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Table 3 Demographic and clinical data collected (where applicable)

From: Study design for development of novel safety biomarkers of drug-induced liver injury by the translational safety biomarker pipeline (TransBioLine) consortium: a study protocol for a nested case–control study

Category

Data collected

Demographics

Age at visit, sex at birth, self-reported ethnicity

Anthropometrics

Height, weight, waist circumference

Health status

Diabetes mellitus diagnosis, presence of hypertension, smoking status (cigarettes per week), alcohol intake (gram per week), current pregnancy

Liver episode

Detection date, symptoms, drug/supplement treatments prior to liver episode (dose and duration), whether biopsy was done, outcome

Results of routine clinical investigations: haematology, clinical biochemistry, immunology, and liver function (all with date of testing)

• Total protein, albumin, transferrin, ceruloplasmin, C-reactive protein

• Glucose, prothrombin time, international normalised ratio

• Urea, creatinine, sodium, potassium

• Alanine transaminase (ALT), aspartate transaminase (AST), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), total bilirubin (TBL), conjugated bilirubin

• Iron, ferritin

• Thyroid-stimulating hormone

• Lactate dehydrogenase, creatine kinase, creatine kinase-MB

• Cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides

• Haemoglobin, platelets, erythrocytes, leukocytes, neutrophils, lymphocytes, monocytes, eosinophils, basophils

Clinical imaging results

Transient elastography, ultrasound

Clinical tests to support diagnosis (routine diagnostics or local practice for clinical care or research)

• Viral serology tests

• Autoantibody serology

• Immunoglobulin levels

• Histological findings for any biopsy performed

Extended clinical information including follow-up information for diagnosis and allocation to study sub-groups

• Comorbidities (past and current)

• Concomitant medications, herbal and/or dietary supplements

• Past alcohol history

• Hospitalisation

  1. Data is captured for drug-induced liver injury cases and nondrug-induced acute liver injury cases and control groups using a standard case report file (CRF) using data from clinical investigations (where available) or from research study visit. Headings are in bold