<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/NCT02978716</url>
  </required_header>
  <id_info>
    <org_study_id>G1T28-04</org_study_id>
    <secondary_id>2016-004466-26</secondary_id>
    <nct_id>NCT02978716</nct_id>
  </id_info>
  <brief_title>Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)</brief_title>
  <official_title>Phase 2 Study of the Safety, Efficacy, and Pharmacokinetics of G1T28 in Patients With Metastatic Triple Negative Breast Cancer Receiving Gemcitabine and Carboplatin Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>G1 Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>G1 Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a study to investigate the potential clinical benefit of trilaciclib (G1T28) in&#xD;
      preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor&#xD;
      efficacy when administered prior to carboplatin and gemcitabine (GC therapy) for participants&#xD;
      with metastatic triple negative breast cancer.&#xD;
&#xD;
      The study was an open-label and 102 participants were randomly assigned (1:1:1 fashion) to 1&#xD;
      of the 3 following treatment groups:&#xD;
&#xD;
        -  Group 1: GC therapy (Days 1 and 8 of 21-day cycles) only (n=34)&#xD;
&#xD;
        -  Group 2: GC therapy (Days 1 and 8) plus trilaciclib (G1T28) on Days 1 and 8 of 21-day&#xD;
           cycles (n=33)&#xD;
&#xD;
        -  Group 3: GC therapy (Days 2 and 9) plus trilaciclib (G1T28) on Days 1, 2, 8, and 9 of&#xD;
           21-day cycles (n=35)&#xD;
&#xD;
      The study included 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up&#xD;
      Phase. The Treatment Phase begins on the day of first dose with study treatment and completes&#xD;
      at the Post-Treatment Visit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The posted results represent the final results of Study G1T28-04, a Phase 2 study of the&#xD;
      safety, efficacy and pharmacokinetics of trilaciclib (G1T28) in patients with locally&#xD;
      recurrent/metastatic triple negative breast cancer receiving gemcitabine and carboplatin&#xD;
      chemotherapy.&#xD;
&#xD;
      The final myelopreservation efficacy results are reported from database lock 1 ([DBL1], data&#xD;
      cut-off [DCO] date of 30 July 2018). Final anti-tumor efficacy (ORR, PFS), and final summary&#xD;
      exposure and safety data are reported from database lock 2 ([DBL2], DCO 28 June 2019) which&#xD;
      occurred to support filing of the trilaciclib New Drug Application (NDA). Final overall&#xD;
      survival (OS) data are reported from the final database lock which occurred on 17 July 2020&#xD;
      (with a last patient last visit date of 28 February 2020).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Primary Analysis and survival follow up completed per protocol. Not stopped due to safety&#xD;
    concerns&#xD;
  </why_stopped>
  <start_date type="Actual">February 2, 2017</start_date>
  <completion_date type="Actual">February 28, 2020</completion_date>
  <primary_completion_date type="Actual">June 28, 2019</primary_completion_date>
  <phase>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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of Severe (Grade 4) Neutropenia (DSN) During Cycle 1</measure>
    <time_frame>From randomization to the end of Cycle 1 (Each cycle= 21 days)</time_frame>
    <description>DSN was defined as the number of days from the date of the first absolute neutrophil count (ANC) value of less than (&lt;) 0.5 × 10^9 cells/liter (L) observed between Day 1 Cycle 1 and the end of Cycle 1 to the date of the first ANC value greater than or equal to (&gt;=) 0.5 × 10^9/L that met the following: (1) occurred after the ANC value of &lt; 0.5 × 10^9 cells/L and (2) no other ANC values &lt; 0.5 × 10^9 cells/L occurred between this day and the end of Cycle 1. Severe neutropenia (SN) was set to zero for participants who did not experience severe (Grade 4) neutropenia in Cycle 1, including those who were randomized but never treated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Severe (Grade 4) Neutropenia (SN)</measure>
    <time_frame>During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days</time_frame>
    <description>Number of participants with Grade 4 SN was a binary variable. If a participants had at least 1 ANC value &lt; 0.5 ×10^9/L during the treatment period, the participants was assigned as &quot;yes&quot; to the occurrence of SN. Otherwise, it was &quot;no&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)</measure>
    <time_frame>From date of randomization until the occurrence of progressive disease or a censoring event, assessed up to a maximum of 875 days</time_frame>
    <description>BOR was defined as the best response across all time points (RECIST v1.1). The best overall response was determined once all the data for the participant is known. Each participant has been assigned one of the following categories (RECIST 1.1): complete response (CR): disappearance of all target lesions; partial response (PR): &gt;= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; progression disease (PD): &gt;= 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study); stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD); NE: not evaluable and missing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Objective Response (DOR) as Per RECIST v1.1 as Determined by Investigator</measure>
    <time_frame>From date of randomization until the occurrence of progressive disease or a censoring event, assessed up to a maximum of 875 days</time_frame>
    <description>DOR is the time between first response by RECIST Version 1.1 of CR or PR and the first date that progressive disease is documented by RECIST Version 1.1, or death. Participants who do not experience PD or death was censored at the last tumor assessment date. 95% Confidence Interval (CI) was calculated using the Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>From date of randomization to date of death due to any cause, assessed up to a maximum of 1120 days</time_frame>
    <description>Overall survival was defined as the time (months) from date of randomization to the date of death due to any cause. Participants who do not die during the study were censored at the date last known to be alive. The OS was calculated using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS) as Per RECIST v1.1 as Determined by Investigator</measure>
    <time_frame>From date of randomization until the occurrence of disease progression, death due to any cause or a censoring event, assessed up to a maximum of 875 days</time_frame>
    <description>PFS was defined as the time (months) from date of randomization until date of documented PD or death due to any cause, whichever comes first. PD: &gt;= 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study). The PFS was calculated using Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative Dose Intensity of Gemcitabine and Carboplatin</measure>
    <time_frame>During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days</time_frame>
    <description>Relative dose intensity was defined as 100% times the actual dose intensity divided by the planned dose intensity. The planned dose intensity was defined as the cumulative planned dose through the study divided by (number of cycles × 3 weeks). Relative dose intensity (%) was calculated as: for gemcitabine (100 * [Dose intensity (mg/m2/week) / (2000/3 (mg/m2/week)]); for carboplatin (100 * [Dose intensity (AUC/week)/ (4/3) (AUC/week)]) and for trilaciclib (100 * [Dose intensity (mg/m2/week)/ (480 /3 (mg/m2/week)] for Group 2 and 100 * [Dose intensity (mg/m2/week) / (960 /3 (mg/m2/week)] for Group 3).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Exposure</measure>
    <time_frame>During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days</time_frame>
    <description>Duration of exposure (days) = First dose date of study drug from the last cycle - first dose date of study drug + 21.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Cycles Participants Received Treatment in Each Treatment Arm</measure>
    <time_frame>During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days</time_frame>
    <description>Participants were considered to have started a cycle if they have received at least 1 dose of any study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Dose of Gemcitabine</measure>
    <time_frame>During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days</time_frame>
    <description>Cumulative dose: Sum of the total doses by cycle administered to a participant in the duration of exposure, i.e. total number of cycles received (milligram per meter square [mg/m^2]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative Dose of Carboplatin</measure>
    <time_frame>During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days</time_frame>
    <description>Cumulative dose: Sum of the total doses by cycle (AUC) administered to a participant in the duration of exposure, i.e. total number of cycles received (in total prescribed AUC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) of Trilaciclib</measure>
    <time_frame>Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)</time_frame>
    <description>The observed peak plasma concentration was determined from the plasma concentration-versus time data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve From Time 0 to t Hours (AUC0-t) of Trilaciclib</measure>
    <time_frame>Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)</time_frame>
    <description>AUC0-t was calculated with the linear/log-trapezoidal method, which uses linear interpolation between data points to calculate the AUC. The linear/log-trapezoidal method will be employed for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method will be used for those arising from decreasing concentrations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Elimination Half-Life (t1/2) of Trilaciclib</measure>
    <time_frame>Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)</time_frame>
    <description>t1/2 was calculated as 0.693 divided by lambda z. lambda z (terminal phase rate constant) was determined by linear regression of at least 3 points on the terminal phase of the log-linear plasma concentration-time curve, the actual body exposure to drug after administration of a dose of the drug ( in mg*h/L).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) of Gemcitabine</measure>
    <time_frame>Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)</time_frame>
    <description>The observed peak plasma concentration was determined from the plasma concentration-versus time data.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve From Time 0 to t Hours (AUC0-t) of Gemcitabine</measure>
    <time_frame>Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)</time_frame>
    <description>AUC0-t was calculated with the linear/log-trapezoidal method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal Elimination Half-Life (t1/2) of Free Carboplatin</measure>
    <time_frame>Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)</time_frame>
    <description>t1/2 was calculated as 0.693 divided by lambda z. lambda z (terminal phase rate constant) was determined by linear regression of at least 3 points on the terminal phase of the log-linear plasma concentration-time curve.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clearance (CL) of of Free Carboplatin</measure>
    <time_frame>Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)</time_frame>
    <description>Clearance after intravenous infusion administration was calculated as: CL=Dose/AUC0-inf. AUC0-inf was calculated as: AUC0-inf=AUClast+Clast/lambdaz where Clast is the last quantifiable concentration in the terminal elimination phase.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of Distribution at Steady State (Vss) of Free Carboplatin</measure>
    <time_frame>Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)</time_frame>
    <description>Vss was the volume of distribution at steady state of free carboplatin was reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Grade 3 and 4 Hematologic Toxicities</measure>
    <time_frame>During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days</time_frame>
    <description>Hematologic toxicities events were defined as any cycle where any hematologic lab value occurs that meets the CTCAE toxicity grade criteria for &gt;= Grade 3 and the value is treatment emergent. The occurrence of Grade 3 and 4 hematologic toxicities was a binary endpoint. If a participant had at least 1 cycle with at least one Grade 3 or 4 hematologic toxicities during the treatment period, the participant was assigned as Yes to the occurrence of Grade 3 and 4 hematologic toxicities; otherwise, it was No. If a participant did not have an event, the value of 0 was assigned to that participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Grade 3 or 4 Thrombocytopenia</measure>
    <time_frame>During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days</time_frame>
    <description>Hematologic toxicities events are defined as any cycle where any hematologic lab value occurs that meets the CTCAE toxicity grade criteria for &gt;= Grade 3 and the value is treatment emergent. The occurrence of Grade 3 and 4 thrombocytopenia was a binary endpoint. If a participant had at least 1 cycle with at least one Grade 3 or 4 thrombocytopenia during the treatment period, the participant was assigned as &quot;Yes&quot; to the occurrence of Grade 3 and 4 thrombocytopenia; otherwise, it was &quot;No&quot;. If a participant did not have an event, the value of 0 was assigned to that participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Hematologic Event (MAHE) Rate</measure>
    <time_frame>During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days</time_frame>
    <description>MAHE was a composite endpoint incorporating the measurement of several clinically meaningful aspects of myelosuppression into a single endpoint by summing of the total number of events across a set of pre-specified components.The individual components for MAHE were all-cause hospitalizations, all-cause dose reductions, febrile neutropenia, prolonged severe neutropenia (duration &gt; 5 days), RBC transfusion and platelet transfusion. Event rate for MAHE was calculated as the number of events/durations of treatment period divided by 7 days/1 week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Febrile Neutropenia (FN)</measure>
    <time_frame>During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days</time_frame>
    <description>The criterion for identifying FN was if the PT was &quot;FEBRILE NEUTROPENIA&quot; the occurrence during the treatment period was defined as a binary variable (Yes or No); Yes if total number of events &gt;=1 was observed, No for other scenarios. If a participant did not have an event, the value of 0 was assigned to that participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Infection SAEs</measure>
    <time_frame>During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days</time_frame>
    <description>Number of participants with infection SAEs during the treatment period was defined as a binary variable (Yes or No); Yes if total number of events &gt;=1 was observed, No for other scenarios. If a participant did not have an event, the value of 0 was assigned to that participant. The criterion for identifying the proper infection SAE records was as follows: If the system organ class (SOC) from Medical Dictionary for Regulatory Activities (MedDRA) takes value &quot;INFECTIONS AND INFESTATIONS,&quot; and the AE was a serious event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Red Blood Cell (RBC) Transfusions On/After Week 5 (Day 35)</measure>
    <time_frame>From Day 35 through the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 508 days</time_frame>
    <description>Each RBC transfusion with a unique start date on/after 5 weeks on study during the treatment period was defined as a separate event. Occurrence during the treatment period was defined as a binary variable (Yes or No); &quot;Yes&quot; if the total number of events &gt;=1 was observed and &quot;No&quot; for other scenarios. If a participant did not have an event, the value of 0 will be assigned to that participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Platelet Transfusions</measure>
    <time_frame>During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days</time_frame>
    <description>Each platelet transfusion with a unique start date during the treatment period was defined as a separate event. The occurrence during the treatment period was defined as a binary variable (Yes or No); Yes if the total number of events &gt;=1 was observed and No for other scenarios. If a participant did not have an event, the value of 0 will be assigned to that participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Granulocyte Colony-stimulating Factor (G-CSF) Administration</measure>
    <time_frame>During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days</time_frame>
    <description>The criterion for selecting proper records is as follows: If the chemical subgroup from the World Health Organization-Drug Dictionary (WHO-DD) takes value &quot;COLONY STIMULATING FACTOR,&quot; the medication was classified as G-CSF. The occurrence during the treatment period was defined as a binary variable (Yes or No); &quot;Yes&quot; if the total number of events &gt;=1 was observed and &quot;No&quot; for other scenarios. If a participant did not have an event, the value of 0 will be assigned to that participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Erythropoiesis Stimulating Agent (ESA) Administration</measure>
