Anaemia
Conditions
Keywords
Anemia, Prolyl hydroxylase inhibitor, Hemoglobin, Chronic kidney disease, pharmacokinetics, recombinant human erythropoietin, GSK1278863
Brief summary
This is a four-week Phase IIa, randomized, double-blind, placebo-controlled, parallel-group, multi-center study to evaluate the safety, efficacy and pharmacokinetics of GSK1278863 in approximately 68 subjects with anemia associated with chronic kidney disease who are not taking rhEPO and are not undergoing dialysis. The range of Hgb values for study eligibility is 8.5-11.0 g/dL. Eligible subjects will be randomized in equal proportions to receive once daily (QD) placebo or GSK1278863 0.5 mg, 2 mg or 5 mg in a double-blind fashion.
Detailed description
This is a four-week Phase IIa, randomized, double-blind, placebo-controlled, parallel-group, multi-center study to evaluate the safety, efficacy and pharmacokinetics of GSK1278863 in approximately 68 subjects with anemia associated with chronic kidney disease who are not taking rhEPO and are not undergoing dialysis. The study consists of a screening phase of up to 2 weeks, a 4-week treatment phase and a 2-week follow-up phase. The range of Hgb values for study eligibility is 8.5-11.0 g/dL. Eligible subjects will be randomized in equal proportions to receive once daily (QD) placebo or GSK1278863 0.5 mg, 2 mg or 5 mg in a double-blind fashion. Study treatment will be stopped if Hgb values fall outside of the range pre-specified in the protocol. This study aims to estimate the relationship between dose of GSK1278863 and Hgb response for correcting anemia in non-dialysis subjects with CKD who are not taking rhEPO (NDD). In addition, the study will characterize the effect of GSK1278863 on various pharmacokinetic/pharmacodynamic (PK/PD) markers, and will investigate the safety and tolerability of GSK1278863. An early interim analysis of the Hgb data is planned after approximately 20 subjects from cohort 1 have completed 3 weeks of treatment. Depending upon the interim findings, a second cohort of subjects may be added to investigate an additional GSK1278863 dose arm. Recruitment to the first cohort will continue during the interim analysis. A second interim analysis is planned after approximately 48 subjects from cohort 1 have completed 4 weeks treatment. The purpose of this interim is three-fold, to investigate whether a second cohort of subjects may be added, to facilitate early development of dose-response and PK/PD statistical models, and to generate interim results to facilitate design and dosing decisions for the next trial. Subject completion is defined as completion of all study phases including the follow-up phase.
Interventions
DRUGGSK1278863
Tablet
OTHERPlacebo
Tablet
Sponsors
PPD Development, LP
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Age and weight: \>/= 18 years of age and \>/= 45 kg. 2. Not routinely undergoing dialysis, regardless of the modality (either hemodialysis or peritoneal dialysis) or dialysis planned during the time the subject would be enrolled in the study. 3. No current or prior rhEPO use within the past 7 weeks; e.g., epoetins (or their biosimilars), darbepoetin, Mircera (methoxy polyethylene glycol epoetin beta), peginesatide or their biosimilars.. 4. KDOQI CKD stages 3/4/5 defined by eGFR using the Modification of Diet for Renal Disease (MDRD). 5. Hgb: Hgb concentrations 8.5-11.0 g/dL (inclusive) as outlined in Section 4.2. 6. Vitamin B12: Above the lower limit of the reference range (may rescreen in 2 months). 7. Folate: \>/=2.0 ng/mL at Screening. May rescreen in a month. 8. Ferritin: \>/=40 ng/mL with the absence of microcytic or hypochromic RBCs. 9. TSAT within the reference range. 10. Iron replacement therapy: Stable maintenance dose of oral iron replacement therapy, if required, that will be maintained throughout the study. NOTE: IV iron replacement therapy is not allowed the two weeks prior to Screening through the end of the study (Week 6). 11. QTc: QTcB \<470 msec or QTcB \<480 msec in subjects with bundle branch block obtained at Screening Visit, based on Central Reader's interpretation. 12. Females: Eligible to participate if she is of childbearing potential, and must agree to use approved contraception methods from Screening until completion of the Follow-up Visit OR of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation of hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH)\>40 MIU/ml and estradiol \<40 pg/ml is confirmatory\]. Females on hormone replacement therapy (HRT) whose menopausal status is in doubt will be required to use one of the approved contraception methods if they wish to continue their HRT during the study. Otherwise they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most types of HRT, at least 2 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method. 13. Males: Must agree to use approved contraceptive methods from the time of Screening until completion of the Follow-up Visit.
Exclusion criteria
1. Dialysis: Planning to initiate dialysis during the study or who have a high potential for initiating dialysis during study participation. 2. Renal transplant: Renal transplant anticipated or scheduled within the study time period or subjects with a functioning renal transplant. 3. Total CPK: \>5x the upper limit of the reference range. 4. HIV: Positive HIV antibody. 5. History of myocardial infarction or acute coronary syndrome within the prior 6 months. 6. History of stroke or TIAs. 7. Heart failure: Class III/IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system. 8. Hypertension: Poorly controlled hypertension, whether due to inadequate treatment, or lack of treatment, defined as DBP \>100 mmHg or SBP\>160 mmHg. 9. Thrombotic disease: History of thrombotic disease (e.g., venous thrombosis such as deep vein thrombosis or pulmonary embolism, or arterial thrombosis such as new onset or worsening limb ischemia requiring intervention), or other thrombosis related condition) within the prior 6 months. 10. Pulmonary hypertension: Known pulmonary hypertension and those at higher risk (than normally associated with CKD) for pre-existing elevation in pulmonary pressure (e.g., significant heart failure or lung disease requiring supplemental oxygen, or those with connective tissue diseases). 11. Inflammatory disease: Chronic inflammatory disease that could impact erythropoiesis (e.g., scleroderma, systemic lupus erythematosis, rheumatoid arthritis, celiac disease). 12. Hematological disease: Any hematological disease including those affecting platelets, the coagulation disorders (e.g., Protein C or S deficiency) or red blood cells (e.g. sickle cell anemia, myelodysplastic syndromes, hematological malignancy, myeloma, hemolytic anemia) or any other cause of anemia other than renal disease. 13. Liver disease: Current liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) or evidence at Screening of abnormal liver function tests \[alkaline phosphatase, ALT or AST \> 2.0 x upper limit of normal (ULN) or total bilirubin \> 1.5 x ULN\]; or other hepatic abnormalities that in the opinion of the investigator would preclude the subject from participation in the study. 14. Major surgery: Within the prior 12 weeks or planned during the study. 15. Transfusion: Blood transfusion within the prior 12 weeks or an anticipated need for blood transfusion during the study. 16. Ulcer and Active GI Bleeding: Evidence of active peptic, duodenal, or esophageal ulcer disease or active GI bleeding within the prior 12 weeks. 17. Acute infection: Clinical evidence of acute infection or history of infection requiring intravenous (IV) antibiotic therapy the eight weeks prior to Screening through Day 1 (randomization). 18. Malignancy: History of malignancy within 5 years of Screening or are receiving treatment for cancer or those with a strong family history of cancer (e.g., familial cancer disorders), with the exception of squamous cell or basal cell carcinoma of the skin that has been definitively treated. 19. Hyperparathyroidism: Clinically significant hyperparathyroidism in the opinion of the Investigator, including subjects with parathyroid hormone (PTH) values ≥600 pg/mL. 20. Eyes: History of proliferative retinopathy requiring treatment within the prior 12 months, or macular edema requiring treatment. 21. Severe reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product. 22. Drugs and supplements: Use of any prescription or non-prescription drugs or dietary supplements that are prohibited from Screening until the Follow-up Visit. 23. Androgens: New androgen therapy or changes to pre-existing androgen regimen within prior 12 weeks. 24. Prior investigational product exposure: The subject has participated in a clinical trial and has received an experimental investigational product within prior 30 days. 25. Protocol compliance: Unwillingness or inability to follow the procedures, or lifestyle and/or dietary restrictions outlined in the protocol. 26. Other conditions: Any condition which in the investigators opinion should exclude the subject from participating in the study. 27. Pregnancy and lactation: Pregnant females as determined by positive urine hCG test, OR women who are lactating at Screening or during the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modeled Hgb Change From Baseline Over 4 Weeks of Treatment | Baseline (average of Week -2, -1 and Day 1) and Week 4 | Modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model. The model included fixed effects for baseline Hgb, treatment and a treatment by day interaction. Random effects was fitted in the intercept and the slope over time. All data up until investigational product discontinuation was included for Hgb efficacy evaluable participants; where efficacy evaluable was defined as having a baseline and at least 2 on-treatment Hgb assessments. Baseline was the average of Week -2 , Week -1 and Day 1 visits. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Up to 4 weeks | Number of participants achieving an increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb from baseline were reported. Entry into the study required a target stable Hgb of 8.5-11.0 g/dL. A stable Hgb value was confirmed from three Hgb values taken during the screening period at Week -2, Week -1 and Day 1 (randomization). The average of these three values was used for Baseline Hgb. |
| Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Up to 4 weeks | Percentage of participants achieving an increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb from baseline were reported. Entry into the study requires a target stable Hgb of 8.5-11.0 g/dL. A stable Hgb value was confirmed from three Hgb values taken during the screening period at Week -2, Week -1 and Day 1 (randomization). The average of these three values was used for Baseline Hgb. |
| Number of Participants Who Reached Hgb Stopping Criteria | Up to Week 4 | The Hgb stopping criteria was defined as reaching to value \<8.0 g/dL, \>=8.0 - \<13.0 (\>= 2g/dL absolute Hgb change over 1 week ) or \>=13.0 g/dL. The number of participants who reached the Hgb stopping criteria of Hgb concentration were presented. |
| Change From Baseline in Hepcidin at Week 2 and Week 4 | Baseline (Pre-dose on Day 1), Week 2 and 4 | Blood samples for hepcidin were collected at Day 1 (pre-dose), Week 2 (approximately between 4 to 8 h) and Week 4 (pre-dose). Hepcidin is a regulator of iron metabolism. Baseline was the last pre-dose value on Day 1. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. Where hepcidin values were missing because the value was below the quantification limit (BQL), the BQL value was imputed. |
| Change From Baseline in Ferritin at Week 2 and Week 4 | Baseline (Day 1 Pre-dose), Week 2 and 4 | Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. |
| Change From Baseline in Transferrin at Week 2 and Week 4 | Baseline (Day 1 Pre-dose), Week 2 and 4 | Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. |
| Change From Baseline in Transferrin Saturation at Week 2 and Week 4 | Baseline (Day 1 Pre-dose), Week 2 and 4 | Transferrin saturation was measured as a percentage, and is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value for transferrin saturation was the pre-dose value on Day 1. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. |
| Change From Baseline in Total Iron Binding Capacity at Week 2 and Week 4 | Baseline (Day 1 Pre-dose), Week 2 and 4 | Total iron-binding capacity is a medical laboratory test that measures the blood's capacity to bind iron with transferrin. Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. |
| Change From Baseline in Total Iron at Week 2 and Week 4 | Baseline (Day 1 Pre-dose), Week 2 and 4 | Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. |
| Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 2 and Week 4 | Baseline (Day 1 Pre-dose), Week 2 and 4 | Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. |
| Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Baseline (Day 1 pre-dose), Week 1, 2, 3, and 4 | Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. |
| Change From Baseline in Erythropoietin at Week 2 and Week 4 | Baseline (Day 1 Pre-dose), Week 2 and 4 | Blood samples for erythropoietin were collected at Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1 and 3 h after this fist sample) and Week 4 (Pre-dose and 3 h post-dose). The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. |
| Change From Baseline in Red Blood Cells Count Over 4 Weeks | Baseline (Day 1 pre-dose), week 1, 2, 3, 4 | Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. |
| Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4 | Baseline (Pre-dose), week 2 and 4 | Blood samples for VEGF were collected at Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1 and 3 h after this fist sample) and Week 4 (Pre-dose and 3 h post-dose). Baseline was the Day 1 pre-dose value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 6 weeks | AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. |
| Number of Participants Discontinuing the Study Treatment Due to AEs | Up to 6 weeks | AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. number of participants discontinuing the study treatment due to AEs. |
| Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | Baseline (Day 1 pre-dose), Week 2, 4, and 6 | Clinical chemistry parameters including ALT, ALP, AST, CK were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6). |
| Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Baseline (Day 1 pre-dose), Week 2, 4, and 6 | Clinical chemistry parameters including albumin, apolipoprotein A1, apolipoprotein total, total protein were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6). |
| Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Baseline (Day 1 pre-dose), Week 2, 4, and 6 | Clinical chemistry parameters including calcium, chloride, cholesterol, glucose, inorganic phosphorus, potassium, sodium were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6). |
| Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Baseline (Day 1 pre-dose), Week 2, 4, and 6 | Clinical chemistry parameters including creatinine, direct bilirubin, indirect bilirubin, total bilirubin were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6). |
| Absolute Values of Urine Total Protein/Creatinine Ratio at Baseline (Day 1), Week 2, 4, and 6 | Baseline (Day 1), Week 2, 4, and 6 | Absolute values of urine total protein/creatinine ratio at Baseline (Day 1), Week 2, 4, and follow-up (week 6) were reported. |
| Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | Baseline (Day 1), Week 2, 4, and 6 | Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the Baseline value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. Change from Baseline values of ALT, AST, ALP and CK at Week 2, 4, and 6 |
| Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Baseline (Day 1), Week 2, 4, and 6 | Baseline values were recorded on Day 1 (Pre dose). If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of albumin, apolipoprotein A1, apolipoprotein total, total protein at Week 2, 4, and 6 were reported. |
| Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Baseline (Day 1), Week 2, 4, and 6 | Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of calcium, chloride, cholesterol, glucose, inorganic phosphorus, potassium, sodium at Week 2, 4, and 6 were reported. |
| Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Baseline (Day 1), Week 2, 4, and 6 | Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of creatinine, direct bilirubin, indirect bilirubin, total bilirubin at Week 2, 4, and 6 were reported. |
| Change From Baseline Values of Urine Total Protein/Creatinine Ratio at Week 2, 4, and 6 | Baseline (Day 1), Week 2, 4, and 6 | Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of urine total protein/creatinine ratio at Week 2, 4, and 6 were reported. |
| Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6 | Hematology parameters including Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet count, WBC count (absolute) were assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6). |
| Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6 | Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6 | Hematology parameter mean corpuscle volume was assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6). |
| Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6 | Hematology parameter Mean Corpuscle Hgb Concentration was assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6). |
| Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6 | Hematology parameter reticulocyte were assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6). |
| Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet count, WBC count (absolute) at Week 1, 2, 3, 4, and 6 were reported. |
| Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 | Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 were reported. |
| Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 | Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 were reported. |
| Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6 | Absolute values of systolic blood pressure and diastolic blood pressure Baseline (Day 1), Week 1, 2, 3, 4, and 6 as vital parameters were reported. Three measurements of systolic blood pressure and diastolic blood pressure were recorded from the participant in a supine position for at least 5 minutes (allowed enough time between measurement to completely deflate and loosen the inflatable cuff). |
| Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6 | Three measurements of SBP and DBP were recorded from the participant in a supine position for at least 5 minutes (allowed enough time between measurement to completely deflate and loosen the inflatable cuff). Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in systolic blood pressure and diastolic blood pressure at Week 1, 2, 3, 4, and 6 were reported. |
| Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6 | Absolute values of heart rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 were reported as vital parameter. Three measurements of heart rate were recorded from the participant in a supine position for at least 5 minutes (allowed enough time between measurement to completely deflate and loosen the inflatable cuff). |
| Model-Adjusted Maximum Hgb Changes Over 4 Weeks | Baseline (average of Week -2 , -1 and Day 1 visits) and 4 weeks | Maximum Hgb change over 4 weeks was analyzed using an ANCOVA model with terms included for treatment and baseline Hgb value. Least square mean estimates and 95% CI for each treatment group were reported. Baseline was the average of Week -2 , Week -1 and Day 1 visits. The change from Baseline was calculated by subtracting the baseline value from the individual post-dose visit values. |
| Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | Baseline (Screening), Week 2, 4, and 6 | Full 12-lead ECGs were recorded in participants who were rested supine or seated for at least 10 minutes before each reading. All ECGs were transmitted to a central reviewer for blinded assessment. Full 12-lead ECGs were recorded on the provided ECG machine that automatically calculates heart rate, PR, QRS, QT and QTc intervals. Absolute ECG parameters including PR interval, QT interval and QRS duration values at Baseline (Screening), Week 2, 4, and 6 were reported. |
| Change From Baseline in ECG Parameters at Week 2, 4 and 6 | Baseline (Screening), Week 2, 4, and 6 | Full 12-lead ECGs were recorded in participants who were rested supine or seated for at least 10 minutes before each reading. All ECGs were transmitted to a central reviewer for blinded assessment. Full 12-lead ECGs were recorded on the provided ECG machine that automatically calculates heart rate, PR, QRS, QT and QTc intervals. Baseline ECG values were defined as measurements taken at screening. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. |
| Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites | Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this first sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose). | Cmax of GSK1278863 and GSK1278863 metabolites (M1, M2, M3, M4, M5 and M6) were reported. For assessment of Pharmacokinetics parameters blood samples were collected at Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this first sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose). |
| Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites | Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this first sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose) | Mean Steady state AUC of GSK1278863 and GSK1278863 metabolites (M1, M2, M3, M4, M5 and M6) were reported. For pharmacokinetic parameter assessment blood samples were collected at Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this fist sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose). |
| Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6 | Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6 | Three measurements of heart rate were recorded from the participant in a supine position for at least 5 minutes (allowed enough time between measurement to completely deflate and loosen the inflatable cuff). Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. change from baseline in heart rate at Week 1, 2, 3, 4, and 6 were reported. |
Countries
Canada, Germany, United States
Participant flow
Recruitment details
The study was conducted at Canada, Germany, and United States between 29 May 2012 and 30 May 2013. A total of 282 participants were screened, 209 were screen failures and 73 eligible participants were randomized. Entry into the study requires a target stable hemoglobin (Hgb) of 8.5-11.0 gram per deciliter (g/dL).
Pre-assignment details
Out of the 73 randomized participants, one participant did not receive any study medication. the remaining 72 participants were included in safety population. Another one participant had no post-randomization data and was excluded from Intent-to-treat (ITT) population (71 participants).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Eligible participants received two matching placebo tablets, one each from bottle A and B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit. | 18 |
| GSK1278863, 0.5 mg Eligible participants received one GSK1278863 0.5 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit. | 17 |
| GSK1278863, 2 mg Eligible participants received one GSK1278863 2 mg tablet from bottle A and one matching placebo tablets from bottle B once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit. | 18 |
| GSK1278863, 5 mg Eligible participants received one GSK1278863 5 mg tablet from bottle B and one matching placebo tablets from bottle A once daily, orally, in the morning of each dosing day with a glass of water for 4 weeks except when the participants were dosed on-site by study personnel on Day 1 and at Week 4 clinic visit. | 19 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 |
| Overall Study | Met haemoglobin stopping criteria | 1 | 1 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 2 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | GSK1278863, 0.5 mg | GSK1278863, 2 mg | GSK1278863, 5 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 69.2 Years STANDARD_DEVIATION 11 | 66.6 Years STANDARD_DEVIATION 11.73 | 66.9 Years STANDARD_DEVIATION 11.45 | 71.3 Years STANDARD_DEVIATION 11.26 | 68.6 Years STANDARD_DEVIATION 11.28 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 5 Participants | 4 Participants | 5 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 12 Participants | 14 Participants | 14 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 14 Participants | 12 Participants | 10 Participants | 16 Participants | 52 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 8 Participants | 3 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 17 | 0 / 18 | 0 / 19 |
| other Total, other adverse events | 8 / 18 | 10 / 17 | 5 / 18 | 5 / 19 |
| serious Total, serious adverse events | 1 / 18 | 0 / 17 | 2 / 18 | 1 / 19 |
Outcome results
Primary
Modeled Hgb Change From Baseline Over 4 Weeks of Treatment
Modeled Hgb change from baseline over 4 weeks was derived using a random coefficient mixed effects linear regression model. The model included fixed effects for baseline Hgb, treatment and a treatment by day interaction. Random effects was fitted in the intercept and the slope over time. All data up until investigational product discontinuation was included for Hgb efficacy evaluable participants; where efficacy evaluable was defined as having a baseline and at least 2 on-treatment Hgb assessments. Baseline was the average of Week -2 , Week -1 and Day 1 visits. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.
