<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/NCT03235544</url>
  </required_header>
  <id_info>
    <org_study_id>INCB 50465-205 (CITADEL-205)</org_study_id>
    <secondary_id>Parsaclisib</secondary_id>
    <secondary_id>2017-003148-19</secondary_id>
    <nct_id>NCT03235544</nct_id>
  </id_info>
  <brief_title>A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor</brief_title>
  <acronym>(CITADEL-205)</acronym>
  <official_title>A Phase 2, Open-Label, 2-Cohort, Multicenter Study of INCB050465, a PI3Kδ Inhibitor, in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a BTK Inhibitor (CITADEL-205)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Incyte Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Incyte Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of&#xD;
      2 parsaclisib treatment regimens in participants with relapsed or refractory mantle cell&#xD;
      lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK)&#xD;
      inhibitor.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 20, 2017</start_date>
  <completion_date type="Anticipated">April 30, 2024</completion_date>
  <primary_completion_date type="Actual">March 3, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>Up to approximately 165 weeks</time_frame>
    <description>ORR=percentage of participants with complete response(CR) or partial response(PR) per revised response criteria for lymphomas,determined by independent review committee(IRC).Criteria for CR:1.Target nodes/nodal masses of lymph nodes,extralymphatic sites regressed to≤1.5cm in longest dimension transverse diameter of lesion(LDi);2.Absence of non-measured lesion;3.Organ enlargement regressed to normal;4.No new lesions;5.Normal bone marrow morphology;if indeterminate,immunohistochemistry negative.Criteria for PR:1.Lymph nodes,extralymphatic sites- ≥50%decrease in sum of product of perpendicular diameters for multiple lesions(SPD)of up to 6 target measurable nodes,extranodal sites;if lesion is too small to measure on computed tomography(CT),assign5mm×5mm as default;if no longer visible,0×0mm.Node&gt;5mm×5mm but smaller than normal,use actual measurement.2.Absent/regressed non-measured lesions,no increase.3.Organ enlargement-Spleen regressed by&gt;50%in length beyond normal.4.No new lesions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>Up to approximately 165 weeks</time_frame>
    <description>DOR=time from first documented evidence of CR or PR until disease progression or death from any cause among participants who achieve an objective response as determined by IRC. Criteria for CR: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative. The criteria for PR included: 1.Lymph nodes and extralymphatic sites- a. ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; b. when a lesion is too small to measure on CT, assign 5 mm×5 mm as the default; c.when no longer visible, 0×0 mm. For a node &gt;5 mm×5 mm but smaller than normal, use actual measurement. 2.Non-measured lesions- Absent/regressed, but no increase. 3. Organ enlargement-Spleen must have regressed by &gt;50% in length beyond normal. 4.No new lesions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Response Rate (CRR)</measure>
    <time_frame>Up to approximately 165 weeks</time_frame>
    <description>CRR is defined as the percentage of participants with a CR as defined by response criteria for lymphomas, as determined by an IRC. The criteria for CR included: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>Up to approximately 165 weeks</time_frame>
    <description>PFS is defined as the time from the date of the first dose of study treatment until the earliest date of disease progression as determined by radiographic disease assessment provided by an IRC, or death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to approximately 165 weeks</time_frame>
    <description>OS is defined as the time from the date of the first dose of study treatment until death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best Percent Change From Baseline in Target Lesion Size</measure>
    <time_frame>Up to approximately 165 weeks</time_frame>
    <description>Target lesion size is measured by the sum of the product of diameters of all target lesion sizes and is determined by the IRC. The best percent change from Baseline is defined as the largest decrease, or smallest increase if no decrease available, from Baseline in target lesion sizes on/before new (next-line) anti-lymphoma therapy during the study. Baseline is the last nonmissing measurement obtained before the first administration of study drug. A negative percent change from Baseline indicates improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>From first dose of study drug up to approximately 165 weeks</time_frame>
    <description>An adverse event (AE) is any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug regardless of starting new anti-lymphoma therapy. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is considered to be an important medical event that may not result in death, be immediately life-threatening, or require hospitalization but may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant or may require medical or surgical intervention.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">162</enrollment>
  <condition>Lymphoma</condition>
  <arm_group>
    <arm_group_label>Cohort 1: Treatment A (Exposed to Ibrutinib)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received parsaclisib 20 mg tablets, orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks.&#xD;
Participants who were exposed to ibrutinib before enrollment were included in this group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1: Treatment B (Exposed to Ibrutinib)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks.&#xD;
Participants who were exposed to ibrutinib before enrollment were included in this group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks.&#xD;
Participants who had not received a BTK inhibitor previously were included in this group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks.&#xD;
Participants who had not received a BTK inhibitor previously were included in this group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Parsaclisib</intervention_name>
    <description>Parsaclisib tablets administered orally with water and without regard to food.</description>
    <arm_group_label>Cohort 1: Treatment A (Exposed to Ibrutinib)</arm_group_label>
    <arm_group_label>Cohort 1: Treatment B (Exposed to Ibrutinib)</arm_group_label>
    <arm_group_label>Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve)</arm_group_label>
    <arm_group_label>Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve)</arm_group_label>
    <other_name>INCB050465</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women, aged 18 years or older.&#xD;
&#xD;
          -  Documented failure to achieve at least partial response (PR) with, or documented&#xD;
             disease progression after, the most recent treatment regimen.&#xD;
&#xD;
          -  Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of central nervous system lymphoma (either primary or metastatic).&#xD;
&#xD;
          -  Prior treatment with idelalisib, other selective phosphatidylinositol 3-kinase delta&#xD;
             (PI3Kδ) inhibitors, or a pan PI3K inhibitor.&#xD;
&#xD;
          -  Allogeneic stem cell transplant within the last 6 months, or autologous stem cell&#xD;
             transplant within the last 3 months before the date of first dose of study treatment.&#xD;
&#xD;
          -  Active graft-versus-host disease.&#xD;
&#xD;
          -  Liver disease: Participants positive for hepatitis B surface antigen or hepatitis B&#xD;
             core antibody will be eligible if they are negative for hepatitis B&#xD;
             virus-deoxyribonucleic acid (HBV-DNA). Participants positive for anti-hepatitis C&#xD;
