Table I.
Item | Data source | Baseline visit | 6-mo study visit | 12- and 24-mo study visit |
---|---|---|---|---|
Eligible patients | Standard DILIa, liver DILIb, control |
Standard DILI, liver DILI |
Chronic DILIc | |
Demographics | Interview | ✓ | ||
Pharmacy use | Interview | ✓ | ||
Medication compliance | Interview | ✓ | ||
Family history | Interview | ✓ | ||
Diagnostic laboratory testsd | Records/visit | ✓ | ||
Suspect medication use | Interview/records | ✓ | ||
HCV/HBV laboratory testse | Records/visit | ✓ | ✓ | |
Concomitant medication and CAM use history |
Interview/records | ✓ | ✓ | ✓ |
Alcohol and smoking | Interview | ✓ | ✓ | ✓ |
Physical examination | Visit | ✓ | ✓ | ✓ |
Symptom score | Interview | ✓ | ✓ | ✓ |
Quality-of-life survey | Interview | ✓ | ✓ | ✓ |
Medical history | Interview/records | ✓ | ✓ | ✓ |
Standard laboratory tests | Records/visit | ✓ | ✓ | ✓ |
Research blood sample | Visit | ✓ | ✓ | ✓ |
Research urine sample | Visit | ✓ | ✓ | ✓ |
Liver imaginga | Records | ✓ | ✓ | ✓ |
Standard DILI case = normal liver biochemistries or no known liver disease before starting the suspect medication.
Liver DILI case = known chronic liver disease such as chronic HCV or HBV or fatty liver before starting the suspect medication.
Chronic DILI case = evidence of persistent laboratory, radiological or pathological abnormalities 6mo after DILI onset.
Not done in control patients.
Only in HCV/HBV liver DILI patients.
CAM=complementary and alternative medicine; DILI=drug-induced liver injury; HBV=hepatitis B virus; HCV=hepatitis C virus.