<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/NCT02997163</url>
  </required_header>
  <id_info>
    <org_study_id>MDV3800-01</org_study_id>
    <secondary_id>C3441001</secondary_id>
    <secondary_id>2016-002536-33</secondary_id>
    <nct_id>NCT02997163</nct_id>
  </id_info>
  <brief_title>An Open-Label Pharmacokinetics and Safety Study of Talazoparib</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 RENAL 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>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial will investigate the pharmacokinetics (PK) and safety of talazoparib in patients&#xD;
      with advanced solid tumors and impaired renal 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 after discussion with the Principal Investigator and&#xD;
      obtaining Sponsor permission. Sponsor decision to allow the patient to continue dosing with&#xD;
      talazoparib in an open-label extension study will be based on potential overall benefit-risk,&#xD;
      patient acceptance and other relevant criteria.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 21, 2017</start_date>
  <completion_date type="Actual">January 30, 2019</completion_date>
  <primary_completion_date type="Actual">January 30, 2019</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>Multiple Dose: Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24) of Talazoparib</measure>
    <time_frame>Predose, 0.5, 1, 2, 4, 6, 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 concentration time curve from time 0 to 24 hours post-dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multiple Dose: Maximum Observed Plasma Concentration (Cmax) of Talazoparib</measure>
    <time_frame>Predose, 0.5, 1, 2, 4, 6, 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>Multiple Dose: Area Under the Curve From Time 0 to 24 Hours for Unbound (AUC0-24u) Talazoparib</measure>
    <time_frame>Predose, 0.5, 1, 2, 4, 6, 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 concentration time curve from time 0 to 24 hours post-dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Multiple Dose: Maximum Observed Plasma Concentration for Unbound (Cmaxu) Talazoparib</measure>
    <time_frame>Predose, 0.5, 1, 2, 4, 6, 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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Single Dose: Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24) of Talazoparib</measure>
    <time_frame>Predose, 0.5, 1, 2, 4, 6, 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 concentration time curve from time 0 to 24 hours post-dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single Dose: Maximum Observed Plasma Concentration (Cmax) of Talazoparib</measure>
    <time_frame>Predose, 0.5, 1, 2, 4, 6, 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>Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib</measure>
    <time_frame>Predose, 0.5, 1, 2, 4, 6, 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>Single Dose: Fraction of Unbound Drug (Fu) in Plasma in Talazoparib</measure>
    <time_frame>Predose, 0.5, 1, 2, 4, 6, 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single Dose: Area Under the Curve From Time 0 to 24 Hour for Unbound (AUC0-24u) Talazoparib</measure>
    <time_frame>Predose, 0.5, 1, 2, 4, 6, 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 concentration time curve from time 0 to 24 hours for unbound talazoparib.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single Dose: Maximum Observed Plasma Concentration for Unbound (Cmaxu) Talazoparib</measure>
    <time_frame>Predose, 0.5, 1, 2, 4, 6, 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib</measure>
    <time_frame>Predose, 0.5, 1, 2, 4, 6, 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>Multiple Dose: Plasma Trough Concentration (Ctrough) of Talazoparib</measure>
    <time_frame>Predose on Day 22</time_frame>
    <description>Ctrough was defined as plasma trough (predose) concentration of talazoparib.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiple Dose: Apparent Oral Clearance (CL/F) of Talazoparib</measure>
    <time_frame>Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22</time_frame>
    <description>Drug clearance is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiple Dose: Accumulation Ratio (Rac) of AUC (0-24)</measure>
    <time_frame>Pre-dose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1 and Day 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>Multiple Dose: Fraction of Unbound Drug (Fu) in Plasma in Talazoparib</measure>
    <time_frame>Predose, 0.5, 1, 2, 4, 6, 8-12, 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiple Dose: Unbound Apparent Oral Clearance (CLu/F) of Talazoparib</measure>
    <time_frame>Predose, 0.5, 1, 2, 4, 6, 8-12, and 24 hours post-dose on Day 22</time_frame>
    <description>Clearance of unbound drug is a measure of the rate at which unbound drug is metabolized or eliminated by normal biological processes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single Dose: Amount of Talazoparib Excreted Unchanged in Urine From Time 0 to 24 Hours (Ae 0-24)</measure>
    <time_frame>0 to 24 hours on Day 1</time_frame>
    <description>Ae 0-24 is the amount of drug excreted unchanged in urine from time 0 to 24 hours postdose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single Dose: Percentage of Dose of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24%) at Day 1</measure>
    <time_frame>0 to 24 hours on Day 1</time_frame>
    <description>Ae0-24% was defined as the amount of drug excreted in urine from time 0 to 24 hours expressed as percentage of administered dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiple Dose: Amount of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24%)</measure>
    <time_frame>0 to 24 hours on Day 22</time_frame>
    <description>Ae 0-24 is the amount of drug excreted unchanged in urine from time 0 to 24 hours postdose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiple Dose: Percentage of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24 %) of Talazoparib at Day 22</measure>
    <time_frame>0 to 24 hours on Day 22</time_frame>
    <description>Ae 0-24% was defined as the amount of drug excreted in urine from time 0 to 24 hours, expressed as percentage of administered dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiple Dose: Renal Clearance (CLr) of Talazoparib at Day 22</measure>
    <time_frame>0 to 24 hours 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 postdose.</description>
  </secondary_outcome>
  <secondary_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. Treatment-emergent were events between first dose of investigational product and up to 30 days after the last dose of investigational product (up to 52 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormalities in Physical Examination</measure>
    <time_frame>Baseline up to 30 days after last dose of study drug (up to 52 days)</time_frame>
    <description>Physical examination included examination of the general appearance, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Findings were considered to be abnormal based on investigator's decision.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Systolic Blood Pressure (SBP) of Participants</measure>
    <time_frame>Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Diastolic Blood Pressure (DBP) of Participants</measure>
    <time_frame>Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Heart Rate of Participants</measure>
    <time_frame>Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)</time_frame>
    <description>Heart rate was measured in terms of beats per minute.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Respiratory Rate of Participants</measure>
    <time_frame>Baseline, Day 8, Day 15, Day 22, Safety follow up (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 Body Weight of Participants</measure>
    <time_frame>Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Electrocardiogram (ECG) Abnormalities</measure>
    <time_frame>Baseline up to 30 days after last dose of study drug (up to 52 days)</time_frame>
    <description>ECG parameters included pulse rate (PR) interval, QRS duration, QT interval and corrected QT interval using Fridericia's formula (QTcF). Abnormality criteria: 1) PR interval: greater than equal to (&gt;=) 25 percent (%) increase when baseline &gt;= 300 msec; 2) QRS duration: &gt;=50% increase when baseline &gt;=140 msec; 3) QT interval: &gt;= 500 msec: 4) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) &gt;= 500 msec when baseline &gt;= 60. IFB stands for increase from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Laboratory Abnormalities</measure>
    <time_frame>Baseline up to 30 days after last dose of study drug (up to 52 days)</time_frame>
    <description>Laboratory parameters: erythrocytes, hematocrit, hemoglobin, white blood cells, absolute neutrophil count, lymphocytes, platelets ; albumin, alkaline phosphatase, alanine aminotransferase, aspartate transaminase , bilirubin, bicarbonate, blood urea nitrogen , calcium, chloride, creatinine, gamma -glutamyl transferase, glucose, lactate dehydrogenase, sodium, phosphate, potassium, total protein, uric acid, follicle-stimulating hormone; international normalized ratio / prothrombin time [activated] partial thromboplastin time; Urinalysis (pH, specific gravity, protein, glucose, ketones, bilirubin, blood, leukocyte esterase); Serum pregnancy test; Serology for Human Immunodeficiency Virus (HIV). Number of participants with laboratory test abnormalities as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) version 4.03 were reported: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status</measure>
    <time_frame>Baseline, Safety follow up (Day 52)</time_frame>
    <description>As per ECOG, participant's performance status was measured on 5 point scale: 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: 5: dead.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Advanced Solid Tumors</condition>
  <arm_group>
    <arm_group_label>Group A (control, normal renal function)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B (mild renal impairment)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C (moderate renal impairment)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D (severe renal impairment)</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 renal function)</arm_group_label>