    <time_frame>During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days</time_frame>
    <description>The occurrence during the treatment period was defined as a binary variable (Yes or No); &quot;Yes&quot; if total number of events &gt;=1 was observed, &quot;No&quot; for other scenarios. If a participant did not have an event, the value of 0 was assigned to that participant. The criterion to select proper records was as follows: If the chemical subgroup from WHO-DD Version September 2017 (i.e., TEXT4 for CODE4) takes value &quot;OTHER ANTIANEMIC PREPARATIONS&quot;, the medication was classified as ESAs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Intravenous Antibiotics Use</measure>
    <time_frame>During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days</time_frame>
    <description>The criteria for identifying an IV antibiotic administration event was (1) if the Therapeutic subgroup from WHO-DD version takes value &quot;ANTIBACTERIALS FOR SYSTEMIC USE&quot;, and (2) the route of medication was &quot;intravenous&quot; or the route was &quot;other&quot; with the detailed specification as &quot;IVPB&quot;. The occurrence during the treatment period was defined as a binary variable (Yes or No); &quot;Yes&quot; if total number of events &gt;=1 was observed, &quot;No&quot; for other scenarios. If a participant did not have an event, the value of 0 was assigned to that participant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-cause Dose Reductions, Event Rate (Per Cycle)</measure>
    <time_frame>During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days</time_frame>
    <description>Dose reductions were not permitted for trilaciclib. Dose reductions for gemcitabine or carboplatin were collected on the dosing page. No more than 3 dose modifications for toxicity in total were allowed for any participant. All dose reductions were counted as a separate event. Discontinuations of an individual component of the chemotherapy regimen were counted as a dose reduction If the participant continued the other chemotherapy drug as a monotherapy. Event rate was calculated as the total number of cycles with an event divided by the total number of cycles.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Modifications: Number of Participants With Cycle Delays</measure>
    <time_frame>During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days</time_frame>
    <description>Dose modifications was summarized for each study drug based on number of cycles received during the treatment period. If the participant was unable to start a new cycle at that next visit, then the cycle is delayed, the reason entered, and the question was asked again at the next visit until the participant either starts a new cycle or discontinues treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Modifications - Number of Participants With Skipped Doses</measure>
    <time_frame>During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days</time_frame>
    <description>Dose modifications was summarized for each study drug based on skipped doses not received during the treatment period. Primary reasons for skipped doses included toxicity, investigator decision and administrative reasons (e.g., holidays).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Modifications: Number of Participants With Any Dose Interruptions</measure>
    <time_frame>During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days</time_frame>
    <description>Dose interruptions was defined as interruption of infusion, regardless of whether the study drug was continued after the interruption.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dose Modifications - Number of Participants With Dose Reductions</measure>
    <time_frame>During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days</time_frame>
    <description>Dose (mg/m2) reductions were not permitted for trilaciclib. Dose reductions for carboplatin and gemcitabine were determined by comparing the planned dose on the respective drug administration pages between the current cycle and the previous cycle.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs</measure>
    <time_frame>During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 1116 days</time_frame>
    <description>An Adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product that did not necessarily have a causal relationship with this treatment. Any AE that started on or after the first dose of study drugs was included as a TEAE. A Serious AE was defined as any AE, occurring at any dose (including after the informed consent form was signed and prior to dosing) and regardless of causality that met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. TEAEs included serious and non-serious TEAEs.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Triple-Negative Breast Neoplasms</condition>
  <condition>Breast Neoplasm</condition>
  <condition>Breast Cancer</condition>
  <condition>Triple-Negative Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received Intravenous (IV) infusion of standard GC chemotherapy (gemcitabine 1000 milligrams per meter square [mg/m^2] and carboplatin area under the curve [AUC] 2) on Days 1 and 8 of 21-day cycle. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: Trilaciclib + Gemcitabine/ Carboplatin (Days 1 and 8)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycle. Trilaciclib was administered prior to chemotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day Cycle. Trilaciclib was administered prior to chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trilaciclib</intervention_name>
    <description>G1T28</description>
    <arm_group_label>Group 2: Trilaciclib + Gemcitabine/ Carboplatin (Days 1 and 8)</arm_group_label>
    <arm_group_label>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</arm_group_label>
    <other_name>G1T28</other_name>
    <other_name>CDK 4/6 Inhibitor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <description>Gemcitabine</description>
    <arm_group_label>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</arm_group_label>
    <arm_group_label>Group 2: Trilaciclib + Gemcitabine/ Carboplatin (Days 1 and 8)</arm_group_label>
    <arm_group_label>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Carboplatin</description>
    <arm_group_label>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</arm_group_label>
    <arm_group_label>Group 2: Trilaciclib + Gemcitabine/ Carboplatin (Days 1 and 8)</arm_group_label>
    <arm_group_label>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmed diagnosis of hormone receptor (HR)-negative, human epidermal growth factor&#xD;
             receptor 2 (HER2)-negative (locally recurrent or metastatic TNBC) breast cancer&#xD;
&#xD;
          -  Available TNBC diagnostic tumor tissue (archived tissue allowed)&#xD;
&#xD;
          -  Evaluable disease&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1&#xD;
&#xD;
          -  Adequate organ function&#xD;
&#xD;
          -  Predicted life expectancy of 3 or more months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  More than 2 prior chemotherapy regimens for locally recurrent or metastatic TNBC. If &gt;&#xD;
             12 months have elapsed between the date of last adjuvant/neoadjuvant chemotherapy&#xD;
             administration and first documented local or distant disease recurrence the therapy&#xD;
             will not be considered a line of therapy in the locally recurrent or metastatic TNBC&#xD;
             setting.&#xD;
&#xD;
          -  CNS metastases or leptomeningeal disease requiring immediate treatment with radiation&#xD;
             therapy or steroids.&#xD;
&#xD;
          -  Investigational drug within 30 days of first trilaciclib (G1T28) dose&#xD;
&#xD;
          -  Concurrent radiotherapy, radiotherapy within 14 days of first trilaciclib (G1T28) dose&#xD;
&#xD;
          -  Cytotoxic chemotherapy within 3 weeks of first trilaciclib (G1T28) dose&#xD;
&#xD;
          -  Prior hematopoietic stem cell or bone marrow transplantation&#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>Clinical Contact</last_name>
    <role>Study Director</role>
    <affiliation>G1 Therapeutics, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arizona Oncology Associates, PC - HOPE</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Disney Family Cancer Center</name>
      <address>
        <city>Burbank</city>
        <state>California</state>
        <zip>91505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sharp Clinical Oncology</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Innovative Clinical Research Institute</name>
      <address>
        <city>Whittier</city>
        <state>California</state>
        <zip>90603</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial UC Health</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80909</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers</name>
      <address>
        <city>Lakewood</city>
        <state>Colorado</state>
        <zip>80228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists</name>
      <address>
        <city>Fort Myers</city>
        <state>Florida</state>
        <zip>33916</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Research Institute, LLC.</name>
      <address>
        <city>Plantation</city>
        <state>Florida</state>
        <zip>33324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists - North (FCS North)</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Cancer Specialists - East (FCS East)</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Regional Medical Center</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois Cancer Specialists</name>
      <address>
        <city>Arlington Heights</city>
        <state>Illinois</state>
        <zip>60005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Health Network</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46250</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland Greenebaum Comprehensive Cancer Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201-1544</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Maryland St. Joseph Medical Center</name>
      <address>
        <city>Towson</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Cancer Institute</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Levine Cancer Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Forsyth Memorial Hospital, Novant Health Oncology Specialists</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tennessee Oncology</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology-Dallas Presbyterian Hospital</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>75231</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology, P.A.</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology, P.A.</name>
      <address>
        <city>Bedford</city>
        <state>Texas</state>
        <zip>76022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology - Baylor Charles A. Sammons Cancer Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology-El Paso Cancer Treatment Center Grandview</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Center for Cancer and Blood Disorders</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology-San Antonio Northeast</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tyler Hematology-Oncology, PA</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology, P.A.</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Specialists, PC</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Oncology Associates</name>
      <address>
        <city>Virginia Beach</city>
        <state>Virginia</state>
        <zip>23456</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Medical Specialties, PLLC</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Antwerp University Hospital (UZA)</name>
      <address>
        <city>Edegem</city>
        <zip>10 2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Multiprofile Hospital for Active Treatment</name>
      <address>
        <city>Sofia</city>
        <zip>1000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MHAT for Womens Health - Nadezhda OOD</name>
      <address>
        <city>Sofia</city>
        <zip>1330</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Special Hospital For Active Treatment In Oncology</name>
      <address>
        <city>Sofia</city>
        <zip>1756</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Multiprofile Hospital for Active Treatment</name>
      <address>
        <city>Varna</city>
        <zip>9000</zip>
        <country>Bulgaria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Centre Osijek</name>
      <address>
        <city>Osijek</city>
        <zip>31000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital Varaždin</name>
      <address>
        <city>Varazdin</city>
        <zip>42000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Centre &quot;Sestre milosrdnice&quot;</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Centre Zagreb</name>
      <address>
        <city>Zagreb</city>
        <zip>10000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital Dr. Trifun Panovski</name>
      <address>
        <city>Bitola</city>
        <zip>7000</zip>
        <country>North Macedonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Clinic of Radiotherapy and Oncology</name>
      <address>
        <city>Skopje</city>
        <zip>1000</zip>
        <country>North Macedonia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Special Hospital for Internal Diseases , Oncomed</name>
      <address>
        <city>Belgrade</city>
        <zip>11000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Hospital Centre Bezanijska Kosa, Oncology Clinic</name>
      <address>
        <city>Belgrade</city>
        <zip>11070</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center for Oncology and Radiotherapy, Clinical Centre</name>
      <address>
        <city>Kragujevac</city>
        <zip>34000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Centre Nis, Clinic of Oncology</name>
      <address>
        <city>Nis</city>
        <zip>18000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology Institute of Vojvodina, Clinic for Internal Oncology</name>
      <address>
        <city>Sremska Kamenica</city>
        <zip>21204</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mammacentrum, Sv.Agáty</name>
      <address>
        <city>Banská Bystrica</city>
        <zip>974 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Institute VOU, Rastislavova</name>
      <address>
        <city>Košice</city>
        <zip>040 01</zip>
        <country>Slovakia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Centre Maribor</name>
      <address>
        <city>Maribor</city>
        <zip>2000</zip>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Bulgaria</country>
    <country>Croatia</country>
    <country>North Macedonia</country>
    <country>Serbia</country>
    <country>Slovakia</country>
    <country>Slovenia</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Macedonia, The Former Yugoslav Republic of</country>
    <country>United Kingdom</country>
  </removed_countries>
  <reference>
    <citation>Tan AR, Wright GS, Thummala AR, Danso MA, Popovic L, Pluard TJ, Han HS, Vojnovic Z, Vasev N, Ma L, Richards DA, Wilks ST, Milenkovic D, Yang Z, Antal JM, Morris SR, O'Shaughnessy J. Trilaciclib plus chemotherapy versus chemotherapy alone in patients with metastatic triple-negative breast cancer: a multicentre, randomised, open-label, phase 2 trial. Lancet Oncol. 2019 Nov;20(11):1587-1601. doi: 10.1016/S1470-2045(19)30616-3. Epub 2019 Sep 28.</citation>
    <PMID>31575503</PMID>
  </reference>
  <reference>
    <citation>Tan AR, Wright GS, Thummala AR, Danso MA, Popovic L, Pluard TJ, Han HS, Vojnovic Z, Vasev N, Ma L, Richards DA, Wilks ST, Milenkovic D, Xiao J, Sorrentino J, Horton J, O'Shaughnessy J. Trilaciclib Prior to Chemotherapy in Patients with Metastatic Triple-Negative Breast Cancer: Final Efficacy and Subgroup Analysis from a Randomized Phase II Study. Clin Cancer Res. 2022 Feb 15;28(4):629-636. doi: 10.1158/1078-0432.CCR-21-2272.</citation>
    <PMID>34887261</PMID>
  </reference>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <results_first_submitted>January 6, 2022</results_first_submitted>
  <results_first_submitted_qc>February 24, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 23, 2022</results_first_posted>
  <disposition_first_submitted>July 18, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>February 24, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">March 23, 2022</disposition_first_posted>
  <last_update_submitted>February 24, 2022</last_update_submitted>
  <last_update_submitted_qc>February 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>CDK 4/6 Inhibitor</keyword>
  <keyword>Triple Negative Breast Cancer</keyword>
