<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/NCT01722292</url>
  </required_header>
  <id_info>
    <org_study_id>14631</org_study_id>
    <secondary_id>I4J-MC-HHBE</secondary_id>
    <secondary_id>2012-003174-83</secondary_id>
    <nct_id>NCT01722292</nct_id>
  </id_info>
  <brief_title>A Study of LY2940680 in Small Cell Lung Cancer</brief_title>
  <official_title>A Phase 1b/2 Double-Blind Randomized Trial of the Hedgehog/SMO Antagonist LY2940680 in Combination With Carboplatin and Etoposide Followed by LY2940680 Versus Carboplatin and Etoposide Plus Placebo Followed by Placebo in Patients With Extensive-Stage Small Cell Lung Cancer</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 find a recommended dose of LY2940680 that can be safely given&#xD;
      in combination with etoposide and carboplatin followed by LY2940680 alone in participants&#xD;
      with extensive-disease small cell lung cancer. The study will also compare progression-free&#xD;
      survival in participants who are administered etoposide, carboplatin and LY2940680 followed&#xD;
      by LY2940680 alone versus etoposide, carboplatin, and placebo followed by placebo alone.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Change in clinical strategy.&#xD;
  </why_stopped>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phase 1b: Recommended Phase 2 Dose of LY2940680: Maximum Tolerated Dose (MTD)</measure>
    <time_frame>Baseline to Completion of the Phase 1b (Up To 12 Months)</time_frame>
    <description>MTD was defined as the highest tested dose that has &lt;33% probability of causing a dose-limiting toxicity(DLT). DLT was defined as an AE during Cycle 1 that is possibly related to the study drug and fulfills any one of the following criterion using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE),version 4.0:Grade 3 non-hematological toxicity except nausea, vomiting, constipation, diarrhea, fatigue, or anorexia that is manageable with appropriate care,transient(i.e., ≤5 days) Grade 3 elevations of alanine aminotransferase(ALT) and/or aspartate aminotransferase(AST), without evidence of other hepatic injury, in the setting of preexisting hepatic metastasis, ≥Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia of any duration,CTCAE Grade 4 hematological toxicity of &gt;5 days duration and any febrile neutropenia. any other significant toxicity deemed by the primary investigator and Lilly clinical research personnel to be dose-limiting.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 2: Progression-Free Survival</measure>
    <time_frame>Randomization to Measured Progressive Disease or Death of Any Cause (Estimated as 18 Months)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Phase 1b and 2: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2940680, LSN3185556 at the Recommended Dose</measure>
    <time_frame>Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1b and 2: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Carboplatin and Etoposide at the Recommended Dose</measure>
    <time_frame>Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1b and 2: Pharmacokinetics: Area Under the Curve ( AUC₀-₂₄) for LY2940680 and LSN3185556 at the Recommended Dose</measure>
    <time_frame>Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1b and 2: Pharmacokinetics: Area Under the Curve ( AUC₀-₂₄) for Etoposide and as AUC₀-₆ for Carboplatin at the Recommended Dose</measure>
    <time_frame>Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1b: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])</measure>
    <time_frame>Baseline to Study Completion Up to 39 Months</time_frame>
    <description>ORR was defined as the percentage of all randomized participants with the best overall response of PR or CR using Response Evaluation Criteria in Solid Tumors (RECIST v1.1). CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm. Tumor marker results must have normalized. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1b: Percentage Inhibition of Expression Levels of Gli1 in Skin Cells</measure>
    <time_frame>Baseline, Cycle 2 Day 1, Cycle 7 Day 1</time_frame>
    <description>The gene expression data (Gli1) was normalized and the level of percentage of Gli1 inhibition post treatment was calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Overall Survival</measure>
    <time_frame>Randomization to Study Completion (Estimated as 38 Months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Percent Change in Tumor Size (CTS)</measure>
    <time_frame>Randomization to End of Cycle 2 (Estimated as 24 Months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Number of Participants With a Complete or Partial Tumor Response (Overall Response Rate)</measure>
    <time_frame>Randomization to Study Completion (Estimated as 38 Months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1b and 2: Pharmacokinetics: Time to Maximal Concentration (Tmax) of LY2940680 andLSN3185556 at the Recommended Dose</measure>
    <time_frame>Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1b and 2: Pharmacokinetics: Time to Maximal Concentration (Tmax) of Carboplatin and Etoposide at the Recommended Dose</measure>
    <time_frame>Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Small Cell Lung Carcinoma</condition>
  <arm_group>
    <arm_group_label>Phase 1b: LY2940680 + C + E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase 1b Dose Escalation: Cycles 1-6 (21 day cycles) LY2940680 administered orally, once daily at escalating doses (100 milligrams [mg] up to 400 mg) in combination with etoposide (E) 100 milligram per square meter (mg/m^2) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle and carboplatin (C) Area Under the Curve [AUC] 5 (mg•min/mL) administered by IV infusion on day 1 each cycle.&#xD;
Phase 1b Maintenance: Cycles 7+ (21 day cycles) LY2940680 administered orally, once daily at the same dose as induction. Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2: Placebo + C + E</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Induction: Cycles 1-6 (21 day cycles) Placebo administered orally once daily in combination with etoposide 100 mg/m2 administered by IV infusion on days 1, 2, 3 of each cycle and carboplatin AUC 5 administered by IV infusion on day 1 each cycle.&#xD;
Maintenance: Cycles 7+ (21 day cycles) Placebo administered orally once daily. Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase 2: LY2940680 + C+ E</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Induction: Cycles 1-6 (21 day cycles) LY2940680 (dose to be determined in Phase 1b portion) administered orally once daily in combination with etoposide 100 mg/m^2 administered by IV infusion on days 1, 2, 3 of each cycle and carboplatin AUC 5 administered by IV infusion on day 1 each cycle.&#xD;
Maintenance: Cycles 7+ (21 day cycles). LY2940680 (dose to be determined in Phase 1 portion) administered orally once daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY2940680</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Phase 1b: LY2940680 + C + E</arm_group_label>
    <arm_group_label>Phase 2: LY2940680 + C+ E</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Administered IV</description>
    <arm_group_label>Phase 1b: LY2940680 + C + E</arm_group_label>
    <arm_group_label>Phase 2: LY2940680 + C+ E</arm_group_label>