    <arm_group_label>Group B (mild renal impairment)</arm_group_label>
    <arm_group_label>Group C (moderate renal impairment)</arm_group_label>
    <arm_group_label>Group D (severe renal impairment)</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) obtained prior to initiation of any&#xD;
             study-specific procedure and treatment.&#xD;
&#xD;
          2. Female or male of at least 18 years of age.&#xD;
&#xD;
          3. Histologically or cytologically confirmed advanced solid tumor with no available&#xD;
             standard approved treatment options in the opinion of the Investigator&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group (ECOG) Performance status (PS) ≤ 2.&#xD;
&#xD;
          5. Expected life expectancy of ≥ 3 months.&#xD;
&#xD;
          6. Able to swallow the study drug (no contra indication to oral agents).&#xD;
&#xD;
          7. Renal function at screening and enrollment as defined by the Modification of Diet in&#xD;
             Renal Disease (MDRD) equation.&#xD;
&#xD;
          8. Patient has had no clinically significant change in renal status within 3 months prior&#xD;
             to screening, according to Investigator's review of clinical patient records.&#xD;
&#xD;
          9. Patient is not currently on hemodialysis and/or peritoneal dialysis for management of&#xD;
             chronic kidney disease or acute failure/conditions.&#xD;
&#xD;
         10. Patient has no unstable renal function, defined as a change in estimated glomerular&#xD;
             filtration rate (eGFR) (calculated with the MDRD equation) of &gt; 25% for patients with&#xD;
             mild and moderate renal impaired or as a change in eGFR &gt; 30% for patients with severe&#xD;
             renal impaired, from screening to enrollment.&#xD;
&#xD;
         11. Adequate other organ function at screening and enrollment.&#xD;
&#xD;
         12. Female patients of childbearing potential must have a negative serum pregnancy test at&#xD;
             screening, and must agree to use a highly effective birth control method from the time&#xD;
             of the first dose of study drug through 45 days after the last dose of study drug.&#xD;
&#xD;
         13. 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 105 days after last dose of study drug.&#xD;
&#xD;
         14. Female patients must not be breastfeeding at screening nor during the study&#xD;
             participation until 45 days after the last dose of study drug.&#xD;
&#xD;
         15. 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 with any type of&#xD;
             systemic anticancer-therapy or any investigational drug, whichever is longer.&#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 undergoing&#xD;
             or requiring treatment.&#xD;
&#xD;
          6. Symptomatic or impending spinal cord compression or cauda equina 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 CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fort Wayne Medical Oncology and Hematology, Inc.</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fort Wayne Medical Oncology and Hematology, Inc.</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer Institute Weisberg Cancer Treatment Center</name>
      <address>
        <city>Farmington Hills</city>
        <state>Michigan</state>
        <zip>48334</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Robert Wood Johnson University Hospital</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rutgers Cancer Institute of New Jersey</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08903</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>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juravinski Cancer Centre</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8V 5C2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3T 1E2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=MDV3800-01</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>December 2020</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>January 6, 2020</results_first_submitted>
  <results_first_submitted_qc>February 18, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 20, 2020</results_first_posted>
  <last_update_submitted>December 11, 2020</last_update_submitted>
  <last_update_submitted_qc>December 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 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>August 31, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT02997163/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 28, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/63/NCT02997163/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Normal Renal Function</title>
          <description>Participants with normal renal function (estimated glomerular filtration rate [eGFR] greater than or equal to [&gt;=] 90 milliliter per minute per 1.73 square meter [mL/min/1.73m^2]) received 0.5 milligrams (mg) (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
        </group>
        <group group_id="P2">
          <title>Mild Renal Impairment</title>
          <description>Participants with mild renal function (eGFR &gt;= 60 and less than or equal to [&lt;=] 89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
        </group>
        <group group_id="P3">
          <title>Moderate Renal Impairment</title>
          <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
        </group>
        <group group_id="P4">
          <title>Severe Renal Impairment</title>
          <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally 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="9"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety analysis included all participants who received any amount of talazoparib.</population>
      <group_list>
        <group group_id="B1">
          <title>Normal Renal Function</title>
          <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
        </group>
        <group group_id="B2">
          <title>Mild Renal Impairment</title>
          <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
        </group>
        <group group_id="B3">
          <title>Moderate Renal Impairment</title>
          <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
        </group>
        <group group_id="B4">
          <title>Severe Renal Impairment</title>
          <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally 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="9"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="8"/>
            <count group_id="B4" value="8"/>
            <count group_id="B5" value="34"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59.1" spread="6.99"/>
                    <measurement group_id="B2" value="65.4" spread="9.13"/>
                    <measurement group_id="B3" value="65.3" spread="6.45"/>
                    <measurement group_id="B4" value="72.8" spread="13.60"/>
                    <measurement group_id="B5" value="65.4" spread="10.20"/>
                  </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="6"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="3"/>
                    <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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</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="1"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="7"/>
                    <measurement group_id="B5" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Multiple Dose: Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24) of Talazoparib</title>
        <description>AUC0-24 of talazoparib was defined as the area under the concentration time curve from time 0 to 24 hours post-dose.</description>
        <time_frame>Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22</time_frame>
        <population>Pharmacokinetic (PK) analysis population included all participants who had at least 1 reportable talazoparib concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Multiple Dose: Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24) of Talazoparib</title>
          <description>AUC0-24 of talazoparib was defined as the area under the concentration time curve from time 0 to 24 hours post-dose.</description>
          <population>Pharmacokinetic (PK) analysis population included all participants who had at least 1 reportable talazoparib concentration.</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="7"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.88" spread="27"/>
                    <measurement group_id="O2" value="106.5" spread="40"/>
                    <measurement group_id="O3" value="135.7" spread="45"/>
                    <measurement group_id="O4" value="249.8" spread="30"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>112.20</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>80.06</ci_lower_limit>
            <ci_upper_limit>157.26</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>142.98</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>103.03</ci_lower_limit>
            <ci_upper_limit>198.42</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>263.32</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>187.88</ci_lower_limit>
            <ci_upper_limit>369.06</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Multiple Dose: Maximum Observed Plasma Concentration (Cmax) of Talazoparib</title>
        <description>Cmax was defined as the maximum observed plasma concentration of talazoparib.</description>
        <time_frame>Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22</time_frame>
        <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Multiple Dose: Maximum Observed Plasma Concentration (Cmax) of Talazoparib</title>
          <description>Cmax was defined as the maximum observed plasma concentration of talazoparib.</description>
          <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration.</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="7"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.609" spread="35"/>
                    <measurement group_id="O2" value="9.568" spread="58"/>
                    <measurement group_id="O3" value="11.33" spread="45"/>
