<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/NCT02981342</url>
  </required_header>
  <id_info>
    <org_study_id>16342</org_study_id>
    <secondary_id>I3Y-MC-JPCJ</secondary_id>
    <secondary_id>2016-002218-36</secondary_id>
    <nct_id>NCT02981342</nct_id>
  </id_info>
  <brief_title>A Study of Abemaciclib (LY2835219) Alone or in Combination With Other Agents in Participants With Previously Treated Pancreatic Ductal Adenocarcinoma</brief_title>
  <official_title>An Adaptive, Open-Label, Randomized Phase 2 Study of Abemaciclib as a Monotherapy and in Combination With Other Agents Versus Choice of Standard of Care (Gemcitabine or Capecitabine) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of abemaciclib alone and in&#xD;
      combination with other drugs versus standard of care in participants with previously treated&#xD;
      metastatic pancreatic ductal adenocarcinoma (PDAC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 12, 2017</start_date>
  <completion_date type="Actual">November 9, 2018</completion_date>
  <primary_completion_date type="Actual">April 20, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Stage 1: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)</measure>
    <time_frame>Baseline to Measured Progressive Disease or Start of New Anticancer Therapy (Up to 6 Months)</time_frame>
    <description>Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stage 2: Progression Free Survival (PFS)</measure>
    <time_frame>Baseline to Measured Progressive Disease or Death Due to Any Cause (Up to 6 Months)</time_frame>
    <description>PFS was defined as the time from the date of randomization until first observation of objective progressive disease as defined by RECIST v1.1 or death from any cause, whichever comes first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a patient does not have a complete baseline disease assessment, then the PFS time will be censored at the randomization date, regardless of whether or not objectively determined disease progression or death has been observed for the patient; otherwise, if a patient is not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time will be censored at the last complete objective progression-free disease assessment date.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stage 1: Objective Response Rate (ORR): Percentage of Participants With a Best Overall Response (BOR) of CR or PR</measure>
    <time_frame>Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Up to 6 Months)</time_frame>
    <description>Objective response rate (ORR) is the percentage of participants with a BOR of CR or PR as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib and Its Metabolites (LSN2839567 (M2), LSN3106726 (M20))</measure>
    <time_frame>Cycle(C)1 Day(D)14: 0 hour(h),0.5h,1h,2h,4h,6h,8h post dose</time_frame>
    <description>Mean steady state exposure was reported as measured by maximum observed plasma concentration (Cmax).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: PK: Area Under the Curve (AUC) (AUC[Tau]) of LY3023414</measure>
    <time_frame>Cycle 1 Day 1 through Cycle 4 Day 1 (28 Day Cycles)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: PK: Maximum Concentration (Cmax) at Steady State of LY3023414</measure>
    <time_frame>Cycle 1 Day 1 through Cycle 4 Day 1 (28 Day Cycles)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and SD</measure>
    <time_frame>Baseline to Measured Progressive Disease or Start of New Anticancer Therapy (Up to 6 Months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2: Clinical Benefit Rate (CBR): Percentage of Participants With Best Overall Response of CR, PR, or SD With Duration of SD for at Least 6 Months</measure>
    <time_frame>Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 6 Months)</time_frame>
    <description>Clinical benefit rate (CBR) is the percentage of participants with a BOR of CR or PR, or SD ≥6 months. CR is defined as the disappearance of all target and non-target lesions &amp; no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.&#xD;
No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2: Duration of Response (DoR)</measure>
    <time_frame>Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Up to 6 Months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2: Overall Survival (OS)</measure>
    <time_frame>Baseline to Death from Any Cause (Up to 10 Months)</time_frame>
    <description>OS duration is measured from the date of randomization to the date of death from any cause. for participants who is not known to have died as of the data-inclusion cutoff date, OS was censored at the last known alive date.&#xD;
No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2: Change From Baseline in Carbohydrate Antigen 19.9 (CA 19-9) Level</measure>
    <time_frame>Baseline, 6 Months</time_frame>
    <description>No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2: Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)</measure>
    <time_frame>Baseline, 6 Months</time_frame>
    <description>mBPI-sf is an 11-item instrument used as a multiple-item measure of cancer pain intensity. In addition to pain intensity (4 items), the mBPI-sf is designed for participants to record the presence of pain in general, pain relief, and pain interference with function (general activity, mood, ability to walk, ability to perform normal work, relations with others, sleep, and enjoyment of life). Responses for the mBPI-sf items are captured through the use of 11-point numeric rating scales anchored at 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). The mBPI-sf recall period is 24 hours, and typical completion time for this instrument is less than 5 minutes.&#xD;
No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 2: Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)</measure>
    <time_frame>Baseline, 6 Months</time_frame>
    <description>The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 items covered by 1 of 3 dimensions:&#xD;
Global health status/quality of life (2 items) with scores ranging from 1 (Very Poor) to 7 (Excellent).&#xD;
Functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), each item scores ranging from 1 (not at all) to 4 (very much)&#xD;
Symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, or financial impact), each item scores ranging from 1 (not at all) to 4 (very much).&#xD;
Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function/QOL or higher levels of symptom burden.&#xD;
No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: PK: Steady State Trough Pre Dose Concentration of LY3023414</measure>
    <time_frame>C2D1: 0h, C3D1: 0h, C4D1: 0h</time_frame>
    <description>Mean steady state exposure was reported by trough pre-dose plasma concentrations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage 1: PK: Mean Single Dose Concentration of LY3023414 at 2h Post-dose</measure>
    <time_frame>C1D1: 2h Post dose</time_frame>
    <description>Mean single dose exposure was reported by plasma concentrations collected approximately 2 hours post-dose.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">106</enrollment>
  <condition>Pancreatic Ductal Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Abemaciclib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Abemaciclib given orally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Abemaciclib + LY3023414</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Abemaciclib given orally and LY3023414 given orally.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care (Gemcitabine or Capecitabine)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gemcitabine given intravenously (IV) OR capecitabine given orally.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abemaciclib</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Abemaciclib</arm_group_label>
    <arm_group_label>Abemaciclib + LY3023414</arm_group_label>
    <other_name>LY2835219</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY3023414</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Abemaciclib + LY3023414</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <description>Administered IV</description>
    <arm_group_label>Standard of Care (Gemcitabine or Capecitabine)</arm_group_label>
    <other_name>LY188011</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Standard of Care (Gemcitabine or Capecitabine)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological or cytological diagnosis of ductal adenocarcinoma of the pancreas.&#xD;
&#xD;
          -  Metastatic disease with documented disease progression following previous treatment&#xD;
             with at least one, but no more than 2 prior therapies, with one of the prior therapies&#xD;
             having been either gemcitabine-based or fluoropyrimidine-based therapy. Neoadjuvant&#xD;
             and/or adjuvant therapies for localized resectable or unresectable PDAC each count as&#xD;
             a line of therapy if multiagent chemotherapy regimens were administered (and&#xD;
             neoadjuvant regimen was different than adjuvant regimen) and if the participant&#xD;
             progressed with metastatic disease while taking or within 6 months of completion of&#xD;
             (neo)adjuvant therapy.&#xD;
&#xD;
          -  Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.&#xD;
&#xD;
          -  Participant for whom treatment with monotherapy chemotherapy such as gemcitabine or&#xD;
             capecitabine is a reasonable choice.&#xD;
&#xD;
          -  Discontinued all prior treatment for cancer at least 14 days prior to initial dose of&#xD;
             study treatment.&#xD;
&#xD;
          -  Adequate organ function.&#xD;
&#xD;
               -  allow alanine aminotransferase (ALT) or aspartate aminotransferase (AST) up to 5x&#xD;
                  upper limit of normal (ULN) if liver metastases.&#xD;
&#xD;
               -  allow bilirubin up to 2.5 times ULN if elevation is not associated with other&#xD;
                  signs of liver toxicity or can be explained by mechanical obstruction - requires&#xD;
                  clinical research physician approval.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have a personal history of any of the following conditions: syncope of either&#xD;
             unexplained or cardiovascular etiology, ventricular arrhythmia (including but not&#xD;
             limited to ventricular tachycardia and ventricular fibrillation), or sudden cardiac&#xD;
             arrest. Exception: Participants with controlled atrial fibrillation for &gt;30 days prior&#xD;
             to study treatment initiation are eligible.&#xD;
&#xD;
          -  Have insulin-dependent diabetes mellitus. Participants with type 2 diabetes mellitus&#xD;
             are eligible if adequate control of blood glucose level is obtained by oral&#xD;
             anti-diabetics as documented by hemoglobin A1c (HbA1c) &lt;7%.&#xD;
&#xD;
          -  Have symptomatic central nervous system metastasis. Screening of asymptomatic&#xD;
             participants is not required for enrollment.&#xD;
&#xD;
          -  Have had major surgery within 7 days prior to initiation of study drug to allow for&#xD;
             postoperative healing of the surgical wound and site(s).&#xD;
&#xD;
          -  Have previously received treatment with any cyclin-dependent kinase (CDK) 4 and 6&#xD;
             inhibitor or phosphatidylinositol 3-kinase (PI3K) and/or mammalian target of rapamycin&#xD;
             (mTOR) inhibitor or have a known hypersensitivity to any component of the&#xD;
             investigational products in this study.&#xD;
&#xD;
          -  Have a known hypersensitivity to investigator's choice of standard of care&#xD;
             (gemcitabine or capecitabine).&#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>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale University School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64132</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>03756-0001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Cancer Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology PLLC</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance</name>
      <address>
        <city>Olympia</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Mason Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin-Madison Hospital and Health Clinic</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792-4108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.</name>
      <address>
        <city>Blacktown</city>
        <zip>2148</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Sydney</city>
        <zip>2010</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Brussels</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.</name>
      <address>
        <city>Wilrijk</city>
        <zip>2610</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Lyon</city>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Pessac</city>
