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Objective(s) The primary study objective is to assess the antiviral effect of 12 weeks of adefovir dipivoxil treatment in Korean patients with chronic hepatitis B and compensated liver disease. The secondary study objectives are to assess the antiviral effect, clinical benefit and safety of 52 weeks of adefovir dipivoxil treatment.
Endpoint(s) The primary efficacy endpoint is "Mean log10 reduction in serum HBV DNA level from baseline to Week 12".
The secondary efficacy endpoints include (a) the proportion of patients achieving serum ALT normalization at Week 52, (b) other assessments of antiviral effects (the proportion of patients achieving HBV DNA no less than 300 copies per mL at Week 52), (c)HBeAg loss, HBeAg seroconversion, HBsAg loss and HBsAg seroconversion, (d)the proportion of patients achieving serum ALT normalization at Week 12.
Study Design This is an open label, multi centre phase IV study for Korean patients with chronic hepatitis B and compensated liver disease, assessing the antiviral effect of 12 weeks treatment of Adefovir dipivoxil as a primary objective and antiviral effect, clinical benefit and safety of 52 weeks treatment as secondary objectives.
Patients will be screened for eligibility criteria and the baseline visit for the treatment initiation should occur no more than 4 weeks after screening. Total treatment period will be 52 weeks and patients will return to the clinic for assessments as scheduled during treatment period. After the 52 week study period, it is likely that the patient will benefit from continued treatment with commercial adefovir. If in the investigator's clinical judgement this is the case, the investigator should ensure that a routine prescription is available in a timely manner, and that no unnecessary interruption in treatment occurs.
Study Population A minimum of 100 male or female Korean patients more than 18 years of age with HBeAg positive chronic hepatitis B and compensated liver disease who meet the eligibility criteria will be enrolled.
Study Assessments and Procedures
Potential patients will be screened prior to study entry and eligible patients who have given their consent will have further baseline assessments. Following the screening, the first doses of study medications will be given at baseline and patients will return to the clinic for assessment as scheduled during treatment period. Patients who discontinue treatment prematurely will be followed up every 4 weeks for 12 weeks following the withdrawal visit. The following key assessment and or measurement will be made at one or more visits during the study. (See section 14.1 Appendix 1. Time and event schedule):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adefovir Dipivoxil 10mg | Experimental | All enrolled subject were enrolled to adefovir dipivoxil 10mg arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adefor dipivoxil | Drug | All enrolled subjects were enrolled to adefovir dipivoxil arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Log 10 Reduction in Serum Hepatitis B Virus (HBV), Deoxyribonucleic Acid (DNA) Level From Baseline to Week 12 | HBV DNA was tested with Roche Cobas Amplicor HBV monitor test, where the lower limit of detection was 300 copies/milliliter (mL), at baseline and other study visits. The mean log 10 reduction in serum HBV DNA level from baseline to week 12 was calculated as the week 12 value minus the baseline value. Baseline was the Day 1 for the study, when participant received study drug. Log 10 reduction implied reduced viral load. | Baseline (Day 1) and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving Alanine Aminotransferase (ALT) Normalization at Week 52 | ALT normalization was defined as measurement less than or equal to the upper limit of the normal range. Only those set of participants with a baseline ALT value above the upper limit of the normal range was included in this analysis. The normal range for ALT is 7 to 43 Units/Liter. | At week 52 |
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Inclusion Criteria:
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
4. Evidence of at least one elevated serum alanine amonotransferase (ALT) levels greater than 2 times (inclusive) the upper limit of the normal range (ULN) in the previous 6 months.
serum ALT levels greater than 2 times (inclusive) the ULN at screening visit. 5. Availability and willingness of subject to provide written informed consent.
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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Of the total 140 participants which were screened only 104 participants were randomized to the study.