                    <measurement group_id="O4" value="16.30" spread="34"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>111.13</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>74.40</ci_lower_limit>
            <ci_upper_limit>166.01</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>131.57</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>89.12</ci_lower_limit>
            <ci_upper_limit>194.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>189.32</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>126.74</ci_lower_limit>
            <ci_upper_limit>282.80</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Multiple Dose: Area Under the Curve From Time 0 to 24 Hours for Unbound (AUC0-24u) Talazoparib</title>
        <description>AUC0-24u for unbound talazoparib was defined as the area under the concentration time curve from time 0 to 24 hours post-dose.</description>
        <time_frame>Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22</time_frame>
        <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Multiple Dose: Area Under the Curve From Time 0 to 24 Hours for Unbound (AUC0-24u) Talazoparib</title>
          <description>AUC0-24u for unbound talazoparib was defined as the area under the concentration time curve from time 0 to 24 hours post-dose.</description>
          <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration.</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="7"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.33" spread="32"/>
                    <measurement group_id="O2" value="33.59" spread="31"/>
                    <measurement group_id="O3" value="39.47" spread="47"/>
                    <measurement group_id="O4" value="81.17" spread="36"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>118.58</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>83.85</ci_lower_limit>
            <ci_upper_limit>167.70</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>139.34</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>99.53</ci_lower_limit>
            <ci_upper_limit>195.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>286.61</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>202.66</ci_lower_limit>
            <ci_upper_limit>405.33</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Multiple Dose: Maximum Observed Plasma Concentration for Unbound (Cmaxu) Talazoparib</title>
        <description>Cmaxu was defined as the maximum observed plasma concentration for unbound talazoparib.</description>
        <time_frame>Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22</time_frame>
        <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Multiple Dose: Maximum Observed Plasma Concentration for Unbound (Cmaxu) Talazoparib</title>
          <description>Cmaxu was defined as the maximum observed plasma concentration for unbound talazoparib.</description>
          <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration.</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="7"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.570" spread="42"/>
                    <measurement group_id="O2" value="3.019" spread="47"/>
                    <measurement group_id="O3" value="3.295" spread="48"/>
                    <measurement group_id="O4" value="5.296" spread="30"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>117.45</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>79.74</ci_lower_limit>
            <ci_upper_limit>172.99</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>128.22</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>88.05</ci_lower_limit>
            <ci_upper_limit>186.72</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Percent Ratio of Geometric Means</param_type>
            <param_value>206.07</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>139.91</ci_lower_limit>
            <ci_upper_limit>303.51</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Single Dose: Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24) of Talazoparib</title>
        <description>AUC0-24 of talazoparib was defined as the area under the concentration time curve from time 0 to 24 hours post-dose.</description>
        <time_frame>Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1</time_frame>
        <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Single Dose: Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24) of Talazoparib</title>
          <description>AUC0-24 of talazoparib was defined as the area under the concentration time curve from time 0 to 24 hours post-dose.</description>
          <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants who were 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="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.51" spread="59"/>
                    <measurement group_id="O2" value="23.60" spread="47"/>
                    <measurement group_id="O3" value="21.96" spread="40"/>
                    <measurement group_id="O4" value="29.98" spread="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Single Dose: Maximum Observed Plasma Concentration (Cmax) of Talazoparib</title>
        <description>Cmax was defined as the maximum observed plasma concentration of talazoparib.</description>
        <time_frame>Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1</time_frame>
        <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Single Dose: Maximum Observed Plasma Concentration (Cmax) of Talazoparib</title>
          <description>Cmax was defined as the maximum observed plasma concentration of talazoparib.</description>
          <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration.</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="7"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.133" spread="56"/>
                    <measurement group_id="O2" value="2.422" spread="29"/>
                    <measurement group_id="O3" value="2.862" spread="75"/>
                    <measurement group_id="O4" value="2.624" spread="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib</title>
        <description>Tmax was defined as the time to reach maximum observed plasma concentration of talazoparib.</description>
        <time_frame>Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1</time_frame>
        <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib</title>
          <description>Tmax was defined as the time to reach maximum observed plasma concentration of talazoparib.</description>
          <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.515" lower_limit="0.500" upper_limit="2.00"/>
                    <measurement group_id="O2" value="1.000" lower_limit="0.970" upper_limit="2.12"/>
                    <measurement group_id="O3" value="0.9900" lower_limit="0.480" upper_limit="2.00"/>
                    <measurement group_id="O4" value="1.830" lower_limit="0.500" upper_limit="8.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Single Dose: Fraction of Unbound Drug (Fu) in Plasma in Talazoparib</title>
        <description>Fraction of unbound drug (fu) was defined as the ratio of unbound drug concentration to the total drug concentration.</description>
        <time_frame>Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1</time_frame>
        <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Single Dose: Fraction of Unbound Drug (Fu) in Plasma in Talazoparib</title>
          <description>Fraction of unbound drug (fu) was defined as the ratio of unbound drug concentration to the total drug concentration.</description>
          <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants who were 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="7"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.74" spread="22"/>
                    <measurement group_id="O2" value="33.71" spread="14"/>
                    <measurement group_id="O3" value="28.77" spread="7"/>
                    <measurement group_id="O4" value="33.91" spread="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Single Dose: Area Under the Curve From Time 0 to 24 Hour for Unbound (AUC0-24u) Talazoparib</title>
        <description>AUC0-24u for unbound talazoparib was defined as the area under the concentration time curve from time 0 to 24 hours for unbound talazoparib.</description>
        <time_frame>Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1</time_frame>
        <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Single Dose: Area Under the Curve From Time 0 to 24 Hour for Unbound (AUC0-24u) Talazoparib</title>
          <description>AUC0-24u for unbound talazoparib was defined as the area under the concentration time curve from time 0 to 24 hours for unbound talazoparib.</description>
          <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants who were 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="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.555" spread="81"/>
                    <measurement group_id="O2" value="7.956" spread="35"/>
                    <measurement group_id="O3" value="6.262" spread="39"/>
                    <measurement group_id="O4" value="10.95" spread="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Single Dose: Maximum Observed Plasma Concentration for Unbound (Cmaxu) Talazoparib</title>
        <description>Cmaxu was defined as the maximum observed plasma concentration for unbound talazoparib.</description>
        <time_frame>Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1</time_frame>
        <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Single Dose: Maximum Observed Plasma Concentration for Unbound (Cmaxu) Talazoparib</title>
          <description>Cmaxu was defined as the maximum observed plasma concentration for unbound talazoparib.</description>
          <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants who were 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="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6772" spread="67"/>
                    <measurement group_id="O2" value="0.8168" spread="62"/>
                    <measurement group_id="O3" value="0.8229" spread="70"/>
                    <measurement group_id="O4" value="1.031" spread="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib</title>
        <description>Tmax was defined as the time to reach maximum observed plasma concentration of talazoparib.</description>