             virus (HCV) antibody will be eligible if they are negative for HCV-ribonucleic acid&#xD;
             (RNA).&#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>Fred Zheng, MD</last_name>
    <role>Study Director</role>
    <affiliation>Incyte Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama At Birmingham Comprehensive Cancer Center</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph Heritage Healthcare</name>
      <address>
        <city>Santa Rosa</city>
        <state>California</state>
        <zip>95403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Center-Aurora</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asclepes Research Centers</name>
      <address>
        <city>Brooksville</city>
        <state>Florida</state>
        <zip>34613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33647</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bond &amp; Steele Clinic, P.A.</name>
      <address>
        <city>Winter Haven</city>
        <state>Florida</state>
        <zip>33880</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois Cancer Specialists</name>
      <address>
        <city>Niles</city>
        <state>Illinois</state>
        <zip>60714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hattiesburg Clinic Hematology</name>
      <address>
        <city>Hattiesburg</city>
        <state>Mississippi</state>
        <zip>39401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Alliance, Inc.</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology Hematology Care, Inc.</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Willamette Valley Cancer Institute</name>
      <address>
        <city>Eugene</city>
        <state>Oregon</state>
        <zip>97401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente - Northwest</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gettysburg Cancer Center</name>
      <address>
        <city>Gettysburg</city>
        <state>Pennsylvania</state>
        <zip>17325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renovatio Clinical</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</name>
      <address>
        <city>Yakima</city>
        <state>Washington</state>
        <zip>98902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Jules Bordet</name>
      <address>
        <city>Brussels</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital de Jolimont</name>
      <address>
        <city>La Louviere</city>
        <zip>07100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaire Ziekenhuis Leuven - Gasthuisberg</name>
      <address>
        <city>Leuven</city>
        <zip>03000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni Nemocnice Hradec Kralove</name>
      <address>
        <city>Hradec Kralove</city>
        <zip>500 05</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni Nemocnice Kralovske Vinohrady</name>
      <address>
        <city>Prague 10</city>
        <zip>500 05</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charles University General Hospital</name>
      <address>
        <city>Prague 2</city>
        <zip>128 08</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni Nemocnice Kralovske Vinohadry, Interni Hematologicka Klinika</name>
      <address>
        <city>Prague</city>
        <zip>10034</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aalborg University Hospital</name>
      <address>
        <city>Aalborg</city>
        <zip>09000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus Universitets Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>DK-8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense Universitetshospital (Ouh) (Odense University Hospital)</name>
      <address>
        <city>Odense C</city>
        <zip>05000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zealand University Hospital</name>
      <address>
        <city>Roskilde</city>
        <zip>04000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avicenne Hospital</name>
      <address>
        <city>Bobigny</city>
        <zip>93000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chu de Clermont - Ferrand- Hospital Estaing</name>
      <address>
        <city>Clermont-ferrand</city>
        <zip>63230</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Henri Mondor</name>
      <address>
        <city>Creteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Grenoble</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Departemental - La-Roche-Sur-Yon - Les Oudairies</name>
      <address>
        <city>La Roche Sur Yon</city>
        <zip>85925</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Grenoble</name>
      <address>
        <city>La Tronche</city>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Versailles</name>
      <address>
        <city>Le Chesnay</city>
        <zip>78157</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospices Civils de Lyon Centre Hospitalier Lyon Sud</name>
      <address>
        <city>Lyon</city>
        <zip>69008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Antoine Lacassagne</name>
      <address>
        <city>Nice</city>
        <zip>06189</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Saint-Louis</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H�Pital Universitaire Piti�-Salp�Tri�Re</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Lyon-Sud</name>
      <address>
        <city>Pierre-Bénite Cedex</city>
        <zip>69310</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Henri Becquerel</name>
      <address>
        <city>Rouen</city>
        <zip>76038</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chru Hopitaux de Tours, Hospital Bretonneau</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute Gustave Roussy (Igr)</name>
      <address>
        <city>Villejuif Cedex</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Brudler, Heinrich, Bangerter</name>
      <address>
        <city>Augsburg</city>
        <zip>86150</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Essen</name>
      <address>
        <city>Essen</city>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universit�Tsklinikum Essen</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Justus-Liebig University</name>
      <address>
        <city>Giessen</city>
        <zip>35392</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kliniken Maria Hilf</name>
      <address>
        <city>Moenchengladbach</city>
        <zip>41063</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rotkreuzklinikum Munich</name>
      <address>
        <city>Munchen</city>
        <zip>80634</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universit�Tsklinikum Ulm</name>
      <address>
        <city>ULM</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Medical Center</name>
      <address>
        <city>Haifa</city>
        <zip>31096</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Hebrew University Medical Center</name>
      <address>
        <city>Jerusalem</city>
        <zip>90000</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Hebrew University Medical Center Ein Karem Hadassah</name>
      <address>
        <city>Jerusalem</city>
        <zip>91120</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rabin Medical Center - Beilinson Hospital</name>
      <address>
        <city>Petach Tikva</city>
        <zip>4841492</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Irccs Istituto Nazionale Dei Tumori</name>
      <address>
        <city>Milano</city>
        <state>MI</state>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Ricerche Cliniche</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Policlinico Vittorio Emanuele</name>
      <address>
        <city>Catania</city>
        <zip>95123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grande Ospedale Metropolitano Niguarda</name>
