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Maribavir use for CMV infection in allogeneic stem cell transplantation: the real-world experience. A retrospective study of IDWP EBMT

Infectious Diseases Working Party (IDWP)
Study type:
Retrospective Studies
Study number:
84140156
Type of treatment:
Allogeneic
Diseases:
Complications: infectious
Short title:
Maribavir study
Primary objective:
The study aims to evaluate in a real world setting the efficacy of commercially available maribavir in EBMT centers.
Key inclusion criteria:
Maribavir treatment for any CMV infection OR disease OR for CMV prophylaxis
Follow-up from maribavir start should be at least 12 weeks or until death, whichever occurs first
Allogeneic stem cell transplantation
Pediatric and adult patients
Consent to have data reported
Core data has been reported to the EBMT registry
Country:
All EBMT member countries
Principal investigator:
Annalisa Paviglianiti
EBMT Study coordinator:
Nina Knelange
Study coordinator email:
idwp@ebmt.org
EBMT Study Unit:
Leiden Study Unit
Reason for processing personal data:
Patients’ data is needed to be able to identify the patient and calculate age at any time (impact on SAEs and response to clinical medications). Health care personal data is part of the CV collected for evidence of proper qualification for running the trial.
Categories of personal data collected:
DOB/YOB, gender
Medical data already reported to the EBMT Registry
Study Specific Questionnaire (MED-C)
Recipients who may access the data:
Leiden Study Unit
Statistical Unit
3rd-party processors of Personal Data on behalf of EBMT/Service provider:
No

Privacy notices

Article 6 lawful basis for processing personal data:
Article 6.1 (a) - Consent (Collection)
Article 9 basis for processing special category data:
Article 9(2) (a) - Consent (Collection)

Data Protection Impact Assessments

Rights available to individuals:
Access
Data portability
Rectification
Objection
Deletion
Is a Data Protection Impact Assessment required?:
DPIA performed for EBMT Registry (WP & NIS Studies)
Retention Schedule (if possible):
at least 5 years after the final report or first publication of study results