SALT-II: Study of Acute Liver Transplant Prolongation and continuation of the SALT-I study “A study of drug-exposed acute liver failure (ALF) in European transplant centres”

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Case-population study

Study drug and medical condition

• Medical condition to be studied:
  Liver transplant

Population studied

• Short description of the study population:
  The cases fulfilling the following eligibility criteria were considered for data collection:; - Adult patients of ≥18 years of age at the time of registration on the transplantation list,; - Patient registered on the transplantation list between 1st January 2008 and 31st December 2013, whether the transplantation was actually performed or not,; - Patients who are residents of the country where they were registered.; The non-eligibility criteria were:; - Patients <18 years of age at the time of registration on the transplantation list,; - Patients not resident in the selected countries.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Hepatic impaired
• Estimated number of subjects:
  360

Study design details

• Main study objective:
  To estimate the risk of drug-exposed ALFT in adults, according to the population exposure to the same drugs.
• Outcomes:
  Global frequency of occurrence of the ALFT (without clinically defined cause) listed on the transplant list, in subjects exposed to a drug 30 days prior to index date (ID, date of the onset of the liver disease) in five European countries over the 6-year period (2008-2013). The relative event rates within drugs of the same class,Inclusion of data from SALT-I to determine the overall frequency over nine years (2005-2013), Frequency of occurrence measured using different denominators (number of subjects, DDD, patient-years),Frequency based on the number of drug-exposed cases aged between 18 and 70 years (age range observed for subjects transplanted).
• Data analysis plan:
  Descriptive analysis: A descriptive analysis of all drug-exposed cases of ALFT will be performed. Rate estimations per country: Per country rates of drug-exposed transplantation registered ALF will be computed as the ratio of the number of cases identified in the country to the population exposure. Population exposure will be measured in treatment-years (source: IMS). The estimation of the rate of drug-exposed ALFT cases within 30 days prior to ID, with a 95% CI from a Poisson distribution, expressed in cases per million treatment-years. The frequency of ALFT will be calculated also for people aged 18 to 70 years.Pooling: Data of SALT-IIEUR will be pooled with data of the previous SALT-I study to estimate the frequency of ALFT identified in nine years (2005-2013). This will allow a greater number of events and a better precision of the risk estimates.