Zedula Special Drug Use Observational Study "Ovarian Cancer"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 354
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Event of Myelosuppression
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •An individual who corresponds to any of the following:
- •Ovarian cancer patients after initial chemotherapy (maintenance therapy)
- •Patients with platinum antineoplastic drug sensitive recurrent ovarian cancer (maintenance therapy)
- •Recurrent ovarian cancer with platinum-sensitive homologous recombination repair defects.
排除标准
- •Has a history of hypersensitivity to any of the ingredients of this drug.
研究组 & 干预措施
Niraparib 200-300 milligrams (mg)
Arm description: Niraparib 200 mg, capsules, orally, once daily. For adult participants weighing 77 kilograms (kg) or more and with platelet count 150,000/mcrL or higher before the first dose of this drug, niraparib 300 mg, capsules, orally, once daily.
干预措施: Niraparib (Drug)
结局指标
主要结局
Number of Participants with Adverse Event of Myelosuppression
时间窗: 1 year
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.
Number of Participants with Adverse Event of Posterior Reversible Encephalopathy Syndrome
时间窗: 1 year
Number of participants with AE of posterior reversible encephalopathy syndrome will be reported.
Number of Participants with Adverse Event of Hypertension
时间窗: 1 year
Number of participants with AE of hypertension will be reported.
Number of Participants with Adverse Event of Secondary Malignant Tumors
时间窗: 1 year
Number of participants with AE of secondary malignant tumors will be reported.
Number of Participants with Adverse Event of Thromboembolism
时间窗: 1 year
Number of participants with AE of thromboembolism will be reported.
Number of Participants with Adverse Event of Interstitial Lung Disease
时间窗: 1 year
Number of participants with AE of interstitial lung disease will be reported.
次要结局
- 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(1 year)
- Number of Participants who Experienced Exacerbation Assessed by Investigator during the Study(1 year)