      <address>
        <city>Milano</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Niguarda Ca Granda</name>
      <address>
        <city>Milano</city>
        <zip>22162</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Di Modena - Policlinico</name>
      <address>
        <city>Modena</city>
        <zip>41124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.O.U. Federico Ii</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aou Maggiore Della Carita</name>
      <address>
        <city>Novara</city>
        <zip>28100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedali Riuniti Villa Sofia Cervello</name>
      <address>
        <city>Palermo</city>
        <zip>90146</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sapienza University</name>
      <address>
        <city>Rome</city>
        <zip>00161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Senese Policlinico Santa Maria Alle Scotte</name>
      <address>
        <city>Siena</city>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beskidzkie Centrum Onkologii Im.Jana Pawla Ii</name>
      <address>
        <city>Bielsko-biala</city>
        <zip>43-300</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza</name>
      <address>
        <city>Brzozow</city>
        <zip>36-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinical Center</name>
      <address>
        <city>Gdansk</city>
        <zip>80-952</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pratia McM Krakow</name>
      <address>
        <city>Krakow</city>
        <zip>30-510</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nu-Med Centrum Diagnostykii I Terapii Onkologicznej</name>
      <address>
        <city>Tomaszow Mazowiecki</city>
        <zip>97-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centrum Onkologii-Instytut Im. Marii Sklodowskiej-Curie</name>
      <address>
        <city>Warszawa</city>
        <zip>02-781</zip>
        <country>Poland</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 General Universitari Vall D Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Mutua Terrassa</name>
      <address>
        <city>Barcelona</city>
        <zip>08221</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Catala D Oncologia</name>
      <address>
        <city>Barcelona</city>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Burgos</name>
      <address>
        <city>Burgos</city>
        <zip>09006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Maranon</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Md Anderson Cancer Centre Madrid</name>
      <address>
        <city>Madrid</city>
        <zip>28033</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramon Y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion Jimenez Diaz University Hospital</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Morales Meseguer</name>
      <address>
        <city>Murcia</city>
        <zip>30008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Navarra</name>
      <address>
        <city>Pamplona</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinico Universitario de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocio</name>
      <address>
        <city>Sevilla</city>
        <zip>41005</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Arnau de Vilanova</name>
      <address>
        <city>Valencia</city>
        <zip>46015</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Dr. Peset</name>
      <address>
        <city>Valencia</city>
        <zip>46017</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Y Politecnic La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham Heartlands Hospital</name>
      <address>
        <city>Birmingham</city>
        <zip>B9 5SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western General Hospital</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH4 2XU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London Hospitals (Uclh)</name>
      <address>
        <city>London</city>
        <zip>NW1 2PG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Derriford Hospital</name>
      <address>
        <city>Plymouth</city>
        <zip>PL6 8DH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Hallamshire Hospital</name>
      <address>
        <city>Sheffield</city>
        <zip>S10 2JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <results_first_submitted>January 14, 2022</results_first_submitted>
  <results_first_submitted_qc>January 14, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 10, 2022</results_first_posted>
  <last_update_submitted>June 16, 2023</last_update_submitted>
  <last_update_submitted_qc>June 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mantle cell lymphoma</keyword>
  <keyword>non-Hodgkin lymphoma</keyword>
  <keyword>Bruton's tyrosine kinase (BTK)</keyword>
  <keyword>phosphatidylinositol 3-kinase (PI3K)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Mantle-Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data (IPD) will be made available to interested researchers after the end of study, a thorough analysis, and the publication of the data in the clinical study report (CSR). As required, results of the data will be posted to ClinicalTrials.gov. Upon request, individual investigators may obtain IPD from the sponsor. The format for data delivery will be determined between sponsor and investigator.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.</ipd_time_frame>
    <ipd_access_criteria>Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://www.incyte.com/our-company/compliance-and-transparency</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>January 30, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03235544/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>January 28, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03235544/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 76 investigative sites in France, Spain, the United States, Italy, Poland, Czech Republic, Great Britain, Denmark, Belgium, Germany, and Israel. Data are reported up to primary completion date, 3 March 2021. This study is ongoing.</recruitment_details>
      <pre_assignment_details>A total of 161 participants with relapsed or refractory mantle cell lymphoma who received 1-3 prior systemic therapies were enrolled into 2 Cohorts and treated: An additional participant was enrolled but not treated. Because this participant was not treated, he/she was not assigned to any treatment/cohort and was not included in the &quot;Full Analysis Set&quot; or &quot;Safety Population&quot; for analysis. Cohort 1 had previously received ibrutinib and Cohort 2 were Bruton's tyrosine kinase (BTK) inhibitor naive.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1: Treatment A (Exposed to Ibrutinib)</title>
          <description>Participants received parsaclisib 20 mg tablets, orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.</description>
        </group>
        <group group_id="P2">
          <title>Cohort 1: Treatment B (Exposed to Ibrutinib)</title>
          <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.</description>
        </group>
        <group group_id="P3">
          <title>Cohort 2: Treatment A (BTK Inhibitor Naïve)</title>
          <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.</description>
        </group>
        <group group_id="P4">
          <title>Cohort 2: Treatment B (BTK Inhibitor Naïve)</title>
          <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="41"/>
                <participants group_id="P3" count="31"/>
                <participants group_id="P4" count="77"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="41"/>
                <participants group_id="P3" count="31"/>
