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This is an international, multicenter trial, evaluating pharmacokinetics (PK) (4 weeks), safety (52 weeks), and hemoglobin (Hgb) response (52 weeks) to daprodustat in children and adolescent participants with anemia associated with chronic kidney disease (CKD) incorporating 2 independent sub-trials (Non dialysis [ND] and Dialysis [D]). This study will enroll participants with anemia associated with CKD, in 2 distinct sub-populations differing only by their CKD stage and dialysis requirement (ND: CKD stage 3 to 5 not yet receiving dialysis and D: CKD stage 5d undergoing peritoneal dialysis [PD] or hemodialysis [HD]).
The maximum duration of the study will be approximately 60 weeks, including Screening period (up to 4 weeks), treatment period (52 weeks), and follow-up period (4 weeks).
Outcome measures are identical for the ND and D sub-trials, but will be separately assessed in each sub- trials, overall and within each age subgroups (12 to less than [<] 18 years, 6 to <12 years, 2 to <6 years, and 3 months to <2 years). Except for PK and dose change, which is within each age group only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daprodustat | Experimental | All participants will receive daprodustat for up to 52 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daprodustat | Drug | Daprodustat will be administered up to Week 52. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other situations as per medical and scientific judgement of the Investigator. | Up to 56 weeks |
| Number of Participants With Adverse Event of Special Interests (AESIs) | AESIs are AEs of scientific interest specific to the drug class as per investigator assessment. AESI included: Death, Myocardial Infarction (MI), stroke, Heart Failure (HF), thromboembolic events, thrombosis of vascular access, Thrombosis and/or tissue ischemia secondary to excessive erythropoiesis, New diagnosis of hypertension or worsening of existing hypertension, Cancer related mortality and tumor progression and recurrence, Esophageal and gastric erosions. Number of participants with any AESIs have been presented. | Up to 56 weeks |
| Number of Participants With AEs Leading to Study Intervention Discontinuation | All AEs leading to study intervention discontinuation were collected. Number of participants with any AEs leading to study intervention discontinuation have been presented | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hematology Parameter: Hematocrit | Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Aichi | 466-8650 | Japan | |||
| GSK Investigational Site |
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
A total of 4 participants were enrolled. As pre-specified in protocol design, data for the 2 sub-trials (ND and D) have been presented in two arms for this study.
Participants were enrolled into two sub-trials based on dialysis status under a master protocol. The non-dialysis (ND) sub-trial enrolled pediatric participants with anemia associated with chronic kidney disease (CKD) not yet requiring dialysis in non-US countries. The dialysis (D) sub-trial enrolled pediatric participants with anemia associated with CKD requiring dialysis in non-US countries. Recruitment was conducted separately for each sub-trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants Requiring Dialysis (D) | Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 milligram (mg), to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL). |
| FG001 | Participants Not Yet Requiring Dialysis (ND) | Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants Requiring Dialysis (D) | Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. SAEs are defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other situations as per medical and scientific judgement of the Investigator. | The analysis was performed on the Safety Set that included all participants who were enrolled and took at least one dose of study medication. | Posted | Count of Participants | Participants | Up to 56 weeks |
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All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected up to 56 weeks.
All-cause mortality, SAEs and non-SAEs were reported for Safety Set which included participants who were enrolled and received at least one dose of study medication.
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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 | Participants Requiring Dialysis (D) | Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Congenital uterine anomaly | Congenital, familial and genetic disorders | MedDRA 27.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 18, 2022 | Oct 28, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 14, 2025 | Sep 17, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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| ID | Term |
|---|---|
| C000599718 | GSK1278863 |
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This is an open-label single arm trial, where all participants are on active treatment with daprodustat.