The study was conducted in participants with chronic hepatitis B and compensated liver disease, at 5 sites in Korea. It was conducted from 01 December 2004 to 28 April 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adefovir Dipivoxil 10mg | The eligible participants received open label treatment of 10 milligram (mg) Adefovir dipivoxil, orally once daily for 52-weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adefovir Dipivoxil 10mg | The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Log 10 Reduction in Serum Hepatitis B Virus (HBV), Deoxyribonucleic Acid (DNA) Level From Baseline to Week 12 | HBV DNA was tested with Roche Cobas Amplicor HBV monitor test, where the lower limit of detection was 300 copies/milliliter (mL), at baseline and other study visits. The mean log 10 reduction in serum HBV DNA level from baseline to week 12 was calculated as the week 12 value minus the baseline value. Baseline was the Day 1 for the study, when participant received study drug. Log 10 reduction implied reduced viral load. | Intent to treat (ITT). All participants regardless of whether or not the participant completed the planned duration of the study were analyzed with no data exclusions. | Posted | Mean | Standard Deviation | Log10 (copies/mL) | Baseline (Day 1) and Week 12 |
|
From treatment initiation (Week 0) to follow-up (up to 52 weeks)
ITT population
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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 | Adefovir Dipivoxil 10mg | The eligible participants received open label treatment of 10 mg Adefovir dipivoxil, orally once daily for 52-weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 8.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 8.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Number of Participants Achieving Virological Response at Week 52 | Virological response was defined as HBV DNA level < 300 copies/ml in serum. The number of participants achieving these DNA levels were reported. | At Week 52 |
| HBV DNA Levels at Each Collection Timepoint Through Week 52 | Serum HBV DNA at different timepoints namely Baseline, Week 4, week 8, week 12, week 20, week 28, week 36, week 44 and week 52 were reported. The HBV DNA copies in the serum were reported in multiples of log 10 copies per mL, detected using Roche COBAS AMPLICOR HBV monitor. | Week 4, week 8, week 12, week 20, week 28, week 36, week 44 and week 52 |
| Number of Participants With Hepatitis B e Viral Protein (HBeAg) Loss, HBeAg Seroconversion, Hepatitis B Virus Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Week 52 | The HBeAg loss, defined as the number of participants with an undetectable level of serum HBeAg. The percentage of participants with a HBeAg seroconversion, defined as an undetectable level of serum HBeAg and a detectable level of serum hepatitis B e antibody (HBeAb) at Week 52. The number of participants with HBsAg loss was defined as an undetectable level of serum HBsAg; and those participants with HBsAg seroconversion were defined as an undetectable level of serum HBsAg and a detectable level of serum HBsAb. All these participant were reported at week 52. Only the subset of participants, with above parameters detectable at baseline were included and for participants with post-baseline values missing were considered as non-responders. | Week 52 |
