<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/NCT03759587</url>
  </required_header>
  <id_info>
    <org_study_id>Niraparib-2001</org_study_id>
    <secondary_id>U1111-1222-4074</secondary_id>
    <secondary_id>JapicCTI-184225</secondary_id>
    <nct_id>NCT03759587</nct_id>
  </id_info>
  <brief_title>Japan Phase 2 Study of Niraparib (Maintenance Therapy) in Participants With Relapsed Ovarian Cancer</brief_title>
  <official_title>A Phase 2, Multicenter, Open-label, Single-arm Study to Evaluate the Safety of Niraparib in Japanese Patients With Platinum-sensitive, Relapsed Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Who Achieved CR or PR in the Last Chemotherapy Containing Platinum-based Anticancer Agents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and efficacy of niraparib in Japanese&#xD;
      participants with platinum-sensitive, relapsed ovarian cancer, fallopian tube cancer, or&#xD;
      primary peritoneal cancer who achieved complete response (CR) or partial response (PR) in the&#xD;
      last chemotherapy containing platinum-based anticancer agents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug being tested in this study is called niraparib. Niraparib is being tested to treat&#xD;
      people who have platinum-sensitive, relapsed ovarian cancer, fallopian tube cancer, or&#xD;
      primary peritoneal cancer. This study will look at the safety and efficacy of niraparib in&#xD;
      Japanese participants.&#xD;
&#xD;
      The study will enroll approximately 15 participants. Participants will be enrolled to one&#xD;
      group and after that will be asked to take niraparib capsules at the same time each day&#xD;
      throughout the study:&#xD;
&#xD;
      - Niraparib 300 mg&#xD;
&#xD;
      This multi-center trial will be conducted in Japan. The overall time to participate in this&#xD;
      study is approximately 28 months. Participants will make multiple visits to the clinic in the&#xD;
      treatment period, and the post-treatment period including follow-up assessments after the&#xD;
      last dose of the study drug.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 28, 2018</start_date>
  <completion_date type="Actual">December 28, 2022</completion_date>
  <primary_completion_date type="Actual">March 17, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Grade 3 or 4 Thrombocytopenia Occurring Within 30 Days After Initial Administration of Niraparib</measure>
    <time_frame>Up to 30 days after the first dose</time_frame>
    <description>An adverse event of 'thrombocytopenia' was collected and graded as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03.As per the NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to Adverse Events (AE).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</measure>
    <time_frame>Up to 30 days after the last dose (Approximately 4 months)</time_frame>
    <description>An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Grade 3 or Higher TEAEs</measure>
    <time_frame>Up to 30 days after the last dose (Approximately 4 months)</time_frame>
    <description>An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A severity grade is defined by the NCI-CTCAE Version 4.03. As per NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to 30 days after the last dose (Approximately 4 months)</time_frame>
    <description>An SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With TEAEs Leading to Drug Discontinuation</measure>
    <time_frame>Up to 30 days after the last dose (Approximately 4 months)</time_frame>
    <description>An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With TEAEs Leading to Dose Interruption</measure>
    <time_frame>Up to 30 days after the last dose (Approximately 4 months)</time_frame>
    <description>An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With TEAEs Leading to Dose Reduction</measure>
    <time_frame>Up to 30 days after the last dose (Approximately 4 months)</time_frame>
    <description>An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS)</measure>
    <time_frame>Until disease progression, death or data cut-off (Approximately 4 months)</time_frame>
    <description>PFS is defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per RECIST 1.1, PD is defined as at least a 20% increase in the SoD (Sum of Diameters) of target lesions, taking as a reference the smallest (nadir) SoD since (and including) baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Up to data cut-off (approximately 4 months)</time_frame>
    <description>OS is defined as the time from the study enrollment to death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR)</measure>
    <time_frame>Up to approximately 4 months</time_frame>
    <description>ORR is defined as the proportion of participants achieving Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST (v.1.1). Per RECIST 1.1, CR is defined as disappearance of all target lesions; PR is defined as atleast 30% decrease in sum of diameters (SoD) of target lesions.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Ovarian Cancer</condition>
  <condition>Fallopian Tube Cancer</condition>
  <condition>Primary Peritoneal Cancer</condition>
  <arm_group>
    <arm_group_label>Niraparib 300 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment Cycle (Up to 3 Cycles till data cut-off 17 March 2019).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Niraparib</intervention_name>
    <description>Niraparib capsule</description>
    <arm_group_label>Niraparib 300 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Japanese female participants aged 20 years or older on the day of signing informed&#xD;
             consent.&#xD;
&#xD;
          2. Voluntary written consent must be given before performance of any study related&#xD;
             procedure not part of standard medical care, with the understanding that consent may&#xD;
             be withdrawn by the participant at any time without prejudice to future medical care.&#xD;
&#xD;
          3. Participant must have a histologically diagnosed ovarian cancer, fallopian tube&#xD;
             cancer, or primary peritoneal cancer.&#xD;
&#xD;
          4. Participant must have a high-grade (or Grade 3) serous or high-grade predominantly&#xD;
