TAK-620-4007: Retrospective Chart Review of Safety Outcomes Associated With Use of Maribavir in Patients With Post-transplant Refractory Cytomegalovirus (CMV) Infection and Comorbid Endstage Renal Disease (ESRD) or Comorbid Severe Chronic Renal Disease Requiring Peritoneal Dialysis or Hemodialysis

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  LIVTENCITY
• Study drug International non-proprietary name (INN) or common name:
  MARIBAVIR
• Anatomical Therapeutic Chemical (ATC) code:
  (J05AX) Other antivirals

  Other antivirals
• Additional medical condition(s):
  Kidney failure

Population studied

• Age groups:
  Adult and elderly population (≥18 years)
• Special population of interest:
  Renal impaired
• Estimated number of subjects:
  10

Study design details

• Main study objective:
  To characterize the safety profile of maribavir when treating refractory cytomegalovirus (CMV) infection after transplantation in adults with end-stage renal disease or severe chronic kidney disease requiring peritoneal dialysis or hemodialysis.
• Outcomes:
  The primary outcomes will assess the number of participants with adverse events (AEs). The secondary outcomes will assess the number of participants with adverse events of special interest (AESIs).
• Data analysis plan:
  The statistical analysis of the data will be primarily descriptive. Continuous variables will be described by the number of eligible participants and missing data, mean, standard deviation or standard error, median, first quartile, third quartile, and minimum and maximum values. Categorical variables will be described by the total number of participants and relative proportion per category.