| Number of Participants Achieving ALT Normalization at Week 12 | ALT normalization was defined as measurement less than or equal to the upper limit of the normal range. The normal range for ALT is 7-43 Units/Liter. Only those set of participants with a baseline ALT value above the upper limit of the normal range were included in this analysis, done at week 12. | at Week 12 |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAEs) | AE is defined as, any untoward medical occurrence in a participant or clinical investigation, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that at any dose, results in death; is life threatening; requires hospitalization or prolongation of hospitalization; results in disability or incapacity, is a congenital anomaly/birth defect or requires medical intervention. | From treatment initiation (Week 0) to follow-up (up to 52 weeks) |
| Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52 | The data for hematology parameters was summarized for Hemoglobin, Red blood cells (RBC), Platelets, Neutrophils, Lymphocytes, Monocytes, and Eosinophil as per the scheduled assessments and also according to maximum grade common terminology criteria (CTC) toxicity grade. The data for number of participants with shift in grade for hematology parameters at Week 12 and Week 52 were reported. | Baseline (Day 1), Week 12 and Week 52 |
| Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52 | The data for clinical chemical parameters namely sodium, potassium, calcium, phosphorus, total protein, albumin, amylase, creatinine phospho kinase, creatinine, blood urea nitrogen, total bilirubin, alkaline phosphatase, aspartate transaminase, alanine transaminase, and prothrombin time as per the scheduled assessments and also according to maximum CTC toxicity grade was reported. The data for number of participants with shift in grade for clinical chemistry parameters at Week 12 and Week 52 were reported. | Baseline (Day 1), Week 12 and Week 52 |
| Mean Log 10 Reduction in Serum HBV DNA Level From Baseline to Week 52 | HBV DNA was tested with Roche Cobas Amplicor HBV monitor test, HBV DNA was tested with Roche Cobas Amplicor HBV monitor test, Lower Limit of Detection 300 copies/mL), at baseline and other study visits. The mean log 10 reduction in serum HBV DNA level from baseline to Week 52 was calculated as the Week 52 value minus the baseline value. Baseline was the Day 1 for the study when participant received study drug. Log 10 reduction implied reduced viral load | Baseline (Day 1) and Week 52 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
|
|
|
| Secondary | Number of Participants Achieving Alanine Aminotransferase (ALT) Normalization at Week 52 | ALT normalization was defined as measurement less than or equal to the upper limit of the normal range. Only those set of participants with a baseline ALT value above the upper limit of the normal range was included in this analysis. The normal range for ALT is 7 to 43 Units/Liter. | ITT population | Posted | Count of Participants | Participants | At week 52 |
|
|
|
| Secondary | Number of Participants Achieving Virological Response at Week 52 | Virological response was defined as HBV DNA level < 300 copies/ml in serum. The number of participants achieving these DNA levels were reported. | ITT population. | Posted | Count of Participants | Participants | At Week 52 |
|
|
|
| Secondary | HBV DNA Levels at Each Collection Timepoint Through Week 52 | Serum HBV DNA at different timepoints namely Baseline, Week 4, week 8, week 12, week 20, week 28, week 36, week 44 and week 52 were reported. The HBV DNA copies in the serum were reported in multiples of log 10 copies per mL, detected using Roche COBAS AMPLICOR HBV monitor. | ITT population. Only those participants available at the specified timepoints were analyzed | Posted | Mean | Standard Deviation | log 10 copies/mL | Week 4, week 8, week 12, week 20, week 28, week 36, week 44 and week 52 |
|
|
|
