<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/NCT03822117</url>
  </required_header>
  <id_info>
    <org_study_id>INCB 54828-207</org_study_id>
    <nct_id>NCT03822117</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)</brief_title>
  <official_title>A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)</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>
      The purpose of this study is to evaluate the efficacy and safety of pemigatinib in&#xD;
      participants with previously treated locally advanced/metastatic or surgically unresectable&#xD;
      solid tumor malignancies harboring activating FGFR mutations or translocations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    A business decision was made to to discontinue further enrollment. There were no safety&#xD;
    concerns that contributed to this decision.&#xD;
  </why_stopped>
  <start_date type="Actual">October 17, 2019</start_date>
  <completion_date type="Actual">March 29, 2022</completion_date>
  <primary_completion_date type="Actual">March 29, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This study consists of 3 cohorts that will have study drug administered in parallel, Cohort A, Cohort B, and Cohort C. There is no difference in the treatment regimen between the cohorts.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Response Rate (ORR), Defined as the Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) Based on RECIST v1.1 or RANO, in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements</measure>
    <time_frame>up to 483 days</time_frame>
    <description>Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1): CR: disappearance of all target/non-target lesions; no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters; no new lesions; no progression of non-target lesions. Per Response Assessment in Neuro-Oncology (RANO; for participants with primary brain tumors): CR: disappearance of all enhancing lesions; stable/improved non-enhancing lesions; stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable enhancing lesions; no progression of non-measurable disease; stable/improved non-enhancing lesions; stable/improved clinically. Cohort determination was based on FGFR status from a central genomics laboratory. Response data were from an independent centralized radiological review committee per RECIST v1.1 and RANO, and response was confirmed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ORR, Defined as the Percentage of Participants With a Best Overall Response of CR or PR Based on RECIST v1.1 or RANO, in Participants With Known or Likely Activating FGFR1-3 Mutations</measure>
    <time_frame>up to 449 days</time_frame>
    <description>Per RECIST v1.1: CR: disappearance of all target/non-target lesions; no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters; no new lesions; no progression of non-target lesions. Per RANO (for participants with primary brain tumors): CR: disappearance of all enhancing lesions; stable/improved non-enhancing lesions; stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable enhancing lesions; no progression of non-measurable disease; stable/improved non-enhancing lesions; stable/improved clinically. Cohort determination was based on FGFR status from a central genomics laboratory. Response data were from an independent centralized radiological review committee per RECIST v1.1 and RANO, and response was confirmed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival (PFS) in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations</measure>
    <time_frame>up to 532 days</time_frame>
    <description>PFS was defined as the time from the first dose until progressive disease (according to RECIST v1.1 or RANO for participants with primary brain tumors and assessed by an independent centralized radiological review committee) or death (whichever occurred first).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR), Defined as the First CR or PR Assessment Until Progressive Disease (PD) or Death, in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations</measure>
    <time_frame>up to 24.90 months</time_frame>
    <description>Assessment was by an independent centralized radiological review committee; response was confirmed. Per RECIST v1.1: CR: disappearance of all target (TLs)/non-target lesions (NTLs); no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of TLs, taking as a reference the baseline sum diameters; no new lesions; no progression of NTLs. PD: progression of a TL/NTL or presence of new lesion. Per RANO (participants with primary brain tumors): CR: disappearance of all enhancing lesions (ELs); stable/improved non-enhancing lesions (NELs); stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable ELs; no progression of non-measurable disease; stable/improved NELs; stable/improved clinically. PD: &gt;25% increase in sum of perpendicular diameters of all measurable ELs; significant increase of NELs; new lesions; clear clinical deterioration; failure to return for evaluation due to death/deteriorating condition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations</measure>
    <time_frame>up to 532 days</time_frame>
    <description>Overall survival was defined as the time from the first dose of study drug to death of any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-related Adverse Event (AE)</measure>
    <time_frame>up to 651 days</time_frame>
    <description>An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as AEs reported for the first time or the worsening of pre-existing events after the first dose of study treatment. Treatment-related AEs were defined as TEAEs judged as related by the investigator or with a missing causality.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">111</enrollment>
  <condition>Solid Tumor Malignancy</condition>
  <arm_group>
    <arm_group_label>Pemigatinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cohort A (Solid tumor malignancies with FGFR1-3 in frame fusions; any FGFR2 rearrangement; FGFR1/3 rearrangement with known partner*). Cohort B (Solid tumor malignancies with known or likely activating mutations (excluding kinase domain) in FGFR1-3) Cohort C (Solid tumor malignancies with FGFR1-3 known activating mutations in kinase domain; FGFR1-3 putatively activating mutations; other FGFR1/3 rearrangements* (not eligible for Cohort A)).&#xD;
*Only FGFR fusions or rearrangements with an intact kinase domain are eligible</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pemigatinib</intervention_name>
    <description>Pemigatinib administered orally once daily (QD).</description>
    <arm_group_label>Pemigatinib</arm_group_label>
    <other_name>INCB054828</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically or cytologically confirmed solid tumor malignancy that is advanced or&#xD;
             metastatic or is surgically unresectable.&#xD;
&#xD;
          -  Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain&#xD;
             tumors). Tumor lesions located in a previously irradiated area or in an area subjected&#xD;
             to other loco-regional therapy are considered measureable if progression has been&#xD;
             clearly demonstrated in the lesion.&#xD;
&#xD;
          -  Documentation of an FGFR1-3 gene mutation or translocation.&#xD;
&#xD;
          -  Objective progression after at least 1 prior therapy and no therapy available that is&#xD;
             likely to provide clinical benefit. Participants who are intolerant to or decline the&#xD;
             approved therapy are eligible only if they have no therapy available that is likely to&#xD;
             provide clinical benefit.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status 0 to 2.&#xD;
&#xD;