    <arm_group_label>Phase 2: Placebo + C + E</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etoposide</intervention_name>
    <description>Administered IV</description>
    <arm_group_label>Phase 1b: LY2940680 + C + E</arm_group_label>
    <arm_group_label>Phase 2: LY2940680 + C+ E</arm_group_label>
    <arm_group_label>Phase 2: Placebo + C + E</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered orally</description>
    <arm_group_label>Phase 2: Placebo + C + E</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological or cytological diagnosis of Small Cell Lung Cancer (SCLC), including&#xD;
             malignant pleural effusion that is extensive stage per the International Staging&#xD;
             System&#xD;
&#xD;
          -  Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG)&#xD;
             performance status schedule&#xD;
&#xD;
          -  No prior systemic chemotherapy, immunotherapy, or biological therapy for SCLC&#xD;
&#xD;
          -  Prior radiation therapy allowed to &lt;25% of the bone marrow. Participants who have&#xD;
             received prior radiation to the whole pelvis or chest for the treatment of SCLC are&#xD;
             not eligible&#xD;
&#xD;
          -  At least 1 unidimensionally measurable lesion meeting Response Evaluation Criteria in&#xD;
             Solid Tumors (RECIST) version 1.1&#xD;
&#xD;
          -  Adequate organ function including the following:&#xD;
&#xD;
               -  Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥1.5 x 10^9/ liter&#xD;
                  (L), platelets ≥100 x 10^9/L, and hemoglobin ≥9 grams/deciliter (g/dL)&#xD;
&#xD;
               -  Hepatic: bilirubin ≤1.5 times the upper limit of normal (ULN), alkaline&#xD;
                  phosphatase (AP), Serum alanine aminotransferase (ALT) and aspartate transaminase&#xD;
                  (AST) ≤3.0 x ULN (AP, AST, and ALT ≤5 x ULN is acceptable if liver has tumor&#xD;
                  involvement)&#xD;
&#xD;
               -  Renal: calculated creatinine clearance (CrCl) ≥50 milliliters per minute (mL/min)&#xD;
                  based on the standard Cockcroft and Gault formula&#xD;
&#xD;
          -  Estimated life expectancy of at least 12 weeks&#xD;
&#xD;
          -  For women: Must be surgically sterile, post-menopausal, or compliant with a medically&#xD;
             approved contraceptive regimen during and for 6 months after the treatment period;&#xD;
             must have a negative serum pregnancy test within 7 days before study enrollment. For&#xD;
             men: Must be surgically sterile or compliant with a contraceptive regimen during and&#xD;
             for 6 months after the treatment period&#xD;
&#xD;
          -  Availability of a tumor tissue sample&#xD;
&#xD;
          -  Able to swallow capsules&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently enrolled in, or discontinued within the last 30 days from, a clinical trial&#xD;
             involving an investigational product or non-approved use of a drug or device, or&#xD;
             concurrently enrolled in any other type of medical research judged not to be&#xD;
             scientifically or medically compatible with this study&#xD;
&#xD;
          -  Have previously participated in a study involving LY2940680&#xD;
&#xD;
          -  Have previously received treatment with carboplatin or etoposide&#xD;
&#xD;
          -  Have a mixed histological diagnosis of SCLC and Non-Small Cell Lung Cancer (NSCLC)&#xD;
&#xD;
          -  Have a serious concomitant systemic disorder that, in the opinion of the investigator,&#xD;
             would compromise the participant's ability to adhere to the protocol&#xD;
&#xD;
          -  Have an active infection [≥38.5 degrees Celsius and/or receiving Intravenous (IV)&#xD;
             antibiotic therapy]&#xD;
&#xD;
          -  Have a serious cardiac condition&#xD;
&#xD;
          -  Have had a prior malignancy other than SCLC, carcinoma in situ of the cervix, or&#xD;
             nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively&#xD;
             treated at least 5 years previously with no subsequent evidence of recurrence.&#xD;
             Participants with a history of non-metastatic prostate cancer, including biochemical&#xD;
             relapse only, will be eligible even if diagnosed less than 5 years previously&#xD;
&#xD;
          -  Symptomatic central nervous system (CNS) metastases and asymptomatic CNS metastases&#xD;
             requiring concurrent corticosteroid therapy. Treated stable CNS metastases are&#xD;
             allowed; the participant must be stable after radiotherapy for ≥2 weeks and off of&#xD;
             corticosteroids for ≥1 week&#xD;
&#xD;
          -  Presence of clinically significant third-space fluid collections that cannot be&#xD;
             controlled prior to study entry&#xD;
&#xD;
          -  Significant weight loss (that is, ≥10%) over the 6-week period prior to study entry&#xD;
&#xD;
          -  Concurrent administration of any other antitumor therapy. An exception will be made&#xD;
             for non-metastatic prostate cancer participants continuing androgen blockade therapy&#xD;
             only or breast cancer participants continuing adjuvant antiestrogen therapy only (for&#xD;
             example, an aromatase inhibitor)&#xD;
&#xD;
          -  Females who are breastfeeding&#xD;
&#xD;
          -  Have corrected QT interval (QTc) of &gt;470 millisecond (msec) on screening&#xD;
             electrocardiogram (ECG)&#xD;
&#xD;
          -  Have received medications that are strong inhibitors of Cytochrome P450 3A4 (CYP3A4)&#xD;
             within 7 days prior to receiving study drug&#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>Highlands Oncology Group</name>
      <address>
        <city>Fayetteville</city>
        <state>Arkansas</state>
        <zip>72703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Georgia Cancer Care, LLC</name>
      <address>
        <city>Athens</city>
        <state>Georgia</state>
        <zip>30607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Oncology Hematology Associate</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Unit (ITOR) Greenville Hospital System</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Accelerated Comm. Oncology Research Network (ACORN)</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The West Clinic</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>US Oncology</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77380</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tyler Cancer Center</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Cancer Specialists PC</name>
      <address>
        <city>Vancouver</city>
        <state>Washington</state>
        <zip>98684</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yakima Valley Memorial Hospital</name>
      <address>
        <city>Yakima</city>
        <state>Washington</state>
        <zip>98902</zip>
        <country>United States</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>SE1 9RT</zip>
        <country>United Kingdom</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>Manchester</city>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Belgium</country>
    <country>Korea, Republic of</country>