| Secondary | Number of Participants With Hepatitis B e Viral Protein (HBeAg) Loss, HBeAg Seroconversion, Hepatitis B Virus Surface Antigen (HBsAg) Loss and HBsAg Seroconversion at Week 52 | The HBeAg loss, defined as the number of participants with an undetectable level of serum HBeAg. The percentage of participants with a HBeAg seroconversion, defined as an undetectable level of serum HBeAg and a detectable level of serum hepatitis B e antibody (HBeAb) at Week 52. The number of participants with HBsAg loss was defined as an undetectable level of serum HBsAg; and those participants with HBsAg seroconversion were defined as an undetectable level of serum HBsAg and a detectable level of serum HBsAb. All these participant were reported at week 52. Only the subset of participants, with above parameters detectable at baseline were included and for participants with post-baseline values missing were considered as non-responders. | ITT population. Only the subset of participants with HBeAg and HBsAg positive at baseline (Day 1) was included in the analysis. | Posted | Count of Participants | Participants | Week 52 |
|
|
|
| Secondary | Number of Participants Achieving ALT Normalization at Week 12 | ALT normalization was defined as measurement less than or equal to the upper limit of the normal range. The normal range for ALT is 7-43 Units/Liter. Only those set of participants with a baseline ALT value above the upper limit of the normal range were included in this analysis, done at week 12. | ITT population | Posted | Count of Participants | Participants | at Week 12 |
|
|
|
| Secondary | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAEs) | AE is defined as, any untoward medical occurrence in a participant or clinical investigation, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that at any dose, results in death; is life threatening; requires hospitalization or prolongation of hospitalization; results in disability or incapacity, is a congenital anomaly/birth defect or requires medical intervention. | ITT population. | Posted | Count of Participants | Participants | From treatment initiation (Week 0) to follow-up (up to 52 weeks) |
|
|
|
| Secondary | Number of Participants With Shift From Baseline Hematology Parameters at Week 12 and Week 52 | The data for hematology parameters was summarized for Hemoglobin, Red blood cells (RBC), Platelets, Neutrophils, Lymphocytes, Monocytes, and Eosinophil as per the scheduled assessments and also according to maximum grade common terminology criteria (CTC) toxicity grade. The data for number of participants with shift in grade for hematology parameters at Week 12 and Week 52 were reported. | ITT population. | Posted | Count of Participants | Participants | Baseline (Day 1), Week 12 and Week 52 |
|
|
|
| Secondary | Number of Participants With Shift From Baseline Clinical Chemistry Parameters at Week 12 and Week 52 | The data for clinical chemical parameters namely sodium, potassium, calcium, phosphorus, total protein, albumin, amylase, creatinine phospho kinase, creatinine, blood urea nitrogen, total bilirubin, alkaline phosphatase, aspartate transaminase, alanine transaminase, and prothrombin time as per the scheduled assessments and also according to maximum CTC toxicity grade was reported. The data for number of participants with shift in grade for clinical chemistry parameters at Week 12 and Week 52 were reported. | ITT population. Only those participants available at the specified time points were analyzed | Posted | Count of Participants | Participants | Baseline (Day 1), Week 12 and Week 52 |
|
|
|
| Secondary | Mean Log 10 Reduction in Serum HBV DNA Level From Baseline to Week 52 | HBV DNA was tested with Roche Cobas Amplicor HBV monitor test, HBV DNA was tested with Roche Cobas Amplicor HBV monitor test, Lower Limit of Detection 300 copies/mL), at baseline and other study visits. The mean log 10 reduction in serum HBV DNA level from baseline to Week 52 was calculated as the Week 52 value minus the baseline value. Baseline was the Day 1 for the study when participant received study drug. Log 10 reduction implied reduced viral load | ITT population | Posted | Mean | Standard Deviation | Log10 (copies/mL) | Baseline (Day 1) and Week 52 |
|
|
|
| 0 |
| 104 |
| 2 |
| 104 |
| 16 |
| 104 |
| Ascites | Hepatobiliary disorders | MedDRA 8.0 | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA 8.0 | 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.
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Week 12 |
|
|
| Week 20 |
|
|
| Week 28 |
|
|
| Week 36 |
|
|
| Week 44 |
|
|
| Week 52 |
|
|
|
| HbsAg loss |
|
|
| HbsAg seroconversion |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Hemoglobin, High to Normal, Week 12 |
|
| Hemoglobin, Normal to Low, Week 12 |
|
| Hemoglobin, Normal to High Week 12 |
|
| Hemoglobin, Low to Normal, Week 52 |
|
| Hemoglobin, Low to High, Week 52 |
|
| Hemoglobin, High to Low, Week 52 |
|
| Hemoglobin, High to Normal, Week 52 |
|
| Hemoglobin, Normal to Low, Week 52 |
|
| Hemoglobin, Normal to High Week 52 |
|
| RBC, Low to Normal, Week 12 |
|
| RBC, Low to High, Week 12 |
|
| RBC, High to Low, Week 12 |
|
| RBC, High to Normal, Week 12 |
|
| RBC, Normal to Low, Week 12 |
|
| RBC, Normal to High Week 12 |
|
| RBC, Low to Normal, Week 52 |
|
| RBC, Low to High, Week 52 |
|
| RBC, High to Low, Week 52 |
|
| RBC, High to Normal, Week 52 |
|
| RBC, Normal to Low, Week 52 |
|
| RBC, Normal to High Week 52 |
|
| Platelets, Low to Normal, Week 12 |
|
| Platelets, Low to High, Week 12 |
|
| Platelets, High to Low, Week 12 |
|
| Platelets, High to Normal, Week 12 |
|
| Platelets, Normal to Low, Week 12 |
|
| Platelet, Normal to High, Week 12 |
|
| Platelets, Low to Normal, Week 52 |
|
| Platelets, Low to High, Week 52 |
|
| Platelets, High to Low, Week 52 |
|
| Platelets, High to Normal, Week 52 |
|
| Platelet, Normal to Low, Week 52 |
|
| Platelets, Normal to High, Week 52 |
|
| Total WBC, Low to Normal, Week 12 |
|
| Total WBC, Low to High, Week 12 |
|
| Total WBC, High to Low, Week 12 |
|
| Total WBC, High to Normal, Week 12 |
|
| Total WBC, Normal to Low, Week 12 |
|
| Total WBC, Normal to High Week 12 |
|
| Total WBC, Low to Normal, Week 52 |
|
| Total WBC, Low to High, Week 52 |
|
| Total WBC, High to Low, Week 52 |
|
| Total WBC, High to Normal, Week 52 |
|
| Total WBC, Normal to Low, Week 52 |
|
| Total WBC, Normal to High, Week 52 |
|
| Neutrophils, Low to Normal, Week 12 |
|
| Neutrophils, Low to High, Week 12 |
|
| Neutrophils, High to Low, Week 12 |
|
| Neutrophils, High to Normal, Week 12 |
|
| Neutrophils, Normal to Low, Week 12 |
|
| Neutrophils, Normal to High, Week 12 |
|
| Neutrophils, Low to Normal, Week 52 |
|
| Neutrophils, Low to High, Week 52 |
|
| Neutrophils, High to Low, Week 52 |
|
| Neutrophils, High to Normal, Week 52 |
|
| Neutrophils, Normal to Low, Week 52 |
|
| Neutrophils, Normal to High, Week 52 |
|
| Lymphocytes, Low to Normal, Week 12 |
|
| Lymphocytes, Low to High, Week 12 |
|
| Lymphocytes, High to Low, Week 12 |
|
| Lymphocytes, High to Normal, Week 12 |
|
| Lymphocytes, Normal to Low, Week 12 |
|
| Lymphocytes, Normal to High Week 12 |
|
| Lymphocytes, Low to Normal, Week 52 |
|
| Lymphocytes, Low to High, Week 52 |
|
| Lymphocytes, High to Low, Week 52 |
|
| Lymphocytes, High to Normal, Week 52 |
|
| Lymphocytes, Normal to Low, Week 52 |
|
| Lymphocytes, Normal to High, Week 52 |
|
| Monocytes, Low to Normal, Week 12 |
|
| Monocytes, Low to High, Week 12 |
|
| Monocytes, High to Low, Week 12 |
|
| Monocytes, High to Normal, Week 12 |
|
| Monocytes, Normal to Low, Week 12 |
|