        <zip>33604</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Ramat Gan</city>
        <zip>5262000</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Tel Aviv</city>
        <zip>6423906</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Hospitalet de Llobregat</city>
        <zip>08908</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion Jimenez Diaz</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Tainan</city>
        <zip>70403</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Taipei city</city>
        <zip>10048</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Taipei</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>London</city>
        <zip>NW1 2BU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>France</country>
    <country>Israel</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Argentina</country>
    <country>Brazil</country>
    <country>Hungary</country>
  </removed_countries>
  <link>
    <url>https://www.lillytrialguide.com/en-US/studies/pancreatic-ductal-adenocarcinoma/JPCJ#?postal=</url>
    <description>A Study of Abemaciclib (LY2835219) Alone or in Combination with Other Agents in Participants with Previously Treated Pancreatic Ductal Adenocarcinoma</description>
  </link>
  <verification_date>August 18, 2019</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <results_first_submitted>April 18, 2019</results_first_submitted>
  <results_first_submitted_qc>May 31, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 25, 2019</results_first_posted>
  <last_update_submitted>November 6, 2019</last_update_submitted>
  <last_update_submitted_qc>November 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pancreatic cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Capecitabine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.&#xD;
More information provided by Eli Lilly and Company</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.</ipd_time_frame>
    <ipd_access_criteria>A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/</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>June 29, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT02981342/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>February 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT02981342/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study was planned for stage 1 &amp; stage 2. No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.&#xD;
Completed participants are those who has CR, PR, SD, or PD and is off treatment.</recruitment_details>
      <pre_assignment_details>Per protocol, no efficacy analysis was planned for safety lead in. Purpose of safety lead in was only safety evaluation. All efficacy was done on randomized pts.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>150mg Abemaciclib + 150mg Galunisertib (Safety Lead-in)</title>
          <description>Participants received oral dose of 150mg Abemaciclib twice daily for 28 day cycles along with oral dose of 150 mg Galunisertib twice daily for 14 days of 28 days cycle.</description>
        </group>
        <group group_id="P2">
          <title>200mg Abemaciclib</title>
          <description>Participants received oral dose of 200mg Abemaciclib twice daily (BID) for 28 day cycles.</description>
        </group>
        <group group_id="P3">
          <title>150mg Abemaciclib + 150mg LY3023414</title>
          <description>Participants received oral dose of 150mg Abemaciclib along with 150mg LY3023414 twice daily for 28 day cycles.</description>
        </group>
        <group group_id="P4">
          <title>Gemcitabine or Capecitabine</title>
          <description>Participants received either 1000 milligram per square meter (mg/m^2) of Gemcitabine by intravenous infusion on days 1, 8, 15 and 22 of 28 day cycle or 1250 mg/m^2 oral dose of Capecitabine twice daily for 14 days of 21 day cycle.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="33"/>
                <participants group_id="P3" count="33"/>
                <participants group_id="P4" count="33"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least One Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="32"/>
                <participants group_id="P3" count="33"/>
                <participants group_id="P4" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="22"/>
                <participants group_id="P3" count="20"/>
                <participants group_id="P4" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="13"/>
                <participants group_id="P4" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</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="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study closed by sponsor</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="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized, Never Treated</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>150mg Abemaciclib + 150mg Galunisertib (Safety Lead-in)</title>
          <description>Participants received oral dose of 150mg Abemaciclib twice daily for 28 day cycles along with oral dose of 150 mg Galunisertib twice daily for 14 days of 28 days cycle.</description>
        </group>
        <group group_id="B2">
          <title>200mg Abemaciclib</title>
          <description>Participants received oral dose of 200mg Abemaciclib twice daily (BID) for 28 day cycles.</description>
        </group>
        <group group_id="B3">
          <title>150mg Abemaciclib + 150mg LY3023414</title>
          <description>Participants received oral dose of 150mg Abemaciclib along with 150mg LY3023414 twice daily for 28 day cycles.</description>
        </group>
        <group group_id="B4">
          <title>Gemcitabine or Capecitabine</title>
          <description>Participants received either 1000 milligram per square meter (mg/m^2) of Gemcitabine by intravenous infusion on days 1, 8, 15 and 22 of 28 day cycle or 1250 mg/m^2 oral dose of Capecitabine twice daily for 14 days of 21 day cycle.</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="7"/>
            <count group_id="B2" value="33"/>
            <count group_id="B3" value="33"/>
            <count group_id="B4" value="33"/>
            <count group_id="B5" value="106"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <population>All randomized participants who received at least one dose of study drug.</population>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="32"/>
                    <count group_id="B3" value="33"/>
                    <count group_id="B4" value="26"/>
                    <count group_id="B5" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.29" spread="6.99"/>
                    <measurement group_id="B2" value="61.09" spread="7.83"/>
                    <measurement group_id="B3" value="62.52" spread="8.97"/>
                    <measurement group_id="B4" value="66.85" spread="7.61"/>
                    <measurement group_id="B5" value="63.40" spread="8.34"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="33"/>
                    <count group_id="B4" value="33"/>
                    <count group_id="B5" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="57"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="33"/>
                    <count group_id="B4" value="33"/>
                    <count group_id="B5" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="24"/>
                    <measurement group_id="B5" value="89"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="33"/>
                    <count group_id="B4" value="33"/>
                    <count group_id="B5" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="25"/>
                    <measurement group_id="B5" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Belgium</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="33"/>
                    <count group_id="B4" value="33"/>
                    <count group_id="B5" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="33"/>
                    <count group_id="B4" value="33"/>
                    <count group_id="B5" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taiwan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="33"/>
                    <count group_id="B4" value="33"/>
                    <count group_id="B5" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="33"/>
                    <count group_id="B4" value="33"/>
                    <count group_id="B5" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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>Israel</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="33"/>
                    <count group_id="B4" value="33"/>
                    <count group_id="B5" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="33"/>
                    <count group_id="B4" value="33"/>
                    <count group_id="B5" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="33"/>
                    <count group_id="B4" value="33"/>
                    <count group_id="B5" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                    <count group_id="B2" value="33"/>
                    <count group_id="B3" value="33"/>
                    <count group_id="B4" value="33"/>
                    <count group_id="B5" value="106"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Stage 1: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)</title>
        <description>Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.</description>
        <time_frame>Baseline to Measured Progressive Disease or Start of New Anticancer Therapy (Up to 6 Months)</time_frame>
        <population>All randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>200mg Abemaciclib</title>
            <description>Participants received oral dose of 200mg Abemaciclib twice daily (BID) for 28 day cycles.</description>
          </group>
          <group group_id="O2">
            <title>150mg Abemaciclib + 150mg LY3023414</title>
            <description>Participants received oral dose of 150mg Abemaciclib along with 150mg LY3023414 twice daily for 28 day cycles.</description>
          </group>
          <group group_id="O3">
            <title>Gemcitabine or Capecitabine</title>
            <description>Participants received either 1000 milligram per square meter (mg/m^2) of Gemcitabine by intravenous infusion on days 1, 8, 15 and 22 of 28 day cycle or 1250 mg/m^2 oral dose of Capecitabine twice daily for 14 days of 21 day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)</title>
          <description>Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.</description>
          <population>All randomized participants.</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="33"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.2" lower_limit="2.9" upper_limit="27.4"/>
                    <measurement group_id="O2" value="12.1" lower_limit="1.0" upper_limit="23.3"/>
                    <measurement group_id="O3" value="36.4" lower_limit="20" upper_limit="52.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0495</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0230</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Stage 2: Progression Free Survival (PFS)</title>
        <description>PFS was defined as the time from the date of randomization until first observation of objective progressive disease as defined by RECIST v1.1 or death from any cause, whichever comes first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a patient does not have a complete baseline disease assessment, then the PFS time will be censored at the randomization date, regardless of whether or not objectively determined disease progression or death has been observed for the patient; otherwise, if a patient is not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time will be censored at the last complete objective progression-free disease assessment date.</description>
        <time_frame>Baseline to Measured Progressive Disease or Death Due to Any Cause (Up to 6 Months)</time_frame>
        <population>All randomized participants. Censored participants: Abemaciclib 200 mg: 3, Abemaciclib 150mg + LY3023414 150mg: 8, Gemcitabine &amp; Capecitabine: 18; No participants were enrolled in stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled in stage 1.</population>
        <group_list>
          <group group_id="O1">
            <title>200mg Abemaciclib</title>
            <description>Participants received oral dose of 200mg Abemaciclib twice daily (BID) for 28 day cycles.</description>
          </group>
          <group group_id="O2">
            <title>150mg Abemaciclib + 150mg LY3023414</title>
            <description>Participants received oral dose of 150mg Abemaciclib along with 150mg LY3023414 twice daily for 28 day cycles.</description>
          </group>