                <participants group_id="P4" count="77"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Participants Still Ongoing in the Study</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="55"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="23"/>
                <participants group_id="P3" count="11"/>
                <participants group_id="P4" count="20"/>
              </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 group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Participant</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Reason not Specified</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full Analysis Set (FAS) included all participants enrolled in the study who received at least 1 dose of parsaclisib.</population>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1: Treatment A (Exposed to Ibrutinib)</title>
          <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.</description>
        </group>
        <group group_id="B2">
          <title>Cohort 1: Treatment B (Exposed to Ibrutinib)</title>
          <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.</description>
        </group>
        <group group_id="B3">
          <title>Cohort 2: Treatment A (BTK Inhibitor Naïve)</title>
          <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.</description>
        </group>
        <group group_id="B4">
          <title>Cohort 2: Treatment B (BTK Inhibitor Naïve)</title>
          <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.</description>
        </group>
        <group group_id="B5">
          <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="12"/>
            <count group_id="B2" value="41"/>
            <count group_id="B3" value="31"/>
            <count group_id="B4" value="77"/>
            <count group_id="B5" value="161"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70.2" lower_limit="53" upper_limit="82"/>
                    <measurement group_id="B2" value="69.8" lower_limit="48" upper_limit="89"/>
                    <measurement group_id="B3" value="72.2" lower_limit="43" upper_limit="89"/>
                    <measurement group_id="B4" value="71.5" lower_limit="51" upper_limit="90"/>
                    <measurement group_id="B5" value="70.9" lower_limit="43" upper_limit="90"/>
                  </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="1"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="60"/>
                    <measurement group_id="B5" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="57"/>
                    <measurement group_id="B5" value="112"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="64"/>
                    <measurement group_id="B5" value="136"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>American-Indian/Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian/Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Objective Response Rate (ORR)</title>
        <description>ORR=percentage of participants with complete response(CR) or partial response(PR) per revised response criteria for lymphomas,determined by independent review committee(IRC).Criteria for CR:1.Target nodes/nodal masses of lymph nodes,extralymphatic sites regressed to≤1.5cm in longest dimension transverse diameter of lesion(LDi);2.Absence of non-measured lesion;3.Organ enlargement regressed to normal;4.No new lesions;5.Normal bone marrow morphology;if indeterminate,immunohistochemistry negative.Criteria for PR:1.Lymph nodes,extralymphatic sites- ≥50%decrease in sum of product of perpendicular diameters for multiple lesions(SPD)of up to 6 target measurable nodes,extranodal sites;if lesion is too small to measure on computed tomography(CT),assign5mm×5mm as default;if no longer visible,0×0mm.Node&gt;5mm×5mm but smaller than normal,use actual measurement.2.Absent/regressed non-measured lesions,no increase.3.Organ enlargement-Spleen regressed by&gt;50%in length beyond normal.4.No new lesions.</description>
        <time_frame>Up to approximately 165 weeks</time_frame>
        <population>FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Treatment A (Exposed to Ibrutinib)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: Treatment B (Exposed to Ibrutinib)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: Treatment A (BTK Inhibitor Naïve)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2: Treatment B (BTK Inhibitor Naïve)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR)</title>
          <description>ORR=percentage of participants with complete response(CR) or partial response(PR) per revised response criteria for lymphomas,determined by independent review committee(IRC).Criteria for CR:1.Target nodes/nodal masses of lymph nodes,extralymphatic sites regressed to≤1.5cm in longest dimension transverse diameter of lesion(LDi);2.Absence of non-measured lesion;3.Organ enlargement regressed to normal;4.No new lesions;5.Normal bone marrow morphology;if indeterminate,immunohistochemistry negative.Criteria for PR:1.Lymph nodes,extralymphatic sites- ≥50%decrease in sum of product of perpendicular diameters for multiple lesions(SPD)of up to 6 target measurable nodes,extranodal sites;if lesion is too small to measure on computed tomography(CT),assign5mm×5mm as default;if no longer visible,0×0mm.Node&gt;5mm×5mm but smaller than normal,use actual measurement.2.Absent/regressed non-measured lesions,no increase.3.Organ enlargement-Spleen regressed by&gt;50%in length beyond normal.4.No new lesions.</description>
          <population>FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib.</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="12"/>
                <count group_id="O2" value="41"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" lower_limit="0.2" upper_limit="38.5"/>
                    <measurement group_id="O2" value="36.6" lower_limit="22.1" upper_limit="53.1"/>
                    <measurement group_id="O3" value="64.5" lower_limit="45.4" upper_limit="80.8"/>
                    <measurement group_id="O4" value="70.1" lower_limit="58.6" upper_limit="80.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR)</title>
        <description>DOR=time from first documented evidence of CR or PR until disease progression or death from any cause among participants who achieve an objective response as determined by IRC. Criteria for CR: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative. The criteria for PR included: 1.Lymph nodes and extralymphatic sites- a. ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; b. when a lesion is too small to measure on CT, assign 5 mm×5 mm as the default; c.when no longer visible, 0×0 mm. For a node &gt;5 mm×5 mm but smaller than normal, use actual measurement. 2.Non-measured lesions- Absent/regressed, but no increase. 3. Organ enlargement-Spleen must have regressed by &gt;50% in length beyond normal. 4.No new lesions.</description>
        <time_frame>Up to approximately 165 weeks</time_frame>
        <population>FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib. Only participants with objective response were analyzed for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Treatment A (Exposed to Ibrutinib)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: Treatment B (Exposed to Ibrutinib)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: Treatment A (BTK Inhibitor Naïve)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2: Treatment B (BTK Inhibitor Naïve)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DOR)</title>
          <description>DOR=time from first documented evidence of CR or PR until disease progression or death from any cause among participants who achieve an objective response as determined by IRC. Criteria for CR: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative. The criteria for PR included: 1.Lymph nodes and extralymphatic sites- a. ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; b. when a lesion is too small to measure on CT, assign 5 mm×5 mm as the default; c.when no longer visible, 0×0 mm. For a node &gt;5 mm×5 mm but smaller than normal, use actual measurement. 2.Non-measured lesions- Absent/regressed, but no increase. 3. Organ enlargement-Spleen must have regressed by &gt;50% in length beyond normal. 4.No new lesions.</description>