Time frame: Baseline (average of Week -2, -1 and Day 1) and Week 4
Population: The ITT population comprised of all randomized participants who received at least one dose of study medication, and had a baseline and at least one corresponding on treatment laboratory assessment. Only those participants with data available at the indicated time points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Modeled Hgb Change From Baseline Over 4 Weeks of Treatment | -0.148 gram per decilitre (g/dL) | Standard Deviation 0.1925 |
| GSK1278863, 0.5 mg | Modeled Hgb Change From Baseline Over 4 Weeks of Treatment | 0.132 gram per decilitre (g/dL) | Standard Deviation 0.22 |
| GSK1278863, 2 mg | Modeled Hgb Change From Baseline Over 4 Weeks of Treatment | 0.463 gram per decilitre (g/dL) | Standard Deviation 0.2173 |
| GSK1278863, 5 mg | Modeled Hgb Change From Baseline Over 4 Weeks of Treatment | 1.010 gram per decilitre (g/dL) | Standard Deviation 0.2614 |
Comparison: Subgroup: Baseline Hgbp-value: 0.5888Mixed effects linear regression model
Comparison: Subgroup: Baseline Weightp-value: 0.66Mixed effects linear regression model
Comparison: Subgroup: Baseline estimated glomerular filtration rate (eGFR)p-value: 0.7999Mixed effects linear regression model
Comparison: Covariate: Ethnicityp-value: 0.2092Mixed effects linear regression model
Comparison: Covariate: Geographic Ancestryp-value: 0.9996Mixed effects linear regression model
Comparison: Covariate: Sexp-value: 0.7002Mixed effects linear regression model
Comparison: Covariate: Agep-value: 0.5536Mixed effects linear regression model
Comparison: Co-administration with foodp-value: 0.0085Mixed effects linear regression model
Comparison: Covariate: Diabeticp-value: 0.0021Mixed effects linear regression model
Comparison: Covariate: Regionp-value: 0.2194Mixed effects linear regression model
Secondary
Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6
Full 12-lead ECGs were recorded in participants who were rested supine or seated for at least 10 minutes before each reading. All ECGs were transmitted to a central reviewer for blinded assessment. Full 12-lead ECGs were recorded on the provided ECG machine that automatically calculates heart rate, PR, QRS, QT and QTc intervals. Absolute ECG parameters including PR interval, QT interval and QRS duration values at Baseline (Screening), Week 2, 4, and 6 were reported.
Time frame: Baseline (Screening), Week 2, 4, and 6
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | PR Interval, Day 1 | 160.750 Milliseconds (msec) | Standard Deviation 31.1849 |
| Placebo | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Bazett's), Day 1 | 430.833 Milliseconds (msec) | Standard Deviation 21.5149 |
| Placebo | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | Uncorrected QT Interval, Week 6 | 404.500 Milliseconds (msec) | Standard Deviation 34.8993 |
| Placebo | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | Uncorrected QT Interval, Day 1 | 412.000 Milliseconds (msec) | Standard Deviation 33.7554 |
| Placebo | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Fridericias's), Week 6 | 430.357 Milliseconds (msec) | Standard Deviation 22.9401 |
| Placebo | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | Uncorrected QT Interval, Week 4 | 413.111 Milliseconds (msec) | Standard Deviation 32.4499 |
| Placebo | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | Uncorrected QT Interval, Week 2 | 411.804 Milliseconds (msec) | Standard Deviation 40.7532 |
| Placebo | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QRS Duration, Day 1 | 99.750 Milliseconds (msec) | Standard Deviation 14.9833 |
| Placebo | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | PR Interval, Week 2 | 165.961 Milliseconds (msec) | Standard Deviation 26.2271 |
| Placebo | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Fridericias's), Week 4 | 427.711 Milliseconds (msec) | Standard Deviation 23.0747 |
| Placebo | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Fridericias's), Week 2 | 430.549 Milliseconds (msec) | Standard Deviation 26.252 |
| Placebo | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QRS Duration, Week 2 | 107.647 Milliseconds (msec) | Standard Deviation 22.2899 |
| Placebo | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | PR Interval, Week 6 | 153.914 Milliseconds (msec) | Standard Deviation 19.9718 |
| Placebo | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Fridericias's), Day 1 | 424.417 Milliseconds (msec) | Standard Deviation 20.231 |
| Placebo | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Bazett's), Week 6 | 444.771 Milliseconds (msec) | Standard Deviation 23.8784 |
| Placebo | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QRS Duration, Week 4 | 101.467 Milliseconds (msec) | Standard Deviation 20.1127 |
| Placebo | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | PR Interval, Week 4 | 161.689 Milliseconds (msec) | Standard Deviation 33.596 |
| Placebo | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Bazett's), Week 4 | 435.556 Milliseconds (msec) | Standard Deviation 23.1025 |
| Placebo | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Bazett's), Week 2 | 440.843 Milliseconds (msec) | Standard Deviation 25.7892 |
| Placebo | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QRS Duration, Week 6 | 96.186 Milliseconds (msec) | Standard Deviation 14.2459 |
| GSK1278863, 0.5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | PR Interval, Week 4 | 180.000 Milliseconds (msec) | Standard Deviation 25.7034 |
| GSK1278863, 0.5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | PR Interval, Week 6 | 183.314 Milliseconds (msec) | Standard Deviation 42.9671 |
| GSK1278863, 0.5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QRS Duration, Day 1 | 101.227 Milliseconds (msec) | Standard Deviation 29.7471 |
| GSK1278863, 0.5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QRS Duration, Week 2 | 101.111 Milliseconds (msec) | Standard Deviation 19.1603 |
| GSK1278863, 0.5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QRS Duration, Week 4 | 104.205 Milliseconds (msec) | Standard Deviation 22.4275 |
| GSK1278863, 0.5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QRS Duration, Week 6 | 104.729 Milliseconds (msec) | Standard Deviation 21.0227 |
| GSK1278863, 0.5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | Uncorrected QT Interval, Day 1 | 432.455 Milliseconds (msec) | Standard Deviation 37.787 |
| GSK1278863, 0.5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | Uncorrected QT Interval, Week 2 | 422.837 Milliseconds (msec) | Standard Deviation 35.015 |
| GSK1278863, 0.5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | Uncorrected QT Interval, Week 4 | 413.333 Milliseconds (msec) | Standard Deviation 34.7435 |
| GSK1278863, 0.5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | Uncorrected QT Interval, Week 6 | 428.077 Milliseconds (msec) | Standard Deviation 34.7094 |
| GSK1278863, 0.5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Bazett's), Day 1 | 446.712 Milliseconds (msec) | Standard Deviation 35.2019 |
| GSK1278863, 0.5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Bazett's), Week 2 | 440.390 Milliseconds (msec) | Standard Deviation 24.2664 |
| GSK1278863, 0.5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Bazett's), Week 4 | 434.590 Milliseconds (msec) | Standard Deviation 20.6551 |
| GSK1278863, 0.5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Bazett's), Week 6 | 441.622 Milliseconds (msec) | Standard Deviation 24.7866 |
| GSK1278863, 0.5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Fridericias's), Day 1 | 441.424 Milliseconds (msec) | Standard Deviation 31.0923 |
| GSK1278863, 0.5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Fridericias's), Week 2 | 434.178 Milliseconds (msec) | Standard Deviation 23.6892 |
| GSK1278863, 0.5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Fridericias's), Week 4 | 427.103 Milliseconds (msec) | Standard Deviation 20.4117 |
| GSK1278863, 0.5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Fridericias's), Week 6 | 436.666 Milliseconds (msec) | Standard Deviation 22.8305 |
| GSK1278863, 0.5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | PR Interval, Day 1 | 164.727 Milliseconds (msec) | Standard Deviation 38.043 |
| GSK1278863, 0.5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | PR Interval, Week 2 | 187.002 Milliseconds (msec) | Standard Deviation 38.5301 |
| GSK1278863, 2 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Bazett's), Day 1 | 435.351 Milliseconds (msec) | Standard Deviation 30.0154 |
| GSK1278863, 2 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Fridericias's), Week 2 | 421.124 Milliseconds (msec) | Standard Deviation 22.9709 |
| GSK1278863, 2 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | PR Interval, Day 1 | 165.313 Milliseconds (msec) | Standard Deviation 29.3513 |
| GSK1278863, 2 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QRS Duration, Day 1 | 99.532 Milliseconds (msec) | Standard Deviation 9.2023 |
| GSK1278863, 2 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | PR Interval, Week 4 | 174.875 Milliseconds (msec) | Standard Deviation 29.2025 |
| GSK1278863, 2 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Fridericias's), Week 4 | 422.943 Milliseconds (msec) | Standard Deviation 28.9082 |
| GSK1278863, 2 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Bazett's), Week 6 | 429.983 Milliseconds (msec) | Standard Deviation 30.9609 |
| GSK1278863, 2 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QRS Duration, Week 4 | 103.965 Milliseconds (msec) | Standard Deviation 20.4125 |
| GSK1278863, 2 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QRS Duration, Week 2 | 102.328 Milliseconds (msec) | Standard Deviation 17.8897 |
| GSK1278863, 2 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | Uncorrected QT Interval, Week 2 | 408.936 Milliseconds (msec) | Standard Deviation 33.1958 |
| GSK1278863, 2 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | PR Interval, Week 6 | 175.321 Milliseconds (msec) | Standard Deviation 32.9893 |
| GSK1278863, 2 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | Uncorrected QT Interval, Day 1 | 405.541 Milliseconds (msec) | Standard Deviation 25.1111 |
| GSK1278863, 2 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | PR Interval, Week 2 | 172.909 Milliseconds (msec) | Standard Deviation 29.4006 |
| GSK1278863, 2 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | Uncorrected QT Interval, Week 4 | 411.859 Milliseconds (msec) | Standard Deviation 42.7345 |
| GSK1278863, 2 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Fridericias's), Day 1 | 424.970 Milliseconds (msec) | Standard Deviation 23.732 |
| GSK1278863, 2 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Bazett's), Week 4 | 429.480 Milliseconds (msec) | Standard Deviation 31.0592 |
| GSK1278863, 2 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Fridericias's), Week 6 | 418.161 Milliseconds (msec) | Standard Deviation 24.9461 |
| GSK1278863, 2 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | Uncorrected QT Interval, Week 6 | 396.778 Milliseconds (msec) | Standard Deviation 32.4936 |
| GSK1278863, 2 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Bazett's), Week 2 | 428.144 Milliseconds (msec) | Standard Deviation 28.4053 |
| GSK1278863, 2 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QRS Duration, Week 6 | 101.811 Milliseconds (msec) | Standard Deviation 18.7734 |
| GSK1278863, 5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | PR Interval, Week 4 | 176.000 Milliseconds (msec) | Standard Deviation 31.8927 |
| GSK1278863, 5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Bazett's), Day 1 | 437.593 Milliseconds (msec) | Standard Deviation 33.7848 |
| GSK1278863, 5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QRS Duration, Week 4 | 104.392 Milliseconds (msec) | Standard Deviation 25.2312 |
| GSK1278863, 5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Bazett's), Week 2 | 431.500 Milliseconds (msec) | Standard Deviation 34.3464 |
| GSK1278863, 5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | PR Interval, Week 2 | 176.875 Milliseconds (msec) | Standard Deviation 24.4073 |
| GSK1278863, 5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Bazett's), Week 4 | 426.549 Milliseconds (msec) | Standard Deviation 32.4467 |