          <group group_id="O3">
            <title>Gemcitabine or Capecitabine</title>
            <description>Participants received either 1000 milligram per square meter (mg/m^2) of Gemcitabine by intravenous infusion on days 1, 8, 15 and 22 of 28 day cycle or 1250 mg/m^2 oral dose of Capecitabine twice daily for 14 days of 21 day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2: Progression Free Survival (PFS)</title>
          <description>PFS was defined as the time from the date of randomization until first observation of objective progressive disease as defined by RECIST v1.1 or death from any cause, whichever comes first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a patient does not have a complete baseline disease assessment, then the PFS time will be censored at the randomization date, regardless of whether or not objectively determined disease progression or death has been observed for the patient; otherwise, if a patient is not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time will be censored at the last complete objective progression-free disease assessment date.</description>
          <population>All randomized participants. Censored participants: Abemaciclib 200 mg: 3, Abemaciclib 150mg + LY3023414 150mg: 8, Gemcitabine &amp; Capecitabine: 18; No participants were enrolled in stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled in stage 1.</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="33"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.68" lower_limit="1.35" upper_limit="1.84"/>
                    <measurement group_id="O2" value="1.81" lower_limit="1.28" upper_limit="1.91"/>
                    <measurement group_id="O3" value="3.25" lower_limit="1.05" upper_limit="5.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0085</p_value>
            <method>Log Rank</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0123</p_value>
            <method>Log Rank</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 1: Objective Response Rate (ORR): Percentage of Participants With a Best Overall Response (BOR) of CR or PR</title>
        <description>Objective response rate (ORR) is the percentage of participants with a BOR of CR or PR as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.</description>
        <time_frame>Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Up to 6 Months)</time_frame>
        <population>All randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>200mg Abemaciclib</title>
            <description>Participants received oral dose of 200mg Abemaciclib twice daily (BID) for 28 day cycles.</description>
          </group>
          <group group_id="O2">
            <title>150mg Abemaciclib + 150mg LY3023414</title>
            <description>Participants received oral dose of 150mg Abemaciclib along with 150mg LY3023414 twice daily for 28 day cycles.</description>
          </group>
          <group group_id="O3">
            <title>Gemcitabine or Capecitabine</title>
            <description>Participants received either 1000 milligram per square meter (mg/m^2) of Gemcitabine by intravenous infusion on days 1, 8, 15 and 22 of 28 day cycle or 1250 mg/m^2 oral dose of Capecitabine twice daily for 14 days of 21 day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: Objective Response Rate (ORR): Percentage of Participants With a Best Overall Response (BOR) of CR or PR</title>
          <description>Objective response rate (ORR) is the percentage of participants with a BOR of CR or PR as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.</description>
          <population>All randomized participants.</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="33"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="0" upper_limit="8.9"/>
                    <measurement group_id="O2" value="0" lower_limit="NA" upper_limit="NA">Data did not allow it to be estimable.</measurement>
                    <measurement group_id="O3" value="3" lower_limit="0" upper_limit="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3017</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 1: Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib and Its Metabolites (LSN2839567 (M2), LSN3106726 (M20))</title>
        <description>Mean steady state exposure was reported as measured by maximum observed plasma concentration (Cmax).</description>
        <time_frame>Cycle(C)1 Day(D)14: 0 hour(h),0.5h,1h,2h,4h,6h,8h post dose</time_frame>
        <population>All randomized participants who received at least one dose of Abemaciclib along with Galunisertib and had evaluable PK samples.</population>
        <group_list>
          <group group_id="O1">
            <title>150mg Abemaciclib + 150mg Galunisertib</title>
            <description>Participants received oral dose of 150mg Abemaciclib twice daily for 28 day cycles along with oral dose of 150 mg Galunisertib twice daily for 14 days of 28 days cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib and Its Metabolites (LSN2839567 (M2), LSN3106726 (M20))</title>
          <description>Mean steady state exposure was reported as measured by maximum observed plasma concentration (Cmax).</description>
          <population>All randomized participants who received at least one dose of Abemaciclib along with Galunisertib and had evaluable PK samples.</population>
          <units>Nanogram per Millilitre (ng/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Abemaciclib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="356" spread="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LSN2839567 (M2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.1" spread="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LSN3106726 (M20)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="153" spread="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 1: PK: Area Under the Curve (AUC) (AUC[Tau]) of LY3023414</title>
        <time_frame>Cycle 1 Day 1 through Cycle 4 Day 1 (28 Day Cycles)</time_frame>
        <population>Zero Participants Analyzed: AUC cannot be calculated due to insufficient data collected.</population>
        <group_list>
          <group group_id="O1">
            <title>150mg Abemaciclib + 150mg LY3023414</title>
            <description>Participants received oral dose of 150mg Abemaciclib along with 150mg LY3023414 twice daily for 28 day cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: PK: Area Under the Curve (AUC) (AUC[Tau]) of LY3023414</title>
          <population>Zero Participants Analyzed: AUC cannot be calculated due to insufficient data collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 1: PK: Maximum Concentration (Cmax) at Steady State of LY3023414</title>
        <time_frame>Cycle 1 Day 1 through Cycle 4 Day 1 (28 Day Cycles)</time_frame>
        <population>Zero Participants Analyzed: Cmax cannot be calculated due to insufficient data collected.</population>
        <group_list>
          <group group_id="O1">
            <title>150mg Abemaciclib + 150mg LY3023414</title>
            <description>Participants received oral dose of 150mg Abemaciclib along with 150mg LY3023414 twice daily for 28 day cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: PK: Maximum Concentration (Cmax) at Steady State of LY3023414</title>
          <population>Zero Participants Analyzed: Cmax cannot be calculated due to insufficient data collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 2: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and SD</title>
        <time_frame>Baseline to Measured Progressive Disease or Start of New Anticancer Therapy (Up to 6 Months)</time_frame>
        <population>Data not reported, no patients were enrolled to stage 2.</population>
        <group_list>
          <group group_id="O1">
            <title>200mg Abemaciclib</title>
            <description>Participants received oral dose of 200mg Abemaciclib twice daily (BID) for 28 day cycles.</description>
          </group>
          <group group_id="O2">
            <title>150mg Abemaciclib + 150mg LY3023414</title>
            <description>Participants received oral dose of 150mg Abemaciclib along with 150mg LY3023414 twice daily for 28 day cycles.</description>
          </group>
          <group group_id="O3">
            <title>Gemcitabine or Capecitabine</title>
            <description>Participants received either 1000 milligram per square meter (mg/m^2) of Gemcitabine by intravenous infusion on days 1, 8, 15 and 22 of 28 day cycle or 1250 mg/m^2 oral dose of Capecitabine twice daily for 14 days of 21 day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and SD</title>
          <population>Data not reported, no patients were enrolled to stage 2.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 2: Clinical Benefit Rate (CBR): Percentage of Participants With Best Overall Response of CR, PR, or SD With Duration of SD for at Least 6 Months</title>
        <description>Clinical benefit rate (CBR) is the percentage of participants with a BOR of CR or PR, or SD ≥6 months. CR is defined as the disappearance of all target and non-target lesions &amp; no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.&#xD;
No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.</description>
        <time_frame>Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 6 Months)</time_frame>
        <population>All randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>200mg Abemaciclib</title>
            <description>Participants received oral dose of 200mg Abemaciclib twice daily (BID) for 28 day cycles.</description>
          </group>
          <group group_id="O2">
            <title>150mg Abemaciclib + 150mg LY3023414</title>
            <description>Participants received oral dose of 150mg Abemaciclib along with 150mg LY3023414 twice daily for 28 day cycles.</description>
          </group>
          <group group_id="O3">
            <title>Gemcitabine or Capecitabine</title>
            <description>Participants received either 1000 milligram per square meter (mg/m^2) of Gemcitabine by intravenous infusion on days 1, 8, 15 and 22 of 28 day cycle or 1250 mg/m^2 oral dose of Capecitabine twice daily for 14 days of 21 day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2: Clinical Benefit Rate (CBR): Percentage of Participants With Best Overall Response of CR, PR, or SD With Duration of SD for at Least 6 Months</title>
          <description>Clinical benefit rate (CBR) is the percentage of participants with a BOR of CR or PR, or SD ≥6 months. CR is defined as the disappearance of all target and non-target lesions &amp; no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.&#xD;
No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.</description>
          <population>All randomized participants.</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="33"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="0" upper_limit="8.9"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="3" lower_limit="0" upper_limit="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3017</p_value>
            <method>Cochran-Mantel-Haenszel</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 2: Duration of Response (DoR)</title>
        <time_frame>Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Up to 6 Months)</time_frame>
        <population>The population for analyzing DoR is the number of participants with response of CR or PR. There was only one participant in 200 mg Abemaciclib arm and one participant in Gemcitabine/Capecitabine arm. Due to small number of participants, the data is not analyzable using the planned time to event analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>200mg Abemaciclib</title>
            <description>Participants received oral dose of 200mg Abemaciclib twice daily (BID) for 28 day cycles.</description>
          </group>
          <group group_id="O2">
            <title>150mg Abemaciclib + 150mg LY3023414</title>
            <description>Participants received oral dose of 150mg Abemaciclib along with 150mg LY3023414 twice daily for 28 day cycles.</description>
          </group>
          <group group_id="O3">
            <title>Gemcitabine or Capecitabine</title>
            <description>Participants received either 1000 milligram per square meter (mg/m^2) of Gemcitabine by intravenous infusion on days 1, 8, 15 and 22 of 28 day cycle or 1250 mg/m^2 oral dose of Capecitabine twice daily for 14 days of 21 day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2: Duration of Response (DoR)</title>
          <population>The population for analyzing DoR is the number of participants with response of CR or PR. There was only one participant in 200 mg Abemaciclib arm and one participant in Gemcitabine/Capecitabine arm. Due to small number of participants, the data is not analyzable using the planned time to event analysis.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 2: Overall Survival (OS)</title>
