Safety and Effectiveness of Letermovir in Allogenic Hematopoietic Stem Cell Transplantation Recipients: Interim Report of Post-marketing Surveillance in Japan.

ABSTRACT:

Objective

Since May 2018, a 6-year post‑marketing surveillance (PMS) has been underway to evaluate the safety and effectiveness of letermovir for cytomegalovirus (CMV) prophylaxis in Japanese patients with allogenic hematopoietic stem-cell transplantation (allo-HSCT). The interim PMS data for 461 patients collected as of March 2021 are reported in this publication.

Methods

The case report forms (CRFs) were drafted in part by the Japanese Data Center for Hematopoietic Cell Transplantation (JDCHCT) using data elements in the Transplant Registry Unified Management Program (TRUMP) and sent to individual HSCT centers to decrease burden of reporting. These CRFs were completed by physicians in the respective HSCT centers and sent to MSD K.K., Tokyo, Japan.

Results

Allo-HSCT

SUBMITTER: Hiraishi I 

PROVIDER: S-EPMC8626406 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature