Liver Injury, Liver Injury, Drug-Induced
Conditions
Brief summary
This is an open-enrollment, retrospective, observational study without interventions. Its primary objective is to understand 1) incidence of liver injury among all the hospitalized patient from participating centers after the administration of immune checkpoint inhibitors or molecularly targeted agents; 2) epidemiologic and clinical characteristics of liver injury, including suspected medications, clinical types, histological characteristics, severity, treatment and outcomes.
Interventions
None listed
Sponsors
Drug Induced Liver Disease Study Group
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Abnormality of liver biochemistry after the administration of any molecularly targeted agent or immune checkpoint inhibitor
Exclusion criteria
* Missing major baseline or clinical data * Prior liver loco-regional therapy or surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ALT (alanine aminotransferase) | on day 10 | Absolute change |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with normalized liver biochemistry | on day 3, 7, 10, 14, 21, and 30 | Count of subjects |
| Change in liver biochemistry | on day 3, 7, 10, 14, 21, and 30 | Absolute change |
| Time to normalization of liver biochemistry | up to 6 month | Days |
| Proportion of patients with ≥ 50% reduction in liver biochemistry | on day 3, 7, 10, 14, 21, and 30 | Count of subjects |
Countries
China
Outcome results
None listed