        <description>OS duration is measured from the date of randomization to the date of death from any cause. for participants who is not known to have died as of the data-inclusion cutoff date, OS was censored at the last known alive date.&#xD;
No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.</description>
        <time_frame>Baseline to Death from Any Cause (Up to 10 Months)</time_frame>
        <population>All randomized participants. Censored participants: Abemaciclib 200mg: 11, Abemaciclib 150mg + LY3023414 150mg: 12, Gemcitabine + Capecitabine: 21;</population>
        <group_list>
          <group group_id="O1">
            <title>200mg Abemaciclib</title>
            <description>Participants received oral dose of 200mg Abemaciclib twice daily (BID) for 28 day cycles.</description>
          </group>
          <group group_id="O2">
            <title>150mg Abemaciclib + 150mg LY3023414</title>
            <description>Participants received oral dose of 150mg Abemaciclib along with 150mg LY3023414 twice daily for 28 day cycles.</description>
          </group>
          <group group_id="O3">
            <title>Gemcitabine or Capecitabine</title>
            <description>Participants received either 1000 milligram per square meter (mg/m^2) of Gemcitabine by intravenous infusion on days 1, 8, 15 and 22 of 28 day cycle or 1250 mg/m^2 oral dose of Capecitabine twice daily for 14 days of 21 day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2: Overall Survival (OS)</title>
          <description>OS duration is measured from the date of randomization to the date of death from any cause. for participants who is not known to have died as of the data-inclusion cutoff date, OS was censored at the last known alive date.&#xD;
No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.</description>
          <population>All randomized participants. Censored participants: Abemaciclib 200mg: 11, Abemaciclib 150mg + LY3023414 150mg: 12, Gemcitabine + Capecitabine: 21;</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="33"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="33"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.71" lower_limit="1.97" upper_limit="5.36"/>
                    <measurement group_id="O2" value="3.29" lower_limit="1.97" upper_limit="5.03"/>
                    <measurement group_id="O3" value="NA" lower_limit="2.53" upper_limit="NA">Data did not allow it to be estimable.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.1938</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.600</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.782</ci_lower_limit>
            <ci_upper_limit>3.272</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.2477</p_value>
            <method>Log Rank</method>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>1.533</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.746</ci_lower_limit>
            <ci_upper_limit>3.150</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 2: Change From Baseline in Carbohydrate Antigen 19.9 (CA 19-9) Level</title>
        <description>No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.</description>
        <time_frame>Baseline, 6 Months</time_frame>
        <population>All randomized participants with baseline and post baseline CA 19-9 measurement.</population>
        <group_list>
          <group group_id="O1">
            <title>200mg Abemaciclib</title>
            <description>Participants received oral dose of 200mg Abemaciclib twice daily (BID) for 28 day cycles.</description>
          </group>
          <group group_id="O2">
            <title>150mg Abemaciclib + 150mg LY3023414</title>
            <description>Participants received oral dose of 150mg Abemaciclib along with 150mg LY3023414 twice daily for 28 day cycles.</description>
          </group>
          <group group_id="O3">
            <title>Gemcitabine or Capecitabine</title>
            <description>Participants received either 1000 milligram per square meter (mg/m^2) of Gemcitabine by intravenous infusion on days 1, 8, 15 and 22 of 28 day cycle or 1250 mg/m^2 oral dose of Capecitabine twice daily for 14 days of 21 day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2: Change From Baseline in Carbohydrate Antigen 19.9 (CA 19-9) Level</title>
          <description>No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.</description>
          <population>All randomized participants with baseline and post baseline CA 19-9 measurement.</population>
          <units>U/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="21"/>
                <count group_id="O3" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4281.53" spread="8177.89"/>
                    <measurement group_id="O2" value="3225.29" spread="5730.25"/>
                    <measurement group_id="O3" value="-501.17" spread="7198.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 2: Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)</title>
        <description>mBPI-sf is an 11-item instrument used as a multiple-item measure of cancer pain intensity. In addition to pain intensity (4 items), the mBPI-sf is designed for participants to record the presence of pain in general, pain relief, and pain interference with function (general activity, mood, ability to walk, ability to perform normal work, relations with others, sleep, and enjoyment of life). Responses for the mBPI-sf items are captured through the use of 11-point numeric rating scales anchored at 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). The mBPI-sf recall period is 24 hours, and typical completion time for this instrument is less than 5 minutes.&#xD;
No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.</description>
        <time_frame>Baseline, 6 Months</time_frame>
        <population>All randomized participants with baseline &amp; post baseline value for the mBPI-sf specified item.</population>
        <group_list>
          <group group_id="O1">
            <title>200mg Abemaciclib</title>
            <description>Participants received oral dose of 200mg Abemaciclib twice daily (BID) for 28 day cycles.</description>
          </group>
          <group group_id="O2">
            <title>150mg Abemaciclib + 150mg LY3023414</title>
            <description>Participants received oral dose of 150mg Abemaciclib along with 150mg LY3023414 twice daily for 28 day cycles.</description>
          </group>
          <group group_id="O3">
            <title>Gemcitabine or Capecitabine</title>
            <description>Participants received either 1000 milligram per square meter (mg/m^2) of Gemcitabine by intravenous infusion on days 1, 8, 15 and 22 of 28 day cycle or 1250 mg/m^2 oral dose of Capecitabine twice daily for 14 days of 21 day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2: Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)</title>
          <description>mBPI-sf is an 11-item instrument used as a multiple-item measure of cancer pain intensity. In addition to pain intensity (4 items), the mBPI-sf is designed for participants to record the presence of pain in general, pain relief, and pain interference with function (general activity, mood, ability to walk, ability to perform normal work, relations with others, sleep, and enjoyment of life). Responses for the mBPI-sf items are captured through the use of 11-point numeric rating scales anchored at 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). The mBPI-sf recall period is 24 hours, and typical completion time for this instrument is less than 5 minutes.&#xD;
No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.</description>
          <population>All randomized participants with baseline &amp; post baseline value for the mBPI-sf specified item.</population>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain at its Worst in Last 24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.63" spread="0.47"/>
                    <measurement group_id="O2" value="-0.33" spread="0.55"/>
                    <measurement group_id="O3" value="-0.02" spread="0.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain at its Least in Last 24 hours</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.86" spread="0.42"/>
                    <measurement group_id="O2" value="0.18" spread="0.49"/>
                    <measurement group_id="O3" value="0.39" spread="0.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain on the Average</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.62" spread="0.45"/>
                    <measurement group_id="O2" value="-0.03" spread="0.51"/>
                    <measurement group_id="O3" value="-0.07" spread="0.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Right Now</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.38" spread="0.34"/>
                    <measurement group_id="O2" value="0.34" spread="0.59"/>
                    <measurement group_id="O3" value="-0.38" spread="0.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Interfered General Activity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.64" spread="0.47"/>
                    <measurement group_id="O2" value="0.07" spread="0.55"/>
                    <measurement group_id="O3" value="0.22" spread="0.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Interfered with Mood</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.54" spread="0.41"/>
                    <measurement group_id="O2" value="0.28" spread="0.48"/>
                    <measurement group_id="O3" value="0.60" spread="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Interfered Walking Ability</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05" spread="0.55"/>
                    <measurement group_id="O2" value="0.83" spread="0.64"/>
                    <measurement group_id="O3" value="0.19" spread="0.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Interfered with Normal Work</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.07" spread="0.51"/>
                    <measurement group_id="O2" value="0.66" spread="0.59"/>
                    <measurement group_id="O3" value="0.19" spread="0.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Interfered with Relations</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.39" spread="0.52"/>
                    <measurement group_id="O2" value="0.67" spread="0.61"/>
                    <measurement group_id="O3" value="0.26" spread="0.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Interfered with Sleep</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.19" spread="0.53"/>
                    <measurement group_id="O2" value="0.34" spread="0.61"/>
                    <measurement group_id="O3" value="-0.56" spread="0.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain Interfered Enjoyment of Life</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.69" spread="0.62"/>
                    <measurement group_id="O2" value="0.39" spread="0.72"/>
                    <measurement group_id="O3" value="-0.13" spread="0.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BPI Mean Pain Interference Score</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.55" spread="0.44"/>
                    <measurement group_id="O2" value="0.50" spread="0.51"/>
                    <measurement group_id="O3" value="0.05" spread="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain at its Worst in Last 24 Hours</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.383</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>0.65</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.74</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.84</ci_lower_limit>
            <ci_upper_limit>2.13</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain at its Worst in Last 24 Hours</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.692</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>-0.31</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.79</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.91</ci_lower_limit>
            <ci_upper_limit>1.28</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain at its Least in Last 24 Hours</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.469</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>0.48</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.66</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.85</ci_lower_limit>
            <ci_upper_limit>1.80</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain at its Least in Last 24 Hours</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.776</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>-0.20</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.70</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.62</ci_lower_limit>
