<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/NCT02997176</url>
  </required_header>
  <id_info>
    <org_study_id>MDV3800-02</org_study_id>
    <secondary_id>C3441002</secondary_id>
    <nct_id>NCT02997176</nct_id>
  </id_info>
  <brief_title>An Open-Label Pharmacokinetics and Safety Study of Talazoparib (MDV3800)</brief_title>
  <official_title>A PHASE I OPEN-LABEL PHARMACOKINETICS AND SAFETY STUDY OF TALAZOPARIB (MDV3800) IN PATIENTS WITH ADVANCED SOLID TUMORS AND NORMAL OR VARYING DEGREES OF HEPATIC IMPAIRMENT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medivation, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Pfizer</source>
  <brief_summary>
    <textblock>
      This is a trial to investigate the pharmacokinetics (PK) and the safety of talazoparib in&#xD;
      patients with advanced solid tumors and impaired hepatic function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At the end of the study, patients with no clinically significant toxicities, no&#xD;
      contraindications to continue treatment with talazoparib, and no disease progression&#xD;
      (underlying cancer progression) may be eligible to continue talazoparib treatment in a&#xD;
      separate open-label extension study. The decision to allow the patient to continue dosing&#xD;
      with talazoparib in an open-label extension (OLE) study will be based on potential overall&#xD;
      benefit-risk and patient meeting eligibility criteria for OLE.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 30, 2016</start_date>
  <completion_date type="Actual">February 12, 2020</completion_date>
  <primary_completion_date type="Actual">February 12, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area Under the Free Plasma Concentration Time Curve From Zero to 24 Hours (AUC0-24) of Talazoparib on Day 22</measure>
    <time_frame>Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22</time_frame>
    <description>AUC0-24 of talazoparib was defined as the area under the free plasma concentration time curve from time 0 to 24 hours post-dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) of Talazoparib on Day 22</measure>
    <time_frame>Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22</time_frame>
    <description>Cmax was defined as the maximum observed plasma concentration of talazoparib.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Unbound Area Under the Free Plasma Concentration Time Curve From Zero to 24 Hours (AUC0-24u) of Talazoparib on Day 22</measure>
    <time_frame>Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22</time_frame>
    <description>AUC0-24u for unbound talazoparib was defined as the area under the free plasma concentration time curve from time 0 to 24 hours post-dose. AUC0-24u = fu*AUC0-24. fu= Fraction of Unbound (fu) Plasma.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Unbound Maximum Observed Plasma Concentration (Cmaxu) of Talazoparib on Day 22</measure>
    <time_frame>Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22</time_frame>
    <description>Cmaxu was defined as the maximum observed plasma concentration for unbound talazoparib. Cmaxu = fu*Cmax.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area Under the Free Plasma Concentration Time Curve From Zero to 24 Hours (AUC0-24) of Talazoparib on Day 1</measure>
    <time_frame>Pre-dose (within 60 minutes prior to dose), 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Day 1</time_frame>
    <description>AUC0-24 of talazoparib was defined as the area under the free plasma concentration time curve from time 0 to 24 hours post-dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) of Talazoparib on Day 1</measure>
    <time_frame>Pre-dose (within 60 minutes prior to dose), 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Day 1</time_frame>
    <description>Cmax was defined as the maximum observed plasma concentration of talazoparib.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib on Day 1</measure>
    <time_frame>Pre-dose (within 60 minutes prior to dose), 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Day 1</time_frame>
    <description>Tmax was defined as the time to reach maximum observed plasma concentration of talazoparib.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fraction of Unbound (fu) Plasma Talazoparib on Day 1</measure>
    <time_frame>Pre-dose (within 60 minutes prior to dose), 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Day 1</time_frame>
    <description>Fraction of unbound drug (fu) was defined as the ratio of unbound drug concentration to the total drug concentration and reported as percentage (%).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unbound Area Under the Free Plasma Concentration Time Curve From Zero to 24 Hours (AUC0-24u) of Talazoparib on Day 1</measure>
    <time_frame>Pre-dose (within 60 minutes prior to dose), 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Day 1</time_frame>
    <description>AUC0-24u for unbound talazoparib was defined as the area under the free plasma concentration time curve from time 0 to 24 hours post-dose. AUC0-24u = fu*AUC0-24.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unbound Maximum Observed Plasma Concentration (Cmaxu) of Talazoparib on Day 1</measure>
    <time_frame>Pre-dose (within 60 minutes prior to dose), 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Day 1</time_frame>
    <description>Cmaxu was defined as the maximum observed plasma concentration for unbound talazoparib. Cmaxu = fu*Cmax</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Trough Concentration (Ctrough) of Talazoparib on Day 8, 15 and 22</measure>
    <time_frame>Pre-dose on Day 8, 15 and 22</time_frame>
    <description>Ctrough was defined as plasma trough (pre-dose) concentration of talazoparib. Acceptance criteria for Ctrough on Day 15 and Day 22: received 10 consecutive days of dosing immediately before PK sampling day; Sample drawn within 24 +/-2 hours of the previous dose, and not more than +10 minute after the drug administration on the PK collection day. Ctrough on Day 8: received 7 consecutive days of dosing immediately before PK sampling day; sample drawn within 24 +/- 2 hours of the previous dose, and not more than +10 minute after the drug administration on the PK collection day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib on Day 22</measure>
    <time_frame>Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22</time_frame>
    <description>Tmax was defined as the time to reach maximum observed plasma concentration of talazoparib.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fraction of Unbound (fu) Plasma Talazoparib on Day 22</measure>
    <time_frame>Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22</time_frame>
    <description>Fraction of unbound drug (fu) was defined as the ratio of unbound drug concentration to the total drug concentration and reported as percentage (%).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulation Ratio (Rac) of Plasma Talazoparib</measure>
    <time_frame>Pre-dose (within 60 minutes prior to dose) on Day 1, pre-dose(24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose) on Day 22 and 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Days 1 and 22</time_frame>
    <description>Accumulation ratio for AUC0-24 was calculated as area under the curve from time zero to 24 hours on Day 22 divided by area under the curve from time zero to 24 hours on Day 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Clearance (CL/F) of Plasma Talazoparib on Day 22</measure>
    <time_frame>Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22</time_frame>
    <description>Talazoparib clearance is a measure of the rate at which talazoparib is metabolized or eliminated by normal biological processes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unbound Apparent Clearance (CLu/F) of PlasmaTalazoparib on Day 22</measure>
    <time_frame>Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22</time_frame>
    <description>Clearance of unbound talazoparib is a measure of the rate at which unbound talazoparib is metabolized or eliminated by normal biological processes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of Talazoparib Excreted Unchanged in Urine From Time Zero to 24 Hours (Ae 0-24) on Day 1</measure>
    <time_frame>A single void at pre-dose, post-dose at any time between 0 to 12 and any time between 12 to 24 hours on Day 1</time_frame>
    <description>Ae 0-24 is the amount of talazoparib excreted unchanged in urine from time 0 to 24 hours post dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Talazoparib Excreted in Urine From Time Zero to 24 Hours (Ae 0-24%) on Day 1</measure>
    <time_frame>A single void at pre-dose, post-dose at any time between 0 to 12 and any time between 12 to 24 hours on Day 1</time_frame>
    <description>Ae0-24% was defined as the amount of talazoparib excreted in urine from time 0 to 24 hours expressed as percentage of administered dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of Talazoparib Excreted Unchanged in Urine From Time Zero to 24 Hours (Ae 0-24) on Day 22</measure>
    <time_frame>Urine voided post-dose at any time between 0 to 12 and any time between 12 to 24 hours on Day 22</time_frame>
    <description>Ae 0-24 is the amount of talazoparib excreted unchanged in urine from time 0 to 24 hours post dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24%) on Day 22</measure>
    <time_frame>Urine voided post-dose at any time between 0 to 12 and any time between 12 to 24 hours (hrs) on Day 22</time_frame>
    <description>Ae 0-24% was defined as the amount of talazoparib excreted in urine from time 0 to 24 hours expressed as percentage of administered dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal Clearance (CLr) of Talazoparib on Day 22</measure>
    <time_frame>Ae: Post-dose at any time between 0 to 12, 12 to 24 hrs on Day 22; AUC0-24: Pre-dose (24 hrs +/- 60 minutes from previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, any time between 8 to12, 24 hrs post-dose on Day 22</time_frame>
    <description>Renal clearance was calculated as cumulative amount of drug excreted in urine during the 24 hours dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to 24 hours post dose (AUC0-24).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Laboratory Abnormalities</measure>
    <time_frame>Baseline up to 30 days after last dose of study drug (up to 52 days)</time_frame>
    <description>Clinically significant laboratory abnormalities included aspartate transaminase (AST) or alanine aminotransferase (ALT) &gt;=3 times ULN (&gt;5 *ULN if baseline ALT/AST is &gt;3 *ULN) and total bilirubin (TBL) &gt;2 times ULN or INR &gt;1.5, AST or ALT &gt;=3 times ULN with signs and symptoms consistent with hepatitis and/or eosinophilia (&gt;=500 eosinophils/microliter).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Vital Sign -Blood Pressure at Day 2, 8, 15, 22 and End of Study</measure>
    <time_frame>Baseline, Day 2, 8, 15, 22 and End of Study (Day 52)</time_frame>
    <description>Systolic blood pressure and diastolic blood pressure were evaluated for examination of vital signs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Vital Sign- Heart Rate at Day 2, 8, 15, 22 and End of Study</measure>
    <time_frame>Baseline, Day 2, 8, 15, 22 and End of Study (Day 52)</time_frame>
    <description>Heart rate was measured in beats per minute.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Vital Sign- Respiratory Rate at Day 8, 15, 22 and End of Study</measure>
    <time_frame>Baseline, Day 8, 15, 22 and End of Study (Day 52)</time_frame>
    <description>Respiratory rate was measured in terms of breaths per minute.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Vital Sign- Weight at Day 8, 15, 22 and End of Study</measure>
    <time_frame>Baseline, Day 8, 15, 22 and End of Study (Day 52)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Who Met the Pre-specified 12-Lead Electrocardiogram (ECG) Criteria</measure>
    <time_frame>Baseline up to 30 days after last dose of study drug (up to 52 days)</time_frame>
    <description>Pre-specified 12-Lead electrocardiogram (ECG) Criteria: QTCF (Fridericia's correction formula) : &gt;=450 to &lt;480 milliseconds, &gt;=480 to &lt;500 milliseconds, &gt;=500 milliseconds, increase from baseline &gt;=30 - &lt;60, increase from baseline &gt;=60, PR interval: &gt;=300 milliseconds, increase from baseline &gt;=25%; QRS duration: &gt;=140 milliseconds, increase from baseline &gt;=50%; QT interval: &gt;=500 milliseconds; QT Interval: &gt;= 500 milliseconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status</measure>
    <time_frame>Screening (2 to 28 days prior to Day 1), Day -1 (1 day prior to Day 1), safety follow up (Visit up to Day 52)</time_frame>
    <description>As per ECOG, participant's performance status was measured as: 0=fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature, e.g., light housework, office work; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50% of waking hours; 3=capable of only limited self-care, confined to bed/chair &gt;50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</measure>
    <time_frame>Baseline up to 30 days after last dose of study drug (up to 52 days)</time_frame>
    <description>An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. TEAEs were events between first dose of Talazoparib and up to 30 days after the last dose of Talazoparib (up to 52 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With TEAEs Leading to Study Drug Discontinuation</measure>
    <time_frame>Baseline up to 30 days after last dose of study drug (up to 52 days)</time_frame>
    <description>An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of Talazoparib and up to 30 days after the last dose of Talazoparib (up to 52 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. Number of participants with TEAEs leading to study drug discontinuation are reported.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With TEAEs Resulting in Death</measure>
    <time_frame>Baseline up to 30 days after last dose of study drug (up to 52 days)</time_frame>