| GSK1278863, 5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QRS Duration, Week 2 | 106.556 Milliseconds (msec) | Standard Deviation 21.4729 |
| GSK1278863, 5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Bazett's), Week 6 | 431.700 Milliseconds (msec) | Standard Deviation 34.0017 |
| GSK1278863, 5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | PR Interval, Day 1 | 177.630 Milliseconds (msec) | Standard Deviation 23.4002 |
| GSK1278863, 5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Fridericias's), Day 1 | 433.815 Milliseconds (msec) | Standard Deviation 28.8483 |
| GSK1278863, 5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QRS Duration, Day 1 | 106.444 Milliseconds (msec) | Standard Deviation 20.6101 |
| GSK1278863, 5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Fridericias's), Week 6 | 426.591 Milliseconds (msec) | Standard Deviation 33.2459 |
| GSK1278863, 5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Fridericias's), Week 2 | 426.944 Milliseconds (msec) | Standard Deviation 30.0734 |
| GSK1278863, 5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QTc Interval (Fridericias's), Week 4 | 424.961 Milliseconds (msec) | Standard Deviation 32.3172 |
| GSK1278863, 5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | Uncorrected QT Interval, Day 1 | 426.074 Milliseconds (msec) | Standard Deviation 25.1141 |
| GSK1278863, 5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | PR Interval, Week 6 | 179.307 Milliseconds (msec) | Standard Deviation 31.1222 |
| GSK1278863, 5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | Uncorrected QT Interval, Week 2 | 419.444 Milliseconds (msec) | Standard Deviation 36.1943 |
| GSK1278863, 5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | Uncorrected QT Interval, Week 4 | 423.255 Milliseconds (msec) | Standard Deviation 44.3408 |
| GSK1278863, 5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | QRS Duration, Week 6 | 105.617 Milliseconds (msec) | Standard Deviation 22.9352 |
| GSK1278863, 5 mg | Absolute Electrocardiogram (ECG) Parameter Values at Baseline (Screening), Week 2, 4, and 6 | Uncorrected QT Interval, Week 6 | 417.686 Milliseconds (msec) | Standard Deviation 45.1037 |
Secondary
Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6
Clinical chemistry parameters including ALT, ALP, AST, CK were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6).
Time frame: Baseline (Day 1 pre-dose), Week 2, 4, and 6
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALP, Day 1 | 86.6 International Units per litre (IU/L) | Standard Deviation 28.5 |
| Placebo | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALT, Week 2 | 10.8 International Units per litre (IU/L) | Standard Deviation 3.68 |
| Placebo | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALT, Week 4 | 11.4 International Units per litre (IU/L) | Standard Deviation 3.61 |
| Placebo | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALT, Week 6 | 10.1 International Units per litre (IU/L) | Standard Deviation 3.11 |
| Placebo | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALT, Day 1 | 11.8 International Units per litre (IU/L) | Standard Deviation 4.85 |
| Placebo | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALP, Week 2 | 84.3 International Units per litre (IU/L) | Standard Deviation 23.73 |
| Placebo | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALP, Week 4 | 84.1 International Units per litre (IU/L) | Standard Deviation 23.02 |
| Placebo | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALP, Week 6 | 83.9 International Units per litre (IU/L) | Standard Deviation 21.32 |
| Placebo | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | AST, Day 1 | 16.7 International Units per litre (IU/L) | Standard Deviation 4.51 |
| Placebo | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | AST, Week 2 | 16.1 International Units per litre (IU/L) | Standard Deviation 3.21 |
| Placebo | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | AST, Week 4 | 15.6 International Units per litre (IU/L) | Standard Deviation 2.44 |
| Placebo | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | AST, Week 6 | 15.2 International Units per litre (IU/L) | Standard Deviation 2.81 |
| Placebo | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | CK, Day 1 | 101.6 International Units per litre (IU/L) | Standard Deviation 73.24 |
| Placebo | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | CK, Week 2 | 86.7 International Units per litre (IU/L) | Standard Deviation 51.04 |
| Placebo | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | CK, Week 4 | 94.4 International Units per litre (IU/L) | Standard Deviation 53.19 |
| Placebo | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | CK, Week 6 | 90.6 International Units per litre (IU/L) | Standard Deviation 60.11 |
| GSK1278863, 0.5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALP, Week 2 | 91.5 International Units per litre (IU/L) | Standard Deviation 28.9 |
| GSK1278863, 0.5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | AST, Day 1 | 19.1 International Units per litre (IU/L) | Standard Deviation 5 |
| GSK1278863, 0.5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | CK, Week 6 | 132.2 International Units per litre (IU/L) | Standard Deviation 97.34 |
| GSK1278863, 0.5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | AST, Week 6 | 20.1 International Units per litre (IU/L) | Standard Deviation 5.69 |
| GSK1278863, 0.5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | CK, Week 4 | 114.2 International Units per litre (IU/L) | Standard Deviation 81.35 |
| GSK1278863, 0.5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | AST, Week 2 | 17.5 International Units per litre (IU/L) | Standard Deviation 5.42 |
| GSK1278863, 0.5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALT, Week 4 | 14.6 International Units per litre (IU/L) | Standard Deviation 8.92 |
| GSK1278863, 0.5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | AST, Week 4 | 18.2 International Units per litre (IU/L) | Standard Deviation 5.37 |
| GSK1278863, 0.5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALP, Day 1 | 95.6 International Units per litre (IU/L) | Standard Deviation 31.47 |
| GSK1278863, 0.5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALP, Week 4 | 90.4 International Units per litre (IU/L) | Standard Deviation 30.57 |
| GSK1278863, 0.5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALT, Week 6 | 14.9 International Units per litre (IU/L) | Standard Deviation 8.57 |
| GSK1278863, 0.5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALT, Week 2 | 12.4 International Units per litre (IU/L) | Standard Deviation 5.28 |
| GSK1278863, 0.5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | CK, Day 1 | 132.4 International Units per litre (IU/L) | Standard Deviation 127.75 |
| GSK1278863, 0.5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALP, Week 6 | 89.2 International Units per litre (IU/L) | Standard Deviation 31.38 |
| GSK1278863, 0.5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | CK, Week 2 | 130.8 International Units per litre (IU/L) | Standard Deviation 124.04 |
| GSK1278863, 0.5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALT, Day 1 | 13.8 International Units per litre (IU/L) | Standard Deviation 5.74 |
| GSK1278863, 2 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALP, Week 2 | 92.2 International Units per litre (IU/L) | Standard Deviation 24.56 |
| GSK1278863, 2 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALP, Day 1 | 97.7 International Units per litre (IU/L) | Standard Deviation 30.48 |
| GSK1278863, 2 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | CK, Week 2 | 150.2 International Units per litre (IU/L) | Standard Deviation 92.89 |
| GSK1278863, 2 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALP, Week 4 | 92.6 International Units per litre (IU/L) | Standard Deviation 23.51 |
| GSK1278863, 2 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALP, Week 6 | 87.1 International Units per litre (IU/L) | Standard Deviation 20.13 |
| GSK1278863, 2 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | CK, Week 6 | 137.4 International Units per litre (IU/L) | Standard Deviation 82.22 |
| GSK1278863, 2 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | AST, Day 1 | 22.9 International Units per litre (IU/L) | Standard Deviation 14.7 |
| GSK1278863, 2 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | AST, Week 2 | 26.1 International Units per litre (IU/L) | Standard Deviation 22.66 |
| GSK1278863, 2 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | CK, Week 4 | 136.4 International Units per litre (IU/L) | Standard Deviation 111.22 |
| GSK1278863, 2 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | AST, Week 4 | 26.7 International Units per litre (IU/L) | Standard Deviation 29.9 |
| GSK1278863, 2 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | AST, Week 6 | 21.4 International Units per litre (IU/L) | Standard Deviation 7.12 |
| GSK1278863, 2 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALT, Day 1 | 18.8 International Units per litre (IU/L) | Standard Deviation 14.4 |
| GSK1278863, 2 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALT, Week 2 | 20.1 International Units per litre (IU/L) | Standard Deviation 23.79 |
| GSK1278863, 2 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | CK, Day 1 | 159.4 International Units per litre (IU/L) | Standard Deviation 129.56 |
| GSK1278863, 2 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALT, Week 4 | 22.2 International Units per litre (IU/L) | Standard Deviation 31.12 |
| GSK1278863, 2 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALT, Week 6 | 16.9 International Units per litre (IU/L) | Standard Deviation 9.55 |
| GSK1278863, 5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | CK, Week 6 | 130.9 International Units per litre (IU/L) | Standard Deviation 269.29 |
| GSK1278863, 5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALP, Week 6 | 92.4 International Units per litre (IU/L) | Standard Deviation 37.56 |
| GSK1278863, 5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALT, Week 4 | 13.2 International Units per litre (IU/L) | Standard Deviation 4.25 |
| GSK1278863, 5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALT, Day 1 | 16.2 International Units per litre (IU/L) | Standard Deviation 7.08 |
| GSK1278863, 5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | CK, Week 2 | 100.0 International Units per litre (IU/L) | Standard Deviation 78.25 |
| GSK1278863, 5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALP, Week 4 | 90.1 International Units per litre (IU/L) | Standard Deviation 34.71 |
| GSK1278863, 5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | CK, Day 1 | 94.4 International Units per litre (IU/L) | Standard Deviation 55.38 |
| GSK1278863, 5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALT, Week 2 | 14.1 International Units per litre (IU/L) | Standard Deviation 6.26 |
| GSK1278863, 5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALP, Day 1 | 85.9 International Units per litre (IU/L) | Standard Deviation 31.47 |
| GSK1278863, 5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | AST, Week 2 | 19.0 International Units per litre (IU/L) | Standard Deviation 7.08 |
| GSK1278863, 5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALP, Week 2 | 87.2 International Units per litre (IU/L) | Standard Deviation 31.54 |
| GSK1278863, 5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | AST, Week 4 | 17.4 International Units per litre (IU/L) | Standard Deviation 6.06 |
| GSK1278863, 5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | CK, Week 4 | 83.1 International Units per litre (IU/L) | Standard Deviation 78.25 |
| GSK1278863, 5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | AST, Day 1 | 18.7 International Units per litre (IU/L) | Standard Deviation 6.68 |
| GSK1278863, 5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | ALT, Week 6 | 16.5 International Units per litre (IU/L) | Standard Deviation 6.16 |
| GSK1278863, 5 mg | Absolute Values of Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase (CK) at Baseline (Day 1), Week 2, 4, and 6 | AST, Week 6 | 19.8 International Units per litre (IU/L) | Standard Deviation 6.77 |
Secondary
Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6
Clinical chemistry parameters including albumin, apolipoprotein A1, apolipoprotein total, total protein were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6).