          -  Baseline archival tumor specimen (if less than 24 months from date of screening) or&#xD;
             willingness to undergo a pretreatment tumor biopsy to obtain the specimen. Must be a&#xD;
             tumor block or approximately 15 unstained slides from biopsy or resection of primary&#xD;
             tumor or metastasis.&#xD;
&#xD;
          -  Willingness to avoid pregnancy or fathering children.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior receipt of a selective FGFR inhibitor in the past 6 months.&#xD;
&#xD;
          -  Receipt of anticancer medications or investigational drugs for any indication or&#xD;
             reason within 28 days before first dose of pemigatinib.&#xD;
&#xD;
          -  Cannot be a candidate for potentially curative surgery.&#xD;
&#xD;
          -  Current evidence of clinically significant corneal or retinal disorder as confirmed by&#xD;
             ophthalmologic examination.&#xD;
&#xD;
          -  Radiation therapy administered within 2 weeks of enrollment/first dose of study&#xD;
             treatment.&#xD;
&#xD;
          -  Untreated brain or central nervous system (CNS) metastases or brain or CNS metastases&#xD;
             that have progressed (eg, evidence of new or enlarging brain metastasis or new&#xD;
             neurological symptoms attributable to brain or CNS metastases).&#xD;
&#xD;
          -  Known additional malignancy that is progressing or requires active treatment.&#xD;
&#xD;
          -  History of calcium and phosphate hemostasis disorder or systemic mineral imbalance&#xD;
             with ectopic calcification of soft tissues.&#xD;
&#xD;
          -  Clinically significant or uncontrolled cardiac disease.&#xD;
&#xD;
          -  Active chronic or current infectious disease requiring systemic antibiotic,&#xD;
             antifungal, or antiviral treatment within 2 weeks before enrollment (participants with&#xD;
             asymptomatic chronic infections on prophylactic treatment are allowed).&#xD;
&#xD;
          -  Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection&#xD;
             (defined as elevated transaminases or cirrhosis; chronic HBV/HCV infection with no&#xD;
             cirrhosis and no elevated transaminases is allowed).&#xD;
&#xD;
          -  Known HIV infection.&#xD;
&#xD;
          -  Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14&#xD;
             days or five half-lives (whichever is longer) before the first dose of study&#xD;
             drug/treatment.&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding.&#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>Peter Langmuir, MD</last_name>
    <role>Study Director</role>
    <affiliation>Incyte Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cancer Treatment Centers of America</name>
      <address>
        <city>Goodyear</city>
        <state>Arizona</state>
        <zip>85338</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Hospital</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Arizona Cancer Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chao Family Comprehensive Cancer Center University of California, Irvine</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Cancer Center</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Wayne Cancer Institute</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</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>Florida Cancer Specialists &amp; Research Institute</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois Cancer Specialists</name>
      <address>
        <city>Arlington Heights</city>
        <state>Illinois</state>
        <zip>60005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Edward H Kaplan &amp; Associates</name>
      <address>
        <city>Skokie</city>
        <state>Illinois</state>
        <zip>60076</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Cancer Center</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Treatment Centers of America</name>
      <address>
        <city>Zion</city>
        <state>Illinois</state>
        <zip>60099</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University Health - Arnett Cancer Care</name>
      <address>
        <city>Lafayette</city>
        <state>Indiana</state>
        <zip>47904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Cancer Center</name>
      <address>
        <city>Westwood</city>
        <state>Kansas</state>
        <zip>66205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Maine Medical Center</name>
      <address>
        <city>Lewiston</city>
        <state>Maine</state>
        <zip>04240</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Umass Memorial Medical Center, Inc.</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summit Medical Group</name>
      <address>
        <city>Florham Park</city>
        <state>New Jersey</state>
        <zip>07932</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Winthrop University Hospital</name>
      <address>
        <city>Mineola</city>
        <state>New York</state>
        <zip>11501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology Specialists of Charlotte</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Cancer Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stephenson Cancer Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwestern Regional Medical Center</name>
      <address>
        <city>Tulsa</city>
        <state>Oklahoma</state>
        <zip>74133</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Institute of Greenville Health System</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The West Clinic Pc</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Houston Methodist Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Joe Arrington Cancer Center</name>
      <address>
        <city>Lubbock</city>
        <state>Texas</state>
        <zip>79410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Specialists, Pc</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Oncology Associates-Lake Wright</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multicare Institute For Research &amp; Innovation</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Virginia University Hospitals Inc</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin Carbone Cancer Center</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Finsen Centre National Hospital</name>
      <address>
        <city>Copenhagen</city>
        <zip>02100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Bergonie</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CENTRE GEORGES FRANï¿½OIS LECLERC</name>
      <address>
        <city>Dijon Cedex</city>
        <zip>21079</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>Hospital Saint Louis</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>A.P.H. Paris Hopital Cochin</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Universitaire Du Cancer de Toulouse Oncopole</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center Freiburg</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Centre Hamburg-Eppendorf, Centre of Oncology</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsklinikum Koln</name>
      <address>
        <city>Koln</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Grosshadern Munich</name>
      <address>
        <city>Munich</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum in Tubingen</name>
      <address>
        <city>Tubingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ha Emek Medical Center</name>
      <address>
        <city>Afula</city>
        <zip>18101</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rambam Health Care Campus</name>
      <address>
        <city>Haifa</city>