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| Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Blood samples were collected to analyze the hematology parameter: Reticulocytes/Erythrocytes. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
| Change From Baseline in Hematology Parameter: Erythrocytes | Blood samples were collected to analyze the hematology parameter: Erythrocytes. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
| Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet count. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
| Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Volume. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
| Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
| Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Blood samples were collected to analyze the clinical chemistry parameters: Calcium, Potassium, Sodium and BUN. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
| Change From Baseline in Clinical Chemistry Parameter: Creatinine | Blood samples were collected to analyze the clinical chemistry parameter: Creatinine. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
| Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | Blood samples were collected to analyze the clinical chemistry parameters: ALT, ALP and AST. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48, and 52 |
| Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Blood samples were collected to analyze the clinical chemistry parameters: Bilirubin and Direct Bilirubin. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48, and 52 |
| Change From Baseline in Clinical Chemistry Parameter: Protein | Blood samples were collected to analyze the clinical chemistry parameter: Protein. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48, and 52 |
| Change From Baseline in Clinical Chemistry Parameter: Ferritin | Blood samples were collected to analyze the clinical chemistry parameter: Ferritin. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
| Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Blood samples were collected to analyze the clinical chemistry parameter: Transferrin saturation. Transferrin saturation is measured as a percentage, it is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
| Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Blood samples were collected to analyze the clinical chemistry parameter: Estimated Glomerular Filtration Rate. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
| Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio | Blood samples were collected to analyze the hematology parameter: Prothrombin International Normalized Ratio. It is used to assess the clotting ability of blood. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48, and 52 |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Systolic and diastolic blood pressure (BP) were assessed using an appropriate size cuff preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones). Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
| Change From Baseline in Heart Rate (HR) | Heart rate (HR) were assessed using an appropriate size cuff preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones). Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
| Change From Baseline in Weight | Weight readings in kilogram (kg) were collected. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
| Change From Baseline in Height | Height readings in centimeters (cm) were collected. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
| Absolute Values of Hemoglobin (Hgb) | Blood samples were collected from all participants for measurement of Hgb values in grams per deciliter (g/dL). Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Hgb results of participants with intercurrent events were excluded from the summary. | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
| Change From Baseline in Hemoglobin (Hgb) | Blood samples were collected from all participants for measurement of Hgb values in g/dL. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Hgb results of participants with intercurrent events were excluded from the summary. | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
| Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Number of participants with Hgb values above, below, and within the target range (10 to 12 g/dL) were assessed. Baseline assessment was defined as the last non-missing value prior to the start date and time of the study drug (Day 1). Hgb results of participants with intercurrent events were excluded from the summary. | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
| Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Daprodustat dose was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for Hgb between 10 to 12 g/dL. Dose change values of daprodustat from starting dose at each study time point were calculated as dose level at indicated time point minus starting dose at Day 1 (Baseline). | Day 1 (Baseline), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 |
| Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | Number of participants who required daprodustat dose adjustments form the starting dose were assessed. Data were categorized for number of participants who required no dose change (0 times) to 10 times and >10 times dose adjustments during the study. | Up to Week 52 |
| Daprodustat Dose at Each Study Time Point | Mean and standard deviation of daprodustat dose received by participants at each study time point has been presented. | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 |
| Maximum Plasma Concentration (Cmax) of Daprodustat | Blood samples were collected for the plasma concentrations of daprodustat from which pharmacokinetic (PK) parameters were determined. Mean and standard deviation of daprodustat Cmax at steady state obtained via modeling in each sub-trial (requiring Dialysis and not yet requiring Dialysis). | Day 1: 1, 2 and 6 hours Post-dose; Week 2: Pre-dose and 1, 2 and 6 hours Post-dose |
| Area Under the Curve (AUC) at Steady State of Daprodustat | Blood samples were collected for the plasma concentrations of daprodustat from which PK parameters were determined. Mean and standard deviation of daprodustat AUC at steady state obtained via modeling in each sub-trial (requiring Dialysis and not yet requiring Dialysis). | Day 1: 1, 2 and 6 hours Post-dose; Week 2: Pre-dose and 1, 2 and 6 hours Post-dose |
| Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough) | Blood samples were collected for the plasma concentrations of daprodustat and metabolites from which PK parameters were determined. Mean and standard deviation of raw daprodustat and metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401) at steady state at pre-dose obtained via modeling in each sub-trial (requiring Dialysis and not yet requiring Dialysis). | Pre-dose on Week 2 |
| Saitama |
| 330-8777 |
| Japan |
| GSK Investigational Site | Tokyo | 162-8666 | Japan |
| GSK Investigational Site | Yangsan | 50612 | South Korea |
| BG001 |
| Participants Not Yet Requiring Dialysis (ND) |
Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL). |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | "All Other Races" category (Asian - East Asian Heritage and Asian - Japanese Heritage where 0\ | Count of Participants | Participants |
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Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL).