    <description>An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of Talazoparib and up to 30 days after the last dose of Talazoparib (up to 52 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. Number of participants with TEAEs resulting in death are reported.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Treatment Emergent Treatment Related Adverse Events and SAEs</measure>
    <time_frame>Baseline up to 30 days after last dose of study drug (up to 52 days)</time_frame>
    <description>A treatment-related adverse event was any untoward medical occurrence attributed to talazoparib in a participant who received talazoparib. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; Congenital anomaly. Relatedness to talazoparib was assessed by the investigator.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Advanced Solid Tumors</condition>
  <arm_group>
    <arm_group_label>Group A (control, normal hepatic function)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B (mild hepatic dysfunction)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C (moderate hepatic dysfunction)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D (severe hepatic dysfunction)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Talazoparib</intervention_name>
    <description>Daily oral doses of talazoparib 0.5 mg</description>
    <arm_group_label>Group A (control, normal hepatic function)</arm_group_label>
    <arm_group_label>Group B (mild hepatic dysfunction)</arm_group_label>
    <arm_group_label>Group C (moderate hepatic dysfunction)</arm_group_label>
    <arm_group_label>Group D (severe hepatic dysfunction)</arm_group_label>
    <other_name>MDV3800</other_name>
    <other_name>BMN673</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed and dated Informed Consent Form (by the patient or a legally acceptable&#xD;
             representative as per the local regulations).&#xD;
&#xD;
          2. Female or male at least 18 years of age.&#xD;
&#xD;
          3. Histologically or cytologically confirmed advanced solid tumor with no available&#xD;
             standard treatment options in the opinion of the Investigator&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2.&#xD;
&#xD;
          5. Expected life expectancy of ≥ 3 months.&#xD;
&#xD;
          6. Able to swallow the study drug (no contraindication to oral agents).&#xD;
&#xD;
          7. Hepatic function at screening and enrollment as defined by the NCI organ dysfunction&#xD;
             working group (NCI-ODWG) criteria.&#xD;
&#xD;
          8. Adequate other organ function at screening and enrollment.&#xD;
&#xD;
          9. Female patients of childbearing potential must have a negative serum pregnancy test at&#xD;
             screening and must agree to use a highly effective form of contraception from the time&#xD;
             of the first dose of study drug through 7 months after the last dose of study drug.&#xD;
&#xD;
         10. Male patients must agree to use a condom when having sex with a pregnant woman or with&#xD;
             a non-pregnant female partner of childbearing potential, from 21 days before the first&#xD;
             dose of study drug through 4 months after last dose of study drug.&#xD;
&#xD;
         11. Female patients must not be breastfeeding at screening nor during the study&#xD;
             participation until 7 months after the last dose of the study drug.&#xD;
&#xD;
         12. Willingness and ability to comply with scheduled visits, treatment plan, laboratory&#xD;
             tests, and other trial procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Treatment within 14 days or five half lives prior to enrollment whichever is longer&#xD;
             with any type of systemic anticancer-therapy or any investigational drug&#xD;
&#xD;
          2. Have not recovered (recovery is defined as CTCAE grade ≤ 1) from the acute toxicities&#xD;
             of previous anticancer standard or investigational therapy, except treatment-related&#xD;
             alopecia or laboratory abnormalities otherwise meeting eligibility requirements.&#xD;
&#xD;
          3. Major surgery within 28 days prior to enrollment.&#xD;
&#xD;
          4. Serious accompanying cardiac disorder&#xD;
&#xD;
          5. Active known or suspected brain metastasis or active leptomeningeal disease needing&#xD;
             treatment&#xD;
&#xD;
          6. Symptomatic or impending spinal cord compression or cauda equine syndrome&#xD;
&#xD;
          7. Has undergone a liver transplant, kidney transplant or nephrectomy.&#xD;
&#xD;
          8. Prior allergic reaction or severe intolerance (meeting the criteria for a serious&#xD;
             adverse event, a grade 3 or 4 AE, or permanent treatment discontinuation) to a poly&#xD;
             ADP ribose polymerase (PARP) inhibitor.&#xD;
&#xD;
          9. Known myelodysplastic syndrome&#xD;
&#xD;
         10. Seropositive for human immunodeficiency virus (HIV).&#xD;
&#xD;
         11. Any serious or unstable medical condition that interferes with ability to tolerate&#xD;
             treatment or assessments associated with the protocol.&#xD;
&#xD;
         12. Gastrointestinal disorder affecting absorption.&#xD;
&#xD;
         13. Known or suspected hypersensitivity to any of the talazoparib capsule components.&#xD;
&#xD;
         14. Any condition or reason that interferes with ability to participate in the study,&#xD;
             tolerate treatment or assessments associated with the protocol, causes undue risk, or&#xD;
             complicates the interpretation of safety data, in the opinion of the Investigator or&#xD;
             Medical Monitor&#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>Pfizer Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA Hematology/Oncology - Alhambra</name>
      <address>
        <city>Alhambra</city>
        <state>California</state>
        <zip>91801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Joseph Heritage Healthcare</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare</name>
      <address>
        <city>Fullerton</city>
        <state>California</state>
        <zip>92835</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Hematology/Oncology</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Hematology/Oncology - Porter Ranch</name>
      <address>
        <city>Porter Ranch</city>
        <state>California</state>
        <zip>91326</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Hematology/Oncology - Santa Monica</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Torrance Oncology</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Hematology/Oncology - Santa Clarita</name>
      <address>
        <city>Valencia</city>
        <state>California</state>
        <zip>91355</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orlando Health, Inc.</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=MDV3800-02</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <results_first_submitted>February 5, 2021</results_first_submitted>
  <results_first_submitted_qc>February 5, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 25, 2021</results_first_posted>
  <last_update_submitted>February 5, 2021</last_update_submitted>
  <last_update_submitted_qc>February 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Talazoparib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
  </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>September 14, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT02997176/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>December 9, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT02997176/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Participants with advanced solid tumors and impaired hepatic function were enrolled. Participants were assigned to 1 of the 4 groups based on their hepatic function as per the national cancer institute organ dysfunction working group (NCI-ODWG) classification.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Talazoparib: Normal Hepatic Function</title>
          <description>Participants with total bilirubin (TB) and aspartate aminotransferase (AST) less than or equal to (&lt;=) upper limit of normal (ULN), received talazoparib 0.5 milligram (mg) (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
        </group>
        <group group_id="P2">
          <title>Talazoparib: Mild Hepatic Impairment</title>
          <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
        </group>
        <group group_id="P3">
          <title>Talazoparib: Moderate Hepatic Impairment</title>
          <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
        </group>
        <group group_id="P4">
          <title>Talazoparib: Severe Hepatic Impairment</title>
          <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive Disease</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety analysis set included all participants who received any amount of talazoparib.</population>
      <group_list>
        <group group_id="B1">
          <title>Talazoparib: Normal Hepatic Function</title>
          <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
        </group>
        <group group_id="B2">
          <title>Talazoparib: Mild Hepatic Impairment</title>
          <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
        </group>
        <group group_id="B3">
          <title>Talazoparib: Moderate Hepatic Impairment</title>
          <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
        </group>
        <group group_id="B4">
          <title>Talazoparib: Severe Hepatic Impairment</title>
          <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="7"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="5"/>
            <count group_id="B4" value="16"/>
            <count group_id="B5" value="38"/>
          </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="60.3" spread="7.61"/>
                    <measurement group_id="B2" value="56.6" spread="17.08"/>
                    <measurement group_id="B3" value="60.4" spread="6.31"/>
                    <measurement group_id="B4" value="52.7" spread="11.98"/>
                    <measurement group_id="B5" value="56.1" spread="12.40"/>
                  </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="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="12"/>
                  </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="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="5"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Free Plasma Concentration Time Curve From Zero to 24 Hours (AUC0-24) of Talazoparib on Day 22</title>
        <description>AUC0-24 of talazoparib was defined as the area under the free plasma concentration time curve from time 0 to 24 hours post-dose.</description>
        <time_frame>Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22</time_frame>
        <population>Pharmacokinetic (PK) evaluable analysis population included all enrolled participants who completed Day 22 visit, missed less than 5 consecutive doses, received at least 10 consecutive days of 0.5 mg talazoparib daily dose immediately preceding Day 22 visit without dose interruption, not vomited talazoparib dose on Day 1 and last day of dose, at least 85% of total plasma PK samples collection was reported and provided at least 1 of talazoparib PK parameters of primary interest from Day 22 visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Free Plasma Concentration Time Curve From Zero to 24 Hours (AUC0-24) of Talazoparib on Day 22</title>
          <description>AUC0-24 of talazoparib was defined as the area under the free plasma concentration time curve from time 0 to 24 hours post-dose.</description>
          <population>Pharmacokinetic (PK) evaluable analysis population included all enrolled participants who completed Day 22 visit, missed less than 5 consecutive doses, received at least 10 consecutive days of 0.5 mg talazoparib daily dose immediately preceding Day 22 visit without dose interruption, not vomited talazoparib dose on Day 1 and last day of dose, at least 85% of total plasma PK samples collection was reported and provided at least 1 of talazoparib PK parameters of primary interest from Day 22 visit.</population>
          <units>nanogram*hour per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111.8" spread="30"/>
                    <measurement group_id="O2" value="159.0" spread="99"/>
                    <measurement group_id="O3" value="123.6" spread="30"/>
                    <measurement group_id="O4" value="NA" spread="NA">Data is not reported, as it was planned to report statistics when there were &gt;=3 evaluable participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>AUC0-24 was natural log-transformed and analyzed using an analysis of variance (ANOVA) model with hepatic function group as a fixed effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bioequivalence</non_inferiority_desc>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>142.19</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>79.92</ci_lower_limit>
            <ci_upper_limit>252.98</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>AUC0-24 was natural log-transformed and analyzed using an analysis of variance (ANOVA) model with hepatic function group as a fixed effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bioequivalence</non_inferiority_desc>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>110.54</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>54.58</ci_lower_limit>
            <ci_upper_limit>223.85</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Maximum Observed Plasma Concentration (Cmax) of Talazoparib on Day 22</title>
        <description>Cmax was defined as the maximum observed plasma concentration of talazoparib.</description>
        <time_frame>Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22</time_frame>