        <zip>3525408</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hadassah Hebrew University Medical Center Ein Karem Hadassah</name>
      <address>
        <city>Jerusalem</city>
        <zip>90000</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>Assaf Harofeh Medical Center</name>
      <address>
        <city>Zerifin</city>
        <zip>7030000</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>L AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA POLICLINICO S. ORSOLA ï¿½ MALPIGHI</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Del Piemonte Per L Oncologia Ircc Candiolo</name>
      <address>
        <city>Candiolo</city>
        <zip>10060</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Irccs Istituto Nazionale Dei Tumori</name>
      <address>
        <city>Milan</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Nazionale Tumori Irccs Fondazione Pascale</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Nazionale Tumori Regina Elena Irccs</name>
      <address>
        <city>Roma</city>
        <zip>00144</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Ricerche Cliniche Di Verona (Crc)</name>
      <address>
        <city>Verona</city>
        <zip>37134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kyushu Cancer Center</name>
      <address>
        <city>Fukuoka</city>
        <zip>811-1395</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanazawa University Hospital</name>
      <address>
        <city>Ishikawa</city>
        <zip>920-8641</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kobe University Hospital</name>
      <address>
        <city>Kobe</city>
        <zip>650-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital</name>
      <address>
        <city>Sendai-shi</city>
        <zip>980-8574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keio University Hospital</name>
      <address>
        <city>Shinjuku-ku</city>
        <zip>160-8582</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shizuoka Cancer Center</name>
      <address>
        <city>Shizuoka</city>
        <zip>411-8777</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanagawa Cancer Center</name>
      <address>
        <city>Yokohama-shi</city>
        <zip>241-8515</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Goyang-si</city>
        <zip>10408</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <zip>13620</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Vall D Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic I Provincial</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centro Integral Oncologico Clara Campal (Ciocc)</name>
      <address>
        <city>Madrid</city>
        <zip>28050</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Regional Universitario de Malaga</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universidad de Navarra (Cun)</name>
      <address>
        <city>Pamplona</city>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Marques de Valdecilla</name>
      <address>
        <city>Santander</city>
        <zip>39008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Y Politcnico de La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inselspital - Universitaetsspital Bern</name>
      <address>
        <city>Bern</city>
        <zip>03010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitatsspital Zurich</name>
      <address>
        <city>Zuerich</city>
        <zip>08091</zip>
        <country>Switzerland</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>Imperial College Healthcare Nhs Trust - Hammersmith Hospital</name>
      <address>
        <city>London</city>
        <zip>W12 0HS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Research Institute</name>
      <address>
        <city>London</city>
        <zip>W1G 6AD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Spain</country>
    <country>Switzerland</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <results_first_submitted>February 16, 2023</results_first_submitted>
  <results_first_submitted_qc>February 16, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 15, 2023</results_first_posted>
  <last_update_submitted>March 16, 2023</last_update_submitted>
  <last_update_submitted_qc>March 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fibroblast growth factor receptor (FGFR) inhibitor</keyword>
  <keyword>FGFR mutations</keyword>
  <keyword>FGFR translocations</keyword>
  <keyword>solid tumor malignancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency</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>February 15, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT03822117/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>September 23, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT03822117/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>This study enrolled participants at 49 study sites in the United States, South Korea, United Kingdom, France, Italy, Israel, Germany, Spain, Denmark, and Japan.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements</title>
          <description>Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
        </group>
        <group group_id="P2">
          <title>Cohort B: Known or Likely Activating FGFR1-3 Mutations</title>
          <description>Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
        </group>
        <group group_id="P3">
          <title>Cohort C: Other FGFR Mutations or Arrangements</title>
          <description>Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
        </group>
        <group group_id="P4">
          <title>Other</title>
          <description>Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="49"/>
                <participants group_id="P2" count="32"/>
                <participants group_id="P3" count="26"/>
                <participants group_id="P4" count="4"/>
              </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="49"/>
                <participants group_id="P2" count="32"/>
                <participants group_id="P3" count="26"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study Terminated by Sponsor</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Disease Progression</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Never Returned to Hospital</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_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements</title>
          <description>Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
        </group>
        <group group_id="B2">
          <title>Cohort B: Known or Likely Activating FGFR1-3 Mutations</title>
          <description>Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
        </group>
        <group group_id="B3">
          <title>Cohort C: Other FGFR Mutations or Arrangements</title>
          <description>Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
        </group>
        <group group_id="B4">
          <title>Other</title>
          <description>Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</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="49"/>
            <count group_id="B2" value="32"/>
            <count group_id="B3" value="26"/>
            <count group_id="B4" value="4"/>
            <count group_id="B5" value="111"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.4" spread="11.51"/>
                    <measurement group_id="B2" value="66.0" spread="10.04"/>
                    <measurement group_id="B3" value="61.5" spread="13.32"/>
                    <measurement group_id="B4" value="48.0" spread="14.45"/>
                    <measurement group_id="B5" value="61.4" spread="12.11"/>