| OG001 | Participants Not Yet Requiring Dialysis (ND) | Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL). |
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| Primary | Number of Participants With Adverse Event of Special Interests (AESIs) | AESIs are AEs of scientific interest specific to the drug class as per investigator assessment. AESI included: Death, Myocardial Infarction (MI), stroke, Heart Failure (HF), thromboembolic events, thrombosis of vascular access, Thrombosis and/or tissue ischemia secondary to excessive erythropoiesis, New diagnosis of hypertension or worsening of existing hypertension, Cancer related mortality and tumor progression and recurrence, Esophageal and gastric erosions. Number of participants with any AESIs have been presented. | Safety Set | Posted | Count of Participants | Participants | Up to 56 weeks |
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| Primary | Number of Participants With AEs Leading to Study Intervention Discontinuation | All AEs leading to study intervention discontinuation were collected. Number of participants with any AEs leading to study intervention discontinuation have been presented | Safety Set | Posted | Count of Participants | Participants | Up to 52 weeks |
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| Secondary | Change From Baseline in Hematology Parameter: Hematocrit | Blood samples were collected to analyze the hematology parameter: hematocrit. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Percentage of red blood cells in blood | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
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| Secondary | Change From Baseline in Hematology Parameter: Reticulocytes/Erythrocytes | Blood samples were collected to analyze the hematology parameter: Reticulocytes/Erythrocytes. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Ratio of Reticulocytes to Erythrocytes | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
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| Secondary | Change From Baseline in Hematology Parameter: Erythrocytes | Blood samples were collected to analyze the hematology parameter: Erythrocytes. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Trillion cells per Liter (10^12 cells/L) | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
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| Secondary | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet Count | Blood samples were collected to analyze the hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Leukocytes and Platelet count. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Giga cells per Liter (10^9 cells/L) | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
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| Secondary | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume | Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Volume. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Femtoliter (fL) | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
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| Secondary | Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin | Blood samples were collected to analyze the hematology parameter: Erythrocytes Mean Corpuscular Hemoglobin. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Picogram (pg) | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
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| Secondary | Change From Baseline in Clinical Chemistry Parameters: Calcium, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Blood samples were collected to analyze the clinical chemistry parameters: Calcium, Potassium, Sodium and BUN. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | millimoles per liter (mmol/L) | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
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| Secondary | Change From Baseline in Clinical Chemistry Parameter: Creatinine | Blood samples were collected to analyze the clinical chemistry parameter: Creatinine. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | micromoles per Liter (µmol/L) | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
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| Secondary | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) | Blood samples were collected to analyze the clinical chemistry parameters: ALT, ALP and AST. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | International units per liter | Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48, and 52 |
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| Secondary | Change From Baseline in Clinical Chemistry Parameters: Bilirubin and Direct Bilirubin | Blood samples were collected to analyze the clinical chemistry parameters: Bilirubin and Direct Bilirubin. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | micromoles per Liter (µmol/L) | Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48, and 52 |
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| Secondary | Change From Baseline in Clinical Chemistry Parameter: Protein | Blood samples were collected to analyze the clinical chemistry parameter: Protein. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Grams per liter | Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48, and 52 |
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| Secondary | Change From Baseline in Clinical Chemistry Parameter: Ferritin | Blood samples were collected to analyze the clinical chemistry parameter: Ferritin. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | micrograms per liter (µg/L) | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
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| Secondary | Change From Baseline in Clinical Chemistry Parameter: Transferrin Saturation | Blood samples were collected to analyze the clinical chemistry parameter: Transferrin saturation. Transferrin saturation is measured as a percentage, it is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Percentage (%) of transferrin saturation | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
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| Secondary | Change From Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate | Blood samples were collected to analyze the clinical chemistry parameter: Estimated Glomerular Filtration Rate. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | mL per minute per 1.73 square meter | Baseline (Day 1), at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
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| Secondary | Change From Baseline in Hematology Parameter: Prothrombin International Normalized Ratio | Blood samples were collected to analyze the hematology parameter: Prothrombin International Normalized Ratio. It is used to assess the clotting ability of blood. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | Ratio | Baseline (Day 1), at Weeks 4, 8, 12, 24, 32, 36, 40, 48, and 52 |