        <time_frame>Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22</time_frame>
        <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib</title>
          <description>Tmax was defined as the time to reach maximum observed plasma concentration of talazoparib.</description>
          <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.500" lower_limit="0.970" upper_limit="4.00"/>
                    <measurement group_id="O2" value="2.000" lower_limit="0.500" upper_limit="4.00"/>
                    <measurement group_id="O3" value="1.490" lower_limit="0.470" upper_limit="4.02"/>
                    <measurement group_id="O4" value="3.880" lower_limit="0.500" upper_limit="8.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Multiple Dose: Plasma Trough Concentration (Ctrough) of Talazoparib</title>
        <description>Ctrough was defined as plasma trough (predose) concentration of talazoparib.</description>
        <time_frame>Predose on Day 22</time_frame>
        <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Multiple Dose: Plasma Trough Concentration (Ctrough) of Talazoparib</title>
          <description>Ctrough was defined as plasma trough (predose) concentration of talazoparib.</description>
          <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration.</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="7"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.172" spread="34"/>
                    <measurement group_id="O2" value="2.680" spread="52"/>
                    <measurement group_id="O3" value="3.893" spread="45"/>
                    <measurement group_id="O4" value="7.917" spread="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Multiple Dose: Apparent Oral Clearance (CL/F) of Talazoparib</title>
        <description>Drug clearance is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.</description>
        <time_frame>Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22</time_frame>
        <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Multiple Dose: Apparent Oral Clearance (CL/F) of Talazoparib</title>
          <description>Drug clearance is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.</description>
          <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration.</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="7"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.270" spread="27"/>
                    <measurement group_id="O2" value="4.698" spread="40"/>
                    <measurement group_id="O3" value="3.687" spread="45"/>
                    <measurement group_id="O4" value="2.000" spread="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Multiple Dose: Accumulation Ratio (Rac) of AUC (0-24)</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, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1 and Day 22</time_frame>
        <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Multiple Dose: Accumulation Ratio (Rac) of AUC (0-24)</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 analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants who were 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="7"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.418" spread="59"/>
                    <measurement group_id="O2" value="4.510" spread="42"/>
                    <measurement group_id="O3" value="6.239" spread="38"/>
                    <measurement group_id="O4" value="8.330" spread="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Multiple Dose: Fraction of Unbound Drug (Fu) in Plasma in Talazoparib</title>
        <description>Fraction of unbound drug (fu) was defined as the ratio of unbound drug concentration to the total drug concentration.</description>
        <time_frame>Predose, 0.5, 1, 2, 4, 6, 8-12, and 24 hours post-dose on Day 22</time_frame>
        <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Multiple Dose: Fraction of Unbound Drug (Fu) in Plasma in Talazoparib</title>
          <description>Fraction of unbound drug (fu) was defined as the ratio of unbound drug concentration to the total drug concentration.</description>
          <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration.</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="7"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.85" spread="24"/>
                    <measurement group_id="O2" value="31.54" spread="10"/>
                    <measurement group_id="O3" value="29.09" spread="9"/>
                    <measurement group_id="O4" value="32.49" spread="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Multiple Dose: Unbound Apparent Oral Clearance (CLu/F) of Talazoparib</title>
        <description>Clearance of unbound drug is a measure of the rate at which unbound drug is metabolized or eliminated by normal biological processes.</description>
        <time_frame>Predose, 0.5, 1, 2, 4, 6, 8-12, and 24 hours post-dose on Day 22</time_frame>
        <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Multiple Dose: Unbound Apparent Oral Clearance (CLu/F) of Talazoparib</title>
          <description>Clearance of unbound drug is a measure of the rate at which unbound drug is metabolized or eliminated by normal biological processes.</description>
          <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration.</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="7"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.66" spread="32"/>
                    <measurement group_id="O2" value="14.89" spread="31"/>
                    <measurement group_id="O3" value="12.68" spread="47"/>
                    <measurement group_id="O4" value="6.614" spread="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Single Dose: Amount of Talazoparib Excreted Unchanged in Urine From Time 0 to 24 Hours (Ae 0-24)</title>
        <description>Ae 0-24 is the amount of drug excreted unchanged in urine from time 0 to 24 hours postdose.</description>
        <time_frame>0 to 24 hours on Day 1</time_frame>
        <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Single Dose: Amount of Talazoparib Excreted Unchanged in Urine From Time 0 to 24 Hours (Ae 0-24)</title>
          <description>Ae 0-24 is the amount of drug excreted unchanged in urine from time 0 to 24 hours postdose.</description>
          <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants who were 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="7"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.05452" spread="51"/>
                    <measurement group_id="O2" value="0.05430" spread="38"/>
                    <measurement group_id="O3" value="0.02765" spread="59"/>
                    <measurement group_id="O4" value="0.01901" spread="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Single Dose: Percentage of Dose of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24%) at Day 1</title>
        <description>Ae0-24% was defined as the amount of drug excreted in urine from time 0 to 24 hours expressed as percentage of administered dose.</description>
        <time_frame>0 to 24 hours on Day 1</time_frame>
        <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Single Dose: Percentage of Dose of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24%) at Day 1</title>
          <description>Ae0-24% was defined as the amount of drug excreted in urine from time 0 to 24 hours expressed as percentage of administered dose.</description>
          <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants who were 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="7"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.91" spread="51"/>
                    <measurement group_id="O2" value="10.85" spread="38"/>
                    <measurement group_id="O3" value="5.532" spread="59"/>
                    <measurement group_id="O4" value="3.795" spread="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Multiple Dose: Amount of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24%)</title>
        <description>Ae 0-24 is the amount of drug excreted unchanged in urine from time 0 to 24 hours postdose.</description>
        <time_frame>0 to 24 hours on Day 22</time_frame>
        <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Multiple Dose: Amount of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24%)</title>
          <description>Ae 0-24 is the amount of drug excreted unchanged in urine from time 0 to 24 hours postdose.</description>
          <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants who were 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="5"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2584" spread="23"/>
                    <measurement group_id="O2" value="0.2321" spread="20"/>
                    <measurement group_id="O3" value="0.1637" spread="54"/>
                    <measurement group_id="O4" value="0.2005" spread="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Multiple Dose: Percentage of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24 %) of Talazoparib at Day 22</title>
        <description>Ae 0-24% was defined as the amount of drug excreted in urine from time 0 to 24 hours, expressed as percentage of administered dose.</description>
        <time_frame>0 to 24 hours on Day 22</time_frame>
        <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Multiple Dose: Percentage of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24 %) of Talazoparib at Day 22</title>
          <description>Ae 0-24% was defined as the amount of drug excreted in urine from time 0 to 24 hours, expressed as percentage of administered dose.</description>
          <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants who were 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="5"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.66" spread="23"/>
                    <measurement group_id="O2" value="46.40" spread="20"/>
                    <measurement group_id="O3" value="32.78" spread="54"/>
                    <measurement group_id="O4" value="40.07" spread="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Multiple Dose: Renal Clearance (CLr) of Talazoparib at 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 postdose.</description>
        <time_frame>0 to 24 hours on Day 22</time_frame>
