An observational, Post-Authorisation Safety Study (PASS) to describe the safety and effectiveness of tabelecleucel in patients with Epstein-Barr Virus positive (EBV+) Post-Transplant Lymphoproliferative Disease (PTLD) in a real-world setting in Europe: EBVOLVE study

22/07/2024
21/05/2025
EU PAS number:
EUPAS1000000113
Study
Ongoing
Data sources

Data source(s), other

The PASS database will contain complete study specific data for each patient enrolled in the study and will be based on the PASS eCRF that incorporates: (1) secondary use of data from the Health Care Professionnal portal database which will be automatically transferred, incorporated, and displayed in the PASS eCRF, and (2) primary data collection.

Data sources (types)

Non-interventional study
Use of a Common Data Model (CDM)

CDM mapping

No
Data quality specifications

Check conformance

Yes

Check completeness

Yes

Check stability

Yes

Check logical consistency

Yes
Data characterisation

Data characterisation conducted

No