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| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Systolic and diastolic blood pressure (BP) were assessed using an appropriate size cuff preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones). Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
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| Secondary | Change From Baseline in Heart Rate (HR) | Heart rate (HR) were assessed using an appropriate size cuff preceded by at least 5 minutes of rest for the participant in a quiet setting without distractions (e.g., television, cell phones). Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
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| Secondary | Change From Baseline in Weight | Weight readings in kilogram (kg) were collected. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | kilograms (Kg) | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
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|
| Secondary | Change From Baseline in Height | Height readings in centimeters (cm) were collected. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | centimeters (cm) | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
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| Secondary | Absolute Values of Hemoglobin (Hgb) | Blood samples were collected from all participants for measurement of Hgb values in grams per deciliter (g/dL). Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Hgb results of participants with intercurrent events were excluded from the summary. | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | grams per deciliter | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
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|
| Secondary | Change From Baseline in Hemoglobin (Hgb) | Blood samples were collected from all participants for measurement of Hgb values in g/dL. Baseline value was defined as the last non-missing value prior to the start date and time of the study medication (Day 1). Change from Baseline was calculated as the value at indicated time point minus the value at Baseline. Hgb results of participants with intercurrent events were excluded from the summary. | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | grams per Liter | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
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| Secondary | Number of Participants With Hgb Values Above, Below and Within the Target Range (10 to 12 g/dL) | Number of participants with Hgb values above, below, and within the target range (10 to 12 g/dL) were assessed. Baseline assessment was defined as the last non-missing value prior to the start date and time of the study drug (Day 1). Hgb results of participants with intercurrent events were excluded from the summary. | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Count of Participants | Participants | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 |
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| Secondary | Change in Daprodustat Dose From Starting Dose at Each Study Time Point | Daprodustat dose was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for Hgb between 10 to 12 g/dL. Dose change values of daprodustat from starting dose at each study time point were calculated as dose level at indicated time point minus starting dose at Day 1 (Baseline). | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | milligrams | Day 1 (Baseline), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 |
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| Secondary | Number of Participants With 0 to 10, or Greater Than (>) 10 Dose Adjustments | Number of participants who required daprodustat dose adjustments form the starting dose were assessed. Data were categorized for number of participants who required no dose change (0 times) to 10 times and >10 times dose adjustments during the study. | Safety Set | Posted | Count of Participants | Participants | Up to Week 52 |
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|
| Secondary | Daprodustat Dose at Each Study Time Point | Mean and standard deviation of daprodustat dose received by participants at each study time point has been presented. | Safety Set. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Mean | Standard Deviation | milligrams | Baseline (Day 1), at Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48 |
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| Secondary | Maximum Plasma Concentration (Cmax) of Daprodustat | Blood samples were collected for the plasma concentrations of daprodustat from which pharmacokinetic (PK) parameters were determined. Mean and standard deviation of daprodustat Cmax at steady state obtained via modeling in each sub-trial (requiring Dialysis and not yet requiring Dialysis). | The analysis was performed on the All Pharmacokinetic Set that included all participants in the Safety analysis who had at least 1 non-missing PK assessment (non-quantifiable values will be considered as non-missing values). | Posted | Mean | Standard Deviation | Nanograms per milliliters (ng/mL) | Day 1: 1, 2 and 6 hours Post-dose; Week 2: Pre-dose and 1, 2 and 6 hours Post-dose |
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| Secondary | Area Under the Curve (AUC) at Steady State of Daprodustat | Blood samples were collected for the plasma concentrations of daprodustat from which PK parameters were determined. Mean and standard deviation of daprodustat AUC at steady state obtained via modeling in each sub-trial (requiring Dialysis and not yet requiring Dialysis). | All Pharmacokinetic Set | Posted | Mean | Standard Deviation | Hours*nanogram per milliliter (h*ng/mL) | Day 1: 1, 2 and 6 hours Post-dose; Week 2: Pre-dose and 1, 2 and 6 hours Post-dose |
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| Secondary | Plasma Concentrations of Daprodustat and Metabolites at Pre-dose (Ctrough) | Blood samples were collected for the plasma concentrations of daprodustat and metabolites from which PK parameters were determined. Mean and standard deviation of raw daprodustat and metabolites (GSK2391220, GSK2487818, GSK2506102, GSK2506104, GSK2531398 and GSK2531401) at steady state at pre-dose obtained via modeling in each sub-trial (requiring Dialysis and not yet requiring Dialysis). | All Pharmacokinetic Set | Posted | Mean | Standard Deviation | Nanograms per milliliters (ng/mL) | Pre-dose on Week 2 |
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|
| 0 |
| 2 |
| 1 |
| 2 |
| 2 |
| 2 |
| EG001 | Participants Not Yet Requiring Dialysis (ND) | Participants received daprodustat orally once daily (QD) from Day 1 up to 52 weeks in the non-dialysis sub-trial. The dose of daprodustat was adjusted, if required, one step at a time in the range of 1 to 24 mg, to maintain the target range for hemoglobin (Hgb) between 10 to 12 grams per deciliter (g/dL). | 0 | 2 | 0 | 2 | 2 | 2 |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
|
| Serum ferritin increased | Investigations | MedDRA 27.1 | 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.