  <keyword>Metastatic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Triple Negative Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 31, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT02978716/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 28, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT02978716/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>This study was conducted at 34 sites in the United States (US), Belgium, Bulgaria, Croatia, Republic of Macedonia, and Serbia from 02 February 2017 (first participant enrolled) to 28 February 2020 (last participant last visit).</recruitment_details>
      <pre_assignment_details>Participants were screened within 28 days before the first dose of the treatment. Informed consent was obtained up to 28 days prior to first study drug administration. For tumor assessment, all sites of disease were assessed radiologically at screening. A total of 102 participants were randomized in this study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
          <description>Participants received Intravenous (IV) infusion of standard GC chemotherapy (gemcitabine 1000 milligrams per meter square [mg/m^2] and carboplatin area under the curve [AUC] 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
        </group>
        <group group_id="P2">
          <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
          <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
        </group>
        <group group_id="P3">
          <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
          <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="33"/>
                <participants group_id="P3" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>ITT Population</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="33"/>
                <participants group_id="P3" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="33"/>
                <participants group_id="P3" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Treated</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="33"/>
                <participants group_id="P3" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="33"/>
                <participants group_id="P3" count="35"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="20"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor terminated</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The ITT analysis set included all randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
          <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
        </group>
        <group group_id="B2">
          <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
          <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
        </group>
        <group group_id="B3">
          <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
          <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</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="34"/>
            <count group_id="B2" value="33"/>
            <count group_id="B3" value="35"/>
            <count group_id="B4" value="102"/>
          </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="55" spread="13.6"/>
                    <measurement group_id="B2" value="56" spread="12.1"/>
                    <measurement group_id="B3" value="58" spread="9.5"/>
                    <measurement group_id="B4" value="56" spread="11.8"/>
                  </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="34"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="35"/>
                    <measurement group_id="B4" value="101"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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>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="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="33"/>
                    <measurement group_id="B4" value="93"/>
                  </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="2"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="6"/>
                  </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="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="78"/>
                  </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="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Duration of Severe (Grade 4) Neutropenia (DSN) During Cycle 1</title>
        <description>DSN was defined as the number of days from the date of the first absolute neutrophil count (ANC) value of less than (&lt;) 0.5 × 10^9 cells/liter (L) observed between Day 1 Cycle 1 and the end of Cycle 1 to the date of the first ANC value greater than or equal to (&gt;=) 0.5 × 10^9/L that met the following: (1) occurred after the ANC value of &lt; 0.5 × 10^9 cells/L and (2) no other ANC values &lt; 0.5 × 10^9 cells/L occurred between this day and the end of Cycle 1. Severe neutropenia (SN) was set to zero for participants who did not experience severe (Grade 4) neutropenia in Cycle 1, including those who were randomized but never treated.</description>
        <time_frame>From randomization to the end of Cycle 1 (Each cycle= 21 days)</time_frame>
        <population>The ITT analysis set included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Severe (Grade 4) Neutropenia (DSN) During Cycle 1</title>
          <description>DSN was defined as the number of days from the date of the first absolute neutrophil count (ANC) value of less than (&lt;) 0.5 × 10^9 cells/liter (L) observed between Day 1 Cycle 1 and the end of Cycle 1 to the date of the first ANC value greater than or equal to (&gt;=) 0.5 × 10^9/L that met the following: (1) occurred after the ANC value of &lt; 0.5 × 10^9 cells/L and (2) no other ANC values &lt; 0.5 × 10^9 cells/L occurred between this day and the end of Cycle 1. Severe neutropenia (SN) was set to zero for participants who did not experience severe (Grade 4) neutropenia in Cycle 1, including those who were randomized but never treated.</description>
          <population>The ITT analysis set included all randomized participants.</population>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" spread="2.2"/>
                    <measurement group_id="O2" value="2" spread="3.5"/>
                    <measurement group_id="O3" value="1" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Duration of SN in Cycle 1 in Group 3 vs Group 1.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7048</p_value>
            <p_value_desc>A Hochberg-based gatekeeping procedure was used to control the global family-wise error rate across the multiple null hypotheses in the strong sense at a 1-sided 0.025 level.</p_value_desc>
            <method>Analysis of covariance (ANCOVA)</method>
            <param_type>Mean difference</param_type>
            <param_value>0.3</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.58</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.8</ci_lower_limit>
            <ci_upper_limit>1.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Duration of SN in Cycle 1 in Group 2 vs Group 1.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.3364</p_value>
            <p_value_desc>2-sided p-value was calculated using a ANCOVA with study baseline ANC value as covariate, stratification factors of lines of systemic therapy, liver involvement and treatment as fixed effects.</p_value_desc>
            <method>ANCOVA</method>
            <param_type>Mean difference</param_type>
            <param_value>0.8</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.71</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.6</ci_lower_limit>
            <ci_upper_limit>2.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Severe (Grade 4) Neutropenia (SN)</title>
        <description>Number of participants with Grade 4 SN was a binary variable. If a participants had at least 1 ANC value &lt; 0.5 ×10^9/L during the treatment period, the participants was assigned as &quot;yes&quot; to the occurrence of SN. Otherwise, it was &quot;no&quot;.</description>
        <time_frame>During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days</time_frame>
        <population>The ITT analysis set included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Severe (Grade 4) Neutropenia (SN)</title>
          <description>Number of participants with Grade 4 SN was a binary variable. If a participants had at least 1 ANC value &lt; 0.5 ×10^9/L during the treatment period, the participants was assigned as &quot;yes&quot; to the occurrence of SN. Otherwise, it was &quot;no&quot;.</description>
          <population>The ITT analysis set included all randomized participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Grade 4 neutropenia: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4 neutropenia: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Number of participants with SN in Group 3 vs Group 1.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7048</p_value>
            <p_value_desc>A 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global familywise error rate across the multiple null hypotheses.</p_value_desc>
            <method>Modified Poisson method</method>
            <param_type>Adjusted rate ratio</param_type>
            <param_value>0.776</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2762</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.386</ci_lower_limit>
            <ci_upper_limit>1.559</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Number of participants with SN in Group 2 vs Group 1.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.9154</p_value>
            <p_value_desc>The p-value was calculated using modified Poisson method adjusting for number of cycles, accounting for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors and baseline ANC as a covariate.</p_value_desc>
            <method>Modified Poisson Regression</method>
            <param_type>Adjusted rate ratio</param_type>
            <param_value>0.961</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.3640</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.457</ci_lower_limit>
            <ci_upper_limit>2.019</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)</title>
        <description>BOR was defined as the best response across all time points (RECIST v1.1). The best overall response was determined once all the data for the participant is known. Each participant has been assigned one of the following categories (RECIST 1.1): complete response (CR): disappearance of all target lesions; partial response (PR): &gt;= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; progression disease (PD): &gt;= 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study); stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD); NE: not evaluable and missing.</description>
        <time_frame>From date of randomization until the occurrence of progressive disease or a censoring event, assessed up to a maximum of 875 days</time_frame>
        <population>The response-evaluable (RE) analysis set included all participants who were in the modified intent-to-treat (mITT) analysis set, had measurable disease (target lesions [TLs]) at the baseline tumor assessment, and had (1) at least 1 post-baseline tumor assessment, (2) clinical progression (as noted by the investigator) before their first post-baseline tumor scan, or (3) died due to disease progression before their first post-baseline tumor scan.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)</title>
          <description>BOR was defined as the best response across all time points (RECIST v1.1). The best overall response was determined once all the data for the participant is known. Each participant has been assigned one of the following categories (RECIST 1.1): complete response (CR): disappearance of all target lesions; partial response (PR): &gt;= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; progression disease (PD): &gt;= 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study); stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD); NE: not evaluable and missing.</description>
          <population>The response-evaluable (RE) analysis set included all participants who were in the modified intent-to-treat (mITT) analysis set, had measurable disease (target lesions [TLs]) at the baseline tumor assessment, and had (1) at least 1 post-baseline tumor assessment, (2) clinical progression (as noted by the investigator) before their first post-baseline tumor scan, or (3) died due to disease progression before their first post-baseline tumor scan.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Complete response (CR)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Partial response (PR)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stable disease (SD)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Progressive disease (PD)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not evaluable (NE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Objective Response (DOR) as Per RECIST v1.1 as Determined by Investigator</title>
        <description>DOR is the time between first response by RECIST Version 1.1 of CR or PR and the first date that progressive disease is documented by RECIST Version 1.1, or death. Participants who do not experience PD or death was censored at the last tumor assessment date. 95% Confidence Interval (CI) was calculated using the Kaplan-Meier method.</description>
        <time_frame>From date of randomization until the occurrence of progressive disease or a censoring event, assessed up to a maximum of 875 days</time_frame>
        <population>The RE analysis set included all participants who were in the mITT analysis set, had measurable disease TLs at the baseline tumor assessment, and had (1) at least 1 post-baseline tumor assessment, (2) clinical progression (as noted by the investigator) before their first post-baseline tumor scan, or (3) died due to disease progression before their first post-baseline tumor scan. Here, &quot;Overall number of participants analyzed&quot; signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Objective Response (DOR) as Per RECIST v1.1 as Determined by Investigator</title>
          <description>DOR is the time between first response by RECIST Version 1.1 of CR or PR and the first date that progressive disease is documented by RECIST Version 1.1, or death. Participants who do not experience PD or death was censored at the last tumor assessment date. 95% Confidence Interval (CI) was calculated using the Kaplan-Meier method.</description>
          <population>The RE analysis set included all participants who were in the mITT analysis set, had measurable disease TLs at the baseline tumor assessment, and had (1) at least 1 post-baseline tumor assessment, (2) clinical progression (as noted by the investigator) before their first post-baseline tumor scan, or (3) died due to disease progression before their first post-baseline tumor scan. Here, &quot;Overall number of participants analyzed&quot; signifies participants who were evaluable for this outcome measure.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="15"/>
                <count group_id="O3" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.8" lower_limit="7.5" upper_limit="NA">Due to small number of events, estimates (upper limit of 95% Confidence interval) from Kaplan-Meier survival curves could not be derived.</measurement>
                    <measurement group_id="O2" value="11.5" lower_limit="4.8" upper_limit="17.8"/>
                    <measurement group_id="O3" value="9.6" lower_limit="3.1" upper_limit="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>Overall survival was defined as the time (months) from date of randomization to the date of death due to any cause. Participants who do not die during the study were censored at the date last known to be alive. The OS was calculated using Kaplan-Meier method.</description>
        <time_frame>From date of randomization to date of death due to any cause, assessed up to a maximum of 1120 days</time_frame>
        <population>The ITT analysis set included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>Overall survival was defined as the time (months) from date of randomization to the date of death due to any cause. Participants who do not die during the study were censored at the date last known to be alive. The OS was calculated using Kaplan-Meier method.</description>
          <population>The ITT analysis set included all randomized participants.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.6" lower_limit="6.3" upper_limit="15.6"/>
                    <measurement group_id="O2" value="NA" lower_limit="10.2" upper_limit="NA">Data could not be estimated due to higher number (&gt;50%) of censored participants.</measurement>
                    <measurement group_id="O3" value="17.8" lower_limit="12.9" upper_limit="32.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Overall survival in Group 3 vs Group 1.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0004</p_value>
            <p_value_desc>P-value was calculated using the stratified log-rank test to account for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors.</p_value_desc>
            <method>stratified log-rank test</method>
            <param_type>Adjusted hazard ratio (HR)</param_type>
            <param_value>0.40</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.125</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.22</ci_lower_limit>
            <ci_upper_limit>0.74</ci_upper_limit>
            <estimate_desc>Cox regression model.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Overall survival in Group 2 vs Group 1.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0016</p_value>