                  </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="28"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participant Declined to Provide</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Available</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Required in Country of Origin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Captured as &quot;Other&quot;</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Objective Response Rate (ORR), Defined as the Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) Based on RECIST v1.1 or RANO, in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements</title>
        <description>Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1): CR: disappearance of all target/non-target lesions; no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters; no new lesions; no progression of non-target lesions. Per Response Assessment in Neuro-Oncology (RANO; for participants with primary brain tumors): CR: disappearance of all enhancing lesions; stable/improved non-enhancing lesions; stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable enhancing lesions; no progression of non-measurable disease; stable/improved non-enhancing lesions; stable/improved clinically. Cohort determination was based on FGFR status from a central genomics laboratory. Response data were from an independent centralized radiological review committee per RECIST v1.1 and RANO, and response was confirmed.</description>
        <time_frame>up to 483 days</time_frame>
        <population>Efficacy Evaluable Population: all enrolled participants in Cohorts A, B, and C who received at least 1 dose of pemigatinib. Confidence interval was calculated based on the exact method for binomial distribution.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements</title>
            <description>Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Known or Likely Activating FGFR1-3 Mutations</title>
            <description>Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O3">
            <title>Cohort C: Other FGFR Mutations or Arrangements</title>
            <description>Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O4">
            <title>Other</title>
            <description>Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Response Rate (ORR), Defined as the Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) Based on RECIST v1.1 or RANO, in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements</title>
          <description>Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1): CR: disappearance of all target/non-target lesions; no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters; no new lesions; no progression of non-target lesions. Per Response Assessment in Neuro-Oncology (RANO; for participants with primary brain tumors): CR: disappearance of all enhancing lesions; stable/improved non-enhancing lesions; stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable enhancing lesions; no progression of non-measurable disease; stable/improved non-enhancing lesions; stable/improved clinically. Cohort determination was based on FGFR status from a central genomics laboratory. Response data were from an independent centralized radiological review committee per RECIST v1.1 and RANO, and response was confirmed.</description>
          <population>Efficacy Evaluable Population: all enrolled participants in Cohorts A, B, and C who received at least 1 dose of pemigatinib. Confidence interval was calculated based on the exact method for binomial distribution.</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="49"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.5" lower_limit="14.95" upper_limit="41.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>ORR, Defined as the Percentage of Participants With a Best Overall Response of CR or PR Based on RECIST v1.1 or RANO, in Participants With Known or Likely Activating FGFR1-3 Mutations</title>
        <description>Per RECIST v1.1: CR: disappearance of all target/non-target lesions; no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters; no new lesions; no progression of non-target lesions. Per RANO (for participants with primary brain tumors): CR: disappearance of all enhancing lesions; stable/improved non-enhancing lesions; stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable enhancing lesions; no progression of non-measurable disease; stable/improved non-enhancing lesions; stable/improved clinically. Cohort determination was based on FGFR status from a central genomics laboratory. Response data were from an independent centralized radiological review committee per RECIST v1.1 and RANO, and response was confirmed.</description>
        <time_frame>up to 449 days</time_frame>
        <population>Efficacy Evaluable Population. Confidence interval was calculated based on the exact method for binomial distribution.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements</title>
            <description>Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Known or Likely Activating FGFR1-3 Mutations</title>
            <description>Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O3">
            <title>Cohort C: Other FGFR Mutations or Arrangements</title>
            <description>Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O4">
            <title>Other</title>
            <description>Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>ORR, Defined as the Percentage of Participants With a Best Overall Response of CR or PR Based on RECIST v1.1 or RANO, in Participants With Known or Likely Activating FGFR1-3 Mutations</title>
          <description>Per RECIST v1.1: CR: disappearance of all target/non-target lesions; no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters; no new lesions; no progression of non-target lesions. Per RANO (for participants with primary brain tumors): CR: disappearance of all enhancing lesions; stable/improved non-enhancing lesions; stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable enhancing lesions; no progression of non-measurable disease; stable/improved non-enhancing lesions; stable/improved clinically. Cohort determination was based on FGFR status from a central genomics laboratory. Response data were from an independent centralized radiological review committee per RECIST v1.1 and RANO, and response was confirmed.</description>
          <population>Efficacy Evaluable Population. Confidence interval was calculated based on the exact method for binomial distribution.</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="0"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="9.4" lower_limit="1.98" upper_limit="25.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression-free Survival (PFS) in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations</title>
        <description>PFS was defined as the time from the first dose until progressive disease (according to RECIST v1.1 or RANO for participants with primary brain tumors and assessed by an independent centralized radiological review committee) or death (whichever occurred first).</description>
        <time_frame>up to 532 days</time_frame>
        <population>Efficacy Evaluable Population. The 95% confidence interval is calculated using the Brookmeyer and Crowley's method.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements</title>
            <description>Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Known or Likely Activating FGFR1-3 Mutations</title>
            <description>Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O3">
            <title>Cohort C: Other FGFR Mutations or Arrangements</title>
            <description>Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O4">
            <title>Other</title>
            <description>Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-free Survival (PFS) in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations</title>