  </removed_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>November 2, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <results_first_submitted>October 16, 2018</results_first_submitted>
  <results_first_submitted_qc>December 6, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 28, 2018</results_first_posted>
  <disposition_first_submitted>May 8, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>May 8, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">May 25, 2015</disposition_first_posted>
  <last_update_submitted>December 6, 2018</last_update_submitted>
  <last_update_submitted_qc>December 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Small Cell Lung Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Etoposide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.&#xD;
This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped. Phase 1b study completer was defined as completion of the dose-limiting toxicity (DLT) period (1 cycle- 21 days cycle for LY2940680 in combination with carboplatin and etoposide.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Phase 1b: 100 mg LY2940680 + C + E</title>
          <description>100 milligrams (mg) LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve (AUC) 5 milligrams*minute*milliliters (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.&#xD;
Maintenance:&#xD;
Single-agent LY2940680 administered orally QD at the same dose as induction at Cycles 7+ (21 day cycles). Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation.</description>
        </group>
        <group group_id="P2">
          <title>Phase 1b: 200 mg LY2940680 + C + E</title>
          <description>200 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve (AUC) 5 milligrams*minute*milliliters (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.&#xD;
Maintenance:&#xD;
Single-agent LY2940680 administered orally QD at the same dose as induction at Cycles 7+ (21 day cycles). Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation.</description>
        </group>
        <group group_id="P3">
          <title>Phase 1B: 400 mg LY2940680 + C + E</title>
          <description>400 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve (AUC) 5 milligrams*minute*milliliters (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.&#xD;
Maintenance:&#xD;
Single-agent LY2940680 administered orally QD at the same dose as induction at Cycles 7+ (21 day cycles). Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least One Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants who received at least one dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Phase 1b: 100 mg LY2940680 + C +E</title>
          <description>100 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 milligrams*minute*milliliters (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.&#xD;
Maintenance:&#xD;
Single-agent LY2940680 administered orally QD at the same dose as induction at Cycles 7+ (21 day cycles). Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation.</description>
        </group>
        <group group_id="B2">
          <title>Phase 1b: 200 mg LY2940680 + C + E</title>
          <description>200 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 milligrams*minute*milliliters (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.&#xD;
Maintenance:&#xD;
Single-agent LY2940680 administered orally QD at the same dose as induction at Cycles 7+ (21 day cycles). Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation.</description>
        </group>
        <group group_id="B3">
          <title>Phase 1b: 400 mg LY2940680 + C + E</title>
          <description>400 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 milligrams*minute*milliliters (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.&#xD;
Maintenance:&#xD;
Single-agent LY2940680 administered orally QD at the same dose as induction at Cycles 7+ (21 day cycles). Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation.</description>
        </group>
        <group group_id="B4">
          <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="6"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="14"/>
            <count group_id="B4" value="26"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.3" spread="9.35"/>
                    <measurement group_id="B2" value="64.8" spread="11.96"/>
                    <measurement group_id="B3" value="60.2" spread="12.19"/>
                    <measurement group_id="B4" value="62.2" spread="11.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="22"/>
                  </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_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="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Phase 1b: Recommended Phase 2 Dose of LY2940680: Maximum Tolerated Dose (MTD)</title>
        <description>MTD was defined as the highest tested dose that has &lt;33% probability of causing a dose-limiting toxicity(DLT). DLT was defined as an AE during Cycle 1 that is possibly related to the study drug and fulfills any one of the following criterion using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE),version 4.0:Grade 3 non-hematological toxicity except nausea, vomiting, constipation, diarrhea, fatigue, or anorexia that is manageable with appropriate care,transient(i.e., ≤5 days) Grade 3 elevations of alanine aminotransferase(ALT) and/or aspartate aminotransferase(AST), without evidence of other hepatic injury, in the setting of preexisting hepatic metastasis, ≥Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia of any duration,CTCAE Grade 4 hematological toxicity of &gt;5 days duration and any febrile neutropenia. any other significant toxicity deemed by the primary investigator and Lilly clinical research personnel to be dose-limiting.</description>
        <time_frame>Baseline to Completion of the Phase 1b (Up To 12 Months)</time_frame>
        <population>All participants who received at least one dose of study drug and were enrolled in Phase1b of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b</title>
            <description>Cohort 1:&#xD;
100 milligrams (mg) LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.&#xD;
Cohort 2:&#xD;
200 milligrams (mg) LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.&#xD;
Cohort 3:&#xD;
400 milligrams (mg) LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1b: Recommended Phase 2 Dose of LY2940680: Maximum Tolerated Dose (MTD)</title>
          <description>MTD was defined as the highest tested dose that has &lt;33% probability of causing a dose-limiting toxicity(DLT). DLT was defined as an AE during Cycle 1 that is possibly related to the study drug and fulfills any one of the following criterion using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE),version 4.0:Grade 3 non-hematological toxicity except nausea, vomiting, constipation, diarrhea, fatigue, or anorexia that is manageable with appropriate care,transient(i.e., ≤5 days) Grade 3 elevations of alanine aminotransferase(ALT) and/or aspartate aminotransferase(AST), without evidence of other hepatic injury, in the setting of preexisting hepatic metastasis, ≥Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia of any duration,CTCAE Grade 4 hematological toxicity of &gt;5 days duration and any febrile neutropenia. any other significant toxicity deemed by the primary investigator and Lilly clinical research personnel to be dose-limiting.</description>
          <population>All participants who received at least one dose of study drug and were enrolled in Phase1b of the study.</population>
          <units>milligrams (mg)</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="400"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Phase 2: Progression-Free Survival</title>
        <time_frame>Randomization to Measured Progressive Disease or Death of Any Cause (Estimated as 18 Months)</time_frame>
        <population>Zero participants analyzed. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 2: 400 mg LY2940680 + C+ E</title>
            <description>400 mg LY2940680 administered orally QD cycles 1-6 (21 day cycle).&#xD;
(AUC) 5 carboplatin (C) administered by IV infusion on day 1 each cycle.&#xD;
100 mg/m^2 etoposide (E) administered by IV infusion on days 1, 2, 3 of each cycle, followed by a single agent of LY2940680.</description>
          </group>
          <group group_id="O2">
            <title>Phase 2: Placebo + C + E</title>
            <description>Placebo administered orally QD for 6 cycles.&#xD;
(AUC) 5 carboplatin administered by IV infusion on day 1 of each cycle.&#xD;
100 mg/m^2 etoposide administered by IV infusion on days 1, 2, 3 of each cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2: Progression-Free Survival</title>
          <population>Zero participants analyzed. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.</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_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1b and 2: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2940680, LSN3185556 at the Recommended Dose</title>
        <time_frame>Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours</time_frame>
        <population>All participants who received at least one dose of study drug and were enrolled in Phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: 100 mg LY2940680 + C + E</title>
            <description>100 mg LY2940680 administered orally once daily (QD) for 6 cycles.&#xD;
100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: 200 mg LY2940680 + C + E</title>
            <description>200 mg LY2940680 administered orally once daily (QD) for 6 cycles.&#xD;
100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.</description>
          </group>
          <group group_id="O3">
            <title>Phase 1B: 400 mg LY2940680 + C + E</title>
            <description>400 mg LY2940680 administered orally once daily (QD) for 6 cycles.&#xD;
100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1b and 2: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2940680, LSN3185556 at the Recommended Dose</title>
          <population>All participants who received at least one dose of study drug and were enrolled in Phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.</population>
          <units>microgram per milliliter (µg/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="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>LY2940680 Cycle 1, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.491" spread="64"/>
                    <measurement group_id="O2" value="1.01" spread="36"/>
                    <measurement group_id="O3" value="1.56" spread="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LY2940680 Cycle 2, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.578" spread="71"/>
                    <measurement group_id="O2" value="1.16" spread="66"/>
                    <measurement group_id="O3" value="3.29" spread="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LSN3185556 Cycle 1, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.444" spread="33"/>
                    <measurement group_id="O2" value="0.737" spread="138"/>
                    <measurement group_id="O3" value="1.75" spread="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LSN3185556 Cycle 2, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="35"/>
                    <measurement group_id="O2" value="2.1" spread="90"/>
                    <measurement group_id="O3" value="6" spread="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1b and 2: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Carboplatin and Etoposide at the Recommended Dose</title>
        <time_frame>Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours</time_frame>
        <population>All participants who received at least one dose of study drug and were enrolled in Phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.&#xD;
C and E doses did not change for the 3 cohorts of LY (100,200 and 400 mg) so we only need to report one grouping.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LY2940680 + C + E</title>
            <description>LY2940680 administered orally once daily (QD) for 6 cycles.&#xD;
100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1b and 2: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Carboplatin and Etoposide at the Recommended Dose</title>
          <population>All participants who received at least one dose of study drug and were enrolled in Phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.&#xD;
C and E doses did not change for the 3 cohorts of LY (100,200 and 400 mg) so we only need to report one grouping.</population>
          <units>microgram per milliliter (µg/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="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Carboplatin Cycle 1, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" spread="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Carboplatin Cycle 2, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.1" spread="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Etoposide Cycle 1, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.9" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Etoposide Cycle 2, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.4" spread="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1b and 2: Pharmacokinetics: Area Under the Curve ( AUC₀-₂₄) for LY2940680 and LSN3185556 at the Recommended Dose</title>
        <time_frame>Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours</time_frame>
        <population>All participants who received at least one dose of study drug and were enrolled in phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: 100 mg LY2940680 + C+ E</title>
            <description>100 mg LY2940680 administered orally once daily (QD) for 6 cycles.&#xD;
100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: 200 mg LY2940680 + C+ E</title>
            <description>200 mg LY2940680 administered orally once daily (QD) for 6 cycles.&#xD;
100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: 400 mg LY2940680 + C+ E</title>
            <description>400 mg LY2940680 administered orally once daily (QD) for 6 cycles.&#xD;
100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1b and 2: Pharmacokinetics: Area Under the Curve ( AUC₀-₂₄) for LY2940680 and LSN3185556 at the Recommended Dose</title>
          <population>All participants who received at least one dose of study drug and were enrolled in phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.</population>
          <units>Hour*microgram per milliliter (h.µg/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="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>LY2940680 Cycle 1, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.34" spread="57"/>