             serous histology or known to have germline breast cancer gene mutation (gBRCAmut).&#xD;
&#xD;
          5. Participants must have completed at least 2 previous lines of platinum-containing&#xD;
             therapy (eg, carboplatin, oxaliplatin, or cisplatin):&#xD;
&#xD;
             Note: The last platinum regimen did not necessarily have to immediately follow the&#xD;
             next-to-last (penultimate) platinum regimen. For example, if a participant received a&#xD;
             non-platinum regimen between the penultimate platinum regimen and last platinum&#xD;
             regimen, she could have been eligible as long as she met all entry criteria.&#xD;
&#xD;
               1. For the penultimate platinum-based chemotherapy prior to study enrollment,&#xD;
                  participants must have had platinum-sensitive disease after this treatment,&#xD;
                  defined as achieving a response (CR or PR) and disease progression &gt;6 months&#xD;
                  after completion of her last dose of platinum therapy (documented 6 to 12 months&#xD;
                  or &gt;12 months). Source documentation was required.&#xD;
&#xD;
               2. For the last line of platinum-based chemotherapy prior to study enrollment:&#xD;
&#xD;
                    -  Participants must have received a platinum-containing regimen for a minimum&#xD;
                       of 4 cycles.&#xD;
&#xD;
                    -  Participants must have achieved a partial or complete tumor response.&#xD;
&#xD;
                    -  Following the last regimen, participants must have had either: CA-125 in the&#xD;
                       normal range, OR; CA-125 decrease by more than 90% during the last platinum&#xD;
                       regimen, and which was stable for at least 7 days (ie, no increase &gt;15%).&#xD;
&#xD;
                    -  Following the last regimen, participants could not have had any measurable&#xD;
                       lesion &gt;2 cm at the time of study enrollment.&#xD;
&#xD;
               3. Participants must have been enrolled within 8 weeks after completion of their&#xD;
                  final dose of the platinum-containing regimen.&#xD;
&#xD;
          6. Participants must have performance status of ≤1 on the Eastern Cooperative Oncology&#xD;
             Group (ECOG) Performance Status Scale.&#xD;
&#xD;
          7. Participants must have adequate organ function as indicated by the following&#xD;
             laboratory values:&#xD;
&#xD;
               1. Absolute neutrophil count (ANC) ≥1,500/μL.&#xD;
&#xD;
               2. Platelet count ≥100,000/μL.&#xD;
&#xD;
               3. Hemoglobin ≥9 g/dL.&#xD;
&#xD;
               4. Serum creatinine ≤1.5× institutional upper limit of normal (ULN) OR calculated&#xD;
                  creatinine clearance ≥50 mL/minute, using the Cockcroft-Gault equation.&#xD;
&#xD;
               5. Total bilirubin ≤1.5×ULN OR direct bilirubin ≤1×ULN.&#xD;
&#xD;
               6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN&#xD;
                  unless liver metastases were present, in which case they had to be ≤5×ULN.&#xD;
&#xD;
          8. Participants must be able to take oral medications.&#xD;
&#xD;
          9. Female participants of childbearing potential must be negative for pregnancy test&#xD;
             (beta-human chorionic gonadotropin [β-hCG]) within 7 days prior to receiving the first&#xD;
             dose of study treatment.&#xD;
&#xD;
         10. Female participants who:&#xD;
&#xD;
               1. Are postmenopausal for at least 1 year before the screening visit, OR&#xD;
&#xD;
               2. Are surgically sterile, OR&#xD;
&#xD;
               3. If they are of childbearing potential, agree to practice 1 highly effective&#xD;
                  method of contraception and 1 additional effective (barrier) method at the same&#xD;
                  time, from the time of signing the informed consent through 180 days after the&#xD;
                  last dose of study drug, OR&#xD;
&#xD;
               4. Agree to practice true abstinence, when this is in line with the preferred and&#xD;
                  usual lifestyle of the participant. (Periodic abstinence [eg, calendar,&#xD;
                  ovulation, symptothermal, postovulation methods], condoms only, withdrawal,&#xD;
                  spermicides only, and lactational amenorrhea are not acceptable methods of&#xD;
                  contraception. Female and male condoms should not be used together.)&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Participants who have had drainage of ascites during last 2 cycles of last&#xD;
             chemotherapy.&#xD;
&#xD;
          2. Participants who have had palliative radiotherapy encompassing &gt;20% of the bone marrow&#xD;
             within 1 week of the first dose of study treatment.&#xD;
&#xD;
          3. Participants who have any, persistent, Grade ≥3 toxicity from last cancer therapy.&#xD;
&#xD;
          4. Participants who have symptomatic, uncontrolled brain or leptomeningeal metastases. To&#xD;
             be considered &quot;controlled,&quot; central nervous system (CNS) disease must have undergone&#xD;
             treatment (eg, radiation or chemotherapy) at least 1 month prior to study enrollment.&#xD;
             The participant must not have had any new or progressive signs or symptoms related to&#xD;
             the CNS disease and must have been taking a stable dose of steroids or no steroids (as&#xD;
             long as these were started at least 4 weeks prior to enrollment] or no steroids). A&#xD;
             scan to confirm the absence of brain metastases at baseline was not required.&#xD;
             Participants with spinal cord compression might have been considered if they had&#xD;
             received definitive treatment for this and evidence of clinically stable disease for&#xD;
             28 days.&#xD;
&#xD;
          5. Participants who have known hypersensitivity to the components of niraparib.&#xD;
&#xD;
          6. Participants who have had prior treatment with a known poly (adenosine diphosphate&#xD;
