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This post-marketing surveillance (PMS) is conducted to collect safety and efficacy data among subjects with chronic hepatitis B and hepatic cirrhosis B who is treated with adefovir tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects prescribed adefovir tablets | Subjects with chronic hepatitis B or hepatic cirrhosis B to whom adefovir tablets are administered |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adefovir tablets | Drug | Administered according to the prescribing information in the locally approved label by the authorities. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse drug reactions | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with chronic hepatitis B or hepatic cirrhosis B who are confirmed of hepatic function abnormality with continuous re-proliferation of hepatitis B virus while treated with lamivudine
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| C053001 | adefovir |
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| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |