The main aim of this study is to check for side effects from treatment with niraparib. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. During the study, participants with ovarian cancer will take capsules of niraparib (Zedula) once a day according to their clinic's standard practice. The study doctors will check for side effects from niraparib for 1 year after treatment starts.
Study Type
OBSERVATIONAL
Enrollment
354
Niraparib capsules
Takeda Selected Site
Tokyo, Japan
Number of Participants with Adverse Event of Myelosuppression
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AE of myelosuppression will be reported.
Time frame: 1 year
Number of Participants with Adverse Event of Hypertension
Number of participants with AE of hypertension will be reported.
Time frame: 1 year
Number of Participants with Adverse Event of Posterior Reversible Encephalopathy Syndrome
Number of participants with AE of posterior reversible encephalopathy syndrome will be reported.
Time frame: 1 year
Number of Participants with Adverse Event of Interstitial Lung Disease
Number of participants with AE of interstitial lung disease will be reported.
Time frame: 1 year
Number of Participants with Adverse Event of Secondary Malignant Tumors
Number of participants with AE of secondary malignant tumors will be reported.
Time frame: 1 year
Number of Participants with Adverse Event of Thromboembolism
Number of participants with AE of thromboembolism will be reported.
Time frame: 1 year
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Percentage of Participants Who Achieve or Maintain Any Best Overall Response Category in Population of Recurrent Ovarian Cancer Participants with Platinum-Sensitive Homologous Recombination Repair Defects
Percentage of participants who achieve or maintain any best overall response category best overall response in population of recurrent ovarian cancer participants with platinum-sensitive homologous recombination repair defects will be reported. Best overall response will be assessed with reference to the excerpts from Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Best overall response is defined as the level of best response in assessment with complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD) and not evaluable (NE) during the observational period.
Time frame: 1 year
Number of Participants who Experienced Exacerbation Assessed by Investigator during the Study
Exacerbation is defined as death or worsened symptom or disease assessed by investigator through tumor assessments, tumor marker assessments, and clinical assessments.
Time frame: 1 year