          <population>FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib. Only participants with objective response were analyzed 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="1"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="20"/>
                <count group_id="O4" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">The median, lower and upper limits of 95% confidence interval (CI) were not estimable due to low number of participants with event.</measurement>
                    <measurement group_id="O2" value="3.71" lower_limit="1.87" upper_limit="7.95"/>
                    <measurement group_id="O3" value="17.45" lower_limit="3.81" upper_limit="NA">The upper limit of 95% CI was not estimable due to low number of participants with event.</measurement>
                    <measurement group_id="O4" value="12.09" lower_limit="9.03" upper_limit="NA">The upper limit of 95% CI was not estimable due to low number of participants with event.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Complete Response Rate (CRR)</title>
        <description>CRR is defined as the percentage of participants with a CR as defined by response criteria for lymphomas, as determined by an IRC. The criteria for CR included: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative.</description>
        <time_frame>Up to approximately 165 weeks</time_frame>
        <population>FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Treatment A (Exposed to Ibrutinib)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: Treatment B (Exposed to Ibrutinib)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: Treatment A (BTK Inhibitor Naïve)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2: Treatment B (BTK Inhibitor Naïve)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Complete Response Rate (CRR)</title>
          <description>CRR is defined as the percentage of participants with a CR as defined by response criteria for lymphomas, as determined by an IRC. The criteria for CR included: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative.</description>
          <population>FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib.</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="12"/>
                <count group_id="O2" value="41"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="26.5"/>
                    <measurement group_id="O2" value="2.4" lower_limit="0.1" upper_limit="12.9"/>
                    <measurement group_id="O3" value="22.6" lower_limit="9.6" upper_limit="41.1"/>
                    <measurement group_id="O4" value="15.6" lower_limit="8.3" upper_limit="25.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-Free Survival (PFS)</title>
        <description>PFS is defined as the time from the date of the first dose of study treatment until the earliest date of disease progression as determined by radiographic disease assessment provided by an IRC, or death from any cause.</description>
        <time_frame>Up to approximately 165 weeks</time_frame>
        <population>FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Treatment A (Exposed to Ibrutinib)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: Treatment B (Exposed to Ibrutinib)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: Treatment A (BTK Inhibitor Naïve)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2: Treatment B (BTK Inhibitor Naïve)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-Free Survival (PFS)</title>
          <description>PFS is defined as the time from the date of the first dose of study treatment until the earliest date of disease progression as determined by radiographic disease assessment provided by an IRC, or death from any cause.</description>
          <population>FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib.</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="12"/>
                <count group_id="O2" value="41"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.94" lower_limit="1.35" upper_limit="NA">The upper limit of 95% CI was not estimable due to low number of participants with event.</measurement>
                    <measurement group_id="O2" value="3.68" lower_limit="1.87" upper_limit="4.14"/>
                    <measurement group_id="O3" value="8.11" lower_limit="5.29" upper_limit="21.62"/>
                    <measurement group_id="O4" value="13.60" lower_limit="10.02" upper_limit="16.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>OS is defined as the time from the date of the first dose of study treatment until death from any cause.</description>
        <time_frame>Up to approximately 165 weeks</time_frame>
        <population>FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Treatment A (Exposed to Ibrutinib)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: Treatment B (Exposed to Ibrutinib)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: Treatment A (BTK Inhibitor Naïve)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2: Treatment B (BTK Inhibitor Naïve)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>OS is defined as the time from the date of the first dose of study treatment until death from any cause.</description>
          <population>FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib.</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="12"/>
                <count group_id="O2" value="41"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.91" lower_limit="1.35" upper_limit="17.64"/>
                    <measurement group_id="O2" value="11.01" lower_limit="7.92" upper_limit="18.40"/>
                    <measurement group_id="O3" value="NA" lower_limit="21.62" upper_limit="NA">The median, and upper limit of 95% CI were not estimable due to low number of participants with event.</measurement>
                    <measurement group_id="O4" value="NA" lower_limit="24.44" upper_limit="NA">The median, and upper limit of 95% CI were not estimable due to low number of participants with event.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Best Percent Change From Baseline in Target Lesion Size</title>
        <description>Target lesion size is measured by the sum of the product of diameters of all target lesion sizes and is determined by the IRC. The best percent change from Baseline is defined as the largest decrease, or smallest increase if no decrease available, from Baseline in target lesion sizes on/before new (next-line) anti-lymphoma therapy during the study. Baseline is the last nonmissing measurement obtained before the first administration of study drug. A negative percent change from Baseline indicates improvement.</description>
        <time_frame>Up to approximately 165 weeks</time_frame>
        <population>FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib. Overall number analyzed are the number of participants with data available for analyses.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Treatment A (Exposed to Ibrutinib)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: Treatment B (Exposed to Ibrutinib)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: Treatment A (BTK Inhibitor Naïve)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2: Treatment B (BTK Inhibitor Naïve)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Best Percent Change From Baseline in Target Lesion Size</title>