        <population>PK evaluable analysis population included all enrolled participants who completed Day 22 visit, missed less than 5 consecutive doses, received at least 10 consecutive days of 0.5 mg talazoparib daily dose immediately preceding Day 22 visit without dose interruption, not vomited talazoparib dose on Day 1 and last day of dose, at least 85% of total plasma PK samples collection was reported and provided at least 1 of talazoparib PK parameters of primary interest from Day 22 visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Plasma Concentration (Cmax) of Talazoparib on Day 22</title>
          <description>Cmax was defined as the maximum observed plasma concentration of talazoparib.</description>
          <population>PK evaluable analysis population included all enrolled participants who completed Day 22 visit, missed less than 5 consecutive doses, received at least 10 consecutive days of 0.5 mg talazoparib daily dose immediately preceding Day 22 visit without dose interruption, not vomited talazoparib dose on Day 1 and last day of dose, at least 85% of total plasma PK samples collection was reported and provided at least 1 of talazoparib PK parameters of primary interest from Day 22 visit.</population>
          <units>nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.30" spread="23"/>
                    <measurement group_id="O2" value="11.30" spread="65"/>
                    <measurement group_id="O3" value="13.56" spread="23"/>
                    <measurement group_id="O4" value="NA" spread="NA">Data is not reported, as it was planned to report statistics when there were &gt;=3 evaluable participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cmax was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bioequivalence</non_inferiority_desc>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>109.76</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>70.93</ci_lower_limit>
            <ci_upper_limit>169.84</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Cmax was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bioequivalence</non_inferiority_desc>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>131.67</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>77.14</ci_lower_limit>
            <ci_upper_limit>224.74</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Unbound Area Under the Free Plasma Concentration Time Curve From Zero to 24 Hours (AUC0-24u) of Talazoparib on Day 22</title>
        <description>AUC0-24u for unbound talazoparib was defined as the area under the free plasma concentration time curve from time 0 to 24 hours post-dose. AUC0-24u = fu*AUC0-24. fu= Fraction of Unbound (fu) Plasma.</description>
        <time_frame>Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22</time_frame>
        <population>PK evaluable analysis population included all enrolled participants who completed Day 22 visit, missed less than 5 consecutive doses, received at least 10 consecutive days of 0.5 mg talazoparib daily dose immediately preceding Day 22 visit without dose interruption, not vomited talazoparib dose on Day 1 and last day of dose, at least 85% of total plasma PK samples collection was reported and provided at least 1 of talazoparib PK parameters of primary interest from Day 22 visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Unbound Area Under the Free Plasma Concentration Time Curve From Zero to 24 Hours (AUC0-24u) of Talazoparib on Day 22</title>
          <description>AUC0-24u for unbound talazoparib was defined as the area under the free plasma concentration time curve from time 0 to 24 hours post-dose. AUC0-24u = fu*AUC0-24. fu= Fraction of Unbound (fu) Plasma.</description>
          <population>PK evaluable analysis population included all enrolled participants who completed Day 22 visit, missed less than 5 consecutive doses, received at least 10 consecutive days of 0.5 mg talazoparib daily dose immediately preceding Day 22 visit without dose interruption, not vomited talazoparib dose on Day 1 and last day of dose, at least 85% of total plasma PK samples collection was reported and provided at least 1 of talazoparib PK parameters of primary interest from Day 22 visit.</population>
          <units>nanogram*hour per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.17" spread="11"/>
                    <measurement group_id="O2" value="45.08" spread="84"/>
                    <measurement group_id="O3" value="33.50" spread="35"/>
                    <measurement group_id="O4" value="NA" spread="NA">Data is not reported, as it was planned to report statistics when there were &gt;=3 evaluable participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>AUC0-24u was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bioequivalence</non_inferiority_desc>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>149.39</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>91.49</ci_lower_limit>
            <ci_upper_limit>243.93</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>AUC0-24u was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bioequivalence</non_inferiority_desc>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>111.04</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>60.91</ci_lower_limit>
            <ci_upper_limit>202.43</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Unbound Maximum Observed Plasma Concentration (Cmaxu) of Talazoparib on Day 22</title>
        <description>Cmaxu was defined as the maximum observed plasma concentration for unbound talazoparib. Cmaxu = fu*Cmax.</description>
        <time_frame>Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22</time_frame>
        <population>PK evaluable analysis population included all enrolled participants who completed Day 22 visit, missed less than 5 consecutive doses, received at least 10 consecutive days of 0.5 mg talazoparib daily dose immediately preceding Day 22 visit without dose interruption, not vomited talazoparib dose on Day 1 and last day of dose, at least 85% of total plasma PK samples collection was reported and provided at least 1 of talazoparib PK parameters of primary interest from Day 22 visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Unbound Maximum Observed Plasma Concentration (Cmaxu) of Talazoparib on Day 22</title>
          <description>Cmaxu was defined as the maximum observed plasma concentration for unbound talazoparib. Cmaxu = fu*Cmax.</description>
          <population>PK evaluable analysis population included all enrolled participants who completed Day 22 visit, missed less than 5 consecutive doses, received at least 10 consecutive days of 0.5 mg talazoparib daily dose immediately preceding Day 22 visit without dose interruption, not vomited talazoparib dose on Day 1 and last day of dose, at least 85% of total plasma PK samples collection was reported and provided at least 1 of talazoparib PK parameters of primary interest from Day 22 visit.</population>
          <units>nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.778" spread="27"/>
                    <measurement group_id="O2" value="3.204" spread="56"/>
                    <measurement group_id="O3" value="3.675" spread="28"/>
                    <measurement group_id="O4" value="NA" spread="NA">Data is not reported, as it was planned to report statistics when there were &gt;=3 evaluable participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bioequivalence</non_inferiority_desc>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>115.32</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>77.95</ci_lower_limit>
            <ci_upper_limit>170.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bioequivalence</non_inferiority_desc>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>132.26</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>81.87</ci_lower_limit>
            <ci_upper_limit>213.67</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Area Under the Free Plasma Concentration Time Curve From Zero to 24 Hours (AUC0-24) of Talazoparib on Day 1</title>
        <description>AUC0-24 of talazoparib was defined as the area under the free plasma concentration time curve from time 0 to 24 hours post-dose.</description>
        <time_frame>Pre-dose (within 60 minutes prior to dose), 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Day 1</time_frame>
        <population>PK parameter analysis population included all enrolled participants who received at least 1 dose of talazoparib and had at least 1 of the talazoparib PK parameters. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Free Plasma Concentration Time Curve From Zero to 24 Hours (AUC0-24) of Talazoparib on Day 1</title>
          <description>AUC0-24 of talazoparib was defined as the area under the free plasma concentration time curve from time 0 to 24 hours post-dose.</description>
          <population>PK parameter analysis population included all enrolled participants who received at least 1 dose of talazoparib and had at least 1 of the talazoparib PK parameters. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>nanogram*hour per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.21" spread="41"/>
                    <measurement group_id="O2" value="27.63" spread="38"/>
                    <measurement group_id="O3" value="25.20" spread="7"/>
                    <measurement group_id="O4" value="21.26" spread="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>AUC0-24 was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bioequivalence</non_inferiority_desc>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>124.40</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>85.19</ci_lower_limit>
            <ci_upper_limit>181.66</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>AUC0-24 was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bioequivalence</non_inferiority_desc>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>113.42</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>73.90</ci_lower_limit>
            <ci_upper_limit>174.07</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>AUC0-24 was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bioequivalence</non_inferiority_desc>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>95.68</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>67.90</ci_lower_limit>
            <ci_upper_limit>134.83</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Observed Plasma Concentration (Cmax) of Talazoparib on Day 1</title>
        <description>Cmax was defined as the maximum observed plasma concentration of talazoparib.</description>
        <time_frame>Pre-dose (within 60 minutes prior to dose), 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Day 1</time_frame>
        <population>PK parameter analysis population included all enrolled participants who received at least 1 dose of talazoparib and had at least 1 of the talazoparib PK parameters. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Plasma Concentration (Cmax) of Talazoparib on Day 1</title>
          <description>Cmax was defined as the maximum observed plasma concentration of talazoparib.</description>
          <population>PK parameter analysis population included all enrolled participants who received at least 1 dose of talazoparib and had at least 1 of the talazoparib PK parameters. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.068" spread="66"/>
                    <measurement group_id="O2" value="3.047" spread="32"/>
                    <measurement group_id="O3" value="2.959" spread="44"/>
                    <measurement group_id="O4" value="1.965" spread="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cmax was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bioequivalence</non_inferiority_desc>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>99.31</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>57.74</ci_lower_limit>
            <ci_upper_limit>170.80</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Cmax was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bioequivalence</non_inferiority_desc>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>96.45</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>52.22</ci_lower_limit>
            <ci_upper_limit>178.14</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Cmax was natural log-transformed and analyzed using ANOVA model with hepatic function group as a fixed effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bioequivalence</non_inferiority_desc>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>64.05</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>39.65</ci_lower_limit>
            <ci_upper_limit>103.46</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib on Day 1</title>
        <description>Tmax was defined as the time to reach maximum observed plasma concentration of talazoparib.</description>
        <time_frame>Pre-dose (within 60 minutes prior to dose), 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Day 1</time_frame>
        <population>PK parameter analysis population included all enrolled participants who received at least 1 dose of talazoparib and had at least 1 of the talazoparib PK parameters. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib on Day 1</title>
          <description>Tmax was defined as the time to reach maximum observed plasma concentration of talazoparib.</description>
          <population>PK parameter analysis population included all enrolled participants who received at least 1 dose of talazoparib and had at least 1 of the talazoparib PK parameters. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.00" lower_limit="0.50" upper_limit="1.02"/>
                    <measurement group_id="O2" value="1.51" lower_limit="0.50" upper_limit="2.05"/>
                    <measurement group_id="O3" value="0.55" lower_limit="0.48" upper_limit="1.02"/>
                    <measurement group_id="O4" value="1.00" lower_limit="0.50" upper_limit="24.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fraction of Unbound (fu) Plasma Talazoparib on Day 1</title>
        <description>Fraction of unbound drug (fu) was defined as the ratio of unbound drug concentration to the total drug concentration and reported as percentage (%).</description>
        <time_frame>Pre-dose (within 60 minutes prior to dose), 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Day 1</time_frame>