| D014570 |
| Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Week 8 |
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| Week 52 |
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| Week 8 |
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| Week 16 |
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| Week 20 |
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| Week 24 |
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| Week 28 |
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| Week 36 |
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| Week 40 |
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| Week 44 |
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| Week 48 |
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| Week 52 |
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| Basophils: Week 8 |
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| Basophils: Week 12 |
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| Basophils: Week 16 |
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| Basophils: Week 20 |
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| Basophils: Week 24 |
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| Basophils: Week 28 |
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| Basophils: Week 32 |
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| Basophils: Week 36 |
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| Basophils: Week 40 |
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| Basophils: Week 44 |
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| Basophils: Week 48 |
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| Basophils: Week 52 |
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| Eosinophils: Week 4 |
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| Eosinophils: Week 8 |
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| Eosinophils: Week 12 |
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| Eosinophils: Week 16 |
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| Eosinophils: Week 20 |
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| Eosinophils: Week 24 |
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| Eosinophils: Week 28 |
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| Eosinophils: Week 32 |
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| Eosinophils: Week 36 |
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| Eosinophils: Week 40 |
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| Eosinophils: Week 44 |
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| Eosinophils: Week 48 |
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| Eosinophils: Week 52 |
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| Lymphocytes: Week 4 |
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| Lymphocytes: Week 8 |
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| Lymphocytes: Week 12 |
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| Lymphocytes: Week 16 |
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| Lymphocytes: Week 20 |
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| Lymphocytes: Week 24 |
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| Lymphocytes: Week 28 |
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| Lymphocytes: Week 32 |
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| Lymphocytes: Week 36 |
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| Lymphocytes: Week 40 |
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| Lymphocytes: Week 44 |
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| Lymphocytes: Week 48 |
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| Lymphocytes: Week 52 |
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| Monocytes: Week 4 |
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| Monocytes: Week 8 |
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| Monocytes: Week 12 |
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| Monocytes: Week 16 |
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| Monocytes: Week 20 |
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| Monocytes: Week 24 |
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| Monocytes: Week 28 |
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| Monocytes: Week 32 |
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| Monocytes: Week 36 |
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| Monocytes: Week 40 |
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| Monocytes: Week 44 |
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| Monocytes: Week 48 |
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| Monocytes: Week 52 |
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| Neutrophils: Week 4 |
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| Neutrophils: Week 8 |
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| Neutrophils: Week 12 |
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| Neutrophils: Week 16 |
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| Neutrophils: Week 20 |
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| Neutrophils: Week 24 |
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| Neutrophils: Week 28 |
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| Neutrophils: Week 32 |
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| Neutrophils: Week 36 |
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| Neutrophils: Week 40 |
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| Neutrophils: Week 44 |
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| Neutrophils: Week 48 |
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| Neutrophils: Week 52 |
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| Leukocytes: Week 4 |
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| Leukocytes: Week 8 |
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| Leukocytes: Week 12 |
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| Leukocytes: Week 16 |
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| Leukocytes: Week 20 |
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| Leukocytes: Week 24 |
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| Leukocytes: Week 28 |
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| Leukocytes: Week 32 |
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| Leukocytes: Week 36 |
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| Leukocytes: Week 40 |
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| Leukocytes: Week 44 |
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| Leukocytes: Week 48 |
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| Leukocytes: Week 52 |
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| Platelet count: Week 4 |
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| Platelet count: Week 8 |
