NIraparib and Quality of LifE is a Longitudinal Study Evaluating in Real Life the Tolerability of Niraparib.

Exclusion Criteria

• •E-1 Known hypersensitivity or allergy to active principle or to any components or excipients of the Niraparib formulation.
• •E-2 Participant must not be simultaneously enrolled in any interventional clinical trial.
• •E-3 Participant must not have had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
• •E-4 Participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.
• •E-5 Participant last treatment with platinum-based chemotherapy was ≥12 weeks from initiation of protocol therapy E-6 Participant has had radiation therapy encompassing \>20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy.
• •E-7 Participant must not have received a transfusion (platelets or red blood cells) ≤ 4 weeks NiQoLe - Study protocol - v3.0 on 08/10/2020 Page 10 on 109 N° EudraCT: 2018-002274-44 prior to initiating protocol therapy. E-8 Participant must not have received colony stimulating factors (e.g., granulocyte colonystimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy. E-9 Participant has had any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted \> 4 weeks and was related to the most recent treatment. E-10 Participant must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). E-11 Participant must not have a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent. E-12 Participant must not be deprived of liberty, under guardianship or under trusteeship.