            <p_value_desc>P-value was calculated using the stratified log-rank test to account for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors.</p_value_desc>
            <method>stratified log-rank test</method>
            <param_type>Adjusted HR</param_type>
            <param_value>0.31</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.111</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.15</ci_lower_limit>
            <ci_upper_limit>0.63</ci_upper_limit>
            <estimate_desc>Cox regression model.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival (PFS) as Per RECIST v1.1 as Determined by Investigator</title>
        <description>PFS was defined as the time (months) from date of randomization until date of documented PD or death due to any cause, whichever comes first. PD: &gt;= 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study). The PFS was calculated using Kaplan-Meier method.</description>
        <time_frame>From date of randomization until the occurrence of disease progression, death due to any cause or a censoring event, assessed up to a maximum of 875 days</time_frame>
        <population>The ITT analysis set included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival (PFS) as Per RECIST v1.1 as Determined by Investigator</title>
          <description>PFS was defined as the time (months) from date of randomization until date of documented PD or death due to any cause, whichever comes first. PD: &gt;= 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study). The PFS was calculated using Kaplan-Meier method.</description>
          <population>The ITT analysis set included all randomized participants.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" lower_limit="3.3" upper_limit="9.2"/>
                    <measurement group_id="O2" value="9.4" lower_limit="6.1" upper_limit="11.9"/>
                    <measurement group_id="O3" value="7.3" lower_limit="6.2" upper_limit="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Relative Dose Intensity of Gemcitabine and Carboplatin</title>
        <description>Relative dose intensity was defined as 100% times the actual dose intensity divided by the planned dose intensity. The planned dose intensity was defined as the cumulative planned dose through the study divided by (number of cycles × 3 weeks). Relative dose intensity (%) was calculated as: for gemcitabine (100 * [Dose intensity (mg/m2/week) / (2000/3 (mg/m2/week)]); for carboplatin (100 * [Dose intensity (AUC/week)/ (4/3) (AUC/week)]) and for trilaciclib (100 * [Dose intensity (mg/m2/week)/ (480 /3 (mg/m2/week)] for Group 2 and 100 * [Dose intensity (mg/m2/week) / (960 /3 (mg/m2/week)] for Group 3).</description>
        <time_frame>During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days</time_frame>
        <population>The safety analysis set included all enrolled participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Relative Dose Intensity of Gemcitabine and Carboplatin</title>
          <description>Relative dose intensity was defined as 100% times the actual dose intensity divided by the planned dose intensity. The planned dose intensity was defined as the cumulative planned dose through the study divided by (number of cycles × 3 weeks). Relative dose intensity (%) was calculated as: for gemcitabine (100 * [Dose intensity (mg/m2/week) / (2000/3 (mg/m2/week)]); for carboplatin (100 * [Dose intensity (AUC/week)/ (4/3) (AUC/week)]) and for trilaciclib (100 * [Dose intensity (mg/m2/week)/ (480 /3 (mg/m2/week)] for Group 2 and 100 * [Dose intensity (mg/m2/week) / (960 /3 (mg/m2/week)] for Group 3).</description>
          <population>The safety analysis set included all enrolled participants who received at least 1 dose of study drug.</population>
          <units>percentage of dose</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Carboplatin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.5" spread="19.20"/>
                    <measurement group_id="O2" value="79.1" spread="15.88"/>
                    <measurement group_id="O3" value="81.7" spread="16.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gemcitabine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.1" spread="18.29"/>
                    <measurement group_id="O2" value="80.8" spread="12.51"/>
                    <measurement group_id="O3" value="81.0" spread="14.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Exposure</title>
        <description>Duration of exposure (days) = First dose date of study drug from the last cycle - first dose date of study drug + 21.</description>
        <time_frame>During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days</time_frame>
        <population>The safety analysis set included all enrolled participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Exposure</title>
          <description>Duration of exposure (days) = First dose date of study drug from the last cycle - first dose date of study drug + 21.</description>
          <population>The safety analysis set included all enrolled participants who received at least 1 dose of study drug.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101" lower_limit="21" upper_limit="469"/>
                    <measurement group_id="O2" value="161" lower_limit="42" upper_limit="637"/>
                    <measurement group_id="O3" value="168" lower_limit="21" upper_limit="436"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Cycles Participants Received Treatment in Each Treatment Arm</title>
        <description>Participants were considered to have started a cycle if they have received at least 1 dose of any study drug.</description>
        <time_frame>During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days</time_frame>
        <population>The safety analysis set included all enrolled participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Cycles Participants Received Treatment in Each Treatment Arm</title>
          <description>Participants were considered to have started a cycle if they have received at least 1 dose of any study drug.</description>
          <population>The safety analysis set included all enrolled participants who received at least 1 dose of study drug.</population>
          <units>number of cycles</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" spread="5.0"/>
                    <measurement group_id="O2" value="9" spread="6.6"/>
                    <measurement group_id="O3" value="8" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cumulative Dose of Gemcitabine</title>
        <description>Cumulative dose: Sum of the total doses by cycle administered to a participant in the duration of exposure, i.e. total number of cycles received (milligram per meter square [mg/m^2]).</description>
        <time_frame>During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days</time_frame>
        <population>The safety analysis set included all enrolled participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Dose of Gemcitabine</title>
          <description>Cumulative dose: Sum of the total doses by cycle administered to a participant in the duration of exposure, i.e. total number of cycles received (milligram per meter square [mg/m^2]).</description>
          <population>The safety analysis set included all enrolled participants who received at least 1 dose of study drug.</population>
          <units>mg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10694.3" spread="9029.11"/>
                    <measurement group_id="O2" value="14680.9" spread="11557.90"/>
                    <measurement group_id="O3" value="13277.2" spread="8722.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cumulative Dose of Carboplatin</title>
        <description>Cumulative dose: Sum of the total doses by cycle (AUC) administered to a participant in the duration of exposure, i.e. total number of cycles received (in total prescribed AUC).</description>
        <time_frame>During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days</time_frame>
        <population>The safety analysis set included all enrolled participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Cumulative Dose of Carboplatin</title>
          <description>Cumulative dose: Sum of the total doses by cycle (AUC) administered to a participant in the duration of exposure, i.e. total number of cycles received (in total prescribed AUC).</description>
          <population>The safety analysis set included all enrolled participants who received at least 1 dose of study drug.</population>
          <units>AUC (mg/mL/min)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.3" spread="16.47"/>
                    <measurement group_id="O2" value="27.8" spread="21.21"/>
                    <measurement group_id="O3" value="26.0" spread="16.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Plasma Concentration (Cmax) of Trilaciclib</title>
        <description>The observed peak plasma concentration was determined from the plasma concentration-versus time data.</description>
        <time_frame>Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)</time_frame>
        <population>The pharmacokinetic (PK) analysis set included all dosed participants with evaluable PK data. Here, &quot;Overall number of participants analyzed&quot; signifies participants who were evaluable for this outcome measure. Since, no participant received Trilaciclib in Group 1, data was not assessed and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Day 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Plasma Concentration (Cmax) of Trilaciclib</title>
          <description>The observed peak plasma concentration was determined from the plasma concentration-versus time data.</description>
          <population>The pharmacokinetic (PK) analysis set included all dosed participants with evaluable PK data. Here, &quot;Overall number of participants analyzed&quot; signifies participants who were evaluable for this outcome measure. Since, no participant received Trilaciclib in Group 1, data was not assessed and reported.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2280" spread="1790"/>
                    <measurement group_id="O3" value="1630" spread="423"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Plasma Concentration-Time Curve From Time 0 to t Hours (AUC0-t) of Trilaciclib</title>
        <description>AUC0-t was calculated with the linear/log-trapezoidal method, which uses linear interpolation between data points to calculate the AUC. The linear/log-trapezoidal method will be employed for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method will be used for those arising from decreasing concentrations.</description>
        <time_frame>Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)</time_frame>
        <population>The PK analysis set included all dosed participants with evaluable PK data. Here, &quot;Overall number of participants analyzed&quot; signifies participants who were evaluable for this outcome measure. Since, no participant received Trilaciclib in Group 1, data was not assessed and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Day 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration-Time Curve From Time 0 to t Hours (AUC0-t) of Trilaciclib</title>
          <description>AUC0-t was calculated with the linear/log-trapezoidal method, which uses linear interpolation between data points to calculate the AUC. The linear/log-trapezoidal method will be employed for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method will be used for those arising from decreasing concentrations.</description>
          <population>The PK analysis set included all dosed participants with evaluable PK data. Here, &quot;Overall number of participants analyzed&quot; signifies participants who were evaluable for this outcome measure. Since, no participant received Trilaciclib in Group 1, data was not assessed and reported.</population>
          <units>hour* nanogram per milliliter (h*ng/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="3610" spread="1870"/>
                    <measurement group_id="O3" value="3800" spread="910"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Terminal Elimination Half-Life (t1/2) of Trilaciclib</title>
        <description>t1/2 was calculated as 0.693 divided by lambda z. lambda z (terminal phase rate constant) was determined by linear regression of at least 3 points on the terminal phase of the log-linear plasma concentration-time curve, the actual body exposure to drug after administration of a dose of the drug ( in mg*h/L).</description>
        <time_frame>Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)</time_frame>
        <population>The PK analysis set included all dosed participants with evaluable PK data. Here, &quot;Overall number of participants analyzed&quot; signifies participants who were evaluable for this outcome measure. Since, no participant received Trilaciclib in Group 1, data was not assessed and reported.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Day 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Elimination Half-Life (t1/2) of Trilaciclib</title>
          <description>t1/2 was calculated as 0.693 divided by lambda z. lambda z (terminal phase rate constant) was determined by linear regression of at least 3 points on the terminal phase of the log-linear plasma concentration-time curve, the actual body exposure to drug after administration of a dose of the drug ( in mg*h/L).</description>
          <population>The PK analysis set included all dosed participants with evaluable PK data. Here, &quot;Overall number of participants analyzed&quot; signifies participants who were evaluable for this outcome measure. Since, no participant received Trilaciclib in Group 1, data was not assessed and reported.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="5.27" lower_limit="3.98" upper_limit="6.64"/>
                    <measurement group_id="O3" value="5.31" lower_limit="4.36" upper_limit="6.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Plasma Concentration (Cmax) of Gemcitabine</title>
        <description>The observed peak plasma concentration was determined from the plasma concentration-versus time data.</description>
        <time_frame>Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)</time_frame>
        <population>The PK analysis set included all dosed participants with evaluable PK data. Here, &quot;Overall number of participants analyzed&quot; signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Day 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Plasma Concentration (Cmax) of Gemcitabine</title>
          <description>The observed peak plasma concentration was determined from the plasma concentration-versus time data.</description>
          <population>The PK analysis set included all dosed participants with evaluable PK data. Here, &quot;Overall number of participants analyzed&quot; signifies participants who were evaluable for this outcome measure.</population>
          <units>microgram per milliliter (mcg/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" spread="NA">Data was not available since only one participant had sample in Group 1 and it was sufficient only for assessment of carboplatin.</measurement>
                    <measurement group_id="O2" value="18.0" spread="4.04"/>
                    <measurement group_id="O3" value="23.8" spread="25.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Plasma Concentration-Time Curve From Time 0 to t Hours (AUC0-t) of Gemcitabine</title>
        <description>AUC0-t was calculated with the linear/log-trapezoidal method.</description>
        <time_frame>Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)</time_frame>
        <population>The PK analysis set included all dosed participants with evaluable PK data. Here, &quot;Overall number of participants analyzed&quot; signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Day 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Plasma Concentration-Time Curve From Time 0 to t Hours (AUC0-t) of Gemcitabine</title>
          <description>AUC0-t was calculated with the linear/log-trapezoidal method.</description>
          <population>The PK analysis set included all dosed participants with evaluable PK data. Here, &quot;Overall number of participants analyzed&quot; signifies participants who were evaluable for this outcome measure.</population>
          <units>hour*microgram per milliliter (h*mcg/mL)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Data was not available since only one participant had sample in Group 1 and it was sufficient only for assessment of carboplatin.</measurement>
                    <measurement group_id="O2" value="20.4" spread="11.6"/>
                    <measurement group_id="O3" value="15.4" spread="7.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Terminal Elimination Half-Life (t1/2) of Free Carboplatin</title>
        <description>t1/2 was calculated as 0.693 divided by lambda z. lambda z (terminal phase rate constant) was determined by linear regression of at least 3 points on the terminal phase of the log-linear plasma concentration-time curve.</description>
        <time_frame>Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)</time_frame>