        <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants who were evaluable for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Multiple Dose: Renal Clearance (CLr) of Talazoparib at 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 postdose.</description>
          <population>PK analysis population included all participants who had at least 1 reportable talazoparib concentration. Here, &quot;Overall Number of Participants Analyzed&quot; signifies participants who were 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="5"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.738" spread="37"/>
                    <measurement group_id="O2" value="2.180" spread="57"/>
                    <measurement group_id="O3" value="1.330" spread="97"/>
                    <measurement group_id="O4" value="0.7094" spread="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</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. Treatment-emergent were events between first dose of investigational product and up to 30 days after the last dose of investigational product (up to 52 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and 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 included all participants who received any amount of talazoparib.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally 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. Treatment-emergent were events between first dose of investigational product and up to 30 days after the last dose of investigational product (up to 52 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.</description>
          <population>Safety analysis 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="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>TEAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="7"/>
                  </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="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Abnormalities in Physical Examination</title>
        <description>Physical examination included examination of the general appearance, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Findings were considered to be abnormal based on investigator's decision.</description>
        <time_frame>Baseline up to 30 days after last dose of study drug (up to 52 days)</time_frame>
        <population>Safety analysis included all participants who received any amount of talazoparib.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormalities in Physical Examination</title>
          <description>Physical examination included examination of the general appearance, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Findings were considered to be abnormal based on investigator's decision.</description>
          <population>Safety analysis 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="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="8"/>
                <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"/>
                    <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>Change From Baseline in Systolic Blood Pressure (SBP) of Participants</title>
        <time_frame>Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)</time_frame>
        <population>Safety analysis included all participants who received any amount of talazoparib. Here, &quot;number analyzed&quot; signifies participants evaluable for specific rows.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Systolic Blood Pressure (SBP) of Participants</title>
          <population>Safety analysis included all participants who received any amount of talazoparib. Here, &quot;number analyzed&quot; signifies participants evaluable for specific rows.</population>
          <units>millimeters 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="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
              </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="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115.4" spread="13.19"/>
                    <measurement group_id="O2" value="124.3" spread="11.55"/>
                    <measurement group_id="O3" value="123.8" spread="11.63"/>
                    <measurement group_id="O4" value="133.6" spread="17.25"/>
                  </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="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0" spread="17.29"/>
                    <measurement group_id="O2" value="-6.7" spread="18.28"/>
                    <measurement group_id="O3" value="-2.5" spread="8.50"/>
                    <measurement group_id="O4" value="-7.3" spread="11.29"/>
                  </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="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="13.48"/>
                    <measurement group_id="O2" value="-6.8" spread="7.03"/>
                    <measurement group_id="O3" value="-5.6" spread="4.87"/>
                    <measurement group_id="O4" value="-2.9" spread="18.05"/>
                  </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="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3" spread="15.72"/>
                    <measurement group_id="O2" value="-7.3" spread="12.66"/>
                    <measurement group_id="O3" value="0.1" spread="7.90"/>
                    <measurement group_id="O4" value="1.0" spread="12.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.0" spread="NA">Standard deviation was not estimable due to 1 participant with SBP.</measurement>
                    <measurement group_id="O2" value="-42.0" spread="NA">Standard deviation was not estimable due to 1 participant with SBP.</measurement>
                    <measurement group_id="O3" value="4.3" spread="9.02"/>
                    <measurement group_id="O4" value="-10.8" spread="18.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Diastolic Blood Pressure (DBP) of Participants</title>
        <time_frame>Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)</time_frame>
        <population>Safety analysis included all participants who received any amount of talazoparib. Here, &quot;number analyzed&quot; signifies participants evaluable for specific rows.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Diastolic Blood Pressure (DBP) of Participants</title>
          <population>Safety analysis included all participants who received any amount of talazoparib. Here, &quot;number analyzed&quot; signifies participants evaluable for specific rows.</population>
          <units>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="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
              </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="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.8" spread="7.69"/>
                    <measurement group_id="O2" value="78.3" spread="8.38"/>
                    <measurement group_id="O3" value="69.8" spread="5.65"/>
                    <measurement group_id="O4" value="74.8" spread="14.10"/>
                  </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="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" spread="4.48"/>
                    <measurement group_id="O2" value="-4.6" spread="10.48"/>
                    <measurement group_id="O3" value="2.8" spread="8.15"/>
                    <measurement group_id="O4" value="-3.4" spread="9.96"/>
                  </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="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="6.02"/>
                    <measurement group_id="O2" value="-5.9" spread="6.62"/>
                    <measurement group_id="O3" value="0.4" spread="8.86"/>
                    <measurement group_id="O4" value="-1.1" spread="11.37"/>
                  </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="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="10.50"/>
                    <measurement group_id="O2" value="-4.6" spread="6.13"/>
                    <measurement group_id="O3" value="5.5" spread="11.95"/>
                    <measurement group_id="O4" value="-4.0" spread="8.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="NA">Standard deviation was not estimable due to 1 participant with DBP.</measurement>
                    <measurement group_id="O2" value="-18.0" spread="NA">Standard deviation was not estimable due to 1 participant with DBP.</measurement>
                    <measurement group_id="O3" value="1.0" spread="6.00"/>
                    <measurement group_id="O4" value="-1.0" spread="20.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Heart Rate of Participants</title>
        <description>Heart rate was measured in terms of beats per minute.</description>
        <time_frame>Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)</time_frame>
        <population>Safety analysis included all participants who received any amount of talazoparib. Here, &quot;number analyzed&quot; signifies participants evaluable for specific rows.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Heart Rate of Participants</title>
          <description>Heart rate was measured in terms of beats per minute.</description>
          <population>Safety analysis included all participants who received any amount of talazoparib. Here, &quot;number analyzed&quot; signifies participants evaluable for specific rows.</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="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
              </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="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.2" spread="11.23"/>
                    <measurement group_id="O2" value="81.6" spread="21.86"/>
                    <measurement group_id="O3" value="80.1" spread="11.54"/>
                    <measurement group_id="O4" value="77.4" spread="23.34"/>
                  </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="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="9.18"/>
                    <measurement group_id="O2" value="-0.2" spread="8.74"/>
                    <measurement group_id="O3" value="2.1" spread="12.22"/>
                    <measurement group_id="O4" value="-4.6" spread="23.40"/>
                  </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="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="8.60"/>
                    <measurement group_id="O2" value="-4.3" spread="10.56"/>
                    <measurement group_id="O3" value="-1.8" spread="11.11"/>
                    <measurement group_id="O4" value="-1.9" spread="16.07"/>
                  </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="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.7" spread="11.86"/>
                    <measurement group_id="O2" value="-8.0" spread="5.85"/>
                    <measurement group_id="O3" value="-0.9" spread="10.38"/>
                    <measurement group_id="O4" value="-7.4" spread="20.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.0" spread="NA">Standard deviation was not estimable due to 1 participant with change in heart rate.</measurement>
                    <measurement group_id="O2" value="-15.0" spread="NA">Standard deviation was not estimable due to 1 participant with change in heart rate.</measurement>
                    <measurement group_id="O3" value="1.7" spread="2.52"/>
                    <measurement group_id="O4" value="-0.8" spread="8.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Respiratory Rate of Participants</title>
        <description>Respiratory rate was measured in terms of breaths per minute.</description>
        <time_frame>Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)</time_frame>
        <population>Safety analysis included all participants who received any amount of talazoparib. Here, &quot;number analyzed&quot; signifies participants evaluable for specific rows.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Respiratory Rate of Participants</title>
          <description>Respiratory rate was measured in terms of breaths per minute.</description>
          <population>Safety analysis included all participants who received any amount of talazoparib. Here, &quot;number analyzed&quot; signifies participants evaluable for specific rows.</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="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
              </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="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.6" spread="0.88"/>
                    <measurement group_id="O2" value="18.4" spread="0.88"/>
                    <measurement group_id="O3" value="18.3" spread="1.67"/>
                    <measurement group_id="O4" value="17.8" spread="4.71"/>
                  </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="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.67"/>
                    <measurement group_id="O2" value="-0.3" spread="1.58"/>
                    <measurement group_id="O3" value="0.5" spread="2.07"/>
                    <measurement group_id="O4" value="-0.8" spread="4.40"/>
                  </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="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="1.05"/>
                    <measurement group_id="O2" value="-0.8" spread="1.72"/>
                    <measurement group_id="O3" value="0.0" spread="2.14"/>
                    <measurement group_id="O4" value="-1.0" spread="4.00"/>
                  </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="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.67"/>
                    <measurement group_id="O2" value="-1.1" spread="1.36"/>
                    <measurement group_id="O3" value="0.6" spread="2.45"/>
                    <measurement group_id="O4" value="-1.0" spread="4.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="NA">Standard deviation was not estimable due to 1 participant with change in respiratory rate.</measurement>
                    <measurement group_id="O2" value="1.0" spread="NA">Standard deviation was not estimable due to 1 participant with change in respiratory rate.</measurement>
                    <measurement group_id="O3" value="1.3" spread="2.31"/>
                    <measurement group_id="O4" value="-1.4" spread="6.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Body Weight of Participants</title>
        <time_frame>Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)</time_frame>
        <population>Safety analysis included all participants who received any amount of talazoparib. Here, &quot;number analyzed&quot; signifies participants evaluable for specific rows.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Body Weight of Participants</title>
          <population>Safety analysis included all participants who received any amount of talazoparib. Here, &quot;number analyzed&quot; signifies participants evaluable for specific rows.</population>
          <units>kilograms</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
              </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="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.60" spread="14.651"/>
                    <measurement group_id="O2" value="69.12" spread="14.914"/>
                    <measurement group_id="O3" value="85.84" spread="20.221"/>
                    <measurement group_id="O4" value="66.79" spread="13.277"/>
                  </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="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.16" spread="1.030"/>
                    <measurement group_id="O2" value="-0.62" spread="0.424"/>
                    <measurement group_id="O3" value="-0.26" spread="0.912"/>
                    <measurement group_id="O4" value="-0.26" spread="1.834"/>
                  </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="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.17" spread="1.707"/>
                    <measurement group_id="O2" value="-0.38" spread="1.045"/>
                    <measurement group_id="O3" value="0.05" spread="1.590"/>
                    <measurement group_id="O4" value="-0.23" spread="2.371"/>
                  </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="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.43" spread="2.366"/>
                    <measurement group_id="O2" value="-0.78" spread="1.058"/>
                    <measurement group_id="O3" value="0.04" spread="1.722"/>
                    <measurement group_id="O4" value="-0.75" spread="3.189"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Day 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.90" spread="NA">Standard deviation was not estimable due to 1 participant with change in weight.</measurement>
                    <measurement group_id="O2" value="0.70" spread="NA">Standard deviation was not estimable due to 1 participant with change in weight.</measurement>
                    <measurement group_id="O3" value="-0.67" spread="2.122"/>
                    <measurement group_id="O4" value="2.88" spread="14.597"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Electrocardiogram (ECG) Abnormalities</title>
        <description>ECG parameters included pulse rate (PR) interval, QRS duration, QT interval and corrected QT interval using Fridericia's formula (QTcF). Abnormality criteria: 1) PR interval: greater than equal to (&gt;=) 25 percent (%) increase when baseline &gt;= 300 msec; 2) QRS duration: &gt;=50% increase when baseline &gt;=140 msec; 3) QT interval: &gt;= 500 msec: 4) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) &gt;= 500 msec when baseline &gt;= 60. IFB stands for increase from baseline.</description>
        <time_frame>Baseline up to 30 days after last dose of study drug (up to 52 days)</time_frame>
        <population>Safety analysis included all participants who received any amount of talazoparib.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Electrocardiogram (ECG) Abnormalities</title>
          <description>ECG parameters included pulse rate (PR) interval, QRS duration, QT interval and corrected QT interval using Fridericia's formula (QTcF). Abnormality criteria: 1) PR interval: greater than equal to (&gt;=) 25 percent (%) increase when baseline &gt;= 300 msec; 2) QRS duration: &gt;=50% increase when baseline &gt;=140 msec; 3) QT interval: &gt;= 500 msec: 4) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) &gt;= 500 msec when baseline &gt;= 60. IFB stands for increase from baseline.</description>
          <population>Safety analysis 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="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Laboratory Abnormalities</title>
        <description>Laboratory parameters: erythrocytes, hematocrit, hemoglobin, white blood cells, absolute neutrophil count, lymphocytes, platelets ; albumin, alkaline phosphatase, alanine aminotransferase, aspartate transaminase , bilirubin, bicarbonate, blood urea nitrogen , calcium, chloride, creatinine, gamma -glutamyl transferase, glucose, lactate dehydrogenase, sodium, phosphate, potassium, total protein, uric acid, follicle-stimulating hormone; international normalized ratio / prothrombin time [activated] partial thromboplastin time; Urinalysis (pH, specific gravity, protein, glucose, ketones, bilirubin, blood, leukocyte esterase); Serum pregnancy test; Serology for Human Immunodeficiency Virus (HIV). Number of participants with laboratory test abnormalities as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) version 4.03 were reported: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.</description>
        <time_frame>Baseline up to 30 days after last dose of study drug (up to 52 days)</time_frame>
        <population>Safety analysis included all participants who received any amount of talazoparib.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Laboratory Abnormalities</title>
          <description>Laboratory parameters: erythrocytes, hematocrit, hemoglobin, white blood cells, absolute neutrophil count, lymphocytes, platelets ; albumin, alkaline phosphatase, alanine aminotransferase, aspartate transaminase , bilirubin, bicarbonate, blood urea nitrogen , calcium, chloride, creatinine, gamma -glutamyl transferase, glucose, lactate dehydrogenase, sodium, phosphate, potassium, total protein, uric acid, follicle-stimulating hormone; international normalized ratio / prothrombin time [activated] partial thromboplastin time; Urinalysis (pH, specific gravity, protein, glucose, ketones, bilirubin, blood, leukocyte esterase); Serum pregnancy test; Serology for Human Immunodeficiency Virus (HIV). Number of participants with laboratory test abnormalities as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) version 4.03 were reported: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.</description>