Time frame: Baseline (Day 1 pre-dose), Week 2, 4, and 6
Population: Safety population. Only those participants available at the specified time points were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Total Protein, Day 1 | 69.4 G/L | Standard Deviation 8.53 |
| Placebo | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Total Protein, Week 6 | 69.8 G/L | Standard Deviation 9.83 |
| Placebo | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein Total, Week 2 | 0.754 G/L | Standard Deviation 0.219 |
| Placebo | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Albumin, Week 4 | 40.6 G/L | Standard Deviation 3 |
| Placebo | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein Total, Week 6 | 0.732 G/L | Standard Deviation 0.1843 |
| Placebo | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein Total, Week 4 | 0.720 G/L | Standard Deviation 0.1727 |
| Placebo | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Albumin, Week 6 | 40.0 G/L | Standard Deviation 4.21 |
| Placebo | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Albumin, Day 1 | 39.8 G/L | Standard Deviation 3.37 |
| Placebo | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Total Protein, Week 4 | 70.7 G/L | Standard Deviation 10.87 |
| Placebo | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein A1, Day 1 | 1.481 G/L | Standard Deviation 0.2352 |
| Placebo | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein A1, Week 2 | 1.418 G/L | Standard Deviation 0.1732 |
| Placebo | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Albumin, Week 2 | 40.8 G/L | Standard Deviation 3.91 |
| Placebo | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Total Protein, Week 2 | 70.8 G/L | Standard Deviation 9.24 |
| Placebo | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein A1, Week 4 | 1.482 G/L | Standard Deviation 0.1712 |
| Placebo | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein A1, Week 6 | 1.472 G/L | Standard Deviation 0.1921 |
| Placebo | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein Total, Day 1 | 0.794 G/L | Standard Deviation 0.2278 |
| GSK1278863, 0.5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein A1, Week 4 | 1.452 G/L | Standard Deviation 0.3034 |
| GSK1278863, 0.5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein Total, Day 1 | 0.936 G/L | Standard Deviation 0.2645 |
| GSK1278863, 0.5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein A1, Day 1 | 1.515 G/L | Standard Deviation 0.2546 |
| GSK1278863, 0.5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein Total, Week 6 | 0.872 G/L | Standard Deviation 0.2062 |
| GSK1278863, 0.5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Total Protein, Week 6 | 69.7 G/L | Standard Deviation 8.36 |
| GSK1278863, 0.5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein Total, Week 2 | 0.901 G/L | Standard Deviation 0.2529 |
| GSK1278863, 0.5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Total Protein, Week 2 | 70.1 G/L | Standard Deviation 7.81 |
| GSK1278863, 0.5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Albumin, Week 2 | 40.3 G/L | Standard Deviation 5.31 |
| GSK1278863, 0.5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein A1, Week 2 | 1.472 G/L | Standard Deviation 0.2901 |
| GSK1278863, 0.5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein Total, Week 4 | 0.888 G/L | Standard Deviation 0.2535 |
| GSK1278863, 0.5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Albumin, Week 4 | 41.3 G/L | Standard Deviation 3.68 |
| GSK1278863, 0.5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Total Protein, Week 4 | 71.8 G/L | Standard Deviation 6.53 |
| GSK1278863, 0.5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Total Protein, Day 1 | 71.1 G/L | Standard Deviation 6.41 |
| GSK1278863, 0.5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Albumin, Week 6 | 39.9 G/L | Standard Deviation 5.04 |
| GSK1278863, 0.5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Albumin, Day 1 | 40.9 G/L | Standard Deviation 4.12 |
| GSK1278863, 0.5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein A1, Week 6 | 1.501 G/L | Standard Deviation 0.2482 |
| GSK1278863, 2 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Albumin, Week 4 | 39.1 G/L | Standard Deviation 4.33 |
| GSK1278863, 2 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Albumin, Day 1 | 39.7 G/L | Standard Deviation 4.38 |
| GSK1278863, 2 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Albumin, Week 2 | 38.8 G/L | Standard Deviation 4.38 |
| GSK1278863, 2 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Albumin, Week 6 | 40.6 G/L | Standard Deviation 3.22 |
| GSK1278863, 2 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein A1, Day 1 | 1.461 G/L | Standard Deviation 0.3561 |
| GSK1278863, 2 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein A1, Week 2 | 1.469 G/L | Standard Deviation 0.3142 |
| GSK1278863, 2 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein A1, Week 4 | 1.436 G/L | Standard Deviation 0.2553 |
| GSK1278863, 2 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein A1, Week 6 | 1.468 G/L | Standard Deviation 0.2514 |
| GSK1278863, 2 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein Total, Day 1 | 0.788 G/L | Standard Deviation 0.2419 |
| GSK1278863, 2 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein Total, Week 2 | 0.733 G/L | Standard Deviation 0.1921 |
| GSK1278863, 2 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein Total, Week 4 | 0.724 G/L | Standard Deviation 0.2071 |
| GSK1278863, 2 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein Total, Week 6 | 0.757 G/L | Standard Deviation 0.2286 |
| GSK1278863, 2 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Total Protein, Day 1 | 68.5 G/L | Standard Deviation 5.5 |
| GSK1278863, 2 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Total Protein, Week 2 | 66.4 G/L | Standard Deviation 4.26 |
| GSK1278863, 2 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Total Protein, Week 4 | 66.9 G/L | Standard Deviation 4.24 |
| GSK1278863, 2 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Total Protein, Week 6 | 68.3 G/L | Standard Deviation 3.26 |
| GSK1278863, 5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein A1, Week 6 | 1.492 G/L | Standard Deviation 0.4378 |
| GSK1278863, 5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein A1, Week 4 | 1.405 G/L | Standard Deviation 0.4564 |
| GSK1278863, 5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Albumin, Week 2 | 40.1 G/L | Standard Deviation 3.54 |
| GSK1278863, 5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Total Protein, Day 1 | 67.7 G/L | Standard Deviation 4.9 |
| GSK1278863, 5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein A1, Week 2 | 1.370 G/L | Standard Deviation 0.3831 |
| GSK1278863, 5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein A1, Day 1 | 1.572 G/L | Standard Deviation 0.4178 |
| GSK1278863, 5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Albumin, Day 1 | 39.8 G/L | Standard Deviation 3.5 |
| GSK1278863, 5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Total Protein, Week 2 | 68.3 G/L | Standard Deviation 4.54 |
| GSK1278863, 5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Albumin, Week 6 | 38.9 G/L | Standard Deviation 3.33 |
| GSK1278863, 5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Albumin, Week 4 | 39.2 G/L | Standard Deviation 4.1 |
| GSK1278863, 5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Total Protein, Week 6 | 66.9 G/L | Standard Deviation 4.88 |
| GSK1278863, 5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein Total, Week 4 | 0.743 G/L | Standard Deviation 0.2921 |
| GSK1278863, 5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein Total, Week 2 | 0.751 G/L | Standard Deviation 0.3278 |
| GSK1278863, 5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein Total, Day 1 | 0.792 G/L | Standard Deviation 0.2884 |
| GSK1278863, 5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Total Protein, Week 4 | 67.6 G/L | Standard Deviation 6.77 |
| GSK1278863, 5 mg | Absolute Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Baseline (Day 1), Week 2, 4, and 6 | Apolipoprotein Total, Week 6 | 0.776 G/L | Standard Deviation 0.3036 |
Secondary
Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6
Hematology parameters including Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet count, WBC count (absolute) were assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6).