                    <measurement group_id="O2" value="8.96" spread="39"/>
                    <measurement group_id="O3" value="15.9" spread="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LY2940680 Cycle 2, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.86" spread="67"/>
                    <measurement group_id="O2" value="15.5" spread="64"/>
                    <measurement group_id="O3" value="37.6" spread="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LSN3185556 Cycle 1, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.23" spread="49"/>
                    <measurement group_id="O2" value="16.2" spread="67"/>
                    <measurement group_id="O3" value="26" spread="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LSN3185556 Cycle 2, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.7" spread="58"/>
                    <measurement group_id="O2" value="31.1" spread="111"/>
                    <measurement group_id="O3" value="92.5" spread="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1b and 2: Pharmacokinetics: Area Under the Curve ( AUC₀-₂₄) for Etoposide and as AUC₀-₆ for Carboplatin at the Recommended Dose</title>
        <time_frame>Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours</time_frame>
        <population>All participants who received at least one dose of study drug and were enrolled in phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.&#xD;
C and E doses did not change for the 3 cohorts of LY (100,200 and 400 mg) so we only need to report one grouping.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LY2940680 + C+ E</title>
            <description>LY2940680 administered orally once daily (QD) for 6 cycles.&#xD;
100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1b and 2: Pharmacokinetics: Area Under the Curve ( AUC₀-₂₄) for Etoposide and as AUC₀-₆ for Carboplatin at the Recommended Dose</title>
          <population>All participants who received at least one dose of study drug and were enrolled in phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.&#xD;
C and E doses did not change for the 3 cohorts of LY (100,200 and 400 mg) so we only need to report one grouping.</population>
          <units>Hour*microgram per milliliter (h.µg/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="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Carboplatin Cycle 1, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.2" spread="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Carboplatin Cycle 2, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.0" spread="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Etoposide Cycle 1, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104" spread="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Etoposide Cycle 2, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.1" spread="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1b: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])</title>
        <description>ORR was defined as the percentage of all randomized participants with the best overall response of PR or CR using Response Evaluation Criteria in Solid Tumors (RECIST v1.1). CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm. Tumor marker results must have normalized. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.</description>
        <time_frame>Baseline to Study Completion Up to 39 Months</time_frame>
        <population>All participants who received at least one dose of drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: 100 mg LY2940680 + C+ E</title>
            <description>100 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: 200 mg LY2940680 + C+ E</title>
            <description>200 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: 400 mg LY2940680 + C+ E</title>
            <description>400 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1b: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])</title>
          <description>ORR was defined as the percentage of all randomized participants with the best overall response of PR or CR using Response Evaluation Criteria in Solid Tumors (RECIST v1.1). CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm. Tumor marker results must have normalized. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.</description>
          <population>All participants who received at least one dose of drug.</population>
          <units>percentage of participants</units>
          <param>Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50" lower_limit="16.4" upper_limit="83.6"/>
                    <measurement group_id="O2" value="50" lower_limit="16.4" upper_limit="83.6"/>
                    <measurement group_id="O3" value="57.1" lower_limit="35.4" upper_limit="78.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1b: Percentage Inhibition of Expression Levels of Gli1 in Skin Cells</title>
        <description>The gene expression data (Gli1) was normalized and the level of percentage of Gli1 inhibition post treatment was calculated.</description>
        <time_frame>Baseline, Cycle 2 Day 1, Cycle 7 Day 1</time_frame>
        <population>All participants who received at least one dose of drug and had samples available.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: 100 mg LY2940680</title>
            <description>100 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: 200 mg LY2940680</title>
            <description>200 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: 400 mg LY2940680</title>
            <description>400 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1b: Percentage Inhibition of Expression Levels of Gli1 in Skin Cells</title>
          <description>The gene expression data (Gli1) was normalized and the level of percentage of Gli1 inhibition post treatment was calculated.</description>
          <population>All participants who received at least one dose of drug and had samples available.</population>
          <units>Percentage of Gli 1 Inhibition</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.7" lower_limit="75.9" upper_limit="94.9"/>
                    <measurement group_id="O2" value="95.1" lower_limit="94.5" upper_limit="97.2"/>
                    <measurement group_id="O3" value="94.8" lower_limit="90.7" upper_limit="97.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 2: Overall Survival</title>
        <time_frame>Randomization to Study Completion (Estimated as 38 Months)</time_frame>
        <population>Zero participants analyzed. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 2: 400 mg LY2940680 + C+ E</title>
            <description>400 mg LY2940680 administered orally QD cycles 1-6 (21 day cycle)&#xD;
(AUC) 5 carboplatin (C) administered by IV infusion on day 1 each cycle.&#xD;
100 mg/m^2 etoposide (E) administered by IV infusion on days 1, 2, 3 of each cycle, followed by a single agent of LY2940680.</description>
          </group>
          <group group_id="O2">
            <title>Phase 2: Placebo + C + E</title>
            <description>Placebo administered orally QD for 6 cycles.&#xD;
(AUC) 5 carboplatin administered by IV infusion on day 1 of each cycle.&#xD;