| Monocytes, Normal to High, Week 12 |
|
| Monocytes, Low to Normal, Week 52 |
|
| Monocytes, Low to High, Week 52 |
|
| Monocytes, High to Low, Week 52 |
|
| Monocytes, High to Normal, Week 52 |
|
| Monocytes, Normal to Low, Week 52 |
|
| Monocytes, Normal to High, Week 52 |
|
| Eosinophils, Low to Normal, Week 12 |
|
| Eosinophils, Low to High, Week 12 |
|
| Eosinophils, High to Low, Week 12 |
|
| Eosinophils, High to Normal, Week 12 |
|
| Eosinophils, Normal to Low, Week 12 |
|
| Eosinophils, Normal to High Week 12 |
|
| Eosinophils, Low to Normal, Week 52 |
|
| Eosinophils, Low to High, Week 52 |
|
| Eosinophils, High to Normal, Week 52 |
|
| Eosinophils, High to Low, Week 52 |
|
| Eosinophils, Normal to High, Week 52 |
|
| Eosinophils, Normal to Low, Week 52 |
|
| Title | Measurements |
|---|---|
|
| Sodium, Normal to Low, Week 12 |
|
| Sodium, High to Normal, Week 12 |
|
| Sodium, Normal to High, Week 12 |
|
| Sodium, Low to Normal, Week 52 |
|
| Sodium, Low to High, Week 52 |
|
| Sodium, High to Low, Week 52 |
|
| Sodium, High to Normal, Week 52 |
|
| Sodium, Normal to Low, Week 52 |
|
| Sodium, Normal to High, Week 52 |
|
| Potassium, Low to Normal, Week 12 |
|
| Potassium, Low to High, Week 12 |
|
| Potassium, High to Low, Week 12 |
|
| Potassium, High to Normal, Week 12 |
|
| Potassium, Normal to Low, Week 12 |
|
| Potassium, Normal to High, Week 12 |
|
| Potassium, Low to Normal, Week 52 |
|
| Potassium, Low to High, Week 52 |
|
| Potassium, High to Low, Week 52 |
|
| Potassium, High to Normal, Week 52 |
|
| Potassium, Normal to Low, Week 52 |
|
| Potassium, Normal to High, Week 52 |
|
| Calcium, Low to Normal, Week 12 |
|
| Calcium, Low to High, Week 12 |
|
| Calcium, High to Low, Week 12 |
|
| Calcium, High to Normal, Week 12 |
|
| Calcium, Normal to Low, Week 12 |
|
| Calcium, Normal to High, Week 12 |
|
| Calcium, Low to Normal, Week 52 |
|
| Calcium, Low to High, Week 52 |
|
| Calcium, High to Low, Week 52 |
|
| Calcium, High to Normal, Week 52 |
|
| Calcium, Normal to Low, Week 52 |
|
| Calcium, Normal to High, Week 52 |
|
| Phosphorus, Low to Normal, Week 12 |
|
| Phosphorus, Low to High, Week 12 |
|
| Phosphorus, High to Low, Week 12 |
|
| Phosphorus, High to Normal, Week 12 |
|
| Phosphorus, Normal to Low, Week 12 |
|
| Phosphorus, Normal to High, Week 12 |
|
| Phosphorus, Low to Normal, Week 52 |
|
| Phosphorus, Low to High, Week 52 |
|
| Phosphorus, High to Low, Week 52 |
|
| Phosphorus, High to Normal, Week 52 |
|
| Phosphorus, Normal to Low, Week 52 |
|
| Phosphorus, Normal to High, Week 52 |
|
| Total Protein, Low to Normal, Week 12 |
|
| Total Protein, Low to High, Week 12 |
|
| Total Protein, High to Low, Week 12 |
|
| Total Protein, High to Normal, Week 12 |
|
| Total Protein, Normal to Low, Week 12 |
|
| Total Protein, Normal to High, Week 12 |
|
| Total Protein, Low to Normal, Week 52 |
|
| Total Protein, Low to High, Week 52 |
|
| Total Protein, High to Low, Week 52 |
|
| Total Protein, High to Normal, Week 52 |
|
| Total Protein, Normal to Low, Week 52 |
|
| Total Protein, Normal to High, Week 52 |
|
| Amylase, Low to Normal, Week 12 |
|
| Amylase, Low to High, Week 12 |
|
| Amylase, High to Low, Week 12 |
|
| Amylase, High to Normal, Week 12 |
|
| Amylase, Normal to Low, Week 12 |
|
| Amylase, Normal to High, Week 12 |
|
| Amylase, Low to Normal, Week 52 |
|
| Amylase, Low to High, Week 52 |
|
| Amylase, High to Low, Week 52 |
|
| Amylase, High to Normal, Week 52 |
|
| Amylase, Normal to Low, Week 52 |
|
| Amylase, Normal to High, Week 52 |
|
| Creatinine phosphokinase, Low to Normal, Week 12 |
|
| Creatinine phosphokinase, Low to High, Week 12 |
|
| Creatinine phosphokinase, High to Low, Week 12 |
|
| Creatinine phosphokinase, High to Normal, Week 12 |
|