Time frame: Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Monocytes, Week 3 | 0.452 10^9 cells/L | Standard Deviation 0.2295 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Monocytes, Week 2 | 0.400 10^9 cells/L | Standard Deviation 0.273 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Eosinophils, Week 6 | 0.202 10^9 cells/L | Standard Deviation 0.2548 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | WBC count (absolute), Day 1 | 7.14 10^9 cells/L | Standard Deviation 2.558 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Monocytes, Week 1 | 0.418 10^9 cells/L | Standard Deviation 0.1731 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Monocytes, Day 1 | 0.384 10^9 cells/L | Standard Deviation 0.1602 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Lymphocytes, Day 1 | 1.844 10^9 cells/L | Standard Deviation 0.5415 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Basophils, Week 3 | 0.027 10^9 cells/L | Standard Deviation 0.0228 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 6 | 1.739 10^9 cells/L | Standard Deviation 0.491 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 4 | 1.795 10^9 cells/L | Standard Deviation 0.4517 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 1 | 1.842 10^9 cells/L | Standard Deviation 0.7012 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Basophils, Week 1 | 0.023 10^9 cells/L | Standard Deviation 0.0141 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 3 | 1.813 10^9 cells/L | Standard Deviation 0.5515 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 2 | 1.629 10^9 cells/L | Standard Deviation 0.4686 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Platelet Count, Week 6 | 195.1 10^9 cells/L | Standard Deviation 58.58 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Platelet Count, Week 4 | 184.6 10^9 cells/L | Standard Deviation 52.35 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Basophils, Week 4 | 0.027 10^9 cells/L | Standard Deviation 0.0252 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 6 | 6.50 10^9 cells/L | Standard Deviation 2.075 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Platelet Count, Week 3 | 211.5 10^9 cells/L | Standard Deviation 71.24 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Platelet Count, Week 2 | 211.3 10^9 cells/L | Standard Deviation 71.56 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Basophils, Week 6 | 0.024 10^9 cells/L | Standard Deviation 0.0122 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Basophils, Day 1 | 0.023 10^9 cells/L | Standard Deviation 0.0136 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Platelet Count, Week 1 | 204.8 10^9 cells/L | Standard Deviation 67.74 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Platelet Count, Day 1 | 199.9 10^9 cells/L | Standard Deviation 67.77 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Eosinophils, Day 1 | 0.226 10^9 cells/L | Standard Deviation 0.2505 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 3 | 7.11 10^9 cells/L | Standard Deviation 1.84 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 6 | 4.163 10^9 cells/L | Standard Deviation 1.6961 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 4 | 3.834 10^9 cells/L | Standard Deviation 1.408 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Eosinophils, Week 1 | 0.212 10^9 cells/L | Standard Deviation 0.2288 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 2 | 6.57 10^9 cells/L | Standard Deviation 2.37 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 3 | 4.588 10^9 cells/L | Standard Deviation 1.7936 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 2 | 4.305 10^9 cells/L | Standard Deviation 2.1472 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Eosinophils, Week 2 | 0.204 10^9 cells/L | Standard Deviation 0.2685 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Basophils, Week 2 | 0.026 10^9 cells/L | Standard Deviation 0.0121 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 1 | 5.076 10^9 cells/L | Standard Deviation 4.0917 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Total Neutrophils, Day 1 | 4.654 10^9 cells/L | Standard Deviation 2.4954 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Eosinophils, Week 3 | 0.216 10^9 cells/L | Standard Deviation 0.2127 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 4 | 6.16 10^9 cells/L | Standard Deviation 1.451 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Monocytes, Week 6 | 0.369 10^9 cells/L | Standard Deviation 0.1085 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Monocytes, Week 4 | 0.305 10^9 cells/L | Standard Deviation 0.142 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Eosinophils, Week 4 | 0.191 10^9 cells/L | Standard Deviation 0.207 |
| Placebo | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 1 | 7.56 10^9 cells/L | Standard Deviation 4.001 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Basophils, Week 6 | 0.029 10^9 cells/L | Standard Deviation 0.0138 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Basophils, Day 1 | 0.035 10^9 cells/L | Standard Deviation 0.0255 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Basophils, Week 1 | 0.023 10^9 cells/L | Standard Deviation 0.0086 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Basophils, Week 2 | 0.022 10^9 cells/L | Standard Deviation 0.0153 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Basophils, Week 3 | 0.031 10^9 cells/L | Standard Deviation 0.0166 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Basophils, Week 4 | 0.033 10^9 cells/L | Standard Deviation 0.0303 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Eosinophils, Day 1 | 0.205 10^9 cells/L | Standard Deviation 0.0859 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Eosinophils, Week 1 | 0.189 10^9 cells/L | Standard Deviation 0.1021 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Eosinophils, Week 2 | 0.223 10^9 cells/L | Standard Deviation 0.1274 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Eosinophils, Week 3 | 0.212 10^9 cells/L | Standard Deviation 0.1259 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Eosinophils, Week 4 | 0.190 10^9 cells/L | Standard Deviation 0.0968 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Eosinophils, Week 6 | 0.229 10^9 cells/L | Standard Deviation 0.1294 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Lymphocytes, Day 1 | 1.662 10^9 cells/L | Standard Deviation 0.4552 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 1 | 1.673 10^9 cells/L | Standard Deviation 0.5261 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 2 | 1.741 10^9 cells/L | Standard Deviation 0.5192 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 3 | 1.765 10^9 cells/L | Standard Deviation 0.5392 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 4 | 1.736 10^9 cells/L | Standard Deviation 0.6919 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 6 | 1.491 10^9 cells/L | Standard Deviation 0.5122 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Monocytes, Day 1 | 0.345 10^9 cells/L | Standard Deviation 0.1516 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Monocytes, Week 1 | 0.375 10^9 cells/L | Standard Deviation 0.111 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Monocytes, Week 2 | 0.339 10^9 cells/L | Standard Deviation 0.1533 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Monocytes, Week 3 | 0.388 10^9 cells/L | Standard Deviation 0.1431 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Monocytes, Week 4 | 0.388 10^9 cells/L | Standard Deviation 0.144 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Monocytes, Week 6 | 0.336 10^9 cells/L | Standard Deviation 0.1363 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Total Neutrophils, Day 1 | 4.808 10^9 cells/L | Standard Deviation 1.8599 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 1 | 4.670 10^9 cells/L | Standard Deviation 1.4631 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 2 | 4.523 10^9 cells/L | Standard Deviation 1.9377 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 3 | 4.789 10^9 cells/L | Standard Deviation 1.8229 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 4 | 5.238 10^9 cells/L | Standard Deviation 1.8348 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 6 | 4.061 10^9 cells/L | Standard Deviation 1.0597 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Platelet Count, Day 1 | 229.9 10^9 cells/L | Standard Deviation 75.44 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Platelet Count, Week 1 | 219.8 10^9 cells/L | Standard Deviation 63.48 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Platelet Count, Week 2 | 230.1 10^9 cells/L | Standard Deviation 67.64 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Platelet Count, Week 3 | 237.3 10^9 cells/L | Standard Deviation 72.13 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Platelet Count, Week 4 | 255.8 10^9 cells/L | Standard Deviation 91.96 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Platelet Count, Week 6 | 207.9 10^9 cells/L | Standard Deviation 78.54 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | WBC count (absolute), Day 1 | 7.06 10^9 cells/L | Standard Deviation 2.311 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 1 | 6.92 10^9 cells/L | Standard Deviation 1.885 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 2 | 6.84 10^9 cells/L | Standard Deviation 2.4 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 3 | 7.18 10^9 cells/L | Standard Deviation 2.231 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 4 | 7.57 10^9 cells/L | Standard Deviation 2.346 |
| GSK1278863, 0.5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 6 | 6.14 10^9 cells/L | Standard Deviation 1.454 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Eosinophils, Week 4 | 0.124 10^9 cells/L | Standard Deviation 0.0928 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Monocytes, Week 3 | 0.362 10^9 cells/L | Standard Deviation 0.2196 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Basophils, Week 2 | 0.024 10^9 cells/L | Standard Deviation 0.0146 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Monocytes, Week 4 | 0.365 10^9 cells/L | Standard Deviation 0.1515 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Eosinophils, Week 3 | 0.105 10^9 cells/L | Standard Deviation 0.089 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Monocytes, Week 6 | 0.350 10^9 cells/L | Standard Deviation 0.1832 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 1 | 6.42 10^9 cells/L | Standard Deviation 1.74 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Total Neutrophils, Day 1 | 4.533 10^9 cells/L | Standard Deviation 1.4186 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Eosinophils, Week 2 | 0.122 10^9 cells/L | Standard Deviation 0.0811 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 1 | 4.203 10^9 cells/L | Standard Deviation 1.1729 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 2 | 4.121 10^9 cells/L | Standard Deviation 1.1545 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Eosinophils, Week 1 | 0.126 10^9 cells/L | Standard Deviation 0.1054 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Basophils, Day 1 | 0.025 10^9 cells/L | Standard Deviation 0.0207 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 3 | 4.181 10^9 cells/L | Standard Deviation 1.1934 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 2 | 5.93 10^9 cells/L | Standard Deviation 1.099 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 4 | 4.315 10^9 cells/L | Standard Deviation 1.5435 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Eosinophils, Day 1 | 0.165 10^9 cells/L | Standard Deviation 0.1067 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 6 | 4.126 10^9 cells/L | Standard Deviation 1.0044 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Basophils, Week 1 | 0.034 10^9 cells/L | Standard Deviation 0.0212 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Platelet Count, Day 1 | 219.2 10^9 cells/L | Standard Deviation 55.11 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Basophils, Week 6 | 0.023 10^9 cells/L | Standard Deviation 0.0134 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Platelet Count, Week 1 | 225.8 10^9 cells/L | Standard Deviation 57.9 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 3 | 6.14 10^9 cells/L | Standard Deviation 1.275 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Platelet Count, Week 2 | 209.7 10^9 cells/L | Standard