          <description>Target lesion size is measured by the sum of the product of diameters of all target lesion sizes and is determined by the IRC. The best percent change from Baseline is defined as the largest decrease, or smallest increase if no decrease available, from Baseline in target lesion sizes on/before new (next-line) anti-lymphoma therapy during the study. Baseline is the last nonmissing measurement obtained before the first administration of study drug. A negative percent change from Baseline indicates improvement.</description>
          <population>FAS included all participants enrolled in the study who received at least 1 dose of parsaclisib. Overall number analyzed are the number of participants with data available for analyses.</population>
          <units>percent change in lesion size</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="25"/>
                <count group_id="O4" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-19.82" spread="35.926"/>
                    <measurement group_id="O2" value="-7.41" spread="135.103"/>
                    <measurement group_id="O3" value="-64.49" spread="53.354"/>
                    <measurement group_id="O4" value="-67.61" spread="32.222"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</title>
        <description>An adverse event (AE) is any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug regardless of starting new anti-lymphoma therapy. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is considered to be an important medical event that may not result in death, be immediately life-threatening, or require hospitalization but may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant or may require medical or surgical intervention.</description>
        <time_frame>From first dose of study drug up to approximately 165 weeks</time_frame>
        <population>Safety Population included all enrolled participants who received at least 1 dose of parsaclisib.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1: Treatment A (Exposed to Ibrutinib)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1: Treatment B (Exposed to Ibrutinib)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: Treatment A (BTK Inhibitor Naïve)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.</description>
          </group>
          <group group_id="O4">
            <title>Cohort 2: Treatment B (BTK Inhibitor Naïve)</title>
            <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</title>
          <description>An adverse event (AE) is any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug regardless of starting new anti-lymphoma therapy. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is considered to be an important medical event that may not result in death, be immediately life-threatening, or require hospitalization but may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant or may require medical or surgical intervention.</description>
          <population>Safety Population included all enrolled participants who received at least 1 dose of parsaclisib.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="41"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.3"/>
                    <measurement group_id="O2" value="87.8"/>
                    <measurement group_id="O3" value="93.5"/>
                    <measurement group_id="O4" value="89.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.7"/>
                    <measurement group_id="O2" value="41.5"/>
                    <measurement group_id="O3" value="35.5"/>
                    <measurement group_id="O4" value="45.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of study drug up to approximately 182 weeks (up to data cut-off: 14 May 2021)</time_frame>
      <desc>Safety Population included all enrolled participants who received at least 1 dose of parsaclisib.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cohort 1: Treatment A (Exposed to Ibrutinib)</title>
          <description>Participants received parsaclisib 20 mg tablets, orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.</description>
        </group>
        <group group_id="E2">
          <title>Cohort 1: Treatment B (Exposed to Ibrutinib)E</title>
          <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.</description>
        </group>
        <group group_id="E3">
          <title>Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve)</title>
          <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who had not received a BTK inhibitor previously were included in this group.</description>
        </group>
        <group group_id="E4">
          <title>Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve)</title>
          <description>Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who were not exposed to BTK inhibitor before enrollment were included in this group.</description>
        </group>
        <group group_id="E5">
          <title>Total</title>
          <description>Total</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 23.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="20" subjects_at_risk="77"/>
                <counts group_id="E5" subjects_affected="65" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="35" subjects_at_risk="77"/>
                <counts group_id="E5" subjects_affected="68" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia supraventricular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Autoimmune colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="77"/>
                <counts group_id="E5" events="7" subjects_affected="7" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="10" subjects_affected="10" subjects_at_risk="77"/>
                <counts group_id="E5" events="17" subjects_affected="14" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Incarcerated inguinal hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Intestinal perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Oesophagitis ulcerative</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Hyperthermia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Nodule</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Sudden death</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatocellular injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Cytomegalovirus infection reactivation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Endocarditis staphylococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Parainfluenzae virus infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Pneumocystis jirovecii pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Pneumonia pneumococcal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Spinal fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Eastern Cooperative Oncology Group performance status worsened</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Diabetic metabolic decompensation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Spondylitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Acute myelomonocytic leukaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Mantle cell lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis exfoliative</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Dermatitis psoriasiform</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Drug reaction with eosinophilia and systemic symptoms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 23.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="12"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="41"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="61" subjects_at_risk="77"/>
                <counts group_id="E5" subjects_affected="124" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="12"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="41"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E4" events="9" subjects_affected="6" subjects_at_risk="77"/>