        <population>PK parameter analysis population included all enrolled participants who received at least 1 dose of talazoparib and had at least 1 of the talazoparib PK parameters. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Fraction of Unbound (fu) Plasma Talazoparib on Day 1</title>
          <description>Fraction of unbound drug (fu) was defined as the ratio of unbound drug concentration to the total drug concentration and reported as percentage (%).</description>
          <population>PK parameter analysis population included all enrolled participants who received at least 1 dose of talazoparib and had at least 1 of the talazoparib PK parameters. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>percentage of drug concentration</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.76" spread="20"/>
                    <measurement group_id="O2" value="28.11" spread="14"/>
                    <measurement group_id="O3" value="27.47" spread="15"/>
                    <measurement group_id="O4" value="34.66" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Unbound Area Under the Free Plasma Concentration Time Curve From Zero to 24 Hours (AUC0-24u) of Talazoparib on Day 1</title>
        <description>AUC0-24u for unbound talazoparib was defined as the area under the free plasma concentration time curve from time 0 to 24 hours post-dose. AUC0-24u = fu*AUC0-24.</description>
        <time_frame>Pre-dose (within 60 minutes prior to dose), 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Day 1</time_frame>
        <population>PK parameter analysis population included all enrolled participants who received at least 1 dose of talazoparib and had at least 1 of the talazoparib PK parameters. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Unbound Area Under the Free Plasma Concentration Time Curve From Zero to 24 Hours (AUC0-24u) of Talazoparib on Day 1</title>
          <description>AUC0-24u for unbound talazoparib was defined as the area under the free plasma concentration time curve from time 0 to 24 hours post-dose. AUC0-24u = fu*AUC0-24.</description>
          <population>PK parameter analysis population included all enrolled participants who received at least 1 dose of talazoparib and had at least 1 of the talazoparib PK parameters. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>nanogram*hour per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.388" spread="42"/>
                    <measurement group_id="O2" value="7.569" spread="35"/>
                    <measurement group_id="O3" value="6.922" spread="14"/>
                    <measurement group_id="O4" value="7.528" spread="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>AUC0-24u was natural log-transformed and analyzed using ANOVA model with hepatic function group as a fixed effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bioequivalence</non_inferiority_desc>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>118.47</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>83.81</ci_lower_limit>
            <ci_upper_limit>167.47</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>AUC0-24u was natural log-transformed and analyzed using ANOVA model with hepatic function group as a fixed effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bioequivalence</non_inferiority_desc>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>108.36</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>73.25</ci_lower_limit>
            <ci_upper_limit>160.30</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>AUC0-24u was natural log-transformed and analyzed using ANOVA model with hepatic function group as a fixed effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bioequivalence</non_inferiority_desc>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>117.84</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>85.29</ci_lower_limit>
            <ci_upper_limit>162.83</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Unbound Maximum Observed Plasma Concentration (Cmaxu) of Talazoparib on Day 1</title>
        <description>Cmaxu was defined as the maximum observed plasma concentration for unbound talazoparib. Cmaxu = fu*Cmax</description>
        <time_frame>Pre-dose (within 60 minutes prior to dose), 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Day 1</time_frame>
        <population>PK parameter analysis population included all enrolled participants who received at least 1 dose of talazoparib and had at least 1 of the talazoparib PK parameters. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Unbound Maximum Observed Plasma Concentration (Cmaxu) of Talazoparib on Day 1</title>
          <description>Cmaxu was defined as the maximum observed plasma concentration for unbound talazoparib. Cmaxu = fu*Cmax</description>
          <population>PK parameter analysis population included all enrolled participants who received at least 1 dose of talazoparib and had at least 1 of the talazoparib PK parameters. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="13"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8823" spread="76"/>
                    <measurement group_id="O2" value="0.8345" spread="35"/>
                    <measurement group_id="O3" value="0.8131" spread="40"/>
                    <measurement group_id="O4" value="0.7448" spread="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bioequivalence</non_inferiority_desc>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>94.58</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>56.74</ci_lower_limit>
            <ci_upper_limit>157.64</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bioequivalence</non_inferiority_desc>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>92.15</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>51.69</ci_lower_limit>
            <ci_upper_limit>164.26</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Cmaxu was natural log-transformed and analyzed using an ANOVA model with hepatic function group as a fixed effect.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Bioequivalence</non_inferiority_desc>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>84.42</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>53.14</ci_lower_limit>
            <ci_upper_limit>134.10</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Plasma Trough Concentration (Ctrough) of Talazoparib on Day 8, 15 and 22</title>
        <description>Ctrough was defined as plasma trough (pre-dose) concentration of talazoparib. Acceptance criteria for Ctrough on Day 15 and Day 22: received 10 consecutive days of dosing immediately before PK sampling day; Sample drawn within 24 +/-2 hours of the previous dose, and not more than +10 minute after the drug administration on the PK collection day. Ctrough on Day 8: received 7 consecutive days of dosing immediately before PK sampling day; sample drawn within 24 +/- 2 hours of the previous dose, and not more than +10 minute after the drug administration on the PK collection day.</description>
        <time_frame>Pre-dose on Day 8, 15 and 22</time_frame>
        <population>Analysis population for this outcome measure included those participants who met acceptance criteria for Ctrough. Here 'number analyzed' signifies number of participants evaluable for each specified row.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Trough Concentration (Ctrough) of Talazoparib on Day 8, 15 and 22</title>
          <description>Ctrough was defined as plasma trough (pre-dose) concentration of talazoparib. Acceptance criteria for Ctrough on Day 15 and Day 22: received 10 consecutive days of dosing immediately before PK sampling day; Sample drawn within 24 +/-2 hours of the previous dose, and not more than +10 minute after the drug administration on the PK collection day. Ctrough on Day 8: received 7 consecutive days of dosing immediately before PK sampling day; sample drawn within 24 +/- 2 hours of the previous dose, and not more than +10 minute after the drug administration on the PK collection day.</description>
          <population>Analysis population for this outcome measure included those participants who met acceptance criteria for Ctrough. Here 'number analyzed' signifies number of participants evaluable for each specified row.</population>
          <units>nanogram per milliliter</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.244" spread="22"/>
                    <measurement group_id="O2" value="4.807" spread="93"/>
                    <measurement group_id="O3" value="3.788" spread="80"/>
                    <measurement group_id="O4" value="3.329" spread="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="2"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="4"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.857" spread="39"/>
                    <measurement group_id="O2" value="NA" spread="NA">Data is not reported, as it was planned to report statistics when there were &gt;=3 evaluable participants.</measurement>
                    <measurement group_id="O3" value="2.909" spread="3"/>
                    <measurement group_id="O4" value="4.208" spread="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.624" spread="28"/>
                    <measurement group_id="O2" value="3.699" spread="197"/>
                    <measurement group_id="O3" value="3.553" spread="8"/>
                    <measurement group_id="O4" value="NA" spread="NA">Data is not reported, as it was planned to report statistics when there were &gt;=3 evaluable participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib on Day 22</title>
        <description>Tmax was defined as the time to reach maximum observed plasma concentration of talazoparib.</description>
        <time_frame>Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22</time_frame>
        <population>PK evaluable analysis population included all enrolled participants who completed Day 22 visit, missed less than 5 consecutive doses, received at least 10 consecutive days of 0.5 mg talazoparib daily dose immediately preceding Day 22 visit without dose interruption, not vomited talazoparib dose on Day 1 and last day of dose, at least 85% of total plasma PK samples collection was reported and provided at least 1 of talazoparib PK parameters of primary interest from Day 22 visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib on Day 22</title>
          <description>Tmax was defined as the time to reach maximum observed plasma concentration of talazoparib.</description>
          <population>PK evaluable analysis population included all enrolled participants who completed Day 22 visit, missed less than 5 consecutive doses, received at least 10 consecutive days of 0.5 mg talazoparib daily dose immediately preceding Day 22 visit without dose interruption, not vomited talazoparib dose on Day 1 and last day of dose, at least 85% of total plasma PK samples collection was reported and provided at least 1 of talazoparib PK parameters of primary interest from Day 22 visit.</population>
          <units>hour</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.50" lower_limit="0.50" upper_limit="2.13"/>
                    <measurement group_id="O2" value="2.13" lower_limit="1.05" upper_limit="4.00"/>
                    <measurement group_id="O3" value="1.05" lower_limit="1.00" upper_limit="2.75"/>
                    <measurement group_id="O4" value="NA" lower_limit="NA" upper_limit="NA">Data is not reported, as it was planned to report statistics when there were &gt;=3 evaluable participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fraction of Unbound (fu) Plasma Talazoparib on Day 22</title>
        <description>Fraction of unbound drug (fu) was defined as the ratio of unbound drug concentration to the total drug concentration and reported as percentage (%).</description>
        <time_frame>Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22</time_frame>
        <population>Analysis population included participants with available data.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Fraction of Unbound (fu) Plasma Talazoparib on Day 22</title>
          <description>Fraction of unbound drug (fu) was defined as the ratio of unbound drug concentration to the total drug concentration and reported as percentage (%).</description>
          <population>Analysis population included participants with available data.</population>
          <units>percentage of drug concentration</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.98" spread="23"/>
                    <measurement group_id="O2" value="27.71" spread="18"/>
                    <measurement group_id="O3" value="27.10" spread="9"/>
                    <measurement group_id="O4" value="33.92" spread="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Accumulation Ratio (Rac) of Plasma Talazoparib</title>
        <description>Accumulation ratio for AUC0-24 was calculated as area under the curve from time zero to 24 hours on Day 22 divided by area under the curve from time zero to 24 hours on Day 1.</description>
        <time_frame>Pre-dose (within 60 minutes prior to dose) on Day 1, pre-dose(24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose) on Day 22 and 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Days 1 and 22</time_frame>
        <population>PK evaluable analysis population was analyzed. Here, &quot;Overall Number of Participants Analyzed&quot; =participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Accumulation Ratio (Rac) of Plasma Talazoparib</title>
          <description>Accumulation ratio for AUC0-24 was calculated as area under the curve from time zero to 24 hours on Day 22 divided by area under the curve from time zero to 24 hours on Day 1.</description>
          <population>PK evaluable analysis population was analyzed. Here, &quot;Overall Number of Participants Analyzed&quot; =participants evaluable for this outcome measure.</population>
          <units>ratio</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.070" spread="24"/>
                    <measurement group_id="O2" value="5.134" spread="68"/>
                    <measurement group_id="O3" value="4.771" spread="31"/>
                    <measurement group_id="O4" value="NA" spread="NA">Data is not reported, as it was planned to report statistics when there were &gt;=3 evaluable participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Apparent Clearance (CL/F) of Plasma Talazoparib on Day 22</title>
        <description>Talazoparib clearance is a measure of the rate at which talazoparib is metabolized or eliminated by normal biological processes.</description>
        <time_frame>Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22</time_frame>
        <population>PK evaluable analysis population included all enrolled participants who completed Day 22 visit, missed less than 5 consecutive doses, received at least 10 consecutive days of 0.5 mg talazoparib daily dose immediately preceding Day 22 visit without dose interruption, not vomited talazoparib dose on Day 1 and last day of dose, at least 85% of total plasma PK samples collection was reported and provided at least 1 of talazoparib PK parameters of primary interest from Day 22 visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Apparent Clearance (CL/F) of Plasma Talazoparib on Day 22</title>
          <description>Talazoparib clearance is a measure of the rate at which talazoparib is metabolized or eliminated by normal biological processes.</description>
          <population>PK evaluable analysis population included all enrolled participants who completed Day 22 visit, missed less than 5 consecutive doses, received at least 10 consecutive days of 0.5 mg talazoparib daily dose immediately preceding Day 22 visit without dose interruption, not vomited talazoparib dose on Day 1 and last day of dose, at least 85% of total plasma PK samples collection was reported and provided at least 1 of talazoparib PK parameters of primary interest from Day 22 visit.</population>
          <units>liter per hour</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.070" spread="24"/>
                    <measurement group_id="O2" value="5.134" spread="68"/>
                    <measurement group_id="O3" value="4.771" spread="31"/>
                    <measurement group_id="O4" value="NA" spread="NA">Data is not reported, as it was planned to report statistics when there were &gt;=3 evaluable participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Unbound Apparent Clearance (CLu/F) of PlasmaTalazoparib on Day 22</title>
        <description>Clearance of unbound talazoparib is a measure of the rate at which unbound talazoparib is metabolized or eliminated by normal biological processes.</description>
        <time_frame>Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22</time_frame>
        <population>PK evaluable analysis population included all enrolled participants who completed Day 22 visit, missed less than 5 consecutive doses, received at least 10 consecutive days of 0.5 mg talazoparib daily dose immediately preceding Day 22 visit without dose interruption, not vomited talazoparib dose on Day 1 and last day of dose, at least 85% of total plasma PK samples collection was reported and provided at least 1 of talazoparib PK parameters of primary interest from Day 22 visit.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Unbound Apparent Clearance (CLu/F) of PlasmaTalazoparib on Day 22</title>
          <description>Clearance of unbound talazoparib is a measure of the rate at which unbound talazoparib is metabolized or eliminated by normal biological processes.</description>
          <population>PK evaluable analysis population included all enrolled participants who completed Day 22 visit, missed less than 5 consecutive doses, received at least 10 consecutive days of 0.5 mg talazoparib daily dose immediately preceding Day 22 visit without dose interruption, not vomited talazoparib dose on Day 1 and last day of dose, at least 85% of total plasma PK samples collection was reported and provided at least 1 of talazoparib PK parameters of primary interest from Day 22 visit.</population>
          <units>liter per hour</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.57" spread="11"/>
                    <measurement group_id="O2" value="11.09" spread="84"/>
                    <measurement group_id="O3" value="14.92" spread="35"/>
                    <measurement group_id="O4" value="NA" spread="NA">Data is not reported, as it was planned to report statistics when there were &gt;=3 evaluable participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Amount of Talazoparib Excreted Unchanged in Urine From Time Zero to 24 Hours (Ae 0-24) on Day 1</title>
        <description>Ae 0-24 is the amount of talazoparib excreted unchanged in urine from time 0 to 24 hours post dose.</description>
        <time_frame>A single void at pre-dose, post-dose at any time between 0 to 12 and any time between 12 to 24 hours on Day 1</time_frame>
        <population>PK parameter analysis population included all enrolled participants who received at least 1 dose of talazoparib and had at least 1 of the talazoparib PK parameters. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Amount of Talazoparib Excreted Unchanged in Urine From Time Zero to 24 Hours (Ae 0-24) on Day 1</title>
          <description>Ae 0-24 is the amount of talazoparib excreted unchanged in urine from time 0 to 24 hours post dose.</description>
          <population>PK parameter analysis population included all enrolled participants who received at least 1 dose of talazoparib and had at least 1 of the talazoparib PK parameters. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>milligram</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.03816" spread="79"/>
                    <measurement group_id="O2" value="0.03534" spread="71"/>
                    <measurement group_id="O3" value="0.04292" spread="85"/>
                    <measurement group_id="O4" value="0.02319" spread="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Talazoparib Excreted in Urine From Time Zero to 24 Hours (Ae 0-24%) on Day 1</title>
        <description>Ae0-24% was defined as the amount of talazoparib excreted in urine from time 0 to 24 hours expressed as percentage of administered dose.</description>
        <time_frame>A single void at pre-dose, post-dose at any time between 0 to 12 and any time between 12 to 24 hours on Day 1</time_frame>
        <population>PK parameter analysis population included all enrolled participants who received at least 1 dose of talazoparib and had at least 1 of the talazoparib PK parameters. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Talazoparib Excreted in Urine From Time Zero to 24 Hours (Ae 0-24%) on Day 1</title>
          <description>Ae0-24% was defined as the amount of talazoparib excreted in urine from time 0 to 24 hours expressed as percentage of administered dose.</description>
          <population>PK parameter analysis population included all enrolled participants who received at least 1 dose of talazoparib and had at least 1 of the talazoparib PK parameters. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants evaluable for this outcome measure.</population>
          <units>percentage of dose</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="8"/>
                <count group_id="O3" value="4"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.638" spread="79"/>
                    <measurement group_id="O2" value="7.070" spread="71"/>
                    <measurement group_id="O3" value="8.582" spread="85"/>
                    <measurement group_id="O4" value="4.641" spread="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Amount of Talazoparib Excreted Unchanged in Urine From Time Zero to 24 Hours (Ae 0-24) on Day 22</title>
        <description>Ae 0-24 is the amount of talazoparib excreted unchanged in urine from time 0 to 24 hours post dose.</description>
        <time_frame>Urine voided post-dose at any time between 0 to 12 and any time between 12 to 24 hours on Day 22</time_frame>
        <population>PK evaluable analysis population was analyzed. Here, &quot;Overall Number of Participants Analyzed&quot; =participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Amount of Talazoparib Excreted Unchanged in Urine From Time Zero to 24 Hours (Ae 0-24) on Day 22</title>
          <description>Ae 0-24 is the amount of talazoparib excreted unchanged in urine from time 0 to 24 hours post dose.</description>
          <population>PK evaluable analysis population was analyzed. Here, &quot;Overall Number of Participants Analyzed&quot; =participants evaluable for this outcome measure.</population>
          <units>milligram</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2229" spread="30"/>
                    <measurement group_id="O2" value="0.1819" spread="34"/>
                    <measurement group_id="O3" value="0.1867" spread="32"/>
                    <measurement group_id="O4" value="NA" spread="NA">Data is not reported, as it was planned to report statistics when there were &gt;=3 evaluable participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24%) on Day 22</title>
        <description>Ae 0-24% was defined as the amount of talazoparib excreted in urine from time 0 to 24 hours expressed as percentage of administered dose.</description>
        <time_frame>Urine voided post-dose at any time between 0 to 12 and any time between 12 to 24 hours (hrs) on Day 22</time_frame>
        <population>PK evaluable analysis population was analyzed. Here, &quot;Overall Number of Participants Analyzed&quot; =participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24%) on Day 22</title>
          <description>Ae 0-24% was defined as the amount of talazoparib excreted in urine from time 0 to 24 hours expressed as percentage of administered dose.</description>
          <population>PK evaluable analysis population was analyzed. Here, &quot;Overall Number of Participants Analyzed&quot; =participants evaluable for this outcome measure.</population>
          <units>percentage of dose</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.58" spread="30"/>
                    <measurement group_id="O2" value="36.36" spread="34"/>
                    <measurement group_id="O3" value="37.40" spread="31"/>
                    <measurement group_id="O4" value="NA" spread="NA">Data is not reported, as it was planned to report statistics when there were &gt;=3 evaluable participants.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Renal Clearance (CLr) of Talazoparib on Day 22</title>
        <description>Renal clearance was calculated as cumulative amount of drug excreted in urine during the 24 hours dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to 24 hours post dose (AUC0-24).</description>
        <time_frame>Ae: Post-dose at any time between 0 to 12, 12 to 24 hrs on Day 22; AUC0-24: Pre-dose (24 hrs +/- 60 minutes from previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, any time between 8 to12, 24 hrs post-dose on Day 22</time_frame>
        <population>PK evaluable analysis population was analyzed. Here, &quot;Overall Number of Participants Analyzed&quot; =participants evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Renal Clearance (CLr) of Talazoparib on Day 22</title>
          <description>Renal clearance was calculated as cumulative amount of drug excreted in urine during the 24 hours dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to 24 hours post dose (AUC0-24).</description>
          <population>PK evaluable analysis population was analyzed. Here, &quot;Overall Number of Participants Analyzed&quot; =participants evaluable for this outcome measure.</population>
          <units>liters per hour</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.993" spread="57"/>
                    <measurement group_id="O2" value="1.449" spread="92"/>
                    <measurement group_id="O3" value="1.510" spread="39"/>
                    <measurement group_id="O4" value="NA" spread="NA">Data is not reported, as it was planned to report statistics when there were &gt;=3 evaluable participants.</measurement>
                  </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 Adverse Events (SAEs)</title>
        <description>An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. TEAEs were events between first dose of Talazoparib and up to 30 days after the last dose of Talazoparib (up to 52 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.</description>
        <time_frame>Baseline up to 30 days after last dose of study drug (up to 52 days)</time_frame>
        <population>Safety analysis set included all participants who received any amount of talazoparib.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)</title>
          <description>An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. TEAEs were events between first dose of Talazoparib and up to 30 days after the last dose of Talazoparib (up to 52 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.</description>
          <population>Safety analysis set included all participants who received any amount of talazoparib.</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="7"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With TEAEs Leading to Study Drug Discontinuation</title>
        <description>An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of Talazoparib and up to 30 days after the last dose of Talazoparib (up to 52 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. Number of participants with TEAEs leading to study drug discontinuation are reported.</description>
        <time_frame>Baseline up to 30 days after last dose of study drug (up to 52 days)</time_frame>
        <population>Safety analysis set included all participants who received any amount of talazoparib.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With TEAEs Leading to Study Drug Discontinuation</title>
          <description>An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of Talazoparib and up to 30 days after the last dose of Talazoparib (up to 52 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. Number of participants with TEAEs leading to study drug discontinuation are reported.</description>