            <ci_upper_limit>1.22</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain on the Average</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.328</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>0.69</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.70</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.72</ci_lower_limit>
            <ci_upper_limit>2.11</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain on the Average</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.954</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>0.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.74</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.45</ci_lower_limit>
            <ci_upper_limit>1.54</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain Right Now</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.350</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>0.75</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.80</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.85</ci_lower_limit>
            <ci_upper_limit>2.36</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain right now.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.405</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>0.72</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.85</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.01</ci_lower_limit>
            <ci_upper_limit>2.44</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain Interfered General Activity</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.565</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>0.43</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.73</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.06</ci_lower_limit>
            <ci_upper_limit>1.91</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain Interfered General Activity</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.848</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>-0.15</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.79</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.74</ci_lower_limit>
            <ci_upper_limit>1.43</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain Interfered with Mood</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.928</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>-0.06</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.65</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.37</ci_lower_limit>
            <ci_upper_limit>1.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain Interfered with Mood</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.650</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>-0.32</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.69</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.71</ci_lower_limit>
            <ci_upper_limit>1.08</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain Interfered Walking Ability</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.865</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>-0.15</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.86</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.89</ci_lower_limit>
            <ci_upper_limit>1.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain Interfered Walking Ability</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.497</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>0.63</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.92</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.23</ci_lower_limit>
            <ci_upper_limit>2.50</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain Interfered with Normal Work</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.272</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>0.89</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.80</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.72</ci_lower_limit>
            <ci_upper_limit>2.50</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain Interfered with Normal Work</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.583</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>0.47</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.85</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.25</ci_lower_limit>
            <ci_upper_limit>2.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain Interfered with Relations</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.876</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>0.13</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.82</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.53</ci_lower_limit>
            <ci_upper_limit>1.79</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain Interfered with relations.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.644</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>0.41</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.88</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.37</ci_lower_limit>
            <ci_upper_limit>2.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain Interfered with Sleep</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.384</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>0.75</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.85</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.97</ci_lower_limit>
            <ci_upper_limit>2.48</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.318</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>0.90</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.89</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.90</ci_lower_limit>
            <ci_upper_limit>2.71</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain Interfered Enjoyment of Life</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.407</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>0.81</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.97</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.15</ci_lower_limit>
            <ci_upper_limit>2.78</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain Interfered Enjoyment of Life</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.620</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>0.52</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.04</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.58</ci_lower_limit>
            <ci_upper_limit>2.62</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>BPI-Mean Interference Score</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.475</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>0.50</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.70</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.90</ci_lower_limit>
            <ci_upper_limit>1.91</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>BPI-Mean Interference Score</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.540</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>0.46</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.74</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.04</ci_lower_limit>
            <ci_upper_limit>1.96</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 2: Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)</title>
        <description>The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 items covered by 1 of 3 dimensions:&#xD;
Global health status/quality of life (2 items) with scores ranging from 1 (Very Poor) to 7 (Excellent).&#xD;
Functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), each item scores ranging from 1 (not at all) to 4 (very much)&#xD;
Symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, or financial impact), each item scores ranging from 1 (not at all) to 4 (very much).&#xD;
Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function/QOL or higher levels of symptom burden.&#xD;
No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.</description>
        <time_frame>Baseline, 6 Months</time_frame>
        <population>All randomized participants with baseline &amp; post baseline value for the EORTC QLQ-C30 specified item.</population>
        <group_list>
          <group group_id="O1">
            <title>200mg Abemaciclib</title>
            <description>Participants received oral dose of 200mg Abemaciclib twice daily (BID) for 28 day cycles.</description>
          </group>
          <group group_id="O2">
            <title>150mg Abemaciclib + 150mg LY3023414</title>
            <description>Participants received oral dose of 150mg Abemaciclib along with 150mg LY3023414 twice daily for 28 day cycles.</description>
          </group>
          <group group_id="O3">
            <title>Gemcitabine or Capecitabine</title>
            <description>Participants received either 1000 milligram per square meter (mg/m^2) of Gemcitabine by intravenous infusion on days 1, 8, 15 and 22 of 28 day cycle or 1250 mg/m^2 oral dose of Capecitabine twice daily for 14 days of 21 day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 2: Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)</title>
          <description>The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 items covered by 1 of 3 dimensions:&#xD;
Global health status/quality of life (2 items) with scores ranging from 1 (Very Poor) to 7 (Excellent).&#xD;
Functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), each item scores ranging from 1 (not at all) to 4 (very much)&#xD;
Symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, or financial impact), each item scores ranging from 1 (not at all) to 4 (very much).&#xD;
Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function/QOL or higher levels of symptom burden.&#xD;
No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.</description>
          <population>All randomized participants with baseline &amp; post baseline value for the EORTC QLQ-C30 specified item.</population>
          <units>units on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Global Health Status</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.21" spread="3.87"/>
                    <measurement group_id="O2" value="-4.82" spread="4.50"/>
                    <measurement group_id="O3" value="-2.40" spread="4.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Functional Scales: Physical Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-14.44" spread="4.40"/>
                    <measurement group_id="O2" value="-11.65" spread="5.12"/>
                    <measurement group_id="O3" value="-5.42" spread="5.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Functional Scales: Role Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-17.09" spread="6.17"/>
                    <measurement group_id="O2" value="-18.05" spread="7.32"/>
                    <measurement group_id="O3" value="-17.10" spread="7.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Functional Scales: Emotional Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.89" spread="4.49"/>
                    <measurement group_id="O2" value="-0.63" spread="5.22"/>
                    <measurement group_id="O3" value="2.06" spread="5.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Functional Scales: Cognitive Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.43" spread="4.10"/>
                    <measurement group_id="O2" value="-8.39" spread="4.77"/>
                    <measurement group_id="O3" value="-5.18" spread="4.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Functional Scale: Social Functioning</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.12" spread="4.90"/>
                    <measurement group_id="O2" value="-17.09" spread="5.72"/>
                    <measurement group_id="O3" value="-2.00" spread="5.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptom Scales: Fatigue</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.13" spread="4.92"/>
                    <measurement group_id="O2" value="14.90" spread="5.73"/>
                    <measurement group_id="O3" value="5.64" spread="5.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptom Scales: Nausea and Vomiting</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.98" spread="5.57"/>
                    <measurement group_id="O2" value="9.42" spread="6.47"/>
                    <measurement group_id="O3" value="11.88" spread="6.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptom Scales: Pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.79" spread="5.63"/>
                    <measurement group_id="O2" value="2.68" spread="6.61"/>
                    <measurement group_id="O3" value="5.43" spread="6.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptom Scale: Dysopnea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.35" spread="5.48"/>
                    <measurement group_id="O2" value="11.19" spread="6.38"/>