             [ADP]-ribose) polymerase (PARP) inhibitor.&#xD;
&#xD;
          7. Participant who have had treatment with any investigational products within 28 days or&#xD;
             5 half-lives (whichever was longer) before the first dose.&#xD;
&#xD;
          8. Participants who have had major surgery per Investigator judgment within 3 weeks of&#xD;
             the first dose. Participant must have recovered from any effects of any major surgery.&#xD;
&#xD;
          9. Participants who have diagnosis, detection, or treatment of invasive second primary&#xD;
             malignancy other than ovarian cancer ≤24 months prior to study enrollment (except&#xD;
             basal or squamous cell carcinoma of the skin that was definitively treated). Note:&#xD;
             Participants must not have any known history or current diagnosis of myelodysplastic&#xD;
             syndrome (MDS) or acute myeloid leukemia (AML), irrespective of the time for disease&#xD;
             history.&#xD;
&#xD;
         10. Participants who are considered a poor medical risk due to a serious, uncontrolled&#xD;
             medical disorder, non-malignant systemic disease, or active, uncontrolled infection.&#xD;
             Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent&#xD;
             (within 90 days of the first dose) myocardial infarction, uncontrolled major seizure&#xD;
             disorder, unstable spinal cord compression, superior vena cava syndrome, small bowel&#xD;
             obstruction or other serious gastrointestinal disorder, or any psychiatric disorder&#xD;
             that prohibits obtaining informed consent.&#xD;
&#xD;
         11. Participants who have received a transfusion (platelets or red blood cells) within 4&#xD;
             weeks of the first dose of study treatment.&#xD;
&#xD;
         12. Participants who have received a live virus or bacterial vaccines within 4 weeks of&#xD;
             the first dose of study treatment.&#xD;
&#xD;
         13. Participants who have a history or current evidence of any condition, therapy, or lab&#xD;
             abnormality (including active or uncontrolled myelosuppression [ie, anemia,&#xD;
             leukopenia, neutropenia, thrombocytopenia]) that might confound the results of the&#xD;
             study, interfere with the participant's participation throughout the study period, or&#xD;
             study participation is not in the best interest of the participant.&#xD;
&#xD;
         14. Participants who are regular user (including &quot;recreational use&quot;) of any illicit drugs&#xD;
             at the time of signing informed consent or have a recent history (within the past&#xD;
             year) of drug or alcohol abuse.&#xD;
&#xD;
         15. Participants who are pregnant or breast-feeding, or expecting to conceive within the&#xD;
             planned duration of the study.&#xD;
&#xD;
             NOTE: If a breast-feeding woman discontinue breast-feeding, she may be enrolled in the&#xD;
             study.&#xD;
&#xD;
         16. Participants who are immunocompromised (participants with splenectomy are allowed).&#xD;
&#xD;
         17. Participants who have known human immunodeficiency virus (HIV) positive.&#xD;
&#xD;
         18. Participants who have known hepatitis B surface antigen (HBsAg) positive, or known or&#xD;
             suspected active hepatitis C virus (HCV) infection.&#xD;
&#xD;
        NOTE: Participants who are positive for hepatitis B core antibody (HBcAb) or hepatitis B&#xD;
        surface antibody (HBsAb) can be enrolled but must have an undetectable hepatitis B virus&#xD;
        (HBV) viral load. Participants who have positive hepatitis C virus antibody (HCVAb) must&#xD;
        have an undetectable HCV viral load.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female participants with platinum-sensitive, relapsed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer were eligible to be enrolled in this study.</gender_description>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aichi Cancer Center Hospital</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hirosaki University Hospital</name>
      <address>
        <city>Hirosaki</city>
        <state>Aomori</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shikoku Cancer Center</name>
      <address>
        <city>Matsuyama</city>
        <state>Ehime</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ehime University Hospital</name>
      <address>
        <city>Toon</city>
        <state>Ehime</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kurume University Hospital</name>
      <address>
        <city>Kurume</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido University Hospital</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sapporo Medical University Hospital</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hyogo Cancer Center</name>
      <address>
        <city>Akashi</city>
        <state>Hyogo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansai Rosai Hospital</name>
      <address>
        <city>Amagasaki</city>
        <state>Hyogo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iwate Medical University Hospital</name>
      <address>
        <city>Morioka</city>
        <state>Iwate</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokai University Hospital</name>
      <address>
        <city>Isehara</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nippon Medical School Musashi Kosugi Hospital</name>
      <address>
        <city>Kawasaki</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mie University Hospital</name>
      <address>
        <city>Tsu</city>
        <state>Mie</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tohoku University Hospital</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of the Ryukyus Hospital</name>
      <address>
        <city>Nakagami-gun</city>
        <state>Okinawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kindai University Hospital</name>
      <address>
        <city>Osakasayama</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Medical University International Medical Center</name>
      <address>
        <city>Hidaka</city>