          <population>Safety analysis set included all participants who received any amount of talazoparib.</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="7"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With TEAEs Resulting in Death</title>
        <description>An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of Talazoparib and up to 30 days after the last dose of Talazoparib (up to 52 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. Number of participants with TEAEs resulting in death are reported.</description>
        <time_frame>Baseline up to 30 days after last dose of study drug (up to 52 days)</time_frame>
        <population>Safety analysis set included all participants who received any amount of talazoparib.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With TEAEs Resulting in Death</title>
          <description>An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of Talazoparib and up to 30 days after the last dose of Talazoparib (up to 52 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. Number of participants with TEAEs resulting in death are reported.</description>
          <population>Safety analysis set included all participants who received any amount of talazoparib.</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="7"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Treatment Emergent Treatment Related Adverse Events and SAEs</title>
        <description>A treatment-related adverse event was any untoward medical occurrence attributed to talazoparib in a participant who received talazoparib. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; Congenital anomaly. Relatedness to talazoparib was assessed by the investigator.</description>
        <time_frame>Baseline up to 30 days after last dose of study drug (up to 52 days)</time_frame>
        <population>Safety analysis set included all participants who received any amount of talazoparib.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Treatment Related Adverse Events and SAEs</title>
          <description>A treatment-related adverse event was any untoward medical occurrence attributed to talazoparib in a participant who received talazoparib. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; Congenital anomaly. Relatedness to talazoparib was assessed by the investigator.</description>
          <population>Safety analysis set included all participants who received any amount of talazoparib.</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="7"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</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 group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Laboratory Abnormalities</title>
        <description>Clinically significant laboratory abnormalities included aspartate transaminase (AST) or alanine aminotransferase (ALT) &gt;=3 times ULN (&gt;5 *ULN if baseline ALT/AST is &gt;3 *ULN) and total bilirubin (TBL) &gt;2 times ULN or INR &gt;1.5, AST or ALT &gt;=3 times ULN with signs and symptoms consistent with hepatitis and/or eosinophilia (&gt;=500 eosinophils/microliter).</description>
        <time_frame>Baseline up to 30 days after last dose of study drug (up to 52 days)</time_frame>
        <population>Safety analysis set included all participants who received any amount of talazoparib.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Laboratory Abnormalities</title>
          <description>Clinically significant laboratory abnormalities included aspartate transaminase (AST) or alanine aminotransferase (ALT) &gt;=3 times ULN (&gt;5 *ULN if baseline ALT/AST is &gt;3 *ULN) and total bilirubin (TBL) &gt;2 times ULN or INR &gt;1.5, AST or ALT &gt;=3 times ULN with signs and symptoms consistent with hepatitis and/or eosinophilia (&gt;=500 eosinophils/microliter).</description>
          <population>Safety analysis set included all participants who received any amount of talazoparib.</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="7"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Vital Sign -Blood Pressure at Day 2, 8, 15, 22 and End of Study</title>
        <description>Systolic blood pressure and diastolic blood pressure were evaluated for examination of vital signs.</description>
        <time_frame>Baseline, Day 2, 8, 15, 22 and End of Study (Day 52)</time_frame>
        <population>Safety analysis set included all participants who received any amount of talazoparib. Here, 'number analyzed' signifies participants evaluable for each specified row.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Sign -Blood Pressure at Day 2, 8, 15, 22 and End of Study</title>
          <description>Systolic blood pressure and diastolic blood pressure were evaluated for examination of vital signs.</description>
          <population>Safety analysis set included all participants who received any amount of talazoparib. Here, 'number analyzed' signifies participants evaluable for each specified row.</population>
          <units>millimeter of mercury (mmHg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Systolic Blood Pressure: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="128.1" spread="19.22"/>
                    <measurement group_id="O2" value="110.3" spread="11.84"/>
                    <measurement group_id="O3" value="121.8" spread="23.15"/>
                    <measurement group_id="O4" value="115.8" spread="13.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic Blood Pressure: Change at Day 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.3" spread="17.72"/>
                    <measurement group_id="O2" value="-1.1" spread="12.86"/>
                    <measurement group_id="O3" value="-12.5" spread="14.48"/>
                    <measurement group_id="O4" value="2.2" spread="10.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic Blood Pressure: Change at Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.0" spread="20.22"/>
                    <measurement group_id="O2" value="-2.8" spread="9.85"/>
                    <measurement group_id="O3" value="-5.6" spread="11.97"/>
                    <measurement group_id="O4" value="-5.3" spread="10.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic Blood Pressure: Change at Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.4" spread="8.64"/>
                    <measurement group_id="O2" value="0.3" spread="12.08"/>
                    <measurement group_id="O3" value="-6.0" spread="23.47"/>
                    <measurement group_id="O4" value="-2.3" spread="13.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic Blood Pressure: Change at Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.5" spread="15.10"/>
                    <measurement group_id="O2" value="-4.3" spread="14.30"/>
                    <measurement group_id="O3" value="-10.7" spread="32.56"/>
                    <measurement group_id="O4" value="-7.8" spread="17.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Systolic Blood Pressure: Change at end of study (Day 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="18.36"/>
                    <measurement group_id="O2" value="0.7" spread="14.22"/>
                    <measurement group_id="O4" value="-26.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure: Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.9" spread="12.52"/>
                    <measurement group_id="O2" value="65.9" spread="10.77"/>
                    <measurement group_id="O3" value="68.4" spread="5.59"/>
                    <measurement group_id="O4" value="73.9" spread="10.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure: Change at Day 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.0" spread="6.76"/>
                    <measurement group_id="O2" value="4.1" spread="7.69"/>
                    <measurement group_id="O3" value="-4.5" spread="6.19"/>
                    <measurement group_id="O4" value="-0.8" spread="7.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure: Change at Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.0" spread="12.04"/>
                    <measurement group_id="O2" value="4.1" spread="6.66"/>
                    <measurement group_id="O3" value="-0.8" spread="9.12"/>
                    <measurement group_id="O4" value="-4.1" spread="9.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure: Change at Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.4" spread="6.92"/>
                    <measurement group_id="O2" value="0.9" spread="9.00"/>
                    <measurement group_id="O3" value="0.8" spread="10.84"/>
                    <measurement group_id="O4" value="-2.1" spread="4.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure: Change at Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.5" spread="9.14"/>
                    <measurement group_id="O2" value="-3.0" spread="7.82"/>
                    <measurement group_id="O3" value="-3.3" spread="15.53"/>
                    <measurement group_id="O4" value="-6.0" spread="11.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diastolic Blood Pressure: Change at end of study (Day 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="8.26"/>
                    <measurement group_id="O2" value="1.9" spread="7.52"/>
                    <measurement group_id="O4" value="-17.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Vital Sign- Heart Rate at Day 2, 8, 15, 22 and End of Study</title>
        <description>Heart rate was measured in beats per minute.</description>
        <time_frame>Baseline, Day 2, 8, 15, 22 and End of Study (Day 52)</time_frame>
        <population>Safety analysis set included all participants who received any amount of talazoparib. Here, 'number analyzed' signifies participants evaluable for each specified row.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Sign- Heart Rate at Day 2, 8, 15, 22 and End of Study</title>
          <description>Heart rate was measured in beats per minute.</description>
          <population>Safety analysis set included all participants who received any amount of talazoparib. Here, 'number analyzed' signifies participants evaluable for each specified row.</population>
          <units>beats per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.9" spread="7.67"/>
                    <measurement group_id="O2" value="89.2" spread="19.34"/>
                    <measurement group_id="O3" value="87.4" spread="22.13"/>
                    <measurement group_id="O4" value="92.3" spread="16.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="7.64"/>
                    <measurement group_id="O2" value="4.7" spread="10.01"/>
                    <measurement group_id="O3" value="1.0" spread="6.16"/>
                    <measurement group_id="O4" value="1.4" spread="11.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="7.78"/>
                    <measurement group_id="O2" value="3.5" spread="16.10"/>
                    <measurement group_id="O3" value="1.6" spread="4.67"/>
                    <measurement group_id="O4" value="-2.7" spread="8.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" spread="9.82"/>
                    <measurement group_id="O2" value="-6.0" spread="12.76"/>
                    <measurement group_id="O3" value="2.5" spread="7.05"/>
                    <measurement group_id="O4" value="3.8" spread="15.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="9.81"/>
                    <measurement group_id="O2" value="-9.9" spread="20.38"/>
                    <measurement group_id="O3" value="-2.0" spread="1.00"/>
                    <measurement group_id="O4" value="2.3" spread="19.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at end of study (Day 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.5" spread="11.90"/>
                    <measurement group_id="O2" value="3.1" spread="15.56"/>
                    <measurement group_id="O4" value="23.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Vital Sign- Respiratory Rate at Day 8, 15, 22 and End of Study</title>
        <description>Respiratory rate was measured in terms of breaths per minute.</description>
        <time_frame>Baseline, Day 8, 15, 22 and End of Study (Day 52)</time_frame>
        <population>Safety analysis set included all participants who received any amount of talazoparib. Here, 'number analyzed' signifies participants evaluable for each specified row.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Sign- Respiratory Rate at Day 8, 15, 22 and End of Study</title>
          <description>Respiratory rate was measured in terms of breaths per minute.</description>
          <population>Safety analysis set included all participants who received any amount of talazoparib. Here, 'number analyzed' signifies participants evaluable for each specified row.</population>
          <units>breaths per minute</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.3" spread="2.63"/>
                    <measurement group_id="O2" value="17.1" spread="1.20"/>
                    <measurement group_id="O3" value="16.8" spread="0.84"/>
                    <measurement group_id="O4" value="17.4" spread="1.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="2.06"/>
                    <measurement group_id="O2" value="0.6" spread="1.77"/>
                    <measurement group_id="O3" value="1.2" spread="2.39"/>
                    <measurement group_id="O4" value="-0.1" spread="2.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.6" spread="3.15"/>
                    <measurement group_id="O2" value="-0.4" spread="1.51"/>
                    <measurement group_id="O3" value="0.3" spread="1.53"/>
                    <measurement group_id="O4" value="0.4" spread="1.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="0.98"/>
                    <measurement group_id="O2" value="-0.6" spread="1.41"/>
                    <measurement group_id="O3" value="1.3" spread="0.58"/>
                    <measurement group_id="O4" value="1.1" spread="1.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at end of study (Day 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="1.00"/>
                    <measurement group_id="O2" value="0.1" spread="1.46"/>
                    <measurement group_id="O4" value="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Vital Sign- Weight at Day 8, 15, 22 and End of Study</title>