          <population>Safety analysis 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="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Grade 1</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>Grade 2</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>Grade 3</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>Grade 4</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 Eastern Cooperative Oncology Group (ECOG) Performance Status</title>
        <description>As per ECOG, participant's performance status was measured on 5 point scale: 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: 5: dead.</description>
        <time_frame>Baseline, Safety follow up (Day 52)</time_frame>
        <population>Safety analysis included all participants who received any amount of talazoparib. Here, &quot;Number Analyzed&quot; signifies participants who were evaluable at specific rows.</population>
        <group_list>
          <group group_id="O1">
            <title>Normal Renal Function</title>
            <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O2">
            <title>Mild Renal Impairment</title>
            <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O3">
            <title>Moderate Renal Impairment</title>
            <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
          </group>
          <group group_id="O4">
            <title>Severe Renal Impairment</title>
            <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally 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 on 5 point scale: 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: 5: dead.</description>
          <population>Safety analysis included all participants who received any amount of talazoparib. Here, &quot;Number Analyzed&quot; signifies participants who were evaluable at specific rows.</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="9"/>
                <count group_id="O2" value="9"/>
                <count group_id="O3" value="8"/>
                <count group_id="O4" value="8"/>
              </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="9"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="8"/>
                    <count group_id="O4" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>ECOG: 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ECOG: 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ECOG: 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ECOG: 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: 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 52</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="4"/>
                    <count group_id="O4" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>ECOG: 0</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: 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ECOG: 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ECOG: 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="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>ECOG: 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="1"/>
                  </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>Normal Renal Function</title>
          <description>Participants with normal renal function (eGFR &gt;= 90 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
        </group>
        <group group_id="E2">
          <title>Mild Renal Impairment</title>
          <description>Participants with mild renal function (eGFR &gt;= 60 and &gt;=89 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
        </group>
        <group group_id="E3">
          <title>Moderate Renal Impairment</title>
          <description>Participants with moderate renal function (eGFR &gt;= 30 and &lt;=59 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
        </group>
        <group group_id="E4">
          <title>Severe Renal Impairment</title>
          <description>Participants with severe renal function (eGFR &gt;= 15 and &lt;= 29 mL/min/1.73m^2) received 0.5 mg (2 capsules of 0.25 mg) of talazoparib daily, orally for 22 days.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA v21.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>CONDITION AGGRAVATED</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>DEHYDRATION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>METABOLIC ACIDOSIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>DYSPNOEA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA v21.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>ANAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>LEUKOCYTOSIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>THROMBOCYTOPENIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>PALPITATIONS</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>TACHYCARDIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>VISION BLURRED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </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="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>ABDOMINAL PAIN UPPER</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>CONSTIPATION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>DRY MOUTH</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>DYSPEPSIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>VOMITING</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>CHILLS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>GAIT DISTURBANCE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>INJECTION SITE BRUISING</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>OEDEMA PERIPHERAL</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>PERIPHERAL SWELLING</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>URINARY TRACT INFECTION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>SUNBURN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>VASCULAR ACCESS COMPLICATION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>ALANINE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>ASPARTATE AMINOTRANSFERASE INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>BLOOD ALBUMIN DECREASED</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>BLOOD BILIRUBIN INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>BLOOD POTASSIUM INCREASED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS WORSENED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>DECREASED APPETITE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>DEHYDRATION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>HYPOCALCAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>HYPOKALAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>HYPOMAGNESAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>HYPONATRAEMIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>BACK PAIN</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>FLANK PAIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>JOINT SWELLING</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>MUSCULOSKELETAL CHEST PAIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>MUSCULOSKELETAL PAIN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>MYALGIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>OSTEOARTHRITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>DIZZINESS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>DYSGEUSIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>HYPOAESTHESIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>PARAESTHESIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>SOMNOLENCE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>DEPRESSION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>DYSURIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </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="2" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>DYSPNOEA</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>PRODUCTIVE COUGH</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>WHEEZING</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>COLD SWEAT</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>DERMATITIS ACNEIFORM</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>ERYTHEMA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>PRURITUS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="9"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="8"/>
              </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/NCT02997163
org study id: MDV3800-01
secondary id: C3441001
secondary id: 2016-002536-33
nct id: NCT02997163
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This trial will investigate the pharmacokinetics (PK) and safety of talazoparib in patients
      with advanced solid tumors and impaired renal 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 after discussion with the Principal Investigator and
      obtaining Sponsor permission. Sponsor decision to allow the patient to continue dosing with
      talazoparib in an open-label extension study will be based on potential overall benefit-risk,
      patient acceptance and other relevant criteria.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Multiple Dose: Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24) of Talazoparib
time frame: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22
description: AUC0-24 of talazoparib was defined as the area under the concentration time curve from time 0 to 24 hours post-dose.
measure: Multiple Dose: Maximum Observed Plasma Concentration (Cmax) of Talazoparib
time frame: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22
description: Cmax was defined as the maximum observed plasma concentration of talazoparib.
measure: Multiple Dose: Area Under the Curve From Time 0 to 24 Hours for Unbound (AUC0-24u) Talazoparib
time frame: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22
description: AUC0-24u for unbound talazoparib was defined as the area under the concentration time curve from time 0 to 24 hours post-dose.
measure: Multiple Dose: Maximum Observed Plasma Concentration for Unbound (Cmaxu) Talazoparib
time frame: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22
description: Cmaxu was defined as the maximum observed plasma concentration for unbound talazoparib.
