Lynparza Ovarian Cancer Clinical Experience Investigation (All Case Investigation)

NCT03505307CompletedOBSERVATIONAL

Summary

\[Objectives\] Objectives include following to capture safety and efficacy of LYNPARZA in actual clinical use. 1. ADR development in actual clinical use 2. Factors which may affect safety and efficacy 3. ADRs not expected from "Precautions for Use"

Key Facts

Lead Sponsor

AstraZeneca

Enrollment

846

Start Date

2018-05-21

Completion Date

2020-12-07

Study Type

OBSERVATIONAL

Official Title

Lynparza Tablets 100mg, 150mg Clinical Experience Investigation (All Case Investigation) in Patients With Platinum-sensitive Relapsed Ovarian Cancer

Conditions

Ovarian Cancer

Eligibility

Sex

FEMALE

Inclusion Criteria:

* Maintenance treatment for patients with recurrent ovarian cancer, who are sensitive to platinum based chemotherapy

Exclusion Criteria:

\-

Outcome Measures

Primary Outcomes

Incidence of ADRs regarding Bone marrow depression, ILD, new primary malignancies, Embryo-foetal toxicity and exposure in patient with renal impairment

To be calculated incidence of ADRs related to LYMPARZA during the observation period regarding Bone marrow depression, ILD, new primary malignancies, Embryo-foetal toxicity and exposure in patient with renal impairment

Time frame: from baseline to 1 year

Factors which may impact incidence of ADRs related to LYMPARZA during the observation period, analysed by patient demographic characteristics

Factors which may impact incidence of ADRs, analysed by patient demographic characteristic(past medical history, and concomitant disease etc)

Time frame: from baseline to 1 year

Incidence of ADRs not expected from "Precautions for Use" of LYNPARZA JPI

To be calculated incidence of ADRs related to LYMPARZA during the observation period not expected from "Precautions for Use" of LYNPARZA JPI

Time frame: from baseline to 1 year

Lynparza Ovarian Cancer Clinical Experience Investigation (All Case Investigation)