Study type

Study type

Not applicable

Scope of the study

Disease epidemiology

If ‘Not applicable’, further details on the study type

Prospective patient data recruitment
Study drug and medical condition

Medical condition to be studied

Drug-induced liver injury
Population studied

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)

Estimated number of subjects

1500
Study design details

Main study objective

Define the main characteristics of patients, type of liver injury, outcome and culprit drugs involved in drug-induced liver injury (DILI), which will serve to guide epidemiologic and genetic studies in order to improve DILI causality assessment and diagnosis

Outcomes

Enhance the knowledge of DILI using collected data for epidemiology and underlying mechanism studies. Generate/amplify signals of risk with the use of new and old drugs that can lead to adoption of regulatory measures ranging from changes in product labeling information to drug withdrawal.

Data analysis plan

All data will be analysed in a descriptive manner, no formal hypotheses will be tested. DILI frequencies and incidence rates will be summarized and reported to the Spanish Medicines Agency (Agencia Española del Medicamentos y Productos Santiarios). Clinical characteristics will be analyzed by frequency and percentages for categorical variables and by mean with standard deviation for continuous variables. Risk estimations will be calculated in the form of Odds Ratio. Multiple regression logistic models will be used for identification of independent variables associated with risk.
Documents
Study publications
Medina-Caliz I, Garcia-Cortes M, Gonzalez-Jimenez A, Cabello MR, Robles-Diaz M,…
Andrade RJ, Lucena MI, Fernández MC, Pelaez G, Pachkoria K, García-Ruiz E, et a…
Medina-Cáliz I, Robles-Díaz M, García-Muñoz B, Stephens C, Ortega-Alonso A, Gar…
Stephens C, Robles-Diaz M, Medina-Caliz I, Garcia-Cortes M, Ortega-Alonso A, Sa…
Robles-Díaz M, Lucena MI, Kaplowitz N, Stephens C, Medina-Cáliz I, González-Jim…