        <population>The PK analysis set included all dosed participants with evaluable PK data. Here, &quot;Overall number of participants analyzed&quot; signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received Intravenous (IV) infusion of standard GC chemotherapy (gemcitabine 1000 milligrams per meter square [mg/m^2] and carboplatin area under the curve [AUC] 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Elimination Half-Life (t1/2) of Free Carboplatin</title>
          <description>t1/2 was calculated as 0.693 divided by lambda z. lambda z (terminal phase rate constant) was determined by linear regression of at least 3 points on the terminal phase of the log-linear plasma concentration-time curve.</description>
          <population>The PK analysis set included all dosed participants with evaluable PK data. Here, &quot;Overall number of participants analyzed&quot; signifies participants who were evaluable for this outcome measure.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.23"/>
                    <measurement group_id="O2" value="2.49" lower_limit="1.32" upper_limit="2.93"/>
                    <measurement group_id="O3" value="1.79" lower_limit="1.35" upper_limit="4.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clearance (CL) of of Free Carboplatin</title>
        <description>Clearance after intravenous infusion administration was calculated as: CL=Dose/AUC0-inf. AUC0-inf was calculated as: AUC0-inf=AUClast+Clast/lambdaz where Clast is the last quantifiable concentration in the terminal elimination phase.</description>
        <time_frame>Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)</time_frame>
        <population>The PK analysis set included all dosed participants with evaluable PK data. Here, &quot;Overall number of participants analyzed&quot; signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received Intravenous (IV) infusion of standard GC chemotherapy (gemcitabine 1000 milligrams per meter square [mg/m^2] and carboplatin area under the curve [AUC] 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Clearance (CL) of of Free Carboplatin</title>
          <description>Clearance after intravenous infusion administration was calculated as: CL=Dose/AUC0-inf. AUC0-inf was calculated as: AUC0-inf=AUClast+Clast/lambdaz where Clast is the last quantifiable concentration in the terminal elimination phase.</description>
          <population>The PK analysis set included all dosed participants with evaluable PK data. Here, &quot;Overall number of participants analyzed&quot; signifies participants who were evaluable for this outcome measure.</population>
          <units>Liter/hour (L/h)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="3"/>
                <count group_id="O3" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.65"/>
                    <measurement group_id="O2" value="14.0" spread="2.80"/>
                    <measurement group_id="O3" value="13.7" spread="4.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Volume of Distribution at Steady State (Vss) of Free Carboplatin</title>
        <description>Vss was the volume of distribution at steady state of free carboplatin was reported.</description>
        <time_frame>Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)</time_frame>
        <population>The PK analysis set included all dosed participants with evaluable PK data. Here, &quot;Overall number of participants analyzed&quot; signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received Intravenous (IV) infusion of standard GC chemotherapy (gemcitabine 1000 milligrams per meter square [mg/m^2] and carboplatin area under the curve [AUC] 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Volume of Distribution at Steady State (Vss) of Free Carboplatin</title>
          <description>Vss was the volume of distribution at steady state of free carboplatin was reported.</description>
          <population>The PK analysis set included all dosed participants with evaluable PK data. Here, &quot;Overall number of participants analyzed&quot; signifies participants who were evaluable for this outcome measure.</population>
          <units>Liter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.4"/>
                    <measurement group_id="O2" value="35.0" spread="12.0"/>
                    <measurement group_id="O3" value="34.0" spread="8.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Grade 3 and 4 Hematologic Toxicities</title>
        <description>Hematologic toxicities events were defined as any cycle where any hematologic lab value occurs that meets the CTCAE toxicity grade criteria for &gt;= Grade 3 and the value is treatment emergent. The occurrence of Grade 3 and 4 hematologic toxicities was a binary endpoint. If a participant had at least 1 cycle with at least one Grade 3 or 4 hematologic toxicities during the treatment period, the participant was assigned as Yes to the occurrence of Grade 3 and 4 hematologic toxicities; otherwise, it was No. If a participant did not have an event, the value of 0 was assigned to that participant.</description>
        <time_frame>During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days</time_frame>
        <population>The ITT analysis set included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Grade 3 and 4 Hematologic Toxicities</title>
          <description>Hematologic toxicities events were defined as any cycle where any hematologic lab value occurs that meets the CTCAE toxicity grade criteria for &gt;= Grade 3 and the value is treatment emergent. The occurrence of Grade 3 and 4 hematologic toxicities was a binary endpoint. If a participant had at least 1 cycle with at least one Grade 3 or 4 hematologic toxicities during the treatment period, the participant was assigned as Yes to the occurrence of Grade 3 and 4 hematologic toxicities; otherwise, it was No. If a participant did not have an event, the value of 0 was assigned to that participant.</description>
          <population>The ITT analysis set included all randomized participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with Grade 3 and 4 hematologic toxicities: Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with Grade 3 and 4 hematologic toxicities: No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Grade 3 or 4 Thrombocytopenia</title>
        <description>Hematologic toxicities events are defined as any cycle where any hematologic lab value occurs that meets the CTCAE toxicity grade criteria for &gt;= Grade 3 and the value is treatment emergent. The occurrence of Grade 3 and 4 thrombocytopenia was a binary endpoint. If a participant had at least 1 cycle with at least one Grade 3 or 4 thrombocytopenia during the treatment period, the participant was assigned as &quot;Yes&quot; to the occurrence of Grade 3 and 4 thrombocytopenia; otherwise, it was &quot;No&quot;. If a participant did not have an event, the value of 0 was assigned to that participant.</description>
        <time_frame>During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days</time_frame>
        <population>The ITT analysis set included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Grade 3 or 4 Thrombocytopenia</title>
          <description>Hematologic toxicities events are defined as any cycle where any hematologic lab value occurs that meets the CTCAE toxicity grade criteria for &gt;= Grade 3 and the value is treatment emergent. The occurrence of Grade 3 and 4 thrombocytopenia was a binary endpoint. If a participant had at least 1 cycle with at least one Grade 3 or 4 thrombocytopenia during the treatment period, the participant was assigned as &quot;Yes&quot; to the occurrence of Grade 3 and 4 thrombocytopenia; otherwise, it was &quot;No&quot;. If a participant did not have an event, the value of 0 was assigned to that participant.</description>
          <population>The ITT analysis set included all randomized participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Major Adverse Hematologic Event (MAHE) Rate</title>
        <description>MAHE was a composite endpoint incorporating the measurement of several clinically meaningful aspects of myelosuppression into a single endpoint by summing of the total number of events across a set of pre-specified components.The individual components for MAHE were all-cause hospitalizations, all-cause dose reductions, febrile neutropenia, prolonged severe neutropenia (duration &gt; 5 days), RBC transfusion and platelet transfusion. Event rate for MAHE was calculated as the number of events/durations of treatment period divided by 7 days/1 week.</description>
        <time_frame>During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days</time_frame>
        <population>The ITT analysis set included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Major Adverse Hematologic Event (MAHE) Rate</title>
          <description>MAHE was a composite endpoint incorporating the measurement of several clinically meaningful aspects of myelosuppression into a single endpoint by summing of the total number of events across a set of pre-specified components.The individual components for MAHE were all-cause hospitalizations, all-cause dose reductions, febrile neutropenia, prolonged severe neutropenia (duration &gt; 5 days), RBC transfusion and platelet transfusion. Event rate for MAHE was calculated as the number of events/durations of treatment period divided by 7 days/1 week.</description>
          <population>The ITT analysis set included all randomized participants.</population>
          <units>event rate per week</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.153"/>
                    <measurement group_id="O2" value="0.108"/>
                    <measurement group_id="O3" value="0.080"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Febrile Neutropenia (FN)</title>
        <description>The criterion for identifying FN was if the PT was &quot;FEBRILE NEUTROPENIA&quot; the occurrence during the treatment period was defined as a binary variable (Yes or No); Yes if total number of events &gt;=1 was observed, No for other scenarios. If a participant did not have an event, the value of 0 was assigned to that participant.</description>
        <time_frame>During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days</time_frame>
        <population>The ITT analysis set included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Febrile Neutropenia (FN)</title>
          <description>The criterion for identifying FN was if the PT was &quot;FEBRILE NEUTROPENIA&quot; the occurrence during the treatment period was defined as a binary variable (Yes or No); Yes if total number of events &gt;=1 was observed, No for other scenarios. If a participant did not have an event, the value of 0 was assigned to that participant.</description>
          <population>The ITT analysis set included all randomized participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Infection SAEs</title>
        <description>Number of participants with infection SAEs during the treatment period was defined as a binary variable (Yes or No); Yes if total number of events &gt;=1 was observed, No for other scenarios. If a participant did not have an event, the value of 0 was assigned to that participant. The criterion for identifying the proper infection SAE records was as follows: If the system organ class (SOC) from Medical Dictionary for Regulatory Activities (MedDRA) takes value &quot;INFECTIONS AND INFESTATIONS,&quot; and the AE was a serious event.</description>
        <time_frame>During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days</time_frame>
        <population>The ITT analysis set included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Infection SAEs</title>
          <description>Number of participants with infection SAEs during the treatment period was defined as a binary variable (Yes or No); Yes if total number of events &gt;=1 was observed, No for other scenarios. If a participant did not have an event, the value of 0 was assigned to that participant. The criterion for identifying the proper infection SAE records was as follows: If the system organ class (SOC) from Medical Dictionary for Regulatory Activities (MedDRA) takes value &quot;INFECTIONS AND INFESTATIONS,&quot; and the AE was a serious event.</description>
          <population>The ITT analysis set included all randomized participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Participants with Infection SAEs: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Participants with Infection SAEs: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="33"/>
                    <measurement group_id="O3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Red Blood Cell (RBC) Transfusions On/After Week 5 (Day 35)</title>
        <description>Each RBC transfusion with a unique start date on/after 5 weeks on study during the treatment period was defined as a separate event. Occurrence during the treatment period was defined as a binary variable (Yes or No); &quot;Yes&quot; if the total number of events &gt;=1 was observed and &quot;No&quot; for other scenarios. If a participant did not have an event, the value of 0 will be assigned to that participant.</description>
        <time_frame>From Day 35 through the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 508 days</time_frame>
        <population>The ITT analysis set included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Red Blood Cell (RBC) Transfusions On/After Week 5 (Day 35)</title>
          <description>Each RBC transfusion with a unique start date on/after 5 weeks on study during the treatment period was defined as a separate event. Occurrence during the treatment period was defined as a binary variable (Yes or No); &quot;Yes&quot; if the total number of events &gt;=1 was observed and &quot;No&quot; for other scenarios. If a participant did not have an event, the value of 0 will be assigned to that participant.</description>
          <population>The ITT analysis set included all randomized participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Participants with RBC transfusions on/after Week 5: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Participants with RBC transfusions on/after Week 5: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>RBC Transfusions in Group 3 vs Group 1.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7048</p_value>
            <p_value_desc>A 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global familywise error rate across the multiple null hypotheses.</p_value_desc>
            <method>modified Poisson regression</method>
            <param_type>Adjusted HR</param_type>
            <param_value>0.493</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.1957</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.226</ci_lower_limit>
            <ci_upper_limit>1.073</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>RBC Transfusions in Group 2 vs Group 1.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7272</p_value>
            <p_value_desc>P-value was calculated using modified Poisson method adjusting for duration of treatment in days accounting for number of prior lines of therapy (0 versus 1 - 2); liver involvement as the stratification factors and baseline hemoglobin as a covariate.</p_value_desc>
            <method>Modified Poisson Regression</method>
            <param_type>Adjusted rate ratio</param_type>
            <param_value>0.885</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.3089</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.447</ci_lower_limit>
            <ci_upper_limit>1.754</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Platelet Transfusions</title>
        <description>Each platelet transfusion with a unique start date during the treatment period was defined as a separate event. The occurrence during the treatment period was defined as a binary variable (Yes or No); Yes if the total number of events &gt;=1 was observed and No for other scenarios. If a participant did not have an event, the value of 0 will be assigned to that participant.</description>
        <time_frame>During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days</time_frame>
        <population>The ITT analysis set included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Platelet Transfusions</title>
          <description>Each platelet transfusion with a unique start date during the treatment period was defined as a separate event. The occurrence during the treatment period was defined as a binary variable (Yes or No); Yes if the total number of events &gt;=1 was observed and No for other scenarios. If a participant did not have an event, the value of 0 will be assigned to that participant.</description>
          <population>The ITT analysis set included all randomized participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Participants with platelet transfusion: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Participants with platelet transfusion: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Platelet Transfusions in Group 3 vs Group 1.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7048</p_value>
            <p_value_desc>A 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global familywise error rate across the multiple null hypotheses.</p_value_desc>
            <method>modified Poisson regression</method>
            <param_type>Adjusted rate ratio</param_type>
            <param_value>0.988</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.6105</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.294</ci_lower_limit>
