Severe Aplastic Anaemia Working Party (SAAWP)
Study type:
Study number:
8409071
Type of treatment:
Allogeneic
Diseases:
Bone marrow failure
Short title:
GRFS
Primary objective:
To extensively describe GRFS after allo-HSCT for idiopathic SAA, including the risk of events for GRFS over time (dynamic prediction) taking into account potential predictive factors (age, donor, conditioning, graft source etc…)
Key inclusion criteria:
- allo-HSCT for idiopathic SAA
- Second allo-HSCT are excluded
- No restriction in terms of age, conditioning regimen, donor type and graft source
- Data available in the DQI
- Second allo-HSCT are excluded
- No restriction in terms of age, conditioning regimen, donor type and graft source
- Data available in the DQI
Country:
All EBMT member countries
Principal investigator:
Raynier Devillier
Study coordinator email:
saawpebmt@lumc.nl
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
Recipients who may access the data:
Leiden Study Unit
Statistical Unit
Investigators
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)
Is a Data Protection Impact Assessment required?:
Not performed because Study began before implementation of GDPR
Retention Schedule (if possible):
at least 5 years after the final report or first publication of study results