Long-term outcomes in patients continuously treated with ADVAGRAF following a liver transplant in routine clinical practice in Spain: a multicenter secondary data (chart review) cohort study

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

  Healthcare resource utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  ADVAGRAF
• Study drug International non-proprietary name (INN) or common name:
  TACROLIMUS
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AD02) tacrolimus

  tacrolimus

Population studied

• Short description of the study population:
  The study will include people who had a liver transplant between 2008 and 2014 and were treated with ADVAGRAF.
• Age groups:
  • Adult and elderly population (≥18 years)
• Estimated number of subjects:
  150

Study design details

• Study design:
  This study is a secondary data project designed as a retrospective, non-interventional, observational, multi-center chart review conducted in adult patients 18 years old and over, who underwent whole liver transplantation and received ADVAGRAF therapy.
• Main study objective:
  The main aim of this study is to collect information about the long-term outcomes of people treated with ADVAGRAF in Spain. ; Researchers will learn about the health of people treated with ADVAGRAF. They will also learn how other factors affect long-term outcomes. ; This includes their age, sex, kidney health, and how severe their liver disease was before the transplant. This will be for people treated with ADVAGRAF after their liver transplant.
• Comparators:
  N/A
• Outcomes:
  1. Patient survival: Time to death; Cumulative mortality at the end of follow-up ; 2. Graft survival: Time to overall graft failure; Cumulative incidence of overall graft failure at the end of follow-up; Time to death-censored graft failure; Cumulative incidence of death-censored graft failure at the end of follow-up;