose of study drug that were absent before treatment or that worsened relative to pretreatment state.
measure: Number of Participants With Clinically Significant Laboratory Abnormalities
time frame: Baseline up to Week 52
description: Criteria for clinically significant laboratory abnormalities included total bilirubin (TB) less than (<) 2*upper limit of normal (ULN), alanine aminotransferase (ALT)<3*ULN; TB<2*ULN, ALT more than (>) 3 equal to (=) *ULN; TB<2*ULN, aspartate aminotransferase (AST)<3*ULN; TB<2*ULN, AST>=3*ULN. Data for only those categories are reported for which at least one participant had clinically significant laboratory abnormality.
measure: Time to Treatment Failure (TTF)
time frame: From randomization until disease progression, death or permanent discontinuation from treatment/study due to any reason, or up to Week 52
description: TTF was defined as the time (in months) from date of randomization to first progression of disease based on central review, death due to any cause, or permanent discontinuation from treatment, or discontinuation from study for any reason, whichever came first. Progression was defined as any new lesion or increase by greater than or equal to (>=) 50% of previously involved sites from nadir. TTF was calculated using Kaplan-Meier method.
measure: Progression-Free Survival (PFS)
time frame: From randomization until disease progression or death due to any cause or up to Week 52
description: PFS was defined as the time (in months) from date of randomization to first progression of disease (PD) based on central review or death due to any cause in the absence of documented PD. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. PFS was calculated using Kaplan-Meier method.
measure: Percentage of Participants With Complete Remission (CR) at Week 26
time frame: Week 26
description: Complete Remission (CR) was defined as disappearance of all evidence of disease. CR was assessed by central review based on scans done at Week 26.
measure: Duration of Response (DOR)
time frame: From date of first documentation of overall response to first documentation of PD or to death due to any cause in absence of PD or up to Week 52
description: DOR was defined as the time (in months) from date of the first documentation of overall response (CR or PR) to the first documentation of progressive disease (PD) based on central review or to death due to any cause in the absence of documented PD. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measureable disease and no new sites. PD was defined as any new lesion or increase by >=50% of previously involved sites from nadir. DOR was calculated using Kaplan-Meier method.
measure: Overall Survival
time frame: From randomization until death due to any cause or up to Week 52
description: Overall survival was defined as the time (in months) from date of randomization to death due to any cause. For participants who were alive, overall survival was censored at the last contact. Overall survival was calculated using Kaplan-Meier method.
measure: Maximum Observed Serum Concentration (Cmax) of PF-05280586 and Rituximab-EU
time frame: Predose (within 4 hours prior to start of infusion) on Days 1, 8, 15 and 22; within 15 minutes prior to end of infusion on Days 1 and 22
measure: Minimum Observed (Trough) Serum Concentration (Ctrough) of PF-05280586 and Rituximab-EU
time frame: Predose (within 4 hours prior to the start of dosing) on Day 1, 8, 15, and 22
measure: Cluster of Differentiation (CD) 19-Positive B-Cell Counts
time frame: Baseline, Week 2, 3, 4, 5, 13, 26, 39, 52
measure: Number of Participants With Positive Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)
time frame: Baseline up to Week 52
description: Human serum ADA samples were analyzed for the presence or absence of anti-rituximab antibodies or anti-PF-05280586 antibodies using the validated drug-specific assay with a tiered approach using screening, confirmation and titer/quantitation. Human NAb serum samples testing ADA positive were analyzed for the presence or absence of neutralizing anti-rituximab antibody and neutralizing anti-PF-05280586 antibody using the validated drug-specific assay with a tiered approach using screening, confirmation and titer/quantitation. Participants with their ADA titer >= 1.88 were considered to be ADA positive. Only participants with a positive ADA result were further tested for NAb.
measure: Number of Participants Reporting Immune-Based Adverse Effects
time frame: Baseline up to Week 52
description: Immune-based adverse effects included infusion related reaction (IRR), adverse events which fulfill Sampson's criteria, and adverse events which belong to the Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs) anaphylaxis or hypersensitivity reactions. Potential allergic and anaphylactic reactions were identified programmatically based on the criteria of Sampson et al, (2006).
arm group label: PF-05280586
arm group type: Experimental
arm group label: MabThera®
arm group type: Active Comparator
intervention type: Biological
intervention name: PF-05280586
description: PF-05280586 (rituximab-Pfizer) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22
arm group label: PF-05280586
intervention type: Biological
intervention name: MabThera®
description: MabThera® (rituximab-EU) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22
arm group label: MabThera®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: Austria
country: Belarus
country: Belgium
country: Brazil
country: Croatia
country: France
country: Georgia
country: Germany
country: Greece
country: India
country: Italy
country: Japan
country: Korea, Republic of
country: Lebanon
country: Mexico
country: Peru
country: Philippines
country: Poland
country: Portugal
country: Puerto Rico
country: Romania
country: Russian Federation
country: South Africa
country: Spain
country: Switzerland
country: Thailand
country: Turkey
country: Ukraine
country: United Kingdom
country: United States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3281006
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Follicular
mesh term: Rituximab
sharing ipd: Yes
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
ipd url: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 