            <ci_upper_limit>3.317</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Platelet Transfusions in Group 2 vs Group 1.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.4078</p_value>
            <p_value_desc>P-value: calculated using modified Poisson method adjusting for duration of treatment in days accounting for number of prior lines of therapy (0 versus 1 - 2); liver involvement as stratification factors and baseline platelet count as a covariate.</p_value_desc>
            <method>Modified Poisson Regression</method>
            <param_type>Adjusted rate ratio</param_type>
            <param_value>0.527</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.4077</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.116</ci_lower_limit>
            <ci_upper_limit>2.399</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Granulocyte Colony-stimulating Factor (G-CSF) Administration</title>
        <description>The criterion for selecting proper records is as follows: If the chemical subgroup from the World Health Organization-Drug Dictionary (WHO-DD) takes value &quot;COLONY STIMULATING FACTOR,&quot; the medication was classified as G-CSF. The occurrence during the treatment period was defined as a binary variable (Yes or No); &quot;Yes&quot; if the total number of events &gt;=1 was observed and &quot;No&quot; for other scenarios. If a participant did not have an event, the value of 0 will be assigned to that participant.</description>
        <time_frame>During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days</time_frame>
        <population>The ITT analysis set included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Granulocyte Colony-stimulating Factor (G-CSF) Administration</title>
          <description>The criterion for selecting proper records is as follows: If the chemical subgroup from the World Health Organization-Drug Dictionary (WHO-DD) takes value &quot;COLONY STIMULATING FACTOR,&quot; the medication was classified as G-CSF. The occurrence during the treatment period was defined as a binary variable (Yes or No); &quot;Yes&quot; if the total number of events &gt;=1 was observed and &quot;No&quot; for other scenarios. If a participant did not have an event, the value of 0 will be assigned to that participant.</description>
          <population>The ITT analysis set included all randomized participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Participants with G-CSF Administration: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="21"/>
                    <measurement group_id="O3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Participants with G-CSF Administration: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>G-CSF Administration in Group 3 vs Group 1.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7048</p_value>
            <p_value_desc>A 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global familywise error rate across the multiple null hypotheses.</p_value_desc>
            <method>modified Poisson regression</method>
            <param_type>Adjusted rate ratio</param_type>
            <param_value>0.645</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.1902</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.362</ci_lower_limit>
            <ci_upper_limit>1.150</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>G-CSF Administration in Group 2 vs Group 1.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7835</p_value>
            <p_value_desc>P-value was calculated using modified Poisson method adjusting for number of cycles, accounting for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors and baseline ANC as a covariate.</p_value_desc>
            <method>Modified Poisson Regression</method>
            <param_type>Adjusted rate ratio</param_type>
            <param_value>0.936</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2260</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.583</ci_lower_limit>
            <ci_upper_limit>1.502</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Erythropoiesis Stimulating Agent (ESA) Administration</title>
        <description>The occurrence during the treatment period was defined as a binary variable (Yes or No); &quot;Yes&quot; if total number of events &gt;=1 was observed, &quot;No&quot; for other scenarios. If a participant did not have an event, the value of 0 was assigned to that participant. The criterion to select proper records was as follows: If the chemical subgroup from WHO-DD Version September 2017 (i.e., TEXT4 for CODE4) takes value &quot;OTHER ANTIANEMIC PREPARATIONS&quot;, the medication was classified as ESAs.</description>
        <time_frame>During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days</time_frame>
        <population>The ITT analysis set included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Erythropoiesis Stimulating Agent (ESA) Administration</title>
          <description>The occurrence during the treatment period was defined as a binary variable (Yes or No); &quot;Yes&quot; if total number of events &gt;=1 was observed, &quot;No&quot; for other scenarios. If a participant did not have an event, the value of 0 was assigned to that participant. The criterion to select proper records was as follows: If the chemical subgroup from WHO-DD Version September 2017 (i.e., TEXT4 for CODE4) takes value &quot;OTHER ANTIANEMIC PREPARATIONS&quot;, the medication was classified as ESAs.</description>
          <population>The ITT analysis set included all randomized participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Participants with ESA Administration: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Participants with ESA Administration: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Intravenous Antibiotics Use</title>
        <description>The criteria for identifying an IV antibiotic administration event was (1) if the Therapeutic subgroup from WHO-DD version takes value &quot;ANTIBACTERIALS FOR SYSTEMIC USE&quot;, and (2) the route of medication was &quot;intravenous&quot; or the route was &quot;other&quot; with the detailed specification as &quot;IVPB&quot;. The occurrence during the treatment period was defined as a binary variable (Yes or No); &quot;Yes&quot; if total number of events &gt;=1 was observed, &quot;No&quot; for other scenarios. If a participant did not have an event, the value of 0 was assigned to that participant.</description>
        <time_frame>During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days</time_frame>
        <population>The ITT analysis set included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Day 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Intravenous Antibiotics Use</title>
          <description>The criteria for identifying an IV antibiotic administration event was (1) if the Therapeutic subgroup from WHO-DD version takes value &quot;ANTIBACTERIALS FOR SYSTEMIC USE&quot;, and (2) the route of medication was &quot;intravenous&quot; or the route was &quot;other&quot; with the detailed specification as &quot;IVPB&quot;. The occurrence during the treatment period was defined as a binary variable (Yes or No); &quot;Yes&quot; if total number of events &gt;=1 was observed, &quot;No&quot; for other scenarios. If a participant did not have an event, the value of 0 was assigned to that participant.</description>
          <population>The ITT analysis set included all randomized participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Participants with Intravenous Antibiotics Use: Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Participants with Intravenous Antibiotics Use: No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>All-cause Dose Reductions, Event Rate (Per Cycle)</title>
        <description>Dose reductions were not permitted for trilaciclib. Dose reductions for gemcitabine or carboplatin were collected on the dosing page. No more than 3 dose modifications for toxicity in total were allowed for any participant. All dose reductions were counted as a separate event. Discontinuations of an individual component of the chemotherapy regimen were counted as a dose reduction If the participant continued the other chemotherapy drug as a monotherapy. Event rate was calculated as the total number of cycles with an event divided by the total number of cycles.</description>
        <time_frame>During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days</time_frame>
        <population>The ITT analysis set included all randomized participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>All-cause Dose Reductions, Event Rate (Per Cycle)</title>
          <description>Dose reductions were not permitted for trilaciclib. Dose reductions for gemcitabine or carboplatin were collected on the dosing page. No more than 3 dose modifications for toxicity in total were allowed for any participant. All dose reductions were counted as a separate event. Discontinuations of an individual component of the chemotherapy regimen were counted as a dose reduction If the participant continued the other chemotherapy drug as a monotherapy. Event rate was calculated as the total number of cycles with an event divided by the total number of cycles.</description>
          <population>The ITT analysis set included all randomized participants.</population>
          <units>event rate per cycle</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.141"/>
                    <measurement group_id="O2" value="0.118"/>
                    <measurement group_id="O3" value="0.133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>All-cause Dose Reductions in Group 3 vs Group 1.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.7048</p_value>
            <p_value_desc>The 1-sided p-value was calculated using Hochberg-based gatekeeping procedure to control the global family wise error rate across the multiple null hypotheses.</p_value_desc>
            <method>negative binomial regression</method>
            <param_type>Adjusted rate ratio</param_type>
            <param_value>0.991</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.3718</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.475</ci_lower_limit>
            <ci_upper_limit>2.067</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>All-cause Dose Reductions in Group 2 vs Group 1.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5541</p_value>
            <p_value_desc>P-value was calculated using negative binomial method adjusting for number of cycles, accounting for the number of prior lines of therapy (0 versus 1 - 2) and liver involvement as the stratification factors.</p_value_desc>
            <method>negative binomial regression</method>
            <param_type>Adjusted rate ratio</param_type>
            <param_value>0.820</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.2744</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.426</ci_lower_limit>
            <ci_upper_limit>1.580</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dose Modifications: Number of Participants With Cycle Delays</title>
        <description>Dose modifications was summarized for each study drug based on number of cycles received during the treatment period. If the participant was unable to start a new cycle at that next visit, then the cycle is delayed, the reason entered, and the question was asked again at the next visit until the participant either starts a new cycle or discontinues treatment.</description>
        <time_frame>During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days</time_frame>
        <population>The safety analysis set included all enrolled participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Dose Modifications: Number of Participants With Cycle Delays</title>
          <description>Dose modifications was summarized for each study drug based on number of cycles received during the treatment period. If the participant was unable to start a new cycle at that next visit, then the cycle is delayed, the reason entered, and the question was asked again at the next visit until the participant either starts a new cycle or discontinues treatment.</description>
          <population>The safety analysis set included all enrolled participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dose Modifications - Number of Participants With Skipped Doses</title>
        <description>Dose modifications was summarized for each study drug based on skipped doses not received during the treatment period. Primary reasons for skipped doses included toxicity, investigator decision and administrative reasons (e.g., holidays).</description>
        <time_frame>During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days</time_frame>
        <population>The safety analysis set included all enrolled participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Dose Modifications - Number of Participants With Skipped Doses</title>
          <description>Dose modifications was summarized for each study drug based on skipped doses not received during the treatment period. Primary reasons for skipped doses included toxicity, investigator decision and administrative reasons (e.g., holidays).</description>
          <population>The safety analysis set included all enrolled participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dose Modifications: Number of Participants With Any Dose Interruptions</title>
        <description>Dose interruptions was defined as interruption of infusion, regardless of whether the study drug was continued after the interruption.</description>
        <time_frame>During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days</time_frame>
        <population>The safety analysis set included all enrolled participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Dose Modifications: Number of Participants With Any Dose Interruptions</title>
          <description>Dose interruptions was defined as interruption of infusion, regardless of whether the study drug was continued after the interruption.</description>
          <population>The safety analysis set included all enrolled participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Trilaciclib</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Here, 'NA' signifies that Trilaciclib drug was not administered in this specified arm.</measurement>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Carboplatin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gemcitabine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Dose Modifications - Number of Participants With Dose Reductions</title>
        <description>Dose (mg/m2) reductions were not permitted for trilaciclib. Dose reductions for carboplatin and gemcitabine were determined by comparing the planned dose on the respective drug administration pages between the current cycle and the previous cycle.</description>
        <time_frame>During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days</time_frame>
        <population>The safety analysis set included all enrolled participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Dose Modifications - Number of Participants With Dose Reductions</title>
          <description>Dose (mg/m2) reductions were not permitted for trilaciclib. Dose reductions for carboplatin and gemcitabine were determined by comparing the planned dose on the respective drug administration pages between the current cycle and the previous cycle.</description>
          <population>The safety analysis set included all enrolled participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Carboplatin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gemcitabine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs</title>
        <description>An Adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product that did not necessarily have a causal relationship with this treatment. Any AE that started on or after the first dose of study drugs was included as a TEAE. A Serious AE was defined as any AE, occurring at any dose (including after the informed consent form was signed and prior to dosing) and regardless of causality that met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. TEAEs included serious and non-serious TEAEs.</description>
        <time_frame>During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 1116 days</time_frame>
        <population>The safety analysis set included all enrolled participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
          </group>
          <group group_id="O2">
            <title>Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
            <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs</title>
          <description>An Adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product that did not necessarily have a causal relationship with this treatment. Any AE that started on or after the first dose of study drugs was included as a TEAE. A Serious AE was defined as any AE, occurring at any dose (including after the informed consent form was signed and prior to dosing) and regardless of causality that met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. TEAEs included serious and non-serious TEAEs.</description>
          <population>The safety analysis set included all enrolled participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="33"/>