        <time_frame>Baseline, Day 8, 15, 22 and End of Study (Day 52)</time_frame>
        <population>Safety analysis set included all participants who received any amount of talazoparib. Here, 'number analyzed' signifies participants evaluable for each specified row.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Vital Sign- Weight at Day 8, 15, 22 and End of Study</title>
          <population>Safety analysis set included all participants who received any amount of talazoparib. Here, 'number analyzed' signifies participants evaluable for each specified row.</population>
          <units>kilogram</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.01" spread="15.749"/>
                    <measurement group_id="O2" value="63.07" spread="11.493"/>
                    <measurement group_id="O3" value="77.78" spread="17.070"/>
                    <measurement group_id="O4" value="66.98" spread="12.979"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.04" spread="0.943"/>
                    <measurement group_id="O2" value="-0.10" spread="1.865"/>
                    <measurement group_id="O3" value="-2.02" spread="1.656"/>
                    <measurement group_id="O4" value="-1.50" spread="3.728"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 15</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.36" spread="0.621"/>
                    <measurement group_id="O2" value="-0.09" spread="2.119"/>
                    <measurement group_id="O3" value="-1.78" spread="0.900"/>
                    <measurement group_id="O4" value="-1.29" spread="5.025"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 22</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.78" spread="0.546"/>
                    <measurement group_id="O2" value="0.28" spread="1.647"/>
                    <measurement group_id="O3" value="-1.57" spread="0.462"/>
                    <measurement group_id="O4" value="-2.06" spread="5.416"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at end of study (Day 52)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.48" spread="1.839"/>
                    <measurement group_id="O2" value="1.81" spread="1.577"/>
                    <measurement group_id="O4" value="0.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Who Met the Pre-specified 12-Lead Electrocardiogram (ECG) Criteria</title>
        <description>Pre-specified 12-Lead electrocardiogram (ECG) Criteria: QTCF (Fridericia's correction formula) : &gt;=450 to &lt;480 milliseconds, &gt;=480 to &lt;500 milliseconds, &gt;=500 milliseconds, increase from baseline &gt;=30 - &lt;60, increase from baseline &gt;=60, PR interval: &gt;=300 milliseconds, increase from baseline &gt;=25%; QRS duration: &gt;=140 milliseconds, increase from baseline &gt;=50%; QT interval: &gt;=500 milliseconds; QT Interval: &gt;= 500 milliseconds.</description>
        <time_frame>Baseline up to 30 days after last dose of study drug (up to 52 days)</time_frame>
        <population>Safety analysis set included all participants who received any amount of talazoparib.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Met the Pre-specified 12-Lead Electrocardiogram (ECG) Criteria</title>
          <description>Pre-specified 12-Lead electrocardiogram (ECG) Criteria: QTCF (Fridericia's correction formula) : &gt;=450 to &lt;480 milliseconds, &gt;=480 to &lt;500 milliseconds, &gt;=500 milliseconds, increase from baseline &gt;=30 - &lt;60, increase from baseline &gt;=60, PR interval: &gt;=300 milliseconds, increase from baseline &gt;=25%; QRS duration: &gt;=140 milliseconds, increase from baseline &gt;=50%; QT interval: &gt;=500 milliseconds; QT Interval: &gt;= 500 milliseconds.</description>
          <population>Safety analysis set included all participants who received any amount of talazoparib.</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="7"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>QTCF: &gt;=450 - &lt;480 milliseconds</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTCF: &gt;=480 - &lt;500 milliseconds</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 group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTCF: &gt;=500 milliseconds</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 group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTCF: Increase from baseline &gt;=30 - &lt;60 milliseconds</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QTCF: Increase from baseline &gt;=60 milliseconds</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR Interval: &gt;=300 milliseconds</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>PR Interval: Increase from baseline &gt;=25%</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS Duration: &gt;=140 milliseconds</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 group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QRS Duration: Increase from baseline &gt;=50%</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 group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>QT Interval: &gt;=500 milliseconds</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 group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status</title>
        <description>As per ECOG, participant's performance status was measured as: 0=fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature, e.g., light housework, office work; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50% of waking hours; 3=capable of only limited self-care, confined to bed/chair &gt;50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair.</description>
        <time_frame>Screening (2 to 28 days prior to Day 1), Day -1 (1 day prior to Day 1), safety follow up (Visit up to Day 52)</time_frame>
        <population>Safety analysis set included all participants who received any amount of talazoparib. Here, 'number analyzed' signifies participants evaluable for each specified row.</population>
        <group_list>
          <group group_id="O1">
            <title>Talazoparib: Normal Hepatic Function</title>
            <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Talazoparib: Mild Hepatic Impairment</title>
            <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Talazoparib: Moderate Hepatic Impairment</title>
            <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Talazoparib: Severe Hepatic Impairment</title>
            <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status</title>
          <description>As per ECOG, participant's performance status was measured as: 0=fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature, e.g., light housework, office work; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50% of waking hours; 3=capable of only limited self-care, confined to bed/chair &gt;50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair.</description>
          <population>Safety analysis set included all participants who received any amount of talazoparib. Here, 'number analyzed' signifies participants evaluable for each specified row.</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="7"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="5"/>
                <count group_id="O4" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Screening</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="5"/>
                    <count group_id="O4" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>ECOG Performance Status: 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ECOG Performance Status: 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ECOG Performance Status: 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ECOG Performance Status: 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ECOG Performance Status: 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day -1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="10"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>ECOG Performance Status: 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ECOG Performance Status: 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ECOG Performance Status: 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ECOG Performance Status: 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ECOG Performance Status: 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Safety follow up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="4"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>ECOG Performance Status: 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ECOG Performance Status: 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ECOG Performance Status: 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ECOG Performance Status: 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ECOG Performance Status: 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline up to 30 days after last dose of study drug (up to 52 days)</time_frame>
      <desc>Same event may appear as AE and SAE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Talazoparib: Normal Hepatic Function</title>
          <description>Participants with TB and AST &lt;=ULN received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
        </group>
        <group group_id="E2">
          <title>Talazoparib: Mild Hepatic Impairment</title>
          <description>Participants with TB &lt;=ULN and AST greater than (&gt;) ULN or TB &gt;1.0 to 1.5* ULN and any AST value, received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
        </group>
        <group group_id="E3">
          <title>Talazoparib: Moderate Hepatic Impairment</title>
          <description>Participants with TB &gt;1.5 to 3.0 *ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
        </group>
        <group group_id="E4">
          <title>Talazoparib: Severe Hepatic Impairment</title>
          <description>Participants with TB &gt;3*ULN and any AST value received talazoparib 0.5 mg (2 capsules of 0.25 mg), orally once daily for 22 days.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (v23.0)</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="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Coronary artery occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Disease progression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Neoplasm progression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Malignant pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (v23.0)</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="6" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Coagulopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Ascites</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Oesophagitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Generalised oedema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperbilirubinaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Hepatosplenomegaly</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Ammonia increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Device occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </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" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Pelvic pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Petechiae</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="16"/>
              </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>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.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/NCT02997176
org study id: MDV3800-02
secondary id: C3441002
nct id: NCT02997176
lead sponsor: 
collaborator: 
This is a trial to investigate the pharmacokinetics (PK) and the safety of talazoparib in
      patients with advanced solid tumors and impaired hepatic function.
At the end of the study, patients with no clinically significant toxicities, no
      contraindications to continue treatment with talazoparib, and no disease progression
      (underlying cancer progression) may be eligible to continue talazoparib treatment in a
      separate open-label extension study. The decision to allow the patient to continue dosing
      with talazoparib in an open-label extension (OLE) study will be based on potential overall
      benefit-risk and patient meeting eligibility criteria for OLE.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Area Under the Free Plasma Concentration Time Curve From Zero to 24 Hours (AUC0-24) of Talazoparib on Day 22
time frame: Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22
description: AUC0-24 of talazoparib was defined as the area under the free plasma concentration time curve from time 0 to 24 hours post-dose.
measure: Maximum Observed Plasma Concentration (Cmax) of Talazoparib on Day 22
time frame: Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22
description: Cmax was defined as the maximum observed plasma concentration of talazoparib.
measure: Unbound Area Under the Free Plasma Concentration Time Curve From Zero to 24 Hours (AUC0-24u) of Talazoparib on Day 22
time frame: Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22
description: AUC0-24u for unbound talazoparib was defined as the area under the free plasma concentration time curve from time 0 to 24 hours post-dose. AUC0-24u = fu*AUC0-24. fu= Fraction of Unbound (fu) Plasma.
measure: Unbound Maximum Observed Plasma Concentration (Cmaxu) of Talazoparib on Day 22
time frame: Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22
description: Cmaxu was defined as the maximum observed plasma concentration for unbound talazoparib. Cmaxu = fu*Cmax.
measure: Area Under the Free Plasma Concentration Time Curve From Zero to 24 Hours (AUC0-24) of Talazoparib on Day 1
time frame: Pre-dose (within 60 minutes prior to dose), 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Day 1
description: AUC0-24 of talazoparib was defined as the area under the free plasma concentration time curve from time 0 to 24 hours post-dose.
measure: Maximum Observed Plasma Concentration (Cmax) of Talazoparib on Day 1
time frame: Pre-dose (within 60 minutes prior to dose), 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Day 1
description: Cmax was defined as the maximum observed plasma concentration of talazoparib.
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib on Day 1
time frame: Pre-dose (within 60 minutes prior to dose), 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Day 1
description: Tmax was defined as the time to reach maximum observed plasma concentration of talazoparib.
measure: Fraction of Unbound (fu) Plasma Talazoparib on Day 1
time frame: Pre-dose (within 60 minutes prior to dose), 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Day 1
description: Fraction of unbound drug (fu) was defined as the ratio of unbound drug concentration to the total drug concentration and reported as percentage (%).
measure: Unbound Area Under the Free Plasma Concentration Time Curve From Zero to 24 Hours (AUC0-24u) of Talazoparib on Day 1
time frame: Pre-dose (within 60 minutes prior to dose), 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Day 1
description: AUC0-24u for unbound talazoparib was defined as the area under the free plasma concentration time curve from time 0 to 24 hours post-dose. AUC0-24u = fu*AUC0-24.
measure: Unbound Maximum Observed Plasma Concentration (Cmaxu) of Talazoparib on Day 1
time frame: Pre-dose (within 60 minutes prior to dose), 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Day 1
description: Cmaxu was defined as the maximum observed plasma concentration for unbound talazoparib. Cmaxu = fu*Cmax
measure: Plasma Trough Concentration (Ctrough) of Talazoparib on Day 8, 15 and 22
time frame: Pre-dose on Day 8, 15 and 22
description: Ctrough was defined as plasma trough (pre-dose) concentration of talazoparib. Acceptance criteria for Ctrough on Day 15 and Day 22: received 10 consecutive days of dosing immediately before PK sampling day; Sample drawn within 24 +/-2 hours of the previous dose, and not more than +10 minute after the drug administration on the PK collection day. Ctrough on Day 8: received 7 consecutive days of dosing immediately before PK sampling day; sample drawn within 24 +/- 2 hours of the previous dose, and not more than +10 minute after the drug administration on the PK collection day.
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib on Day 22
time frame: Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22
description: Tmax was defined as the time to reach maximum observed plasma concentration of talazoparib.
measure: Fraction of Unbound (fu) Plasma Talazoparib on Day 22
time frame: Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22
description: Fraction of unbound drug (fu) was defined as the ratio of unbound drug concentration to the total drug concentration and reported as percentage (%).
measure: Accumulation Ratio (Rac) of Plasma Talazoparib
time frame: Pre-dose (within 60 minutes prior to dose) on Day 1, pre-dose(24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose) on Day 22 and 0.5, 1, 2, 4, 6, anytime between 8 to 12 and 24 hours post-dose on Days 1 and 22
description: Accumulation ratio for AUC0-24 was calculated as area under the curve from time zero to 24 hours on Day 22 divided by area under the curve from time zero to 24 hours on Day 1.
measure: Apparent Clearance (CL/F) of Plasma Talazoparib on Day 22
time frame: Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22
description: Talazoparib clearance is a measure of the rate at which talazoparib is metabolized or eliminated by normal biological processes.
measure: Unbound Apparent Clearance (CLu/F) of PlasmaTalazoparib on Day 22
time frame: Pre-dose (24 hours +/- 60 minutes from the previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, anytime from 8 to 12 and 24 hours post-dose on Day 22
description: Clearance of unbound talazoparib is a measure of the rate at which unbound talazoparib is metabolized or eliminated by normal biological processes.
measure: Amount of Talazoparib Excreted Unchanged in Urine From Time Zero to 24 Hours (Ae 0-24) on Day 1
time frame: A single void at pre-dose, post-dose at any time between 0 to 12 and any time between 12 to 24 hours on Day 1
description: Ae 0-24 is the amount of talazoparib excreted unchanged in urine from time 0 to 24 hours post dose.
measure: Percentage of Talazoparib Excreted in Urine From Time Zero to 24 Hours (Ae 0-24%) on Day 1
time frame: A single void at pre-dose, post-dose at any time between 0 to 12 and any time between 12 to 24 hours on Day 1
description: Ae0-24% was defined as the amount of talazoparib excreted in urine from time 0 to 24 hours expressed as percentage of administered dose.
measure: Amount of Talazoparib Excreted Unchanged in Urine From Time Zero to 24 Hours (Ae 0-24) on Day 22
time frame: Urine voided post-dose at any time between 0 to 12 and any time between 12 to 24 hours on Day 22
description: Ae 0-24 is the amount of talazoparib excreted unchanged in urine from time 0 to 24 hours post dose.
measure: Percentage of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24%) on Day 22
time frame: Urine voided post-dose at any time between 0 to 12 and any time between 12 to 24 hours (hrs) on Day 22
description: Ae 0-24% was defined as the amount of talazoparib excreted in urine from time 0 to 24 hours expressed as percentage of administered dose.
measure: Renal Clearance (CLr) of Talazoparib on Day 22
time frame: Ae: Post-dose at any time between 0 to 12, 12 to 24 hrs on Day 22; AUC0-24: Pre-dose (24 hrs +/- 60 minutes from previous dose on Day 21 but within 60 minutes prior to next dose), 0.5, 1, 2, 4, 6, any time between 8 to12, 24 hrs post-dose on Day 22
description: Renal clearance was calculated as cumulative amount of drug excreted in urine during the 24 hours dosing interval (Ae) divided by area under the plasma concentration time-curve from time zero to 24 hours post dose (AUC0-24).
measure: Number of Participants With Clinically Significant Laboratory Abnormalities
time frame: Baseline up to 30 days after last dose of study drug (up to 52 days)
description: Clinically significant laboratory abnormalities included aspartate transaminase (AST) or alanine aminotransferase (ALT) >=3 times ULN (>5 *ULN if baseline ALT/AST is >3 *ULN) and total bilirubin (TBL) >2 times ULN or INR >1.5, AST or ALT >=3 times ULN with signs and symptoms consistent with hepatitis and/or eosinophilia (>=500 eosinophils/microliter).
measure: Change From Baseline in Vital Sign -Blood Pressure at Day 2, 8, 15, 22 and End of Study
time frame: Baseline, Day 2, 8, 15, 22 and End of Study (Day 52)
description: Systolic blood pressure and diastolic blood pressure were evaluated for examination of vital signs.
measure: Change From Baseline in Vital Sign- Heart Rate at Day 2, 8, 15, 22 and End of Study
time frame: Baseline, Day 2, 8, 15, 22 and End of Study (Day 52)
description: Heart rate was measured in beats per minute.
measure: Change From Baseline in Vital Sign- Respiratory Rate at Day 8, 15, 22 and End of Study
time frame: Baseline, Day 8, 15, 22 and End of Study (Day 52)
description: Respiratory rate was measured in terms of breaths per minute.
measure: Change From Baseline in Vital Sign- Weight at Day 8, 15, 22 and End of Study
time frame: Baseline, Day 8, 15, 22 and End of Study (Day 52)
measure: Number of Participants Who Met the Pre-specified 12-Lead Electrocardiogram (ECG) Criteria
time frame: Baseline up to 30 days after last dose of study drug (up to 52 days)
description: Pre-specified 12-Lead electrocardiogram (ECG) Criteria: QTCF (Fridericia's correction formula) : >=450 to <480 milliseconds, >=480 to <500 milliseconds, >=500 milliseconds, increase from baseline >=30 - <60, increase from baseline >=60, PR interval: >=300 milliseconds, increase from baseline >=25%; QRS duration: >=140 milliseconds, increase from baseline >=50%; QT interval: >=500 milliseconds; QT Interval: >= 500 milliseconds.
measure: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
time frame: Screening (2 to 28 days prior to Day 1), Day -1 (1 day prior to Day 1), safety follow up (Visit up to Day 52)
description: As per ECOG, participant's performance status was measured as: 0=fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature, e.g., light housework, office work; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50% of waking hours; 3=capable of only limited self-care, confined to bed/chair >50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed/chair.
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
time frame: Baseline up to 30 days after last dose of study drug (up to 52 days)
description: An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. TEAEs were events between first dose of Talazoparib and up to 30 days after the last dose of Talazoparib (up to 52 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.
measure: Number of Participants With TEAEs Leading to Study Drug Discontinuation
time frame: Baseline up to 30 days after last dose of study drug (up to 52 days)
description: An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of Talazoparib and up to 30 days after the last dose of Talazoparib (up to 52 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. Number of participants with TEAEs leading to study drug discontinuation are reported.
measure: Number of Participants With TEAEs Resulting in Death
time frame: Baseline up to 30 days after last dose of study drug (up to 52 days)
description: An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of Talazoparib and up to 30 days after the last dose of Talazoparib (up to 52 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs. Number of participants with TEAEs resulting in death are reported.
measure: Number of Participants With Treatment Emergent Treatment Related Adverse Events and SAEs
time frame: Baseline up to 30 days after last dose of study drug (up to 52 days)
description: A treatment-related adverse event was any untoward medical occurrence attributed to talazoparib in a participant who received talazoparib. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; Congenital anomaly. Relatedness to talazoparib was assessed by the investigator.
arm group label: Group A (control, normal hepatic function)
arm group type: Experimental
arm group label: Group B (mild hepatic dysfunction)
arm group type: Experimental
arm group label: Group C (moderate hepatic dysfunction)
arm group type: Experimental
arm group label: Group D (severe hepatic dysfunction)
arm group type: Experimental
intervention type: Drug
intervention name: Talazoparib
description: Daily oral doses of talazoparib 0.5 mg
arm group label: Group A (control, normal hepatic function)
arm group label: Group B (mild hepatic dysfunction)
arm group label: Group C (moderate hepatic dysfunction)
arm group label: Group D (severe hepatic dysfunction)
other name: MDV3800
other name: BMN673
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: United States
url: https://pmiform.com/clinical-trial-info-request?StudyID=MDV3800-02
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Talazoparib
sharing ipd: No
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
provided document: 
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reported events: 
certain agreements: 
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