          <description>PFS was defined as the time from the first dose until progressive disease (according to RECIST v1.1 or RANO for participants with primary brain tumors and assessed by an independent centralized radiological review committee) or death (whichever occurred first).</description>
          <population>Efficacy Evaluable Population. The 95% confidence interval is calculated using the Brookmeyer and Crowley's method.</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="49"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.53" lower_limit="3.58" upper_limit="6.28"/>
                    <measurement group_id="O2" value="3.68" lower_limit="2.07" upper_limit="4.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Response (DOR), Defined as the First CR or PR Assessment Until Progressive Disease (PD) or Death, in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations</title>
        <description>Assessment was by an independent centralized radiological review committee; response was confirmed. Per RECIST v1.1: CR: disappearance of all target (TLs)/non-target lesions (NTLs); no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of TLs, taking as a reference the baseline sum diameters; no new lesions; no progression of NTLs. PD: progression of a TL/NTL or presence of new lesion. Per RANO (participants with primary brain tumors): CR: disappearance of all enhancing lesions (ELs); stable/improved non-enhancing lesions (NELs); stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable ELs; no progression of non-measurable disease; stable/improved NELs; stable/improved clinically. PD: &gt;25% increase in sum of perpendicular diameters of all measurable ELs; significant increase of NELs; new lesions; clear clinical deterioration; failure to return for evaluation due to death/deteriorating condition.</description>
        <time_frame>up to 24.90 months</time_frame>
        <population>Efficacy Evaluable Population. The 95% confidence interval is calculated using the Brookmeyer and Crowley's method. Only participants with a CR or PR were analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements</title>
            <description>Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Known or Likely Activating FGFR1-3 Mutations</title>
            <description>Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O3">
            <title>Cohort C: Other FGFR Mutations or Arrangements</title>
            <description>Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O4">
            <title>Other</title>
            <description>Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Response (DOR), Defined as the First CR or PR Assessment Until Progressive Disease (PD) or Death, in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations</title>
          <description>Assessment was by an independent centralized radiological review committee; response was confirmed. Per RECIST v1.1: CR: disappearance of all target (TLs)/non-target lesions (NTLs); no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of TLs, taking as a reference the baseline sum diameters; no new lesions; no progression of NTLs. PD: progression of a TL/NTL or presence of new lesion. Per RANO (participants with primary brain tumors): CR: disappearance of all enhancing lesions (ELs); stable/improved non-enhancing lesions (NELs); stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable ELs; no progression of non-measurable disease; stable/improved NELs; stable/improved clinically. PD: &gt;25% increase in sum of perpendicular diameters of all measurable ELs; significant increase of NELs; new lesions; clear clinical deterioration; failure to return for evaluation due to death/deteriorating condition.</description>
          <population>Efficacy Evaluable Population. The 95% confidence interval is calculated using the Brookmeyer and Crowley's method. Only participants with a CR or PR were analyzed.</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="13"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.79" lower_limit="4.17" upper_limit="NA">The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.</measurement>
                    <measurement group_id="O2" value="6.93" lower_limit="4.01" upper_limit="NA">The upper limit of the confidence interval was not estimable because too few participants had disease progression or died.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations</title>
        <description>Overall survival was defined as the time from the first dose of study drug to death of any cause.</description>
        <time_frame>up to 532 days</time_frame>
        <population>Efficacy Evaluable Population. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements</title>
            <description>Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Known or Likely Activating FGFR1-3 Mutations</title>
            <description>Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O3">
            <title>Cohort C: Other FGFR Mutations or Arrangements</title>
            <description>Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O4">
            <title>Other</title>
            <description>Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations</title>
          <description>Overall survival was defined as the time from the first dose of study drug to death of any cause.</description>
          <population>Efficacy Evaluable Population. The 95% confidence interval was calculated using the Brookmeyer and Crowley's method.</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="49"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.48" lower_limit="7.79" upper_limit="NA">The upper limit of the confidence interval was not estimable because too few participants had died.</measurement>
                    <measurement group_id="O2" value="11.37" lower_limit="6.57" upper_limit="NA">The upper limit of the confidence interval was not estimable because too few participants had died.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-related Adverse Event (AE)</title>
        <description>An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as AEs reported for the first time or the worsening of pre-existing events after the first dose of study treatment. Treatment-related AEs were defined as TEAEs judged as related by the investigator or with a missing causality.</description>
        <time_frame>up to 651 days</time_frame>
        <population>Safety Population: all enrolled participants who received at least 1 dose of pemigatinib</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements</title>
            <description>Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O2">
            <title>Cohort B: Known or Likely Activating FGFR1-3 Mutations</title>
            <description>Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O3">
            <title>Cohort C: Other FGFR Mutations or Arrangements</title>
            <description>Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
          </group>
          <group group_id="O4">
            <title>Other</title>
            <description>Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-related Adverse Event (AE)</title>
          <description>An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as AEs reported for the first time or the worsening of pre-existing events after the first dose of study treatment. Treatment-related AEs were defined as TEAEs judged as related by the investigator or with a missing causality.</description>
          <population>Safety Population: all enrolled participants who received at least 1 dose of pemigatinib</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49"/>
                <count group_id="O2" value="32"/>
