EU Clinical Trial Information System (CTIS)

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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To characterise the development of ADRs of bone marrow depression in patients under actual post-marketing use

Lynparza breast cancer Clinical Experience Investigation

To characterise the development of adverse drug reactions (ADRs) of bone marrow depression in patients with unresectable or recurrent BRCA mutated HER2 negative breast cancer who have previously received anticancer chemotherapy under actual post-marketing use.

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Patient Level Data

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Research Site

Lynparza Tablets 100mg, 150mg CEI, Investigation on development of bone marrow depression in patients with unresectable or recurrent BRCA mutated HER2 negative breast cancer who have previously received anticancer chemotherapy

Bone marrow depression will be investigated as safety specification topics

Lynparza breast cancer Clinical Experience Investigation

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Documents available

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