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An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of adefovir dipivoxil administered in Korean CHB patients according to the prescribing information
This study is a post-marketing surveillance to monitor safety and efficacy of adefovir dipivoxil and identify SAEs, adverse drug reactions (ADRs), and unexpected AEs not described as precautions or warnings and to identify possible factors that have an effect on the AEs and to assess effectiveness of adefovir dipivoxil in real clinical practices after marketing. The subjects are patients prescribed for adefovir dipivoxil by the investigators at the sites based on prescription information in normal clinical practices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adefovir dipivoxil | Patients administrated adefovir at the site |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adefovir dipivoxil | Drug | Basically there is no treatment allocation. Subjects who would be administered of adefovir at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Adverse Event | An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, please see the table entitled "Other (non-serious) adverse events" in the Adverse Event section of the results record. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Serious Adverse Event | A serious adverse event is any untoward medical occurrence that, at any dose: results in death /is life-threatening; requires hospitalization or prolongation of exixting hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is another medically significant event. For a list of all serious adverse events occurring during the course of the study, please see the table entitled "Serious Adverse Events" in the Adverse Event section of the results record. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients administrated adefovir dipivoxil at the site
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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The objective of this post-marketing surveillance (PMS) study was to monitor the safety and efficacy of Hepsera in the real clinical setting after launch.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hepsera 10 mg Once a Day | Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Hepsera 10 mg Once a Day | Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline characteristics were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who had been administered the investigational drug at least once and had undergone all safety assessments. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With an Adverse Event | An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. For a list of all adverse events occurring during the course of the study, please see the table entitled "Other (non-serious) adverse events" in the Adverse Event section of the results record. | Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had undergone all safety assessments | Posted | Number | participants | 12 weeks |
|
February 19, 2004 to February 18, 2010
Adverse events were coded by using World Health Organization Adverse Reactions Terminology (WHOART, preferred term level) according to the local regulation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hepsera 10 mg Once a Day | Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatic Failure | Hepatobiliary disorders | WHOART | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | WHOART | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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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 |
|---|---|
| C106812 | adefovir dipivoxil |
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|
| 12 weeks |
| Number of Participants With the Indicated Unexpected Adverse Events | An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings. | 12 weeks |
| Mean |
| Standard Deviation |
| Years |
|
| Sex/Gender, Customized | Baseline characteristics were collected in members of the ITT Population, comprised of all participants who had been administered the investigational drug at least once and had undergone all safety assessments. | Number | Participants |
|
| Race/Ethnicity, Customized | Baseline characteristics were collected in members of the ITT Population, comprised of all participants who had been administered the investigational drug at least once and had undergone all safety assessments. | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Participants With a Serious Adverse Event | A serious adverse event is any untoward medical occurrence that, at any dose: results in death /is life-threatening; requires hospitalization or prolongation of exixting hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is another medically significant event. For a list of all serious adverse events occurring during the course of the study, please see the table entitled "Serious Adverse Events" in the Adverse Event section of the results record. | ITT Population | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | Number of Participants With the Indicated Unexpected Adverse Events | An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unexpected adverse events include those not listed in the approved product information and not described as precautions or warnings. | ITT Population | Posted | Number | participants | 12 weeks |
|
|
|
| 32 |
| 4,158 |
| 74 |
| 4,158 |
| Hepatic Cirrhosis | Hepatobiliary disorders | WHOART | Systematic Assessment |
|
| Vein Varicose | Blood and lymphatic system disorders | WHOART | Systematic Assessment |
|
| Gastric Ulcer Hemorrhagic | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | WHOART | Systematic Assessment |