                <count group_id="O3" value="26"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="26"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-related AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="32"/>
                    <measurement group_id="O3" value="26"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>up to 651 days</time_frame>
      <desc>Treatment-emergent adverse events (TEAEs), defined as adverse events reported for the first time or the worsening of pre-existing events after the first dose of study treatment, are reported.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cohort A: FGFR1-3 In-frame Fusions or FGFR2 Arrangements</title>
          <description>Participants with fibroblast growth factor receptor (FGFR) 1-3 in-frame fusions or fibroblast growth factor receptor 2 (FGFR2) rearrangements self-administered oral pemigatinib at a starting dose of 13.5 milligrams (mg) once daily (QD) continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
        </group>
        <group group_id="E2">
          <title>Cohort B: Known or Likely Activating FGFR1-3 Mutations</title>
          <description>Participants with known or likely activating mutations in FGFR1-3 self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
        </group>
        <group group_id="E3">
          <title>Cohort C: Other FGFR Mutations or Arrangements</title>
          <description>Participants with other FGFR mutations or arrangements self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
        </group>
        <group group_id="E4">
          <title>Other</title>
          <description>Participants with an FGF/FGFR status for whom the local laboratory FGF/FGFR results could not be confirmed centrally self-administered oral pemigatinib at a starting dose of 13.5 mg QD continuously in 21-day cycles. Pemigatinib was administered until documented disease progression or unacceptable toxicity.</description>
        </group>
        <group group_id="E5">
          <title>Total</title>
          <description>Total</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 24</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="18" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="52" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="40" subjects_at_risk="111"/>
              </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="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Lymphopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Long QT syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Corneal erosion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Obstruction gastric</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="111"/>
              </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="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="2" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Biliary obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Fascial infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Implant site infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="3" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Post procedural haematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </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="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </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="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Pathological fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Rhabdomyolysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Metastases to central nervous system</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Spinal cord compression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Stent malfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="111"/>
              </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="49"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Ureteric obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Cutaneous calcification</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Stevens-Johnson syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 24</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="49" subjects_at_risk="49"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="26"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E5" subjects_affected="111" subjects_at_risk="111"/>
              </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="9" subjects_affected="8" subjects_at_risk="49"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="15" subjects_affected="14" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="5" subjects_affected="4" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" events="13" subjects_affected="12" subjects_at_risk="49"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="32"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="28" subjects_affected="25" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Keratitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Serous retinal detachment</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="10" subjects_affected="9" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="9" subjects_affected="8" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="10" subjects_affected="7" subjects_at_risk="49"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="18" subjects_affected="15" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="8" subjects_affected="7" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Cheilitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="20" subjects_affected="18" subjects_at_risk="49"/>
                <counts group_id="E2" events="18" subjects_affected="13" subjects_at_risk="32"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="44" subjects_affected="37" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="28" subjects_affected="19" subjects_at_risk="49"/>
                <counts group_id="E2" events="30" subjects_affected="17" subjects_at_risk="32"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="65" subjects_affected="43" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="15" subjects_affected="13" subjects_at_risk="49"/>
                <counts group_id="E2" events="13" subjects_affected="11" subjects_at_risk="32"/>
                <counts group_id="E3" events="8" subjects_affected="7" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="37" subjects_affected="32" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="7" subjects_affected="6" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Dysphagia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="49"/>
                <counts group_id="E2" events="12" subjects_affected="8" subjects_at_risk="32"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="26"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E5" events="33" subjects_affected="27" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="39" subjects_affected="27" subjects_at_risk="49"/>
                <counts group_id="E2" events="25" subjects_affected="17" subjects_at_risk="32"/>
                <counts group_id="E3" events="21" subjects_affected="13" subjects_at_risk="26"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E5" events="87" subjects_affected="59" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="14" subjects_affected="10" subjects_at_risk="49"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="25" subjects_affected="20" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="49"/>