        <state>Saitama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shizuoka Cancer Center</name>
      <address>
        <city>Nagaizumi-cho</city>
        <state>Shizuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Institute Hospital</name>
      <address>
        <city>Koto-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Jikei University Hospital</name>
      <address>
        <city>Minato-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keio University Hospital</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiba Cancer Center</name>
      <address>
        <city>Chiba</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kagoshima City Hospital</name>
      <address>
        <city>Kagoshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyoto University Hospital</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nagasaki University Hospital</name>
      <address>
        <city>Nagasaki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niigata University Medical &amp; Dental Hospital</name>
      <address>
        <city>Niigata</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.takeda.com/study-detail/5f6b60284db2bf003ab49986?idFilter=%5B%22Niraparib-2001%22%5D</url>
    <description>To obtain more information on the study, click here/on this link</description>
  </link>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <results_first_submitted>March 1, 2020</results_first_submitted>
  <results_first_submitted_qc>March 23, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 25, 2020</results_first_posted>
  <last_update_submitted>January 15, 2023</last_update_submitted>
  <last_update_submitted_qc>January 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
    <mesh_term>Fallopian Tube Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Niraparib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_access_criteria>IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/takeda/</ipd_url>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT03759587/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>June 3, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT03759587/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 27 investigative sites in Japan from 28 Dec 2018 up to Data cut-off: 17 Mar 2019. The study is ongoing.</recruitment_details>
      <pre_assignment_details>Participants with a diagnosis of with platinum-sensitive, relapsed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, who had achieved complete response (CR) or partial response (PR) in the last chemotherapy containing platinum-based anticancer agents were enrolled to received niraparib 300 mg in this study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Niraparib 300 mg</title>
          <description>Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment Cycle (Up to 3 Cycles till data cut-off 17 March 2019).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Ongoing</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Analysis Set included participants who received at least 1 dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Niraparib 300 mg</title>
          <description>Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment Cycle (Up to 3 Cycles till data cut-off 17 March 2019).</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="19"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60.9" spread="9.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" 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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Japan</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="156.7" spread="4.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.47" spread="10.445"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <description>Body Mass Index=weight (kg)/[height (m)^2]</description>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.46" spread="4.471"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Breast Cancer (Gene) (BRCA1) Mutant</title>
          <description>Participants with mutation of BRCA1 gene.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Without Mutant</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BRCA2 Mutant</title>
          <description>Participants with mutation of BRCA2 gene.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Without Mutant</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time to Progression after the Penultimate (Next to Last) Platinum Therapy</title>
          <description>Participants with time to progression were categorized as 6-12 months and more than 12 months. Time to progression is defined as the time from the date of last administration of platinum therapy to the first documentation of disease progression.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>6-12 Months</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More Than 12 Months</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Best Response during the Last Platinum Regimen</title>
          <description>Best response is based on the investigators assessment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Complete Response (CR)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Partial Response (PR)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Time from Last Platinum Therapy to Start of Study Drug (days)</title>
          <description>Duration in days from the date of last platinum therapy to the date of start of study drug.</description>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42.0" lower_limit="14" upper_limit="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Eastern Cooperative Oncology Group (ECOG) Performance Status</title>
          <description>The ECOG scale is as follows: Grade 0: Fully active, able to perform all pre-disease activities without restriction; Grade 1: Restricted in physically strenuous activity, ambulatory, able to carry out light work; Grade 2: Ambulatory and capable of all self-care but unable to work. Up and about more than 50% of waking hours; Grade 3: Capable of only limited self-care, confined to bed or chair &gt; 50% of waking hours; Grade 4: Completely disabled. Cannot carry on any self-care. Only categories with participants is reported.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>0</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Primary Tumor Site</title>