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| Platelet count: Week 12 |
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| Platelet count: Week 16 |
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| Platelet count: Week 20 |
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| Platelet count: Week 24 |
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| Platelet count: Week 28 |
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| Platelet count: Week 32 |
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| Platelet count: Week 36 |
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| Platelet count: Week 40 |
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| Platelet count: Week 44 |
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| Platelet count: Week 48 |
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| Platelet count: Week 52 |
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| Week 8 |
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| Week 12 |
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| Week 16 |
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| Week 20 |
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| Week 24 |
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| Week 28 |
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| Week 36 |
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| Week 48 |
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| Week 52 |
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| Week 8 |
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| Week 12 |
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| Week 16 |
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| Week 20 |
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| Week 24 |
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| Week 28 |
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| Week 36 |
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| Week 40 |
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| Week 44 |
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| Week 48 |
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| Week 52 |
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| Calcium: Week 8 |
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| Calcium: Week 12 |
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| Calcium: Week 16 |
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| Calcium: Week 20 |
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| Calcium: Week 24 |
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| Calcium: Week 28 |
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| Calcium: Week 32 |
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| Calcium: Week 36 |
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| Calcium: Week 40 |
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| Calcium: Week 44 |
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| Calcium: Week 48 |
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| Calcium: Week 52 |
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| Potassium: Week 4 |
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| Potassium: Week 8 |
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| Potassium: Week 12 |
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| Potassium: Week 16 |
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| Potassium: Week 20 |
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| Potassium: Week 24 |
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| Potassium: Week 28 |
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| Potassium: Week 32 |
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| Potassium: Week 36 |
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| Potassium: Week 40 |
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| Potassium: Week 44 |
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| Potassium: Week 48 |
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| Potassium: Week 52 |
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| Sodium: Week 4 |
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| Sodium: Week 8 |
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| Sodium: Week 12 |
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| Sodium: Week 16 |
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| Sodium: Week 20 |
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| Sodium: Week 24 |
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| Sodium: Week 28 |
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| Sodium: Week 32 |
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| Sodium: Week 36 |
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| Sodium: Week 40 |
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| Sodium: Week 44 |
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| Sodium: Week 48 |
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| Sodium: Week 52 |
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| BUN: Week 4 |
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| BUN: Week 8 |
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| BUN: Week 12 |
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| BUN: Week 16 |
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| BUN: Week 20 |
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| BUN: Week 24 |
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| BUN: Week 28 |
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| BUN: Week 32 |
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| BUN: Week 36 |
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| BUN: Week 40 |
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| BUN: Week 44 |
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| BUN: Week 48 |
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| ALT: Week 8 |
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| ALT: Week 12 |
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| ALT: Week 24 |
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| ALT: Week 32 |
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| ALT: Week 36 |
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| ALT: Week 40 |
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| ALT: Week 48 |
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| ALT: Week 52 |
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| ALP: Week 4 |
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| ALP: Week 8 |
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| ALP: Week 12 |
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| ALP: Week 24 |
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| ALP: Week 32 |
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| ALP: Week 36 |