Deviation 46.4 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Basophils, Week 4 | 0.023 10^9 cells/L | Standard Deviation 0.0124 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Platelet Count, Week 3 | 208.5 10^9 cells/L | Standard Deviation 42.24 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Platelet Count, Week 4 | 215.3 10^9 cells/L | Standard Deviation 52.46 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Basophils, Week 3 | 0.024 10^9 cells/L | Standard Deviation 0.0132 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 2 | 1.356 10^9 cells/L | Standard Deviation 0.5137 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 1 | 1.677 10^9 cells/L | Standard Deviation 0.7965 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 6 | 6.06 10^9 cells/L | Standard Deviation 1.044 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 3 | 1.475 10^9 cells/L | Standard Deviation 0.6234 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Platelet Count, Week 6 | 217.9 10^9 cells/L | Standard Deviation 52.66 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 4 | 1.428 10^9 cells/L | Standard Deviation 0.598 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Lymphocytes, Day 1 | 1.473 10^9 cells/L | Standard Deviation 0.6332 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 6 | 1.427 10^9 cells/L | Standard Deviation 0.6358 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Monocytes, Day 1 | 0.319 10^9 cells/L | Standard Deviation 0.1405 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Eosinophils, Week 6 | 0.134 10^9 cells/L | Standard Deviation 0.0982 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 4 | 6.26 10^9 cells/L | Standard Deviation 1.617 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Monocytes, Week 1 | 0.371 10^9 cells/L | Standard Deviation 0.1564 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | WBC count (absolute), Day 1 | 6.51 10^9 cells/L | Standard Deviation 1.57 |
| GSK1278863, 2 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Monocytes, Week 2 | 0.305 10^9 cells/L | Standard Deviation 0.1543 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 3 | 1.461 10^9 cells/L | Standard Deviation 0.4769 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | WBC count (absolute), Day 1 | 6.76 10^9 cells/L | Standard Deviation 1.747 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Platelet Count, Week 1 | 238.8 10^9 cells/L | Standard Deviation 65.47 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Monocytes, Week 3 | 0.418 10^9 cells/L | Standard Deviation 0.1424 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Eosinophils, Week 3 | 0.122 10^9 cells/L | Standard Deviation 0.0831 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Basophils, Week 4 | 0.024 10^9 cells/L | Standard Deviation 0.0182 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Lymphocytes, Day 1 | 1.602 10^9 cells/L | Standard Deviation 0.7284 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Monocytes, Week 4 | 0.367 10^9 cells/L | Standard Deviation 0.103 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Monocytes, Week 2 | 0.383 10^9 cells/L | Standard Deviation 0.1502 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 4 | 6.42 10^9 cells/L | Standard Deviation 2.106 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Platelet Count, Week 2 | 229.9 10^9 cells/L | Standard Deviation 70.86 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Monocytes, Week 6 | 0.430 10^9 cells/L | Standard Deviation 0.2099 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Eosinophils, Week 2 | 0.112 10^9 cells/L | Standard Deviation 0.0568 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Monocytes, Day 1 | 0.373 10^9 cells/L | Standard Deviation 0.1056 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 3 | 7.04 10^9 cells/L | Standard Deviation 1.98 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Total Neutrophils, Day 1 | 4.614 10^9 cells/L | Standard Deviation 1.5539 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 4 | 1.330 10^9 cells/L | Standard Deviation 0.4753 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 1 | 7.67 10^9 cells/L | Standard Deviation 2.08 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Platelet Count, Week 3 | 224.6 10^9 cells/L | Standard Deviation 63.49 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 1 | 5.337 10^9 cells/L | Standard Deviation 1.8429 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Eosinophils, Week 1 | 0.169 10^9 cells/L | Standard Deviation 0.0893 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Basophils, Week 1 | 0.030 10^9 cells/L | Standard Deviation 0.0157 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Basophils, Week 3 | 0.026 10^9 cells/L | Standard Deviation 0.0252 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 2 | 4.746 10^9 cells/L | Standard Deviation 1.6545 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Basophils, Day 1 | 0.025 10^9 cells/L | Standard Deviation 0.0179 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Monocytes, Week 1 | 0.452 10^9 cells/L | Standard Deviation 0.1438 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Platelet Count, Week 4 | 240.5 10^9 cells/L | Standard Deviation 82.69 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 3 | 5.011 10^9 cells/L | Standard Deviation 2.1326 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Eosinophils, Day 1 | 0.141 10^9 cells/L | Standard Deviation 0.0657 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 1 | 1.676 10^9 cells/L | Standard Deviation 0.4949 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Platelet Count, Week 6 | 227.1 10^9 cells/L | Standard Deviation 68.05 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 4 | 4.539 10^9 cells/L | Standard Deviation 2.1457 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Eosinophils, Week 4 | 0.146 10^9 cells/L | Standard Deviation 0.0788 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 2 | 6.80 10^9 cells/L | Standard Deviation 1.798 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 2 | 1.533 10^9 cells/L | Standard Deviation 0.4984 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 6 | 4.891 10^9 cells/L | Standard Deviation 2.2261 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Basophils, Week 6 | 0.024 10^9 cells/L | Standard Deviation 0.0141 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 6 | 1.466 10^9 cells/L | Standard Deviation 0.489 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Eosinophils, Week 6 | 0.150 10^9 cells/L | Standard Deviation 0.1001 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Platelet Count, Day 1 | 223.5 10^9 cells/L | Standard Deviation 54.94 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | Basophils, Week 2 | 0.029 10^9 cells/L | Standard Deviation 0.0261 |
| GSK1278863, 5 mg | Absolute Values of Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count, WBC Count (Absolute) at Baseline, Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 6 | 6.97 10^9 cells/L | Standard Deviation 2.327 |
Secondary
Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6
Clinical chemistry parameters including calcium, chloride, cholesterol, glucose, inorganic phosphorus, potassium, sodium were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6).
Time frame: Baseline (Day 1 pre-dose), Week 2, 4, and 6
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Calcium, Day 1 | 2.258 Millimol per Litre (MMOL/L) | Standard Deviation 0.1026 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Sodium, Week 4 | 140.6 Millimol per Litre (MMOL/L) | Standard Deviation 3.13 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Glucose, Week 6 | 8.88 Millimol per Litre (MMOL/L) | Standard Deviation 5.534 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Chloride, Day 1 | 105.4 Millimol per Litre (MMOL/L) | Standard Deviation 3.05 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Potassium, Day 1 | 4.57 Millimol per Litre (MMOL/L) | Standard Deviation 0.452 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Phosphorus, inorganic, Day 1 | 1.325 Millimol per Litre (MMOL/L) | Standard Deviation 0.2686 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Phosphorus, inorganic, Week 2 | 1.309 Millimol per Litre (MMOL/L) | Standard Deviation 0.2116 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Glucose, Week 4 | 6.49 Millimol per Litre (MMOL/L) | Standard Deviation 3.246 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Phosphorus, inorganic, Week 6 | 1.319 Millimol per Litre (MMOL/L) | Standard Deviation 0.281 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Phosphorus, inorganic, Week 4 | 1.293 Millimol per Litre (MMOL/L) | Standard Deviation 0.2235 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Chloride, Week 2 | 105.6 Millimol per Litre (MMOL/L) | Standard Deviation 2.69 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Sodium, Week 2 | 139.8 Millimol per Litre (MMOL/L) | Standard Deviation 2.6 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Chloride, Week 4 | 106.6 Millimol per Litre (MMOL/L) | Standard Deviation 3.91 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Sodium, Week 6 | 140.3 Millimol per Litre (MMOL/L) | Standard Deviation 2.46 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Chloride, Week 6 | 106.7 Millimol per Litre (MMOL/L) | Standard Deviation 3.52 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Calcium, Week 4 | 2.274 Millimol per Litre (MMOL/L) | Standard Deviation 0.0872 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Sodium, Day 1 | 140.1 Millimol per Litre (MMOL/L) | Standard Deviation 2.65 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Cholesterol, Day 1 | 4.147 Millimol per Litre (MMOL/L) | Standard Deviation 0.9085 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Cholesterol, Week 2 | 3.997 Millimol per Litre (MMOL/L) | Standard Deviation 0.7547 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Potassium, Week 6 | 4.56 Millimol per Litre (MMOL/L) | Standard Deviation 0.51 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Cholesterol, Week 4 | 3.893 Millimol per Litre (MMOL/L) | Standard Deviation 0.588 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Cholesterol, Week 6 | 3.944 Millimol per Litre (MMOL/L) | Standard Deviation 0.6613 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Calcium, Week 6 | 2.255 Millimol per Litre (MMOL/L) | Standard Deviation 0.1049 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Potassium, Week 4 | 4.54 Millimol per Litre (MMOL/L) | Standard Deviation 0.46 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Glucose, Day 1 | 6.97 Millimol per Litre (MMOL/L) | Standard Deviation 3.082 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Glucose, Week 2 | 6.78 Millimol per Litre (MMOL/L) | Standard Deviation 3.333 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Calcium, Week 2 | 2.299 Millimol per Litre (MMOL/L) | Standard Deviation 0.0915 |