| Creatinine phosphokinase, Normal to Low, Week 12 |
|
| Creatinine phosphokinase, Normal to High, Week 12 |
|
| Creatinine phosphokinase, Low to Normal, Week 52 |
|
| Creatinine phosphokinase, Low to High, Week 52 |
|
| Creatinine phosphokinase, High to Low, Week 52 |
|
| Creatinine phosphokinase, High to Normal, Week 52 |
|
| Creatinine phosphokinase, Normal to Low, Week 52 |
|
| Creatinine phosphokinase, Normal to High, Week 52 |
|
| Creatinine, Low to Normal, Week 12 |
|
| Creatinine, Low to High, Week 12 |
|
| Creatinine, High to Low, Week 12 |
|
| Creatinine, High to Normal, Week 12 |
|
| Creatinine, Normal to Low, Week 12 |
|
| Creatinine, Normal to High, Week 12 |
|
| Creatinine, Low to Normal, Week 52 |
|
| Creatinine, Low to High, Week 52 |
|
| Creatinine, High to Low, Week 52 |
|
| Creatinine, High to Normal, Week 52 |
|
| Creatinine, Normal to Low, Week 52 |
|
| Creatinine, Normal to High, Week 52 |
|
| Blood urea nitrogen, Low to Normal, Week 12 |
|
| Blood urea nitrogen, Low to High, Week 12 |
|
| Blood urea nitrogen, High to Low, Week 12 |
|
| Blood urea nitrogen, High to Normal, Week 12 |
|
| Blood urea nitrogen, Normal to Low, Week 12 |
|
| Blood urea nitrogen, Normal to High, Week 12 |
|
| Blood urea nitrogen, Low to Normal, Week 52 |
|
| Blood urea nitrogen, Low to High, Week 52 |
|
| Blood urea nitrogen, High to Low, Week 52 |
|
| Blood urea nitrogen, High to Normal, Week 52 |
|
| Blood urea nitrogen, Normal to Low, Week 52 |
|
| Blood urea nitrogen, Normal to High, Week 52 |
|
| Total bilirubin, Low to Normal, Week 12 |
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| Total bilirubin, Low to High, Week 12 |
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| Total bilirubin, High to Low, Week 12 |
|
| Total bilirubin, High to Normal, Week 12 |
|
| Total bilirubin, Normal to Low, Week 12 |
|
| Total bilirubin, Low to Normal, Week 52 |
|
| Total bilirubin, Low to High, Week 52 |
|
| Total bilirubin, High to Low, Week 52 |
|
| Total bilirubin, High to Normal, Week 52 |
|
| Total bilirubin, Normal to Low, Week 52 |
|
| Total bilirubin, Normal to High, Week 52 |
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| Alkaline phosphatase, Low to Normal, Week 12 |
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| Alkaline phosphatase, Low to High, Week 12 |
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| Alkaline phosphatase, High to Low, Week 12 |
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| Alkaline phosphatase, High to Normal, Week 12 |
|
| Alkaline phosphatase, Normal to Low, Week 12 |
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| Alkaline phosphatase, Normal to High, Week 12 |
|
| Alkaline phosphatase, Low to Normal, Week 52 |
|
| Alkaline phosphatase, Low to High, Week 52 |
|
| Alkaline phosphatase, High to Low, Week 52 |
|
| Alkaline phosphatase, High to Normal, Week 52 |
|
| Alkaline phosphatase, Normal to Low, Week 52 |
|
| Alkaline phosphatase, Normal to High, Week 52 |
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| Prothrombin Time, Low to Normal, Week 12 |
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| Prothrombin Time, Low to High, Week 12 |
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| Prothrombin Time, High to Low, Week 12 |
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| Prothrombin Time, High to Normal, Week 12 |
|
| Prothrombin Time, Normal to Low, Week 12 |
|
| Prothrombin Time, Normal to High, Week 12 |
|
| Prothrombin Time, Low to Normal, Week 52 |
|
| Prothrombin Time, Low to High, Week 52 |
|
| Prothrombin Time, High to Low, Week 52 |
|
| Prothrombin Time, High to Normal, Week 52 |
|
| Prothrombin Time, Normal to Low, Week 52 |
|
| Prothrombin Time, Normal to High, Week 52 |
|