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| ALP: Week 40 |
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| ALP: Week 48 |
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| ALP: Week 52 |
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| AST: Week 4 |
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| AST: Week 8 |
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| AST: Week 12 |
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| AST: Week 24 |
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| AST: Week 32 |
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| AST: Week 36 |
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| AST: Week 40 |
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| AST: Week 48 |
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| AST: Week 52 |
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| Bilirubin: Week 8 |
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| Bilirubin: Week 12 |
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| Bilirubin: Week 24 |
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| Bilirubin: Week 32 |
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| Bilirubin: Week 36 |
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| Bilirubin: Week 40 |
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| Bilirubin: Week 48 |
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| Bilirubin: Week 52 |
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| Direct Bilirubin: Week 4 |
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| Direct Bilirubin: Week 8 |
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| Direct Bilirubin: Week 12 |
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| Direct Bilirubin: Week 24 |
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| Direct Bilirubin: Week 32 |
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| Direct Bilirubin: Week 36 |
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| Direct Bilirubin: Week 40 |
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| Direct Bilirubin: Week 48 |
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| Direct Bilirubin: Week 52 |
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| Week 8 |
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| Week 12 |
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| Week 24 |
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| Week 32 |
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| Week 36 |
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| Week 40 |
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| Week 48 |
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| Week 52 |
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| Week 8 |
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| Week 12 |
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| Week 16 |
|
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| Week 20 |
|
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| Week 24 |
|
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| Week 28 |
|
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| Week 32 |
|
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| Week 36 |
|
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| Week 40 |
|
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| Week 44 |
|
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| Week 48 |
|
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| Week 52 |
|
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| Week 8 |
|
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| Week 12 |
|
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| Week 16 |
|
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| Week 20 |
|
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| Week 24 |
|
|
| Week 28 |
|
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| Week 32 |
|
|
| Week 36 |
|
|
| Week 40 |
|
|
| Week 44 |
|
|
| Week 48 |
|
|
| Week 52 |
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 20 |
|
|
| Week 24 |
|
|
| Week 28 |
|
|
| Week 32 |
|
|
| Week 36 |
|
|
| Week 40 |
|
|
| Week 44 |
|
|
| Week 48 |
|
|
| Week 52 |
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 24 |
|
|
| Week 32 |
|
|
| Week 36 |
|
|
| Week 40 |
|
|
| Week 48 |
|
|
| Week 52 |
|
|
| SBP: Week 4 |
|
|
| SBP: Week 8 |
|
|
| SBP: Week 12 |
|
|
| SBP: Week 16 |
|
|
| SBP: Week 20 |
|
|
| SBP: Week 24 |
|
|
| SBP: Week 28 |
|
|
| SBP: Week 32 |
|
|
| SBP: Week 36 |
|
|
| SBP: Week 40 |
|
|
| SBP: Week 44 |
|
|
| SBP: Week 48 |
|
|
| SBP: Week 52 |
|
|
| DBP: Week 2 |
|
|
| DBP: Week 4 |
|
|
| DBP: Week 8 |
|
|
| DBP: Week 12 |
|
|
| DBP: Week 16 |
|
|
| DBP: Week 20 |
|
|
| DBP: Week 24 |
|
|
| DBP: Week 28 |
|
|
| DBP: Week 32 |
|
|
| DBP: Week 36 |
|
|
| DBP: Week 40 |
|
|
| DBP: Week 44 |
|
|
| DBP: Week 48 |
|
|
| DBP: Week 52 |
|
|
| Week 4 |
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 20 |
|
|
| Week 24 |
|
|
| Week 28 |
|
|
| Week 32 |
|
|
| Week 36 |
|
|
| Week 40 |
|
|
| Week 44 |
|
|
| Week 48 |
|
|
| Week 52 |
|
|
| Week 4 |
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 20 |
|
|
| Week 24 |
|
|
| Week 28 |
|
|
| Week 32 |
|
|
| Week 36 |
|
|
| Week 40 |
|
|
| Week 44 |
|
|
| Week 48 |
|
|
| Week 52 |
|
|
| Week 4 |
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 20 |
|
|
| Week 24 |
|
|
| Week 28 |
|
|
| Week 32 |
|
|
| Week 36 |
|
|
| Week 40 |
|
|
| Week 44 |
|
|
| Week 48 |
|
|
| Week 52 |
|
|
| Week 2 |
|
|
| Week 4 |
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 20 |
|
|
| Week 24 |
|
|
| Week 28 |
|
|
| Week 32 |
|
|
| Week 36 |
|
|
| Week 40 |
|
|
| Week 44 |
|
|
| Week 48 |
|
|
| Week 52 |
|
|
| Week 4 |
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 20 |
|
|
| Week 24 |
|
|
| Week 28 |
|
|
| Week 32 |
|
|
| Week 36 |
|
|
| Week 40 |
|
|
| Week 44 |
|
|
| Week 48 |
|
|
| Week 52 |
|
|
| Within Target Range |
|
| Below Target Range |
|
| Week 2 |
|
|
| Week 4 |
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 20 |
|
|
| Week 24 |
|
|
| Week 28 |
|
|
| Week 32 |
|
|
| Week 36 |
|
|
| Week 40 |
|
|
| Week 44 |
|
|
| Week 48 |
|
|
| Week 52 |
|
|
| Week 4 |
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 20 |
|
|
| Week 24 |
|
|
| Week 28 |
|
|
| Week 32 |
|
|
| Week 36 |
|
|
| Week 40 |
|
|
| Week 44 |
|
|
| Week 48 |
|
|
| 2 times |
|
| 3 times |
|
| 4 times |
|
| 5 times |
|
| 6 times |
|
| 7 times |
|
| 8 times |
|
| 9 times |
|
| 10 times |
|
| >10 times |
|
| Week 2 |
|
|
| Week 4 |
|
|
| Week 8 |
|
|
| Week 12 |
|
|
| Week 16 |
|
|
| Week 20 |
|
|
| Week 24 |
|
|
| Week 28 |
|
|
| Week 32 |
|
|
| Week 36 |
|
|
| Week 40 |
|
|
| Week 44 |
|
|
| Week 48 |
|
|
| GSK2391220 |
|
|
| GSK2487818 |
|
|
| GSK2506102 |
|
|
| GSK2506104 |
|
|
| GSK2531398 |
|
|
| GSK2531401 |
|
|