100 mg/m^2 etoposide administered by IV infusion on days 1, 2, 3 of each cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2: Overall Survival</title>
          <population>Zero participants analyzed. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.</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_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 2: Percent Change in Tumor Size (CTS)</title>
        <time_frame>Randomization to End of Cycle 2 (Estimated as 24 Months)</time_frame>
        <population>Zero participants analyzed. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 2: 400 mg LY2940680 + C+ E</title>
            <description>400 mg LY2940680 administered orally QD cycles 1-6 (21 day cycle)&#xD;
(AUC) 5 carboplatin (C) administered by IV infusion on day 1 each cycle.&#xD;
100 mg/m^2 etoposide (E) administered by IV infusion on days 1, 2, 3 of each cycle, followed by a single agent of LY2940680.</description>
          </group>
          <group group_id="O2">
            <title>Phase 2: Placebo + C + E</title>
            <description>Placebo administered orally QD for 6 cycles.&#xD;
(AUC) 5 carboplatin administered by IV infusion on day 1 of each cycle.&#xD;
100 mg/m^2 etoposide administered by IV infusion on days 1, 2, 3 of each cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2: Percent Change in Tumor Size (CTS)</title>
          <population>Zero participants analyzed. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.</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_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 2: Number of Participants With a Complete or Partial Tumor Response (Overall Response Rate)</title>
        <time_frame>Randomization to Study Completion (Estimated as 38 Months)</time_frame>
        <population>Zero participants analyzed. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 2: Placebo + C + E</title>
            <description>Induction: Cycles 1-6 (21 day cycles) Placebo administered orally once daily in combination with etoposide 100 mg/m^2 administered by IV infusion on days 1, 2, 3 of each cycle and carboplatin AUC 5 administered by IV infusion on day 1 each cycle.&#xD;
Maintenance: Cycles 7+ (21 day cycles) Placebo administered orally once daily. Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation.</description>
          </group>
          <group group_id="O2">
            <title>Phase 2: LY2940680 + C+ E</title>
            <description>Induction: Cycles 1-6 (21 day cycles) LY2940680 (dose to be determined in Phase 1b portion) administered orally once daily in combination with etoposide 100 mg/m^2 administered by IV infusion on days 1, 2, 3 of each cycle and carboplatin AUC 5 administered by IV infusion on day 1 each cycle.&#xD;
Maintenance: Cycles 7+ (21 day cycles). LY2940680 (dose to be determined in Phase 1 portion) administered orally once daily.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 2: Number of Participants With a Complete or Partial Tumor Response (Overall Response Rate)</title>
          <population>Zero participants analyzed. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.</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_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1b and 2: Pharmacokinetics: Time to Maximal Concentration (Tmax) of LY2940680 andLSN3185556 at the Recommended Dose</title>
        <time_frame>Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours</time_frame>
        <population>All participants who received at least one dose of study drug and were enrolled in phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: 100 mg LY2940680 + C+ E</title>
            <description>100 mg LY2940680 administered orally once daily (QD) for 6 cycles.&#xD;
100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.</description>
          </group>
          <group group_id="O2">
            <title>Phase 1b: 200 mg LY2940680 + C+ E</title>
            <description>200 mg LY2940680 administered orally once daily (QD) for 6 cycles.&#xD;
100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.</description>
          </group>
          <group group_id="O3">
            <title>Phase 1b: 400 mg LY2940680 + C+ E</title>
            <description>400 mg LY2940680 administered orally once daily (QD) for 6 cycles.&#xD;
100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1b and 2: Pharmacokinetics: Time to Maximal Concentration (Tmax) of LY2940680 andLSN3185556 at the Recommended Dose</title>
          <population>All participants who received at least one dose of study drug and were enrolled in phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.</population>
          <units>Hour (h)</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>LY2940680 Cycle 1, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.05" lower_limit="1" upper_limit="3.98"/>
                    <measurement group_id="O2" value="2.01" lower_limit="1.03" upper_limit="2.05"/>
                    <measurement group_id="O3" value="1.51" lower_limit="0.5" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LY2940680 Cycle 2, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.96" lower_limit="0.08" upper_limit="5.83"/>
                    <measurement group_id="O2" value="4" lower_limit="1.88" upper_limit="4.08"/>
                    <measurement group_id="O3" value="1" lower_limit="0.5" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LSN3185556 Cycle 1, Day 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.14" lower_limit="2" upper_limit="24.03"/>
                    <measurement group_id="O2" value="5.87" lower_limit="2.07" upper_limit="24.97"/>
                    <measurement group_id="O3" value="6" lower_limit="2.05" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LSN3185556 Cycle 2, Day 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="O2" value="4.08" lower_limit="4" upper_limit="23.83"/>
                    <measurement group_id="O3" value="2.21" lower_limit="0.5" upper_limit="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Phase 1b and 2: Pharmacokinetics: Time to Maximal Concentration (Tmax) of Carboplatin and Etoposide at the Recommended Dose</title>
        <time_frame>Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours</time_frame>
        <population>All participants who received at least one dose of study drug and were enrolled in phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped. C and E doses did not change for the 3 cohorts of LY (100,200 and 400 mg) so we only need to report one grouping.</population>
        <group_list>
          <group group_id="O1">
            <title>Phase 1b: LY2940680 + C+ E</title>
            <description>LY2940680 administered orally once daily (QD) for 6 cycles.&#xD;
100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 (mg*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Phase 1b and 2: Pharmacokinetics: Time to Maximal Concentration (Tmax) of Carboplatin and Etoposide at the Recommended Dose</title>
          <population>All participants who received at least one dose of study drug and were enrolled in phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped. C and E doses did not change for the 3 cohorts of LY (100,200 and 400 mg) so we only need to report one grouping.</population>