|
| Hepatic Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHOART | Systematic Assessment |
|
| Hematemesis | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | WHOART | Systematic Assessment |
|
| Hepatic Encephalopathy | Hepatobiliary disorders | WHOART | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | WHOART | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | WHOART | Systematic Assessment |
|
| Alanine Transaminase/Aspartate Aminotransferase Increased | Hepatobiliary disorders | WHOART | Systematic Assessment |
|
| Fever | General disorders | WHOART | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | WHOART | Systematic Assessment |
|
| Ascites | General disorders | WHOART | Systematic Assessment |
|
| Pulmonary Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHOART | Systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | WHOART | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | WHOART | Systematic Assessment |
|
| Hernia Inguinal | Reproductive system and breast disorders | WHOART | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | WHOART | Systematic Assessment |
|
| Fasciitis Necrotising | Musculoskeletal and connective tissue disorders | WHOART | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Gagging | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Diarrhea | General disorders | WHOART | Systematic Assessment |
|
| Esophageal Varices | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Hemorrhage Rectum | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Gastric Ulcer Hemorrhagic | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Hematemesis | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Melaena | Gastrointestinal disorders | WHOART | Systematic Assessment |
|
| Hepatic Failure | Hepatobiliary disorders | WHOART | Systematic Assessment |
|
| Hepatic Cirrhosis | Hepatobiliary disorders | WHOART | Systematic Assessment |
|
| Alanine Transaminase/Aspartate Aminotransferase Increased | Hepatobiliary disorders | WHOART | Systematic Assessment |
|
| Hepatic Encephalopathy | Hepatobiliary disorders | WHOART | Systematic Assessment |
|
| Hepatitis Chronic Active Aggrava | Hepatobiliary disorders | WHOART | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | WHOART | Systematic Assessment |
|
| Asthenia | General disorders | WHOART | Systematic Assessment |
|
| Ascites | General disorders | WHOART | Systematic Assessment |
|
| Fatigue | General disorders | WHOART | Systematic Assessment |
|
| Tolerance | General disorders | WHOART | Systematic Assessment |
|
| Edema Peripheral | General disorders | WHOART | Systematic Assessment |
|
| Fever | General disorders | WHOART | Systematic Assessment |
|
| Coughing | Respiratory, thoracic and mediastinal disorders | WHOART | Systematic Assessment |
|
| Sputum Increased | Respiratory, thoracic and mediastinal disorders | WHOART | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | WHOART | Systematic Assessment |
|
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | WHOART | Systematic Assessment |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | WHOART | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | WHOART | Systematic Assessment |
|
| Hepatic Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHOART | Systematic Assessment |
|
| Pulmonary Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHOART | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | WHOART | Systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | WHOART | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | WHOART | Systematic Assessment |
|
| Urethral Disorder | Renal and urinary disorders | WHOART | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | WHOART | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | WHOART | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | WHOART | Systematic Assessment |
|
| Skin Reaction Localised | Skin and subcutaneous tissue disorders | WHOART | Systematic Assessment |
|
| Vein Varicose | Blood and lymphatic system disorders | WHOART | Systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | WHOART | Systematic Assessment |
|
| Fasciitis Necrotising | Musculoskeletal and connective tissue disorders | WHOART | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | WHOART | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | WHOART | Systematic Assessment |
|
| Headache | Nervous system disorders | WHOART | Systematic Assessment |
|
| Hernia Inguinal | Renal and urinary disorders | WHOART | Systematic Assessment |
|
| Red Blood Cell Abnormality | Blood and lymphatic system disorders | WHOART | Systematic Assessment |
|
| Marrow Hyperplasia | Blood and lymphatic system disorders | WHOART | Systematic Assessment |
|
| Marrow Depression | Blood and lymphatic system disorders | WHOART | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | WHOART | Systematic Assessment |
|
| Splenomegaly | Blood and lymphatic system disorders | WHOART | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| Title | Measurements |
|---|---|
|
| Hepatic Neoplasm |
|
| Hypoaesthesia |
|
| Hemoptysis |
|
| Azotaemia |
|
| Marrow Hyperplasia |
|
| Marrow Depression |
|
| Fracture |
|
| Fasciitis Necrotising |
|
| Skin Reaction Localised |
|
| Myalgia |
|
| Resistance |
|
| Proteinuria |
|
| Edema Peripheral |
|
| Dysuria |
|
| Pancytopenia |
|
| Ascites |
|
| Splenomegaly |
|
| Hernia Inguinal |
|
| Esophageal Varices |
|
| Urethral Disorder |
|
| Erythrocytes Abnormal |
|
| Vein Varicose |
|
| Hemorrhage Rectum |
|
| Gastric Ulcer Hemorrhagic |
|
| Hematemesis |
|
| Pneumonia |
|
| Pulmonary Carcinoma |
|
| Fatigue |
|
| Dyspnea |
|
| Jaundice |
|
| Melaena |
|