                <counts group_id="E5" events="26" subjects_affected="20" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Eosinophilia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" events="8" subjects_affected="5" subjects_at_risk="41"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E4" events="10" subjects_affected="9" subjects_at_risk="77"/>
                <counts group_id="E5" events="24" subjects_affected="19" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="6" subjects_affected="5" subjects_at_risk="77"/>
                <counts group_id="E5" events="14" subjects_affected="11" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial flutter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="77"/>
                <counts group_id="E5" events="7" subjects_affected="7" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E4" events="12" subjects_affected="11" subjects_at_risk="77"/>
                <counts group_id="E5" events="20" subjects_affected="18" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" events="14" subjects_affected="10" subjects_at_risk="41"/>
                <counts group_id="E3" events="8" subjects_affected="6" subjects_at_risk="31"/>
                <counts group_id="E4" events="31" subjects_affected="23" subjects_at_risk="77"/>
                <counts group_id="E5" events="56" subjects_affected="41" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="77"/>
                <counts group_id="E5" events="15" subjects_affected="14" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E5" events="7" subjects_affected="7" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="41"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="11" subjects_affected="10" subjects_at_risk="77"/>
                <counts group_id="E5" events="21" subjects_affected="20" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="77"/>
                <counts group_id="E5" events="14" subjects_affected="14" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="77"/>
                <counts group_id="E5" events="13" subjects_affected="11" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="41"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="31"/>
                <counts group_id="E4" events="14" subjects_affected="11" subjects_at_risk="77"/>
                <counts group_id="E5" events="25" subjects_affected="22" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E5" events="9" subjects_affected="7" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E5" events="9" subjects_affected="7" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="77"/>
                <counts group_id="E5" events="10" subjects_affected="9" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="7" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E5" events="9" subjects_affected="4" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Pseudomonas test positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Respiratory rate increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="8" subjects_affected="7" subjects_at_risk="77"/>
                <counts group_id="E5" events="14" subjects_affected="13" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="77"/>
                <counts group_id="E5" events="12" subjects_affected="12" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Hypernatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="5" subjects_affected="3" subjects_at_risk="77"/>
                <counts group_id="E5" events="12" subjects_affected="8" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="11" subjects_affected="8" subjects_at_risk="77"/>
                <counts group_id="E5" events="12" subjects_affected="9" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="77"/>
                <counts group_id="E5" events="11" subjects_affected="11" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="31"/>
                <counts group_id="E4" events="6" subjects_affected="6" subjects_at_risk="77"/>
                <counts group_id="E5" events="12" subjects_affected="12" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="77"/>
                <counts group_id="E5" events="6" subjects_affected="5" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E5" events="7" subjects_affected="6" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="77"/>
                <counts group_id="E5" events="9" subjects_affected="8" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="77"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="5" subjects_affected="3" subjects_at_risk="77"/>
                <counts group_id="E5" events="9" subjects_affected="6" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Testicular oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="41"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="10" subjects_affected="9" subjects_at_risk="77"/>
                <counts group_id="E5" events="18" subjects_affected="17" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="41"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="31"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E5" events="9" subjects_affected="9" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="77"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="77"/>
                <counts group_id="E5" events="8" subjects_affected="7" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="41"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="31"/>
                <counts group_id="E4" events="13" subjects_affected="11" subjects_at_risk="77"/>
                <counts group_id="E5" events="19" subjects_affected="17" subjects_at_risk="161"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="12"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="41"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="31"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="77"/>
                <counts group_id="E5" events="7" subjects_affected="7" subjects_at_risk="161"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="41"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="77"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="161"/>
              </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>Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Incyte Corporation</organization>
      <phone>1-855-463-3463</phone>
      <email>medinfo@incyte.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/NCT03235544
org study id: INCB 50465-205 (CITADEL-205)
secondary id: Parsaclisib
secondary id: 2017-003148-19
nct id: NCT03235544
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 2, open-label, 2-cohort study designed to evaluate the efficacy and safety of
      2 parsaclisib treatment regimens in participants with relapsed or refractory mantle cell
      lymphoma (MCL) previously treated either with or without a Bruton's tyrosine kinase (BTK)
      inhibitor.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate (ORR)
time frame: Up to approximately 165 weeks
description: ORR=percentage of participants with complete response(CR) or partial response(PR) per revised response criteria for lymphomas,determined by independent review committee(IRC).Criteria for CR:1.Target nodes/nodal masses of lymph nodes,extralymphatic sites regressed to≤1.5cm in longest dimension transverse diameter of lesion(LDi);2.Absence of non-measured lesion;3.Organ enlargement regressed to normal;4.No new lesions;5.Normal bone marrow morphology;if indeterminate,immunohistochemistry negative.Criteria for PR:1.Lymph nodes,extralymphatic sites- ≥50%decrease in sum of product of perpendicular diameters for multiple lesions(SPD)of up to 6 target measurable nodes,extranodal sites;if lesion is too small to measure on computed tomography(CT),assign5mm×5mm as default;if no longer visible,0×0mm.Node>5mm×5mm but smaller than normal,use actual measurement.2.Absent/regressed non-measured lesions,no increase.3.Organ enlargement-Spleen regressed by>50%in length beyond normal.4.No new lesions.
measure: Duration of Response (DOR)
time frame: Up to approximately 165 weeks
description: DOR=time from first documented evidence of CR or PR until disease progression or death from any cause among participants who achieve an objective response as determined by IRC. Criteria for CR: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative. The criteria for PR included: 1.Lymph nodes and extralymphatic sites- a. ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; b. when a lesion is too small to measure on CT, assign 5 mm×5 mm as the default; c.when no longer visible, 0×0 mm. For a node >5 mm×5 mm but smaller than normal, use actual measurement. 2.Non-measured lesions- Absent/regressed, but no increase. 3. Organ enlargement-Spleen must have regressed by >50% in length beyond normal. 4.No new lesions.
measure: Complete Response Rate (CRR)
time frame: Up to approximately 165 weeks
description: CRR is defined as the percentage of participants with a CR as defined by response criteria for lymphomas, as determined by an IRC. The criteria for CR included: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative.
measure: Progression-Free Survival (PFS)
time frame: Up to approximately 165 weeks
description: PFS is defined as the time from the date of the first dose of study treatment until the earliest date of disease progression as determined by radiographic disease assessment provided by an IRC, or death from any cause.
measure: Overall Survival (OS)
time frame: Up to approximately 165 weeks
description: OS is defined as the time from the date of the first dose of study treatment until death from any cause.
measure: Best Percent Change From Baseline in Target Lesion Size
time frame: Up to approximately 165 weeks
description: Target lesion size is measured by the sum of the product of diameters of all target lesion sizes and is determined by the IRC. The best percent change from Baseline is defined as the largest decrease, or smallest increase if no decrease available, from Baseline in target lesion sizes on/before new (next-line) anti-lymphoma therapy during the study. Baseline is the last nonmissing measurement obtained before the first administration of study drug. A negative percent change from Baseline indicates improvement.
measure: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
time frame: From first dose of study drug up to approximately 165 weeks
description: An adverse event (AE) is any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug regardless of starting new anti-lymphoma therapy. A SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is considered to be an important medical event that may not result in death, be immediately life-threatening, or require hospitalization but may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant or may require medical or surgical intervention.
arm group label: Cohort 1: Treatment A (Exposed to Ibrutinib)
arm group type: Experimental
description: Participants received parsaclisib 20 mg tablets, orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks.
Participants who were exposed to ibrutinib before enrollment were included in this group.
arm group label: Cohort 1: Treatment B (Exposed to Ibrutinib)
arm group type: Experimental
description: Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks.
Participants who were exposed to ibrutinib before enrollment were included in this group.
arm group label: Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve)
arm group type: Experimental
description: Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks.
Participants who had not received a BTK inhibitor previously were included in this group.
arm group label: Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve)
arm group type: Experimental
description: Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks.
Participants who had not received a BTK inhibitor previously were included in this group.
intervention type: Drug
intervention name: Parsaclisib
description: Parsaclisib tablets administered orally with water and without regard to food.
arm group label: Cohort 1: Treatment A (Exposed to Ibrutinib)
arm group label: Cohort 1: Treatment B (Exposed to Ibrutinib)
arm group label: Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve)
arm group label: Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve)
other name: INCB050465
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fred Zheng, MD
role: Study Director
affiliation: Incyte Corporation
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country: Belgium
country: Czechia
country: Denmark
country: France
country: Germany
country: Israel
country: Italy
country: Poland
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Mantle-Cell
sharing ipd: Yes
ipd description: Individual participant data (IPD) will be made available to interested researchers after the end of study, a thorough analysis, and the publication of the data in the clinical study report (CSR). As required, results of the data will be posted to ClinicalTrials.gov. Upon request, individual investigators may obtain IPD from the sponsor. The format for data delivery will be determined between sponsor and investigator.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
ipd access criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
ipd url: https://www.incyte.com/our-company/compliance-and-transparency
provided document: 
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participant flow: 
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reported events: 
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