          <description>Participants with site of tumor are reported.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Ovarian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Primary Peritoneal</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Fallopian Tube</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration since Initial Diagnosis of Primary Cancer</title>
          <description>Duration since initial diagnosis is defined as the time elapsed since the first diagnosis to the date of enrolment.</description>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.35" lower_limit="1.2" upper_limit="19.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cancer Stage at time of Initial Diagnosis</title>
          <description>Cancer stage was determined based on federation of obstetrics and gynecology (FIGO) staging system. Stage I; Only in ovaries, Stage II; Has grown outside ovaries and is growing within pelvis, Stage III; Has spread outside pelvis into abdominal cavity or to lymph nodes (Stage IIIB means there are cancer growths that are 2cm or smaller in size on lining of abdomen (peritoneum) and there might also be cancer in lymph nodes and Stage IIIC means there are cancer growths larger than 2 cm on lining of abdomen (peritoneum) and might also be in lymph nodes.), Stage IV; Has spread to other body organs.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>IC</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IIC</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IIIB</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IIIC</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>IV</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sites of Metastatic Disease</title>
          <description>All sites of metastatic disease are counted.</description>
          <population>Number analyzed is the number of participants with sites of metastatic disease at baseline.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Ascites or pleural effusion</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Peritoneum</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Lymph Nodes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Metastatic Sites</title>
          <population>Number analyzed is the number of participants with sites of metastatic disease.</population>
          <units>metastatic Sites</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.0" spread="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Radiation Therapy</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Had Radiation Therapy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Had No Radiation Therapy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Surgery/Procedure</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Had Surgery/ Procedure</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Chemotherapy</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Had Chemotherapy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Prior Surgery/Procedure for Study Indication</title>
          <units>number of surgery</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.3" spread="1.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior History of Myelosuppression</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Had Myelosuppression</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Thrombocytopenia</title>
          <description>Thrombocytopenia was defined as decrease in thrombocytes i.e. platelet count in participant. Thrombocytopenia was graded as per the NCI-CTCAE .As per the NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to Adverse Events (AE).</description>
          <population>Number analyzed is the number of participants with prior thrombocytopenia at baseline.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="18"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Leukopenia</title>
          <description>Leukonpenia is defined as decrease in the leukocytes i.e white blood cells in participant. Leukopenia was graded as per the NCI-CTCAE. As per the NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to Adverse Events (AE). Only categories with participants is reported.</description>
          <population>Number analyzed is the number of participants with prior leukopenia at baseline.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Anemia</title>
          <description>Anaemia is defined as a condition in which the number of red blood cells or their oxygen-carrying capacity is insufficient to meet physiologic needs. Anaemia was graded as per the NCI-CTCAE. As per the NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to Adverse Events (AE). Only categories with participants is reported.</description>
          <population>Number analyzed is the number of participants with prior anemia at baseline.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Grade 1</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Neutropenia</title>
          <description>Neutropenia is defined as low level of neutrophils i.e. white blood cells in participants. Neutropenia was graded as per the NCI-CTCAE. As per the NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to Adverse Events (AE). Only categories with participants is reported.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Grade 2</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Grade 4</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Platelets Count</title>
          <units>10^9 platelets/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="214.1" spread="58.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ovarian Cancer Pathology Histological</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tumor Grade</title>