          <units>Hour (h)</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Carboplatin Cycle 1, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0.42" upper_limit="1.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Carboplatin Cycle 2, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0.42" upper_limit="1.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Etoposide Cycle 1, Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.96" lower_limit="0.48" upper_limit="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Etoposide Cycle 2 ,Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.99" lower_limit="0.33" upper_limit="1.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Phase 1b: 100 mg LY2940680 + C + E</title>
          <description>100 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.</description>
        </group>
        <group group_id="E2">
          <title>Phase 1b: 200 mg LY2940680 + C + E</title>
          <description>200 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.</description>
        </group>
        <group group_id="E3">
          <title>Phase 1b: 400 mg LY2940680 + C + E</title>
          <description>400 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.&#xD;
Area under the Curve [AUC] 5 (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="14"/>
              </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="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Enterocolitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Systemic inflammatory response syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Malignant neoplasm progression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Nervous system disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </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="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypovolaemic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 18.0</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="6" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="14"/>
              </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="3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E3" events="12" subjects_affected="8" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E2" events="8" subjects_affected="5" subjects_at_risk="6"/>
                <counts group_id="E3" events="13" subjects_affected="7" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E3" events="14" subjects_affected="8" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Thrombocytosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Diplopia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Eyelid ptosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Visual acuity reduced</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="10" subjects_affected="8" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="11" subjects_affected="6" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Haematemesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Intestinal ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E3" events="13" subjects_affected="10" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Paraesthesia oral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="5" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E3" events="9" subjects_affected="5" subjects_at_risk="14"/>
              </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="6"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E3" events="15" subjects_affected="11" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Gait disturbance</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Escherichia urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Folliculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Furuncle</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Gastrointestinal viral infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Rash pustular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Tinea cruris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Urinary tract infection bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="14"/>
              </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="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Post procedural inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Sunburn</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Tooth fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Blood potassium decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Creatinine renal clearance decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Lipase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </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="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Hypophagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Aphasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Cognitive disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Dizziness postural</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="6"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Dyskinesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Head discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Tremor</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Agitation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Cold sweat</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Skin discolouration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Skin plaque</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>Orthostatic hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="14"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.</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/NCT01722292
org study id: 14631
secondary id: I4J-MC-HHBE
secondary id: 2012-003174-83
nct id: NCT01722292
lead sponsor: 
has dmc: No
The purpose of this study is to find a recommended dose of LY2940680 that can be safely given
      in combination with etoposide and carboplatin followed by LY2940680 alone in participants
      with extensive-disease small cell lung cancer. The study will also compare progression-free
      survival in participants who are administered etoposide, carboplatin and LY2940680 followed
      by LY2940680 alone versus etoposide, carboplatin, and placebo followed by placebo alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Phase 1b: Recommended Phase 2 Dose of LY2940680: Maximum Tolerated Dose (MTD)
time frame: Baseline to Completion of the Phase 1b (Up To 12 Months)
description: MTD was defined as the highest tested dose that has <33% probability of causing a dose-limiting toxicity(DLT). DLT was defined as an AE during Cycle 1 that is possibly related to the study drug and fulfills any one of the following criterion using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE),version 4.0:Grade 3 non-hematological toxicity except nausea, vomiting, constipation, diarrhea, fatigue, or anorexia that is manageable with appropriate care,transient(i.e., ≤5 days) Grade 3 elevations of alanine aminotransferase(ALT) and/or aspartate aminotransferase(AST), without evidence of other hepatic injury, in the setting of preexisting hepatic metastasis, ≥Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia of any duration,CTCAE Grade 4 hematological toxicity of >5 days duration and any febrile neutropenia. any other significant toxicity deemed by the primary investigator and Lilly clinical research personnel to be dose-limiting.