                <count group_id="O3" value="35"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants with any TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="33"/>
                    <measurement group_id="O3" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants with any Serious TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From date of randomization up to 1121 days</time_frame>
      <desc>Safety evaluations were conducted at baseline and throughout the study. Safety surveillance reporting of AEs and SAEs commenced at the time of informed consent and continued through 30 days after the last dose of study drug (safety follow-up phone call). The safety analysis set included all enrolled participants who received at least 1 dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Group 1: Gemcitabine/Carboplatin (Days 1 and 8)</title>
          <description>Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).</description>
        </group>
        <group group_id="E2">
          <title>Group 2: Trilaciclib (G1T28)+ Gemcitabine/Carboplatin (Days 1 and 8)</title>
          <description>Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
        </group>
        <group group_id="E3">
          <title>Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)</title>
          <description>Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Normochromic normocytic anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute left ventricular failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Right ventricular failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Faecaloma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Oesophageal stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Varices oesophageal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Subdural haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic ketoacidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicidal ideation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Urinary tract obstruction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Obstructive airways disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="33"/>
                <counts group_id="E3" subjects_affected="34" subjects_at_risk="35"/>
              </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="61" subjects_affected="22" subjects_at_risk="30"/>
                <counts group_id="E2" events="46" subjects_affected="16" subjects_at_risk="33"/>
                <counts group_id="E3" events="35" subjects_affected="15" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="49" subjects_affected="13" subjects_at_risk="30"/>
                <counts group_id="E2" events="79" subjects_affected="15" subjects_at_risk="33"/>
                <counts group_id="E3" events="31" subjects_affected="12" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="68" subjects_affected="13" subjects_at_risk="30"/>
                <counts group_id="E2" events="55" subjects_affected="13" subjects_at_risk="33"/>
                <counts group_id="E3" events="55" subjects_affected="11" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E2" events="12" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Lacrimation increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="30"/>
                <counts group_id="E2" events="19" subjects_affected="14" subjects_at_risk="33"/>
                <counts group_id="E3" events="31" subjects_affected="17" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="30"/>
                <counts group_id="E2" events="23" subjects_affected="8" subjects_at_risk="33"/>
                <counts group_id="E3" events="18" subjects_affected="11" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E2" events="16" subjects_affected="9" subjects_at_risk="33"/>
                <counts group_id="E3" events="11" subjects_affected="9" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" events="15" subjects_affected="9" subjects_at_risk="33"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="17" subjects_affected="11" subjects_at_risk="30"/>
                <counts group_id="E2" events="22" subjects_affected="14" subjects_at_risk="33"/>
                <counts group_id="E3" events="35" subjects_affected="16" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" events="7" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E3" events="8" subjects_affected="4" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Catheter site pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="4" subjects_affected="2" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Infusion site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Mucosal inflammation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Infusion related reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="35" subjects_affected="7" subjects_at_risk="33"/>
                <counts group_id="E3" events="6" subjects_affected="4" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="20" subjects_affected="8" subjects_at_risk="30"/>
                <counts group_id="E2" events="50" subjects_affected="12" subjects_at_risk="33"/>
                <counts group_id="E3" events="30" subjects_affected="11" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="38" subjects_affected="8" subjects_at_risk="30"/>
                <counts group_id="E2" events="13" subjects_affected="8" subjects_at_risk="33"/>
                <counts group_id="E3" events="44" subjects_affected="12" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="6" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E3" events="7" subjects_affected="4" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="7" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="7" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E3" events="5" subjects_affected="2" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Weight increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E3" events="7" subjects_affected="4" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" events="15" subjects_affected="7" subjects_at_risk="33"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="33"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="6" subjects_affected="4" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="6" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="7" subjects_affected="3" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="33"/>
                <counts group_id="E3" events="22" subjects_affected="14" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="8" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E2" events="7" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E3" events="11" subjects_affected="6" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Cognitive disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Restless legs syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Burning sensation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Pollakiuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Breast pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" events="4" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="33"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="33"/>
                <counts group_id="E3" events="9" subjects_affected="7" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Upper-airway cough syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </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="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="33"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="21" subjects_affected="4" subjects_at_risk="33"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="33"/>
                <counts group_id="E3" events="4" subjects_affected="3" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="4" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="35"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="7" subjects_affected="1" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="33"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis superficial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="33"/>
                <counts group_id="E3" events="7" subjects_affected="3" subjects_at_risk="35"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="33"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="35"/>
              </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 investigator will submit results communications for review by the sponsor at least 60 days prior to expected submission to the intended publisher or meeting committee. This review period may be shortened upon mutual consent. The sponsor may request modification of any publication, presentation or use by the investigator if such activity may jeopardize a patent application, an existing patent, or other proprietary rights.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Limitations of this study are the small sample size and open-label design. Antitumor outcomes were not the primary endpoints.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Clinical Trial Info</name_or_title>
      <organization>G1 Therapeutics, Inc</organization>
      <phone>+1 9192139835</phone>
      <email>clinicalinfo@g1therapeutics.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/NCT02978716
org study id: G1T28-04
secondary id: 2016-004466-26
nct id: NCT02978716
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This was a study to investigate the potential clinical benefit of trilaciclib (G1T28) in
      preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor
      efficacy when administered prior to carboplatin and gemcitabine (GC therapy) for participants
      with metastatic triple negative breast cancer.

      The study was an open-label and 102 participants were randomly assigned (1:1:1 fashion) to 1
      of the 3 following treatment groups:

        -  Group 1: GC therapy (Days 1 and 8 of 21-day cycles) only (n=34)

        -  Group 2: GC therapy (Days 1 and 8) plus trilaciclib (G1T28) on Days 1 and 8 of 21-day
           cycles (n=33)

        -  Group 3: GC therapy (Days 2 and 9) plus trilaciclib (G1T28) on Days 1, 2, 8, and 9 of
           21-day cycles (n=35)

      The study included 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up
      Phase. The Treatment Phase begins on the day of first dose with study treatment and completes
      at the Post-Treatment Visit.
The posted results represent the final results of Study G1T28-04, a Phase 2 study of the
      safety, efficacy and pharmacokinetics of trilaciclib (G1T28) in patients with locally
      recurrent/metastatic triple negative breast cancer receiving gemcitabine and carboplatin
      chemotherapy.

      The final myelopreservation efficacy results are reported from database lock 1 ([DBL1], data
      cut-off [DCO] date of 30 July 2018). Final anti-tumor efficacy (ORR, PFS), and final summary
      exposure and safety data are reported from database lock 2 ([DBL2], DCO 28 June 2019) which
      occurred to support filing of the trilaciclib New Drug Application (NDA). Final overall
      survival (OS) data are reported from the final database lock which occurred on 17 July 2020
      (with a last patient last visit date of 28 February 2020).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Duration of Severe (Grade 4) Neutropenia (DSN) During Cycle 1
time frame: From randomization to the end of Cycle 1 (Each cycle= 21 days)
description: DSN was defined as the number of days from the date of the first absolute neutrophil count (ANC) value of less than (<) 0.5 × 10^9 cells/liter (L) observed between Day 1 Cycle 1 and the end of Cycle 1 to the date of the first ANC value greater than or equal to (>=) 0.5 × 10^9/L that met the following: (1) occurred after the ANC value of < 0.5 × 10^9 cells/L and (2) no other ANC values < 0.5 × 10^9 cells/L occurred between this day and the end of Cycle 1. Severe neutropenia (SN) was set to zero for participants who did not experience severe (Grade 4) neutropenia in Cycle 1, including those who were randomized but never treated.
measure: Number of Participants With Severe (Grade 4) Neutropenia (SN)
time frame: During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days
description: Number of participants with Grade 4 SN was a binary variable. If a participants had at least 1 ANC value < 0.5 ×10^9/L during the treatment period, the participants was assigned as "yes" to the occurrence of SN. Otherwise, it was "no".
measure: Number of Participants With Best Overall Response (BOR) as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
time frame: From date of randomization until the occurrence of progressive disease or a censoring event, assessed up to a maximum of 875 days
description: BOR was defined as the best response across all time points (RECIST v1.1). The best overall response was determined once all the data for the participant is known. Each participant has been assigned one of the following categories (RECIST 1.1): complete response (CR): disappearance of all target lesions; partial response (PR): >= 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters; progression disease (PD): >= 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study); stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD); NE: not evaluable and missing.
measure: Duration of Objective Response (DOR) as Per RECIST v1.1 as Determined by Investigator
time frame: From date of randomization until the occurrence of progressive disease or a censoring event, assessed up to a maximum of 875 days
description: DOR is the time between first response by RECIST Version 1.1 of CR or PR and the first date that progressive disease is documented by RECIST Version 1.1, or death. Participants who do not experience PD or death was censored at the last tumor assessment date. 95% Confidence Interval (CI) was calculated using the Kaplan-Meier method.
measure: Overall Survival (OS)
time frame: From date of randomization to date of death due to any cause, assessed up to a maximum of 1120 days
description: Overall survival was defined as the time (months) from date of randomization to the date of death due to any cause. Participants who do not die during the study were censored at the date last known to be alive. The OS was calculated using Kaplan-Meier method.
measure: Progression Free Survival (PFS) as Per RECIST v1.1 as Determined by Investigator
time frame: From date of randomization until the occurrence of disease progression, death due to any cause or a censoring event, assessed up to a maximum of 875 days
description: PFS was defined as the time (months) from date of randomization until date of documented PD or death due to any cause, whichever comes first. PD: >= 20% increase in the sum of diameters of target lesions (taking as reference the smallest sum on study). The PFS was calculated using Kaplan-Meier method.
measure: Relative Dose Intensity of Gemcitabine and Carboplatin
time frame: During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days
description: Relative dose intensity was defined as 100% times the actual dose intensity divided by the planned dose intensity. The planned dose intensity was defined as the cumulative planned dose through the study divided by (number of cycles × 3 weeks). Relative dose intensity (%) was calculated as: for gemcitabine (100 * [Dose intensity (mg/m2/week) / (2000/3 (mg/m2/week)]); for carboplatin (100 * [Dose intensity (AUC/week)/ (4/3) (AUC/week)]) and for trilaciclib (100 * [Dose intensity (mg/m2/week)/ (480 /3 (mg/m2/week)] for Group 2 and 100 * [Dose intensity (mg/m2/week) / (960 /3 (mg/m2/week)] for Group 3).
measure: Duration of Exposure
time frame: During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days
description: Duration of exposure (days) = First dose date of study drug from the last cycle - first dose date of study drug + 21.
measure: Number of Cycles Participants Received Treatment in Each Treatment Arm
time frame: During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days
description: Participants were considered to have started a cycle if they have received at least 1 dose of any study drug.
measure: Cumulative Dose of Gemcitabine
time frame: During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days
description: Cumulative dose: Sum of the total doses by cycle administered to a participant in the duration of exposure, i.e. total number of cycles received (milligram per meter square [mg/m^2]).
measure: Cumulative Dose of Carboplatin
time frame: During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days
description: Cumulative dose: Sum of the total doses by cycle (AUC) administered to a participant in the duration of exposure, i.e. total number of cycles received (in total prescribed AUC).
measure: Maximum Observed Plasma Concentration (Cmax) of Trilaciclib
time frame: Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)
description: The observed peak plasma concentration was determined from the plasma concentration-versus time data.
measure: Area Under the Plasma Concentration-Time Curve From Time 0 to t Hours (AUC0-t) of Trilaciclib
time frame: Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)
description: AUC0-t was calculated with the linear/log-trapezoidal method, which uses linear interpolation between data points to calculate the AUC. The linear/log-trapezoidal method will be employed for all incremental trapezoids arising from increasing concentrations and the logarithmic trapezoidal method will be used for those arising from decreasing concentrations.
