Post-Marketing Observational Prospective Study to Assess Real World Outcomes and the Risk of Myelodysplastic syndromes (MDS)/acute myeloid leukaemia (AML) in Platinum Sensitive Relapsed breast cancer susceptibility gene (BRCA) Mutated Ovarian Cancer Patients Treated with Lynparza (olaparib); the LOCALISE Study

30/06/2016
02/07/2024
EU PAS number:
EUPAS13757
Study
Finalised

ENCePP Code of conduct

No
Data sources

Data sources (types)

Other

Data sources (types), other

All data will be entered by site staff directly into an electronic data capture (EDC) system for review, real-time screening, and query by the designated contract research organisation (CRO) Data Management personnel.
Use of a Common Data Model (CDM)

CDM mapping

No
Data quality specifications

Check conformance

Unknown

Check completeness

Unknown

Check stability

Unknown

Check logical consistency

Unknown
Data characterisation

Data characterisation conducted

Unknown