                    <measurement group_id="O3" value="-4.51" spread="6.36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptom Scale: Insomnia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="14"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.19" spread="5.17"/>
                    <measurement group_id="O2" value="1.83" spread="6.01"/>
                    <measurement group_id="O3" value="-6.71" spread="6.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptom Scale: Appetite Loss</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.54" spread="5.79"/>
                    <measurement group_id="O2" value="15.32" spread="6.77"/>
                    <measurement group_id="O3" value="9.51" spread="7.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptom Scale: Constipation</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.96" spread="5.95"/>
                    <measurement group_id="O2" value="-6.51" spread="6.96"/>
                    <measurement group_id="O3" value="12.93" spread="7.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptom Scale: Diarrhoea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.71" spread="6.76"/>
                    <measurement group_id="O2" value="26.28" spread="7.83"/>
                    <measurement group_id="O3" value="20.51" spread="7.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Symptom Scale: Financial difficulties</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.96" spread="4.82"/>
                    <measurement group_id="O2" value="2.45" spread="5.68"/>
                    <measurement group_id="O3" value="-3.30" spread="5.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global health status</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.818</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>-1.39</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>5.98</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.46</ci_lower_limit>
            <ci_upper_limit>10.68</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Global health status</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.533</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>-3.80</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.06</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.03</ci_lower_limit>
            <ci_upper_limit>8.42</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Functional Scales: Physical functioning</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.681</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>-2.79</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.75</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.40</ci_lower_limit>
            <ci_upper_limit>10.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Functional Scales: Physical functioning</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.189</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>-9.02</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.75</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-22.63</ci_lower_limit>
            <ci_upper_limit>4.59</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Functional Scales: Role functioning</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.921</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>0.96</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>9.54</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.29</ci_lower_limit>
            <ci_upper_limit>20.21</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Functional Scales: Role functioning.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.999</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>0.01</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>9.62</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.40</ci_lower_limit>
            <ci_upper_limit>19.42</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Functional Scales: Emotional functioning</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.541</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>-4.26</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.91</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.20</ci_lower_limit>
            <ci_upper_limit>9.68</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Functional Scales: Emotional functioning</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.330</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>-6.95</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.05</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-21.17</ci_lower_limit>
            <ci_upper_limit>7.27</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Functional Scales: Cognitive Functioning</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.747</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>-2.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.29</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.74</ci_lower_limit>
            <ci_upper_limit>10.66</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Functional Scales: Cognitive functioning</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.419</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>-5.25</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>6.43</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.22</ci_lower_limit>
            <ci_upper_limit>7.73</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Functional Scales: Social functioning</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.596</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>-4.02</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.53</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.23</ci_lower_limit>
            <ci_upper_limit>11.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Functional Scales: Social functioning</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.017</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>-19.12</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.71</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-34.68</ci_lower_limit>
            <ci_upper_limit>-3.55</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Symptoms Scales: Fatigue</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.919</p_value>
            <p_value_desc>Social Scales: Fatigue</p_value_desc>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>-0.77</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.57</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.03</ci_lower_limit>
            <ci_upper_limit>14.49</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Symptom Scales: Fatigue</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.267</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>8.48</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.54</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.72</ci_lower_limit>
            <ci_upper_limit>23.69</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Symptom Scales: Nausea and Vomiting</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.866</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>-1.45</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>8.54</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-18.66</ci_lower_limit>
            <ci_upper_limit>15.77</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Symptom Scales: Nausea and Vomiting</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.652</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>-3.90</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>8.59</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-21.23</ci_lower_limit>
            <ci_upper_limit>13.43</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Symptom Scales: Pain</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.417</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>7.11</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>8.67</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.39</ci_lower_limit>
            <ci_upper_limit>24.60</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Symptom Scales: Pain</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.618</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>4.36</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>8.69</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.16</ci_lower_limit>
            <ci_upper_limit>21.89</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Symptom Scales: Dyspnoea</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.206</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>-10.84</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>8.44</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-27.85</ci_lower_limit>
            <ci_upper_limit>6.18</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Symptom Scales: Dyspnoea</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.566</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>4.86</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>8.40</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-12.08</ci_lower_limit>
            <ci_upper_limit>21.80</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Symptom Scales: Insomnia</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.380</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>-7.02</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.93</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-23.01</ci_lower_limit>
            <ci_upper_limit>8.96</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Symptom Scales: Insomnia</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.850</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>1.52</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.99</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.60</ci_lower_limit>
            <ci_upper_limit>17.64</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Symptom Scales: Appetite loss</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.756</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>-2.79</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>8.91</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-20.78</ci_lower_limit>
            <ci_upper_limit>15.21</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Symptom Scales: Appetite loss</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.747</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>3.02</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>9.31</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.77</ci_lower_limit>
            <ci_upper_limit>21.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Symptom Scales: Constipation</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.311</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>9.47</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>9.23</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.16</ci_lower_limit>
            <ci_upper_limit>28.09</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Symptom Scales: Constipation</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.290</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>-9.97</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>9.30</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-28.75</ci_lower_limit>
            <ci_upper_limit>8.80</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Symptom Scales: Diarrhoea</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.323</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>-10.57</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>10.58</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-31.93</ci_lower_limit>
            <ci_upper_limit>10.78</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Symptom Scales: Diarrhoea</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.651</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>-4.80</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>10.54</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-26.08</ci_lower_limit>
            <ci_upper_limit>16.48</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Symptom Scales: Financial Difficulties</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.841</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>1.51</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.47</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-13.57</ci_lower_limit>
            <ci_upper_limit>16.59</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Symptom Scales: Financial Difficulties</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.344</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>LSMean Difference</param_type>
            <param_value>7.26</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>7.57</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.03</ci_lower_limit>
            <ci_upper_limit>22.54</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 1: PK: Steady State Trough Pre Dose Concentration of LY3023414</title>
