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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Change in ALT (alanine aminotransferase) | Absolute change | on day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with normalized liver biochemistry | Count of subjects | on day 3, 7, 10, 14, 21, and 30 |
| Change in liver biochemistry | Absolute change |
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Inclusion Criteria:
Exclusion Criteria:
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All hospitalized patients from participating medical centers.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200127 | China |
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| ID | Term |
|---|---|
| D056486 | Chemical and Drug Induced Liver Injury |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
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| on day 3, 7, 10, 14, 21, and 30 |
| Time to normalization of liver biochemistry | Days | up to 6 month |
| Proportion of patients with ≥ 50% reduction in liver biochemistry | Count of subjects | on day 3, 7, 10, 14, 21, and 30 |
| D011041 | Poisoning |