measure: Single Dose: Area Under the Concentration Time Curve From 0 to 24 Hours (AUC0-24) of Talazoparib
time frame: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1
description: AUC0-24 of talazoparib was defined as the area under the concentration time curve from time 0 to 24 hours post-dose.
measure: Single Dose: Maximum Observed Plasma Concentration (Cmax) of Talazoparib
time frame: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1
description: Cmax was defined as the maximum observed plasma concentration of talazoparib.
measure: Single Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib
time frame: Predose, 0.5, 1, 2, 4, 6, 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: Single Dose: Fraction of Unbound Drug (Fu) in Plasma in Talazoparib
time frame: Predose, 0.5, 1, 2, 4, 6, 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.
measure: Single Dose: Area Under the Curve From Time 0 to 24 Hour for Unbound (AUC0-24u) Talazoparib
time frame: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1
description: AUC0-24u for unbound talazoparib was defined as the area under the concentration time curve from time 0 to 24 hours for unbound talazoparib.
measure: Single Dose: Maximum Observed Plasma Concentration for Unbound (Cmaxu) Talazoparib
time frame: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1
description: Cmaxu was defined as the maximum observed plasma concentration for unbound talazoparib.
measure: Multiple Dose: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Talazoparib
time frame: Predose, 0.5, 1, 2, 4, 6, 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: Multiple Dose: Plasma Trough Concentration (Ctrough) of Talazoparib
time frame: Predose on Day 22
description: Ctrough was defined as plasma trough (predose) concentration of talazoparib.
measure: Multiple Dose: Apparent Oral Clearance (CL/F) of Talazoparib
time frame: Predose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 22
description: Drug clearance is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
measure: Multiple Dose: Accumulation Ratio (Rac) of AUC (0-24)
time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8 to 12, and 24 hours post-dose on Day 1 and Day 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: Multiple Dose: Fraction of Unbound Drug (Fu) in Plasma in Talazoparib
time frame: Predose, 0.5, 1, 2, 4, 6, 8-12, 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.
measure: Multiple Dose: Unbound Apparent Oral Clearance (CLu/F) of Talazoparib
time frame: Predose, 0.5, 1, 2, 4, 6, 8-12, and 24 hours post-dose on Day 22
description: Clearance of unbound drug is a measure of the rate at which unbound drug is metabolized or eliminated by normal biological processes.
measure: Single Dose: Amount of Talazoparib Excreted Unchanged in Urine From Time 0 to 24 Hours (Ae 0-24)
time frame: 0 to 24 hours on Day 1
description: Ae 0-24 is the amount of drug excreted unchanged in urine from time 0 to 24 hours postdose.
measure: Single Dose: Percentage of Dose of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24%) at Day 1
time frame: 0 to 24 hours on Day 1
description: Ae0-24% was defined as the amount of drug excreted in urine from time 0 to 24 hours expressed as percentage of administered dose.
measure: Multiple Dose: Amount of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24%)
time frame: 0 to 24 hours on Day 22
description: Ae 0-24 is the amount of drug excreted unchanged in urine from time 0 to 24 hours postdose.
measure: Multiple Dose: Percentage of Talazoparib Excreted in Urine From Time 0 to 24 Hours (Ae 0-24 %) of Talazoparib at Day 22
time frame: 0 to 24 hours on Day 22
description: Ae 0-24% was defined as the amount of drug excreted in urine from time 0 to 24 hours, expressed as percentage of administered dose.
measure: Multiple Dose: Renal Clearance (CLr) of Talazoparib at Day 22
time frame: 0 to 24 hours 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 postdose.
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. Treatment-emergent were events between first dose of investigational product and up to 30 days after the last dose of investigational product (up to 52 days) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
measure: Number of Participants With Abnormalities in Physical Examination
time frame: Baseline up to 30 days after last dose of study drug (up to 52 days)
description: Physical examination included examination of the general appearance, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. Findings were considered to be abnormal based on investigator's decision.
measure: Change From Baseline in Systolic Blood Pressure (SBP) of Participants
time frame: Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)
measure: Change From Baseline in Diastolic Blood Pressure (DBP) of Participants
time frame: Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)
measure: Change From Baseline in Heart Rate of Participants
time frame: Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)
description: Heart rate was measured in terms of beats per minute.
measure: Change From Baseline in Respiratory Rate of Participants
time frame: Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)
description: Respiratory rate was measured in terms of breaths per minute.
measure: Change From Baseline in Body Weight of Participants
time frame: Baseline, Day 8, Day 15, Day 22, Safety follow up (Day 52)
measure: Number of Participants With Electrocardiogram (ECG) Abnormalities
time frame: Baseline up to 30 days after last dose of study drug (up to 52 days)
description: ECG parameters included pulse rate (PR) interval, QRS duration, QT interval and corrected QT interval using Fridericia's formula (QTcF). Abnormality criteria: 1) PR interval: greater than equal to (>=) 25 percent (%) increase when baseline >= 300 msec; 2) QRS duration: >=50% increase when baseline >=140 msec; 3) QT interval: >= 500 msec: 4) QTCF interval: QTc interval using Fridericia's formula (QTcF interval) >= 500 msec when baseline >= 60. IFB stands for increase from baseline.
measure: Number of Participants With Laboratory Abnormalities
time frame: Baseline up to 30 days after last dose of study drug (up to 52 days)
description: Laboratory parameters: erythrocytes, hematocrit, hemoglobin, white blood cells, absolute neutrophil count, lymphocytes, platelets ; albumin, alkaline phosphatase, alanine aminotransferase, aspartate transaminase , bilirubin, bicarbonate, blood urea nitrogen , calcium, chloride, creatinine, gamma -glutamyl transferase, glucose, lactate dehydrogenase, sodium, phosphate, potassium, total protein, uric acid, follicle-stimulating hormone; international normalized ratio / prothrombin time [activated] partial thromboplastin time; Urinalysis (pH, specific gravity, protein, glucose, ketones, bilirubin, blood, leukocyte esterase); Serum pregnancy test; Serology for Human Immunodeficiency Virus (HIV). Number of participants with laboratory test abnormalities as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) version 4.03 were reported: Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.
measure: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status
time frame: Baseline, Safety follow up (Day 52)
description: As per ECOG, participant's performance status was measured on 5 point scale: 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: 5: dead.
arm group label: Group A (control, normal renal function)
arm group type: Experimental
arm group label: Group B (mild renal impairment)
arm group type: Experimental
arm group label: Group C (moderate renal impairment)
arm group type: Experimental
arm group label: Group D (severe renal impairment)
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 renal function)
arm group label: Group B (mild renal impairment)
arm group label: Group C (moderate renal impairment)
arm group label: Group D (severe renal impairment)
other name: MDV3800
other name: BMN673
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
url: https://pmiform.com/clinical-trial-info-request?StudyID=MDV3800-01
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: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 