          <description>With regard to tumor grading, conventional FIGO/ gynecologic oncology group (GOG)/ world health organisation (WHO) criteria or two-tier system for grading ovarian serous carcinoma is used; participants with grade 3 tumors in FIGO/GOG/WHO criteria (among grade 1 as well differentiated, grade 2 as moderately differentiated, and grade 3 indicates poorly differentiated) or participants with high-grade tumors in two-tier system (among low-grade or high-grade) are enrolled.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Grade 3</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Higher Grade</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Grade 3 or 4 Thrombocytopenia Occurring Within 30 Days After Initial Administration of Niraparib</title>
        <description>An adverse event of 'thrombocytopenia' was collected and graded as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03.As per the NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to Adverse Events (AE).</description>
        <time_frame>Up to 30 days after the first dose</time_frame>
        <population>Safety Analysis Set included participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Niraparib 300 mg</title>
            <description>Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment Cycle (Up to 3 Cycles till data cut-off 17 March 2019).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Grade 3 or 4 Thrombocytopenia Occurring Within 30 Days After Initial Administration of Niraparib</title>
          <description>An adverse event of 'thrombocytopenia' was collected and graded as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03.As per the NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to Adverse Events (AE).</description>
          <population>Safety Analysis Set included participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</title>
        <description>An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.</description>
        <time_frame>Up to 30 days after the last dose (Approximately 4 months)</time_frame>
        <population>Safety Analysis Set included participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Niraparib 300 mg</title>
            <description>Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment Cycle (Up to 3 Cycles till data cut-off 17 March 2019).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</title>
          <description>An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.</description>
          <population>Safety Analysis Set included participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Grade 3 or Higher TEAEs</title>
        <description>An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A severity grade is defined by the NCI-CTCAE Version 4.03. As per NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.</description>
        <time_frame>Up to 30 days after the last dose (Approximately 4 months)</time_frame>
        <population>Safety Analysis Set included participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Niraparib 300 mg</title>
            <description>Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment Cycle (Up to 3 Cycles till data cut-off 17 March 2019).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Grade 3 or Higher TEAEs</title>
          <description>An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A severity grade is defined by the NCI-CTCAE Version 4.03. As per NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.</description>
          <population>Safety Analysis Set included participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Serious Adverse Events (SAEs)</title>
        <description>An SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.</description>
        <time_frame>Up to 30 days after the last dose (Approximately 4 months)</time_frame>
        <population>Safety Analysis Set included participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Niraparib 300 mg</title>
            <description>Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment Cycle (Up to 3 Cycles till data cut-off 17 March 2019).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Adverse Events (SAEs)</title>
          <description>An SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.</description>
          <population>Safety Analysis Set included participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With TEAEs Leading to Drug Discontinuation</title>
        <description>An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.</description>
        <time_frame>Up to 30 days after the last dose (Approximately 4 months)</time_frame>
        <population>Safety Analysis Set included participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Niraparib 300 mg</title>
            <description>Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment Cycle (Up to 3 Cycles till data cut-off 17 March 2019).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With TEAEs Leading to Drug Discontinuation</title>
          <description>An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.</description>
          <population>Safety Analysis Set included participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With TEAEs Leading to Dose Interruption</title>
        <description>An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.</description>
        <time_frame>Up to 30 days after the last dose (Approximately 4 months)</time_frame>
        <population>Safety Analysis Set included participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Niraparib 300 mg</title>
            <description>Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment Cycle (Up to 3 Cycles till data cut-off 17 March 2019).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With TEAEs Leading to Dose Interruption</title>
          <description>An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.</description>
          <population>Safety Analysis Set included participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With TEAEs Leading to Dose Reduction</title>
        <description>An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.</description>
        <time_frame>Up to 30 days after the last dose (Approximately 4 months)</time_frame>
        <population>Safety Analysis Set included participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Niraparib 300 mg</title>
            <description>Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment Cycle (Up to 3 Cycles till data cut-off 17 March 2019).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With TEAEs Leading to Dose Reduction</title>
          <description>An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.</description>
          <population>Safety Analysis Set included participants who received at least 1 dose of study drug.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Progression Free Survival (PFS)</title>
        <description>PFS is defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per RECIST 1.1, PD is defined as at least a 20% increase in the SoD (Sum of Diameters) of target lesions, taking as a reference the smallest (nadir) SoD since (and including) baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm.</description>
        <time_frame>Until disease progression, death or data cut-off (Approximately 4 months)</time_frame>
        <population>Full Analysis Set included participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Niraparib 300 mg</title>
            <description>Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment Cycle (Up to 3 Cycles till data cut-off 17 March 2019).</description>
          </group>
        </group_list>
        <measure>
          <title>Progression Free Survival (PFS)</title>
          <description>PFS is defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per RECIST 1.1, PD is defined as at least a 20% increase in the SoD (Sum of Diameters) of target lesions, taking as a reference the smallest (nadir) SoD since (and including) baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm.</description>
          <population>Full Analysis Set included participants who received at least 1 dose of study drug.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="0" upper_limit="NA">PFS was not estimable to due to low number of participants with events.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>OS is defined as the time from the study enrollment to death due to any cause.</description>
        <time_frame>Up to data cut-off (approximately 4 months)</time_frame>
        <population>Full Analysis Set included participants who received at least 1 dose of study drug.</population>
        <group_list>
          <group group_id="O1">
            <title>Niraparib 300 mg</title>
            <description>Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment Cycle (Up to 3 Cycles till data cut-off 17 March 2019).</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>OS is defined as the time from the study enrollment to death due to any cause.</description>
          <population>Full Analysis Set included participants who received at least 1 dose of study drug.</population>
          <units>months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">OS was not estimable as all participants were known to be alive.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Response Rate (ORR)</title>
        <description>ORR is defined as the proportion of participants achieving Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST (v.1.1). Per RECIST 1.1, CR is defined as disappearance of all target lesions; PR is defined as atleast 30% decrease in sum of diameters (SoD) of target lesions.</description>
        <time_frame>Up to approximately 4 months</time_frame>
        <population>Response-evaluable Analysis Set included participants who received at least 1 dose of study drug and had at least one measurable disease at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>Niraparib 300 mg</title>
            <description>Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment Cycle (Up to 3 Cycles till data cut-off 17 March 2019).</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Response Rate (ORR)</title>
          <description>ORR is defined as the proportion of participants achieving Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST (v.1.1). Per RECIST 1.1, CR is defined as disappearance of all target lesions; PR is defined as atleast 30% decrease in sum of diameters (SoD) of target lesions.</description>
          <population>Response-evaluable Analysis Set included participants who received at least 1 dose of study drug and had at least one measurable disease at baseline.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to Month 4</time_frame>
      <desc>At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.</desc>
      <group_list>
        <group group_id="E1">
          <title>Niraparib 300 mg</title>
          <description>Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment Cycle (Up to 3 Cycles till data cut-off 17 March 2019).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA: 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA: 21.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="19"/>
              </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="3" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Periodontal disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Catheter site thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </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="7" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dizziness postural</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </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="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Oropharyngeal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermal cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dermatitis exfoliative generalised</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Haemorrhage subcutaneous</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Director</name_or_title>
      <organization>Takeda</organization>
      <phone>+1-877-825-3327</phone>
      <email>clinicaltrialregistry@tpna.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/NCT03759587
org study id: Niraparib-2001
secondary id: U1111-1222-4074
secondary id: JapicCTI-184225
nct id: NCT03759587
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to evaluate the safety and efficacy of niraparib in Japanese
      participants with platinum-sensitive, relapsed ovarian cancer, fallopian tube cancer, or
      primary peritoneal cancer who achieved complete response (CR) or partial response (PR) in the
      last chemotherapy containing platinum-based anticancer agents.
The drug being tested in this study is called niraparib. Niraparib is being tested to treat
      people who have platinum-sensitive, relapsed ovarian cancer, fallopian tube cancer, or
      primary peritoneal cancer. This study will look at the safety and efficacy of niraparib in
      Japanese participants.

      The study will enroll approximately 15 participants. Participants will be enrolled to one
      group and after that will be asked to take niraparib capsules at the same time each day
      throughout the study:

      - Niraparib 300 mg

      This multi-center trial will be conducted in Japan. The overall time to participate in this
      study is approximately 28 months. Participants will make multiple visits to the clinic in the
      treatment period, and the post-treatment period including follow-up assessments after the
      last dose of the study drug.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Grade 3 or 4 Thrombocytopenia Occurring Within 30 Days After Initial Administration of Niraparib
time frame: Up to 30 days after the first dose
description: An adverse event of 'thrombocytopenia' was collected and graded as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03.As per the NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to Adverse Events (AE).
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
time frame: Up to 30 days after the last dose (Approximately 4 months)
description: An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
measure: Number of Participants With Grade 3 or Higher TEAEs
time frame: Up to 30 days after the last dose (Approximately 4 months)
description: An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A severity grade is defined by the NCI-CTCAE Version 4.03. As per NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.
measure: Number of Participants With Serious Adverse Events (SAEs)
time frame: Up to 30 days after the last dose (Approximately 4 months)
description: An SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.
measure: Number of Participants With TEAEs Leading to Drug Discontinuation
time frame: Up to 30 days after the last dose (Approximately 4 months)
description: An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
measure: Number of Participants With TEAEs Leading to Dose Interruption
time frame: Up to 30 days after the last dose (Approximately 4 months)
description: An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
measure: Number of Participants With TEAEs Leading to Dose Reduction
time frame: Up to 30 days after the last dose (Approximately 4 months)
description: An AE is defined as any untoward medical occurrence in a participant who has enrolled in a study; it does not necessarily have a causal relationship with this treatment. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
measure: Progression Free Survival (PFS)
time frame: Until disease progression, death or data cut-off (Approximately 4 months)
description: PFS is defined as the time in months from the date of first study drug administration to the date of first documentation of progressive disease (PD) or death as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Per RECIST 1.1, PD is defined as at least a 20% increase in the SoD (Sum of Diameters) of target lesions, taking as a reference the smallest (nadir) SoD since (and including) baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm.
measure: Overall Survival (OS)
time frame: Up to data cut-off (approximately 4 months)
description: OS is defined as the time from the study enrollment to death due to any cause.
measure: Overall Response Rate (ORR)
time frame: Up to approximately 4 months
description: ORR is defined as the proportion of participants achieving Complete Response (CR) or Partial Response (PR) as assessed by the investigator per RECIST (v.1.1). Per RECIST 1.1, CR is defined as disappearance of all target lesions; PR is defined as atleast 30% decrease in sum of diameters (SoD) of target lesions.
arm group label: Niraparib 300 mg
arm group type: Experimental
description: Niraparib 300 mg, capsules, orally, once daily on Days 1 to 28 of each 28-day treatment Cycle (Up to 3 Cycles till data cut-off 17 March 2019).
intervention type: Drug
intervention name: Niraparib
description: Niraparib capsule
arm group label: Niraparib 300 mg
criteria: 
gender: Female
gender based: Yes
gender description: Female participants with platinum-sensitive, relapsed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer were eligible to be enrolled in this study.
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Takeda
facility: 
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country: Japan
url: https://clinicaltrials.takeda.com/study-detail/5f6b60284db2bf003ab49986?idFilter=%5B%22Niraparib-2001%22%5D
description: To obtain more information on the study, click here/on this link
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Fallopian Tube Neoplasms
mesh term: Niraparib
sharing ipd: Yes
ipd description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
ipd url: https://vivli.org/ourmember/takeda/
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 