                <counts group_id="E2" events="15" subjects_affected="11" subjects_at_risk="32"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="32" subjects_affected="27" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="14" subjects_affected="10" subjects_at_risk="49"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="32"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="29" subjects_affected="23" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="13" subjects_affected="13" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="4"/>
                <counts group_id="E5" events="8" subjects_affected="8" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Xerosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>COVID-19</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="8" subjects_affected="7" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Nail infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="32"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="15" subjects_affected="14" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="16" subjects_affected="15" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="5" subjects_affected="4" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="16" subjects_affected="14" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="9" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="20" subjects_affected="14" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="49"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="18" subjects_affected="18" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="7" subjects_affected="5" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="49"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="17" subjects_affected="16" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="14" subjects_affected="10" subjects_at_risk="49"/>
                <counts group_id="E2" events="15" subjects_affected="12" subjects_at_risk="32"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="34" subjects_affected="27" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E3" events="8" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="15" subjects_affected="8" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Hyperphosphataemia</sub_title>
                <counts group_id="E1" events="72" subjects_affected="45" subjects_at_risk="49"/>
                <counts group_id="E2" events="51" subjects_affected="27" subjects_at_risk="32"/>
                <counts group_id="E3" events="27" subjects_affected="17" subjects_at_risk="26"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="4"/>
                <counts group_id="E5" events="154" subjects_affected="93" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="8" subjects_affected="7" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="7" subjects_affected="6" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="12" subjects_affected="10" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="5" subjects_affected="4" subjects_at_risk="111"/>
              </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="12" subjects_affected="11" subjects_at_risk="49"/>
                <counts group_id="E2" events="14" subjects_affected="11" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="27" subjects_affected="23" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="8" subjects_affected="8" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="5" subjects_affected="4" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="10" subjects_affected="10" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="11" subjects_affected="10" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="9" subjects_affected="7" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="12" subjects_affected="10" subjects_at_risk="49"/>
                <counts group_id="E2" events="17" subjects_affected="14" subjects_at_risk="32"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="36" subjects_affected="30" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="7" subjects_affected="7" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Taste disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic kidney disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="5" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="5" subjects_affected="2" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="111"/>
              </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="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="12" subjects_affected="11" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="10" subjects_affected="9" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="49"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="9" subjects_affected="9" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Nasal dryness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="49"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="20" subjects_affected="20" subjects_at_risk="49"/>
                <counts group_id="E2" events="21" subjects_affected="17" subjects_at_risk="32"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="49" subjects_affected="45" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="49"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="32"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="26"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="4"/>
                <counts group_id="E5" events="21" subjects_affected="18" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="5" subjects_affected="4" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Nail discolouration</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="49"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="13" subjects_affected="13" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Nail disorder</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="49"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="10" subjects_affected="10" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Onychalgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Onycholysis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="12" subjects_affected="10" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Onychomadesis</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="49"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="32"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="18" subjects_affected="17" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Palmar-plantar erythrodysaesthesia syndrome</sub_title>
                <counts group_id="E1" events="15" subjects_affected="13" subjects_at_risk="49"/>
                <counts group_id="E2" events="11" subjects_affected="8" subjects_at_risk="32"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="31" subjects_affected="26" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="6" subjects_affected="6" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Skin exfoliation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="49"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="111"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="49"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="111"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="49"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="4"/>
                <counts group_id="E5" events="8" subjects_affected="6" subjects_at_risk="111"/>
              </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/NCT03822117
org study id: INCB 54828-207
nct id: NCT03822117
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to evaluate the efficacy and safety of pemigatinib in
      participants with previously treated locally advanced/metastatic or surgically unresectable
      solid tumor malignancies harboring activating FGFR mutations or translocations.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This study consists of 3 cohorts that will have study drug administered in parallel, Cohort A, Cohort B, and Cohort C. There is no difference in the treatment regimen between the cohorts.
