Hepatitis B
Conditions
Brief summary
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
Detailed description
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.
Interventions
DRUGadefovir dipivoxil
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.
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients administrated adefovir dipivoxil at the site
Exclusion criteria
* Patients administrated adefovir dipivoxil before center initiated date
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Adverse Event | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Serious Adverse Event | 12 weeks | 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. |
| Number of Participants With the Indicated Unexpected Adverse Events | 12 weeks | 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. |
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Hepsera 10 mg Once a Day Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily | 4,158 |
| Total | 4,158 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 235 |
Baseline characteristics
| Characteristic | Hepsera 10 mg Once a Day |
|---|---|
| Age, Continuous | 43.9 Years STANDARD_DEVIATION 11 |
| Race/Ethnicity, Customized Korean | 4158 participants |
| Race/Ethnicity, Customized Not Korean | 0 participants |
| Sex/Gender, Customized Female | 874 Participants |
| Sex/Gender, Customized Male | 3280 Participants |
| Sex/Gender, Customized Missing | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 74 / 4,158 |
| serious Total, serious adverse events | 32 / 4,158 |
Outcome results
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.
Time frame: 12 weeks
Population: Intent-to-Treat (ITT) Population: all participants who had been administered the investigational drug at least once and had undergone all safety assessments
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hepsera 10 mg Once a Day | Number of Participants With an Adverse Event | 74 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.
Time frame: 12 weeks
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hepsera 10 mg Once a Day | Number of Participants With a Serious Adverse Event | 32 participants |
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.
Time frame: 12 weeks
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Sputum Increased | 5 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Hepatic Cirrhosis | 4 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Hepatic Encephalopathy | 2 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Hepatic Neoplasm | 7 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Hypoaesthesia | 2 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Hemoptysis | 1 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Azotaemia | 1 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Marrow Hyperplasia | 1 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Marrow Depression | 1 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Fracture | 1 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Fasciitis Necrotising | 1 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Skin Reaction Localised | 1 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Myalgia | 1 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Resistance | 1 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Proteinuria | 1 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Edema Peripheral | 1 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Dysuria | 2 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Pancytopenia | 1 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Ascites | 3 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Splenomegaly | 1 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Hernia Inguinal | 1 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Esophageal Varices | 1 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Urethral Disorder | 1 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Erythrocytes Abnormal | 1 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Vein Varicose | 4 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Hemorrhage Rectum | 1 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Gastric Ulcer Hemorrhagic | 1 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Hematemesis | 1 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Pneumonia | 2 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Pulmonary Carcinoma | 1 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Fatigue | 3 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Dyspnea | 1 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Jaundice | 2 participants |
| Hepsera 10 mg Once a Day | Number of Participants With the Indicated Unexpected Adverse Events | Melaena | 1 participants |