        <description>Mean steady state exposure was reported by trough pre-dose plasma concentrations.</description>
        <time_frame>C2D1: 0h, C3D1: 0h, C4D1: 0h</time_frame>
        <population>All randomized participants who received at least one dose of 150mg LY3023414 and had evaluable PK samples.</population>
        <group_list>
          <group group_id="O1">
            <title>150mg Abemaciclib + 150mg LY3023414</title>
            <description>Participants received oral dose of 150mg Abemaciclib twice daily along with 150mg LY3023414 twice daily for 28 day cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: PK: Steady State Trough Pre Dose Concentration of LY3023414</title>
          <description>Mean steady state exposure was reported by trough pre-dose plasma concentrations.</description>
          <population>All randomized participants who received at least one dose of 150mg LY3023414 and had evaluable PK samples.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.3" spread="450"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stage 1: PK: Mean Single Dose Concentration of LY3023414 at 2h Post-dose</title>
        <description>Mean single dose exposure was reported by plasma concentrations collected approximately 2 hours post-dose.</description>
        <time_frame>C1D1: 2h Post dose</time_frame>
        <population>All randomized participants who received at least one dose of 150mg LY3023414 and had evaluable PK samples.</population>
        <group_list>
          <group group_id="O1">
            <title>150mg Abemaciclib + 150mg LY3023414</title>
            <description>Participants received oral dose of 150mg Abemaciclib twice daily along with 150mg LY3023414 twice daily for 28 day cycles.</description>
          </group>
        </group_list>
        <measure>
          <title>Stage 1: PK: Mean Single Dose Concentration of LY3023414 at 2h Post-dose</title>
          <description>Mean single dose exposure was reported by plasma concentrations collected approximately 2 hours post-dose.</description>
          <population>All randomized participants who received at least one dose of 150mg LY3023414 and had evaluable PK samples.</population>
          <units>ng/mL</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="518" spread="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 30 weeks</time_frame>
      <desc>All randomized participants who received at least one dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.</desc>
      <group_list>
        <group group_id="E1">
          <title>150mg Abemaciclib + 150mg Galunisertib (Safety Lead - In)</title>
          <description>Participants received oral dose of 150mg Abemaciclib twice daily for 28 day cycles along with oral dose of 150 mg Galunisertib twice daily for 14 days of 28 days cycle.</description>
        </group>
        <group group_id="E2">
          <title>200mg Abemaciclib</title>
          <description>Participants received oral dose of 200mg Abemaciclib twice daily (BID) for 28 day cycles.</description>
        </group>
        <group group_id="E3">
          <title>150mg Abemaciclib + 150mg LY3023414</title>
          <description>Participants received oral dose of 150mg Abemaciclib along with 150mg LY3023414 twice daily for 28 day cycles.</description>
        </group>
        <group group_id="E4">
          <title>Gemcitabine or Capecitabine</title>
          <description>Participants received either 1000 milligram per square meter (mg/m^2) of Gemcitabine by intravenous infusion on days 1, 8, 15 and 22 of 28 day cycle or 1250 mg/m^2 oral dose of Capecitabine twice daily for 14 days of 21 day cycle.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.0</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="5" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="15" subjects_at_risk="26"/>
              </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="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="8" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Duodenal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Gastric ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Gastrointestinal perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Large intestinal obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Obstruction gastric</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Subileus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Multiple organ dysfunction syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Cholangitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Escherichia bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Peritonitis bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Acidosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Tumour lysis syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </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="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Ischaemic cerebral infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Mental status changes</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.0</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="7" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="33" subjects_at_risk="33"/>
                <counts group_id="E4" subjects_affected="25" subjects_at_risk="26"/>
              </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="14" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E2" events="18" subjects_affected="10" subjects_at_risk="32"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="33"/>
                <counts group_id="E4" events="19" subjects_affected="11" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Cytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" events="9" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" events="5" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E4" events="17" subjects_affected="4" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Photopsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="32"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E4" events="8" subjects_affected="6" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" events="7" subjects_affected="7" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E2" events="21" subjects_affected="12" subjects_at_risk="32"/>
                <counts group_id="E3" events="19" subjects_affected="17" subjects_at_risk="33"/>
                <counts group_id="E4" events="16" subjects_affected="8" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Eructation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Gastrointestinal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="7"/>
                <counts group_id="E2" events="14" subjects_affected="9" subjects_at_risk="32"/>
                <counts group_id="E3" events="18" subjects_affected="15" subjects_at_risk="33"/>
                <counts group_id="E4" events="10" subjects_affected="9" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="16" subjects_affected="12" subjects_at_risk="33"/>
                <counts group_id="E4" events="9" subjects_affected="6" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="32"/>
                <counts group_id="E3" events="22" subjects_affected="15" subjects_at_risk="33"/>
                <counts group_id="E4" events="8" subjects_affected="6" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="7" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E2" events="22" subjects_affected="16" subjects_at_risk="32"/>
                <counts group_id="E3" events="25" subjects_affected="17" subjects_at_risk="33"/>
                <counts group_id="E4" events="12" subjects_affected="11" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Feeling cold</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Oedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacterial sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </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="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="8" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" events="3" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="9" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="16" subjects_affected="5" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E4" events="3" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Blood potassium decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Blood sodium decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>International normalised ratio increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="7" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" events="8" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Occult blood positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="20" subjects_affected="10" subjects_at_risk="32"/>
                <counts group_id="E3" events="11" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E4" events="9" subjects_affected="4" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="32"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" events="5" subjects_affected="3" subjects_at_risk="26"/>
              </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="4" subjects_affected="3" subjects_at_risk="7"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="32"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="33"/>
                <counts group_id="E4" events="8" subjects_affected="8" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Fluid retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="4" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E4" events="5" subjects_affected="4" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="6" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hypophagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Tumour pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Confusional state</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="32"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </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="7"/>
                <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="33"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Prostatomegaly</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="32"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E4" events="5" subjects_affected="3" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Upper-airway cough syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Palmar-plantar erythrodysaesthesia syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="24" subjects_affected="10" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="32"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Skin discolouration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Skin ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Peripheral coldness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="7"/>
                <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="33"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="26"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Study was planned for stage 1 &amp; stage 2. Stage 2 did not occur, no participants were enrolled to stage 2;</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-545-5979</phone>
      <email>ClinicalTrials.gov@lilly.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/NCT02981342
org study id: 16342
secondary id: I3Y-MC-JPCJ
secondary id: 2016-002218-36
nct id: NCT02981342
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety and efficacy of abemaciclib alone and in
      combination with other drugs versus standard of care in participants with previously treated
      metastatic pancreatic ductal adenocarcinoma (PDAC).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Stage 1: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD)
time frame: Baseline to Measured Progressive Disease or Start of New Anticancer Therapy (Up to 6 Months)
description: Disease control rate (DCR) is the percentage of participants with a best overall response of CR, PR or SD as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
measure: Stage 2: Progression Free Survival (PFS)
time frame: Baseline to Measured Progressive Disease or Death Due to Any Cause (Up to 6 Months)
description: PFS was defined as the time from the date of randomization until first observation of objective progressive disease as defined by RECIST v1.1 or death from any cause, whichever comes first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a patient does not have a complete baseline disease assessment, then the PFS time will be censored at the randomization date, regardless of whether or not objectively determined disease progression or death has been observed for the patient; otherwise, if a patient is not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time will be censored at the last complete objective progression-free disease assessment date.
measure: Stage 1: Objective Response Rate (ORR): Percentage of Participants With a Best Overall Response (BOR) of CR or PR
time frame: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Up to 6 Months)
description: Objective response rate (ORR) is the percentage of participants with a BOR of CR or PR as defined by RECIST v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
measure: Stage 1: Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib and Its Metabolites (LSN2839567 (M2), LSN3106726 (M20))
time frame: Cycle(C)1 Day(D)14: 0 hour(h),0.5h,1h,2h,4h,6h,8h post dose
description: Mean steady state exposure was reported as measured by maximum observed plasma concentration (Cmax).
measure: Stage 1: PK: Area Under the Curve (AUC) (AUC[Tau]) of LY3023414
time frame: Cycle 1 Day 1 through Cycle 4 Day 1 (28 Day Cycles)
measure: Stage 1: PK: Maximum Concentration (Cmax) at Steady State of LY3023414
time frame: Cycle 1 Day 1 through Cycle 4 Day 1 (28 Day Cycles)
measure: Stage 2: Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of CR, PR, and SD
time frame: Baseline to Measured Progressive Disease or Start of New Anticancer Therapy (Up to 6 Months)
measure: Stage 2: Clinical Benefit Rate (CBR): Percentage of Participants With Best Overall Response of CR, PR, or SD With Duration of SD for at Least 6 Months
time frame: Baseline to Disease Progression or Start of New Anticancer Therapy (Up to 6 Months)
description: Clinical benefit rate (CBR) is the percentage of participants with a BOR of CR or PR, or SD ≥6 months. CR is defined as the disappearance of all target and non-target lesions & no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.
measure: Stage 2: Duration of Response (DoR)
time frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Up to 6 Months)
measure: Stage 2: Overall Survival (OS)
time frame: Baseline to Death from Any Cause (Up to 10 Months)
description: OS duration is measured from the date of randomization to the date of death from any cause. for participants who is not known to have died as of the data-inclusion cutoff date, OS was censored at the last known alive date.
No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.
measure: Stage 2: Change From Baseline in Carbohydrate Antigen 19.9 (CA 19-9) Level
time frame: Baseline, 6 Months
description: No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.
measure: Stage 2: Change From Baseline in Pain and Symptom Burden Assessment on the Modified Brief Pain Inventory-Short Form (mBPI-sf)
time frame: Baseline, 6 Months
description: mBPI-sf is an 11-item instrument used as a multiple-item measure of cancer pain intensity. In addition to pain intensity (4 items), the mBPI-sf is designed for participants to record the presence of pain in general, pain relief, and pain interference with function (general activity, mood, ability to walk, ability to perform normal work, relations with others, sleep, and enjoyment of life). Responses for the mBPI-sf items are captured through the use of 11-point numeric rating scales anchored at 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). The mBPI-sf recall period is 24 hours, and typical completion time for this instrument is less than 5 minutes.
No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.
measure: Stage 2: Change From Baseline in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)
time frame: Baseline, 6 Months
description: The EORTC QLQ-C30 self-reported general cancer instrument consists of 30 items covered by 1 of 3 dimensions:
Global health status/quality of life (2 items) with scores ranging from 1 (Very Poor) to 7 (Excellent).
Functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), each item scores ranging from 1 (not at all) to 4 (very much)
Symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, or financial impact), each item scores ranging from 1 (not at all) to 4 (very much).
Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function/QOL or higher levels of symptom burden.
No participants were enrolled to stage 2; however, results for stage 2 outcomes are reported from the data collected for participants enrolled to stage 1.
measure: Stage 1: PK: Steady State Trough Pre Dose Concentration of LY3023414
time frame: C2D1: 0h, C3D1: 0h, C4D1: 0h
description: Mean steady state exposure was reported by trough pre-dose plasma concentrations.
measure: Stage 1: PK: Mean Single Dose Concentration of LY3023414 at 2h Post-dose
time frame: C1D1: 2h Post dose
description: Mean single dose exposure was reported by plasma concentrations collected approximately 2 hours post-dose.
arm group label: Abemaciclib
arm group type: Experimental
description: Abemaciclib given orally.
arm group label: Abemaciclib + LY3023414
arm group type: Experimental
description: Abemaciclib given orally and LY3023414 given orally.
arm group label: Standard of Care (Gemcitabine or Capecitabine)
arm group type: Experimental
description: Gemcitabine given intravenously (IV) OR capecitabine given orally.
intervention type: Drug
intervention name: Abemaciclib
description: Administered orally
arm group label: Abemaciclib
arm group label: Abemaciclib + LY3023414
other name: LY2835219
intervention type: Drug
intervention name: LY3023414
description: Administered orally
arm group label: Abemaciclib + LY3023414
intervention type: Drug
intervention name: Gemcitabine
description: Administered IV
arm group label: Standard of Care (Gemcitabine or Capecitabine)
other name: LY188011
intervention type: Drug
intervention name: Capecitabine
description: Administered orally
arm group label: Standard of Care (Gemcitabine or Capecitabine)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
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country: Australia
country: Belgium
country: France
country: Israel
country: Spain
country: Taiwan
country: United Kingdom
country: United States
country: Argentina
country: Brazil
country: Hungary
url: https://www.lillytrialguide.com/en-US/studies/pancreatic-ductal-adenocarcinoma/JPCJ#?postal=
description: A Study of Abemaciclib (LY2835219) Alone or in Combination with Other Agents in Participants with Previously Treated Pancreatic Ductal Adenocarcinoma
responsible party type: Sponsor
mesh term: Adenocarcinoma
mesh term: Gemcitabine
mesh term: Capecitabine
sharing ipd: Yes
ipd description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
More information provided by Eli Lilly and Company
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
ipd access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
ipd url: https://vivli.org/
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study was planned for stage 1 & stage 2. Stage 2 did not occur, no participants were enrolled to stage 2;
point of contact: 