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate (ORR), Defined as the Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) Based on RECIST v1.1 or RANO, in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements
time frame: up to 483 days
description: Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1): CR: disappearance of all target/non-target lesions; no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters; no new lesions; no progression of non-target lesions. Per Response Assessment in Neuro-Oncology (RANO; for participants with primary brain tumors): CR: disappearance of all enhancing lesions; stable/improved non-enhancing lesions; stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable enhancing lesions; no progression of non-measurable disease; stable/improved non-enhancing lesions; stable/improved clinically. Cohort determination was based on FGFR status from a central genomics laboratory. Response data were from an independent centralized radiological review committee per RECIST v1.1 and RANO, and response was confirmed.
measure: ORR, Defined as the Percentage of Participants With a Best Overall Response of CR or PR Based on RECIST v1.1 or RANO, in Participants With Known or Likely Activating FGFR1-3 Mutations
time frame: up to 449 days
description: Per RECIST v1.1: CR: disappearance of all target/non-target lesions; no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters; no new lesions; no progression of non-target lesions. Per RANO (for participants with primary brain tumors): CR: disappearance of all enhancing lesions; stable/improved non-enhancing lesions; stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable enhancing lesions; no progression of non-measurable disease; stable/improved non-enhancing lesions; stable/improved clinically. Cohort determination was based on FGFR status from a central genomics laboratory. Response data were from an independent centralized radiological review committee per RECIST v1.1 and RANO, and response was confirmed.
measure: Progression-free Survival (PFS) in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations
time frame: up to 532 days
description: PFS was defined as the time from the first dose until progressive disease (according to RECIST v1.1 or RANO for participants with primary brain tumors and assessed by an independent centralized radiological review committee) or death (whichever occurred first).
measure: Duration of Response (DOR), Defined as the First CR or PR Assessment Until Progressive Disease (PD) or Death, in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations
time frame: up to 24.90 months
description: Assessment was by an independent centralized radiological review committee; response was confirmed. Per RECIST v1.1: CR: disappearance of all target (TLs)/non-target lesions (NTLs); no appearance of new lesions. PR: complete disappearance or a ≥30% decrease in the sum of the diameters of TLs, taking as a reference the baseline sum diameters; no new lesions; no progression of NTLs. PD: progression of a TL/NTL or presence of new lesion. Per RANO (participants with primary brain tumors): CR: disappearance of all enhancing lesions (ELs); stable/improved non-enhancing lesions (NELs); stable/improved clinically. PR: ≥50% decrease in sum of perpendicular diameters of measurable ELs; no progression of non-measurable disease; stable/improved NELs; stable/improved clinically. PD: >25% increase in sum of perpendicular diameters of all measurable ELs; significant increase of NELs; new lesions; clear clinical deterioration; failure to return for evaluation due to death/deteriorating condition.
measure: Overall Survival in Participants With FGFR1-3 In-frame Fusions or FGFR2 Arrangements and in Participants With Known or Likely Activating FGFR1-3 Mutations
time frame: up to 532 days
description: Overall survival was defined as the time from the first dose of study drug to death of any cause.
measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) and Any Treatment-related Adverse Event (AE)
time frame: up to 651 days
description: An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. TEAEs were defined as AEs reported for the first time or the worsening of pre-existing events after the first dose of study treatment. Treatment-related AEs were defined as TEAEs judged as related by the investigator or with a missing causality.
arm group label: Pemigatinib
arm group type: Experimental
description: Cohort A (Solid tumor malignancies with FGFR1-3 in frame fusions; any FGFR2 rearrangement; FGFR1/3 rearrangement with known partner*). Cohort B (Solid tumor malignancies with known or likely activating mutations (excluding kinase domain) in FGFR1-3) Cohort C (Solid tumor malignancies with FGFR1-3 known activating mutations in kinase domain; FGFR1-3 putatively activating mutations; other FGFR1/3 rearrangements* (not eligible for Cohort A)).
*Only FGFR fusions or rearrangements with an intact kinase domain are eligible
intervention type: Drug
intervention name: Pemigatinib
description: Pemigatinib administered orally once daily (QD).
arm group label: Pemigatinib
other name: INCB054828
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Langmuir, MD
role: Study Director
affiliation: Incyte Corporation
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country: Denmark
country: France
country: Germany
country: Israel
country: Italy
country: Japan
country: Korea, Republic of
country: Spain
country: Switzerland
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: Yes
ipd description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
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: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 