measure: Phase 2: Progression-Free Survival
time frame: Randomization to Measured Progressive Disease or Death of Any Cause (Estimated as 18 Months)
measure: Phase 1b and 2: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2940680, LSN3185556 at the Recommended Dose
time frame: Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours
measure: Phase 1b and 2: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Carboplatin and Etoposide at the Recommended Dose
time frame: Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours
measure: Phase 1b and 2: Pharmacokinetics: Area Under the Curve ( AUC₀-₂₄) for LY2940680 and LSN3185556 at the Recommended Dose
time frame: Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours
measure: Phase 1b and 2: Pharmacokinetics: Area Under the Curve ( AUC₀-₂₄) for Etoposide and as AUC₀-₆ for Carboplatin at the Recommended Dose
time frame: Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours
measure: Phase 1b: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])
time frame: Baseline to Study Completion Up to 39 Months
description: ORR was defined as the percentage of all randomized participants with the best overall response of PR or CR using Response Evaluation Criteria in Solid Tumors (RECIST v1.1). CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.
measure: Phase 1b: Percentage Inhibition of Expression Levels of Gli1 in Skin Cells
time frame: Baseline, Cycle 2 Day 1, Cycle 7 Day 1
description: The gene expression data (Gli1) was normalized and the level of percentage of Gli1 inhibition post treatment was calculated.
measure: Phase 2: Overall Survival
time frame: Randomization to Study Completion (Estimated as 38 Months)
measure: Phase 2: Percent Change in Tumor Size (CTS)
time frame: Randomization to End of Cycle 2 (Estimated as 24 Months)
measure: Phase 2: Number of Participants With a Complete or Partial Tumor Response (Overall Response Rate)
time frame: Randomization to Study Completion (Estimated as 38 Months)
measure: Phase 1b and 2: Pharmacokinetics: Time to Maximal Concentration (Tmax) of LY2940680 andLSN3185556 at the Recommended Dose
time frame: Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours
measure: Phase 1b and 2: Pharmacokinetics: Time to Maximal Concentration (Tmax) of Carboplatin and Etoposide at the Recommended Dose
time frame: Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours
arm group label: Phase 1b: LY2940680 + C + E
arm group type: Experimental
description: Phase 1b Dose Escalation: Cycles 1-6 (21 day cycles) LY2940680 administered orally, once daily at escalating doses (100 milligrams [mg] up to 400 mg) in combination with etoposide (E) 100 milligram per square meter (mg/m^2) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle and carboplatin (C) Area Under the Curve [AUC] 5 (mg•min/mL) administered by IV infusion on day 1 each cycle.
Phase 1b Maintenance: Cycles 7+ (21 day cycles) LY2940680 administered orally, once daily at the same dose as induction. Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation.
arm group label: Phase 2: Placebo + C + E
arm group type: Placebo Comparator
description: Induction: Cycles 1-6 (21 day cycles) Placebo administered orally once daily in combination with etoposide 100 mg/m2 administered by IV infusion on days 1, 2, 3 of each cycle and carboplatin AUC 5 administered by IV infusion on day 1 each cycle.
Maintenance: Cycles 7+ (21 day cycles) Placebo administered orally once daily. Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation.
arm group label: Phase 2: LY2940680 + C+ E
arm group type: Experimental
description: Induction: Cycles 1-6 (21 day cycles) LY2940680 (dose to be determined in Phase 1b portion) administered orally once daily in combination with etoposide 100 mg/m^2 administered by IV infusion on days 1, 2, 3 of each cycle and carboplatin AUC 5 administered by IV infusion on day 1 each cycle.
Maintenance: Cycles 7+ (21 day cycles). LY2940680 (dose to be determined in Phase 1 portion) administered orally once daily.
intervention type: Drug
intervention name: LY2940680
description: Administered orally
arm group label: Phase 1b: LY2940680 + C + E
arm group label: Phase 2: LY2940680 + C+ E
intervention type: Drug
intervention name: Carboplatin
description: Administered IV
arm group label: Phase 1b: LY2940680 + C + E
arm group label: Phase 2: LY2940680 + C+ E
arm group label: Phase 2: Placebo + C + E
intervention type: Drug
intervention name: Etoposide
description: Administered IV
arm group label: Phase 1b: LY2940680 + C + E
arm group label: Phase 2: LY2940680 + C+ E
arm group label: Phase 2: Placebo + C + E
intervention type: Drug
intervention name: Placebo
description: Administered orally
arm group label: Phase 2: Placebo + C + E
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
facility: 
facility: 
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facility: 
country: United Kingdom
country: United States
country: Belgium
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Small Cell Lung Carcinoma
mesh term: Carboplatin
mesh term: Etoposide
sharing ipd: Yes
ipd description: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.
This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.
point of contact: 