\[Objectives\] 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"
The objective of the Clinical Experience Investigation (CEI) is to collect following data to characterise safety and efficacy of LYMPARZA Tablets 100mg and 150mg (LYMPARZA) in usual post-marketing use. 1. Development of adverse drug reactions (ADRs) 2. Factors which may affect safety and efficacy of LYMPARZA 3. Development of adverse drug reactions (ADRs) unexpected from "Precautions for Use" of the LYMPARZA JPI
Study Type
OBSERVATIONAL
Enrollment
846
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
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