Post-authorization safety study to evaluate the risks of myelodysplastic syndrome/acute myeloid leukemia and second primary malignancies in adult patients with platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer receiving maintenance treatment with ZEJULA® (niraparib) (213705 - Zejula PASS 3000-04-001)

07/06/2019
28/08/2025
EU PAS number:
EUPAS29407
Study
Finalised
Documents
Study protocol
Initial protocol
English (848.12 KB - PDF) View document
Updated protocol
English (2.26 MB - PDF) View document
English (569.13 KB - PDF) View document
Study results
Study report
Study report
English (4.6 MB - PDF) View document
Other information