measure: Terminal Elimination Half-Life (t1/2) of Trilaciclib
time frame: Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)
description: t1/2 was calculated as 0.693 divided by lambda z. lambda z (terminal phase rate constant) was determined by linear regression of at least 3 points on the terminal phase of the log-linear plasma concentration-time curve, the actual body exposure to drug after administration of a dose of the drug ( in mg*h/L).
measure: Maximum Observed Plasma Concentration (Cmax) of Gemcitabine
time frame: Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)
description: The observed peak plasma concentration was determined from the plasma concentration-versus time data.
measure: Area Under the Plasma Concentration-Time Curve From Time 0 to t Hours (AUC0-t) of Gemcitabine
time frame: Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)
description: AUC0-t was calculated with the linear/log-trapezoidal method.
measure: Terminal Elimination Half-Life (t1/2) of Free Carboplatin
time frame: Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)
description: t1/2 was calculated as 0.693 divided by lambda z. lambda z (terminal phase rate constant) was determined by linear regression of at least 3 points on the terminal phase of the log-linear plasma concentration-time curve.
measure: Clearance (CL) of of Free Carboplatin
time frame: Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)
description: Clearance after intravenous infusion administration was calculated as: CL=Dose/AUC0-inf. AUC0-inf was calculated as: AUC0-inf=AUClast+Clast/lambdaz where Clast is the last quantifiable concentration in the terminal elimination phase.
measure: Volume of Distribution at Steady State (Vss) of Free Carboplatin
time frame: Cycle 1 Day 1 (Group 1): Pre-dose, 0.5, 1, 2, 3.5, 5, 24 hours post-dose; Cycle 1 Day 1 (Group 2) and Cycle 1 Day 2 (Group 3): Pre-dose, 0.5, 1, 1.5, 2.5, 4, 5.5, 24 hours post-dose (Each cycle is of 21 days)
description: Vss was the volume of distribution at steady state of free carboplatin was reported.
measure: Number of Participants With Grade 3 and 4 Hematologic Toxicities
time frame: During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days
description: Hematologic toxicities events were defined as any cycle where any hematologic lab value occurs that meets the CTCAE toxicity grade criteria for >= Grade 3 and the value is treatment emergent. The occurrence of Grade 3 and 4 hematologic toxicities was a binary endpoint. If a participant had at least 1 cycle with at least one Grade 3 or 4 hematologic toxicities during the treatment period, the participant was assigned as Yes to the occurrence of Grade 3 and 4 hematologic toxicities; otherwise, it was No. If a participant did not have an event, the value of 0 was assigned to that participant.
measure: Number of Participants With Grade 3 or 4 Thrombocytopenia
time frame: During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days
description: Hematologic toxicities events are defined as any cycle where any hematologic lab value occurs that meets the CTCAE toxicity grade criteria for >= Grade 3 and the value is treatment emergent. The occurrence of Grade 3 and 4 thrombocytopenia was a binary endpoint. If a participant had at least 1 cycle with at least one Grade 3 or 4 thrombocytopenia during the treatment period, the participant was assigned as "Yes" to the occurrence of Grade 3 and 4 thrombocytopenia; otherwise, it was "No". If a participant did not have an event, the value of 0 was assigned to that participant.
measure: Major Adverse Hematologic Event (MAHE) Rate
time frame: During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days
description: MAHE was a composite endpoint incorporating the measurement of several clinically meaningful aspects of myelosuppression into a single endpoint by summing of the total number of events across a set of pre-specified components.The individual components for MAHE were all-cause hospitalizations, all-cause dose reductions, febrile neutropenia, prolonged severe neutropenia (duration > 5 days), RBC transfusion and platelet transfusion. Event rate for MAHE was calculated as the number of events/durations of treatment period divided by 7 days/1 week.
measure: Number of Participants With Febrile Neutropenia (FN)
time frame: During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days
description: The criterion for identifying FN was if the PT was "FEBRILE NEUTROPENIA" the occurrence during the treatment period was defined as a binary variable (Yes or No); Yes if total number of events >=1 was observed, No for other scenarios. If a participant did not have an event, the value of 0 was assigned to that participant.
measure: Number of Participants With Infection SAEs
time frame: During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days
description: Number of participants with infection SAEs during the treatment period was defined as a binary variable (Yes or No); Yes if total number of events >=1 was observed, No for other scenarios. If a participant did not have an event, the value of 0 was assigned to that participant. The criterion for identifying the proper infection SAE records was as follows: If the system organ class (SOC) from Medical Dictionary for Regulatory Activities (MedDRA) takes value "INFECTIONS AND INFESTATIONS," and the AE was a serious event.
measure: Number of Participants With Red Blood Cell (RBC) Transfusions On/After Week 5 (Day 35)
time frame: From Day 35 through the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 508 days
description: Each RBC transfusion with a unique start date on/after 5 weeks on study during the treatment period was defined as a separate event. Occurrence during the treatment period was defined as a binary variable (Yes or No); "Yes" if the total number of events >=1 was observed and "No" for other scenarios. If a participant did not have an event, the value of 0 will be assigned to that participant.
measure: Number of Participants With Platelet Transfusions
time frame: During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days
description: Each platelet transfusion with a unique start date during the treatment period was defined as a separate event. The occurrence during the treatment period was defined as a binary variable (Yes or No); Yes if the total number of events >=1 was observed and No for other scenarios. If a participant did not have an event, the value of 0 will be assigned to that participant.
measure: Number of Participants With Granulocyte Colony-stimulating Factor (G-CSF) Administration
time frame: During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days
description: The criterion for selecting proper records is as follows: If the chemical subgroup from the World Health Organization-Drug Dictionary (WHO-DD) takes value "COLONY STIMULATING FACTOR," the medication was classified as G-CSF. The occurrence during the treatment period was defined as a binary variable (Yes or No); "Yes" if the total number of events >=1 was observed and "No" for other scenarios. If a participant did not have an event, the value of 0 will be assigned to that participant.
measure: Number of Participants With Erythropoiesis Stimulating Agent (ESA) Administration
time frame: During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days
description: The occurrence during the treatment period was defined as a binary variable (Yes or No); "Yes" if total number of events >=1 was observed, "No" for other scenarios. If a participant did not have an event, the value of 0 was assigned to that participant. The criterion to select proper records was as follows: If the chemical subgroup from WHO-DD Version September 2017 (i.e., TEXT4 for CODE4) takes value "OTHER ANTIANEMIC PREPARATIONS", the medication was classified as ESAs.
measure: Number of Participants With Intravenous Antibiotics Use
time frame: During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days
description: The criteria for identifying an IV antibiotic administration event was (1) if the Therapeutic subgroup from WHO-DD version takes value "ANTIBACTERIALS FOR SYSTEMIC USE", and (2) the route of medication was "intravenous" or the route was "other" with the detailed specification as "IVPB". The occurrence during the treatment period was defined as a binary variable (Yes or No); "Yes" if total number of events >=1 was observed, "No" for other scenarios. If a participant did not have an event, the value of 0 was assigned to that participant.
measure: All-cause Dose Reductions, Event Rate (Per Cycle)
time frame: During the treatment period. From date of randomization, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 542 days
description: Dose reductions were not permitted for trilaciclib. Dose reductions for gemcitabine or carboplatin were collected on the dosing page. No more than 3 dose modifications for toxicity in total were allowed for any participant. All dose reductions were counted as a separate event. Discontinuations of an individual component of the chemotherapy regimen were counted as a dose reduction If the participant continued the other chemotherapy drug as a monotherapy. Event rate was calculated as the total number of cycles with an event divided by the total number of cycles.
measure: Dose Modifications: Number of Participants With Cycle Delays
time frame: During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days
description: Dose modifications was summarized for each study drug based on number of cycles received during the treatment period. If the participant was unable to start a new cycle at that next visit, then the cycle is delayed, the reason entered, and the question was asked again at the next visit until the participant either starts a new cycle or discontinues treatment.
measure: Dose Modifications - Number of Participants With Skipped Doses
time frame: During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days
description: Dose modifications was summarized for each study drug based on skipped doses not received during the treatment period. Primary reasons for skipped doses included toxicity, investigator decision and administrative reasons (e.g., holidays).
measure: Dose Modifications: Number of Participants With Any Dose Interruptions
time frame: During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days
description: Dose interruptions was defined as interruption of infusion, regardless of whether the study drug was continued after the interruption.
measure: Dose Modifications - Number of Participants With Dose Reductions
time frame: During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 871 days
description: Dose (mg/m2) reductions were not permitted for trilaciclib. Dose reductions for carboplatin and gemcitabine were determined by comparing the planned dose on the respective drug administration pages between the current cycle and the previous cycle.
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
time frame: During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator, assessed up to a maximum of 1116 days
description: An Adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product that did not necessarily have a causal relationship with this treatment. Any AE that started on or after the first dose of study drugs was included as a TEAE. A Serious AE was defined as any AE, occurring at any dose (including after the informed consent form was signed and prior to dosing) and regardless of causality that met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. TEAEs included serious and non-serious TEAEs.
arm group label: Group 1: Gemcitabine/Carboplatin (Days 1 and 8)
arm group type: Experimental
description: Participants received Intravenous (IV) infusion of standard GC chemotherapy (gemcitabine 1000 milligrams per meter square [mg/m^2] and carboplatin area under the curve [AUC] 2) on Days 1 and 8 of 21-day cycle. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg).
arm group label: Group 2: Trilaciclib + Gemcitabine/ Carboplatin (Days 1 and 8)
arm group type: Experimental
description: Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycle. Trilaciclib was administered prior to chemotherapy.
arm group label: Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)
arm group type: Experimental
description: Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day Cycle. Trilaciclib was administered prior to chemotherapy.
intervention type: Drug
intervention name: Trilaciclib
description: G1T28
arm group label: Group 2: Trilaciclib + Gemcitabine/ Carboplatin (Days 1 and 8)
arm group label: Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)
other name: G1T28
other name: CDK 4/6 Inhibitor
intervention type: Drug
intervention name: Gemcitabine
description: Gemcitabine
arm group label: Group 1: Gemcitabine/Carboplatin (Days 1 and 8)
arm group label: Group 2: Trilaciclib + Gemcitabine/ Carboplatin (Days 1 and 8)
arm group label: Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)
intervention type: Drug
intervention name: Carboplatin
description: Carboplatin
arm group label: Group 1: Gemcitabine/Carboplatin (Days 1 and 8)
arm group label: Group 2: Trilaciclib + Gemcitabine/ Carboplatin (Days 1 and 8)
arm group label: Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Contact
role: Study Director
affiliation: G1 Therapeutics, Inc.
facility: 
facility: 
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country: Belgium
country: Bulgaria
country: Croatia
country: North Macedonia
country: Serbia
country: Slovakia
country: Slovenia
country: United States
country: Macedonia, The Former Yugoslav Republic of
country: United Kingdom
citation: Tan AR, Wright GS, Thummala AR, Danso MA, Popovic L, Pluard TJ, Han HS, Vojnovic Z, Vasev N, Ma L, Richards DA, Wilks ST, Milenkovic D, Yang Z, Antal JM, Morris SR, O'Shaughnessy J. Trilaciclib plus chemotherapy versus chemotherapy alone in patients with metastatic triple-negative breast cancer: a multicentre, randomised, open-label, phase 2 trial. Lancet Oncol. 2019 Nov;20(11):1587-1601. doi: 10.1016/S1470-2045(19)30616-3. Epub 2019 Sep 28.
PMID: 31575503
citation: Tan AR, Wright GS, Thummala AR, Danso MA, Popovic L, Pluard TJ, Han HS, Vojnovic Z, Vasev N, Ma L, Richards DA, Wilks ST, Milenkovic D, Xiao J, Sorrentino J, Horton J, O'Shaughnessy J. Trilaciclib Prior to Chemotherapy in Patients with Metastatic Triple-Negative Breast Cancer: Final Efficacy and Subgroup Analysis from a Randomized Phase II Study. Clin Cancer Res. 2022 Feb 15;28(4):629-636. doi: 10.1158/1078-0432.CCR-21-2272.
PMID: 34887261
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Neoplasms
mesh term: Triple Negative Breast Neoplasms
mesh term: Carboplatin
mesh term: Gemcitabine
sharing ipd: No
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reported events: 
certain agreements: 
limitations and caveats: Limitations of this study are the small sample size and open-label design. Antitumor outcomes were not the primary endpoints.
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