| Placebo | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Potassium, Week 2 | 4.67 Millimol per Litre (MMOL/L) | Standard Deviation 0.41 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Sodium, Week 4 | 139.2 Millimol per Litre (MMOL/L) | Standard Deviation 2.65 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Glucose, Week 4 | 9.03 Millimol per Litre (MMOL/L) | Standard Deviation 4.94 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Chloride, Week 6 | 105.3 Millimol per Litre (MMOL/L) | Standard Deviation 3.99 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Potassium, Day 1 | 4.65 Millimol per Litre (MMOL/L) | Standard Deviation 0.632 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Potassium, Week 4 | 4.61 Millimol per Litre (MMOL/L) | Standard Deviation 0.468 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Glucose, Week 6 | 8.34 Millimol per Litre (MMOL/L) | Standard Deviation 3.503 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Glucose, Day 1 | 9.11 Millimol per Litre (MMOL/L) | Standard Deviation 5.189 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Cholesterol, Week 6 | 4.520 Millimol per Litre (MMOL/L) | Standard Deviation 1.0775 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Cholesterol, Day 1 | 4.632 Millimol per Litre (MMOL/L) | Standard Deviation 1.216 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Phosphorus, inorganic, Day 1 | 1.364 Millimol per Litre (MMOL/L) | Standard Deviation 0.2545 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Chloride, Day 1 | 103.1 Millimol per Litre (MMOL/L) | Standard Deviation 3.83 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Phosphorus, inorganic, Week 6 | 1.345 Millimol per Litre (MMOL/L) | Standard Deviation 0.2527 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Calcium, Week 4 | 2.302 Millimol per Litre (MMOL/L) | Standard Deviation 0.1234 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Phosphorus, inorganic, Week 2 | 1.421 Millimol per Litre (MMOL/L) | Standard Deviation 0.2848 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Potassium, Week 6 | 4.58 Millimol per Litre (MMOL/L) | Standard Deviation 0.496 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Calcium, Week 6 | 2.331 Millimol per Litre (MMOL/L) | Standard Deviation 0.1861 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Cholesterol, Week 2 | 4.623 Millimol per Litre (MMOL/L) | Standard Deviation 1.1469 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Phosphorus, inorganic, Week 4 | 1.388 Millimol per Litre (MMOL/L) | Standard Deviation 0.2922 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Calcium, Week 2 | 2.298 Millimol per Litre (MMOL/L) | Standard Deviation 0.1472 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Sodium, Week 2 | 137.9 Millimol per Litre (MMOL/L) | Standard Deviation 2 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Sodium, Week 6 | 139.4 Millimol per Litre (MMOL/L) | Standard Deviation 2.13 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Chloride, Week 2 | 104.2 Millimol per Litre (MMOL/L) | Standard Deviation 4.31 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Calcium, Day 1 | 2.296 Millimol per Litre (MMOL/L) | Standard Deviation 0.1404 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Potassium, Week 2 | 4.61 Millimol per Litre (MMOL/L) | Standard Deviation 0.703 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Glucose, Week 2 | 8.48 Millimol per Litre (MMOL/L) | Standard Deviation 4.322 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Chloride, Week 4 | 105.0 Millimol per Litre (MMOL/L) | Standard Deviation 4.43 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Cholesterol, Week 4 | 4.448 Millimol per Litre (MMOL/L) | Standard Deviation 1.0808 |
| GSK1278863, 0.5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Sodium, Day 1 | 137.8 Millimol per Litre (MMOL/L) | Standard Deviation 3 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Phosphorus, inorganic, Week 2 | 1.435 Millimol per Litre (MMOL/L) | Standard Deviation 0.3297 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Calcium, Day 1 | 2.259 Millimol per Litre (MMOL/L) | Standard Deviation 0.1537 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Calcium, Week 2 | 2.331 Millimol per Litre (MMOL/L) | Standard Deviation 0.1293 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Calcium, Week 4 | 2.301 Millimol per Litre (MMOL/L) | Standard Deviation 0.0922 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Calcium, Week 6 | 2.309 Millimol per Litre (MMOL/L) | Standard Deviation 0.1489 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Chloride, Day 1 | 103.9 Millimol per Litre (MMOL/L) | Standard Deviation 5.98 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Chloride, Week 2 | 103.6 Millimol per Litre (MMOL/L) | Standard Deviation 6.31 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Chloride, Week 4 | 104.0 Millimol per Litre (MMOL/L) | Standard Deviation 5.56 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Chloride, Week 6 | 103.8 Millimol per Litre (MMOL/L) | Standard Deviation 6.19 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Cholesterol, Day 1 | 4.088 Millimol per Litre (MMOL/L) | Standard Deviation 1.1424 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Cholesterol, Week 2 | 3.800 Millimol per Litre (MMOL/L) | Standard Deviation 0.8787 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Cholesterol, Week 4 | 3.776 Millimol per Litre (MMOL/L) | Standard Deviation 0.9276 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Cholesterol, Week 6 | 3.928 Millimol per Litre (MMOL/L) | Standard Deviation 1.0253 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Glucose, Day 1 | 9.46 Millimol per Litre (MMOL/L) | Standard Deviation 4.84 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Glucose, Week 2 | 9.64 Millimol per Litre (MMOL/L) | Standard Deviation 4.16 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Glucose, Week 4 | 8.63 Millimol per Litre (MMOL/L) | Standard Deviation 2.653 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Glucose, Week 6 | 9.14 Millimol per Litre (MMOL/L) | Standard Deviation 4.243 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Phosphorus, inorganic, Day 1 | 1.403 Millimol per Litre (MMOL/L) | Standard Deviation 0.3165 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Phosphorus, inorganic, Week 4 | 1.403 Millimol per Litre (MMOL/L) | Standard Deviation 0.266 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Phosphorus, inorganic, Week 6 | 1.366 Millimol per Litre (MMOL/L) | Standard Deviation 0.3567 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Potassium, Day 1 | 4.65 Millimol per Litre (MMOL/L) | Standard Deviation 0.489 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Potassium, Week 2 | 4.71 Millimol per Litre (MMOL/L) | Standard Deviation 0.627 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Potassium, Week 4 | 4.56 Millimol per Litre (MMOL/L) | Standard Deviation 0.671 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Potassium, Week 6 | 4.70 Millimol per Litre (MMOL/L) | Standard Deviation 0.52 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Sodium, Day 1 | 137.5 Millimol per Litre (MMOL/L) | Standard Deviation 3.92 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Sodium, Week 2 | 138.2 Millimol per Litre (MMOL/L) | Standard Deviation 3.88 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Sodium, Week 4 | 138.5 Millimol per Litre (MMOL/L) | Standard Deviation 3.59 |
| GSK1278863, 2 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Sodium, Week 6 | 137.9 Millimol per Litre (MMOL/L) | Standard Deviation 4.65 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Glucose, Week 2 | 9.42 Millimol per Litre (MMOL/L) | Standard Deviation 6.596 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Glucose, Day 1 | 7.75 Millimol per Litre (MMOL/L) | Standard Deviation 3.077 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Calcium, Week 4 | 2.348 Millimol per Litre (MMOL/L) | Standard Deviation 0.161 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Potassium, Week 2 | 4.62 Millimol per Litre (MMOL/L) | Standard Deviation 0.593 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Cholesterol, Week 6 | 4.406 Millimol per Litre (MMOL/L) | Standard Deviation 1.4561 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Cholesterol, Week 4 | 4.091 Millimol per Litre (MMOL/L) | Standard Deviation 1.4236 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Sodium, Week 6 | 138.8 Millimol per Litre (MMOL/L) | Standard Deviation 2.83 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Potassium, Week 4 | 4.42 Millimol per Litre (MMOL/L) | Standard Deviation 0.602 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Cholesterol, Week 2 | 4.282 Millimol per Litre (MMOL/L) | Standard Deviation 1.5566 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Cholesterol, Day 1 | 4.411 Millimol per Litre (MMOL/L) | Standard Deviation 1.4333 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Sodium, Week 4 | 140.2 Millimol per Litre (MMOL/L) | Standard Deviation 3.53 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Potassium, Week 6 | 4.65 Millimol per Litre (MMOL/L) | Standard Deviation 0.624 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Chloride, Week 6 | 104.2 Millimol per Litre (MMOL/L) | Standard Deviation 3.9 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Chloride, Week 4 | 106.4 Millimol per Litre (MMOL/L) | Standard Deviation 3.97 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Calcium, Week 2 | 2.347 Millimol per Litre (MMOL/L) | Standard Deviation 0.151 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Sodium, Day 1 | 138.6 Millimol per Litre (MMOL/L) | Standard Deviation 3.45 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Chloride, Week 2 | 103.1 Millimol per Litre (MMOL/L) | Standard Deviation 5.9 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Chloride, Day 1 | 104.7 Millimol per Litre (MMOL/L) | Standard Deviation 5.11 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Calcium, Day 1 | 2.335 Millimol per Litre (MMOL/L) | Standard Deviation 0.1351 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Phosphorus, inorganic, Week 4 | 1.244 Millimol per Litre (MMOL/L) | Standard Deviation 0.2674 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Phosphorus, inorganic, Week 2 | 1.285 Millimol per Litre (MMOL/L) | Standard Deviation 0.2871 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Phosphorus, inorganic, Day 1 | 1.313 Millimol per Litre (MMOL/L) | Standard Deviation 0.2655 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Sodium, Week 2 | 137.5 Millimol per Litre (MMOL/L) | Standard Deviation 4.62 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Phosphorus, inorganic, Week 6 | 1.203 Millimol per Litre (MMOL/L) | Standard Deviation 0.2322 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Glucose, Week 6 | 7.81 Millimol per Litre (MMOL/L) | Standard Deviation 3.506 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Glucose, Week 4 | 6.71 Millimol per Litre (MMOL/L) | Standard Deviation 2.162 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Calcium, Week 6 | 2.322 Millimol per Litre (MMOL/L) | Standard Deviation 0.136 |
| GSK1278863, 5 mg | Absolute Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Baseline (Day 1), Week 2, 4, and 6 | Potassium, Day 1 | 4.63 Millimol per Litre (MMOL/L) | Standard Deviation 0.498 |
Secondary
Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6
Clinical chemistry parameters including creatinine, direct bilirubin, indirect bilirubin, total bilirubin were assessed at Baseline (Day 1 pre-dose), Week 2, 4, and at follow-up visit (Week 6).
Time frame: Baseline (Day 1 pre-dose), Week 2, 4, and 6
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Direct bilirubin, Day 1 | 1.9 Micromol/L | Standard Deviation 1.11 |
| Placebo | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Creatinine, Week 2 | 235.92 Micromol/L | Standard Deviation 86.636 |
| Placebo | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Creatinine, Week 4 | 242.21 Micromol/L | Standard Deviation 106.796 |
| Placebo | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Creatinine, Week 6 | 244.43 Micromol/L | Standard Deviation 94.682 |
| Placebo | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Creatinine, Day 1 | 250.67 Micromol/L | Standard Deviation 110.117 |
| Placebo | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Direct bilirubin, Week 2 | 1.5 Micromol/L | Standard Deviation 1.12 |
| Placebo | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Direct bilirubin, Week 4 | 1.6 Micromol/L | Standard Deviation 0.85 |
| Placebo | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Direct bilirubin, Week 6 | 1.8 Micromol/L | Standard Deviation 1.44 |
| Placebo | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Indirect bilirubin, Day 1 | 4.0 Micromol/L | Standard Deviation 1.41 |
| Placebo | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Indirect bilirubin, Week 2 | 5.1 Micromol/L | Standard Deviation 2.01 |
| Placebo | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Indirect bilirubin, Week 4 | 4.3 Micromol/L | Standard Deviation 1.07 |
| Placebo | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Indirect bilirubin, Week 6 | 4.4 Micromol/L | Standard Deviation 1.67 |
| Placebo | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Total bilirubin, Day 1 | 5.9 Micromol/L | Standard Deviation 1.5 |
| Placebo | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Total bilirubin, Week 2 | 6.6 Micromol/L | Standard Deviation 2.09 |
| Placebo | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Total bilirubin, Week 4 | 5.9 Micromol/L | Standard Deviation 1.23 |
| Placebo | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Total bilirubin, Week 6 | 6.1 Micromol/L | Standard Deviation 1.36 |
| GSK1278863, 0.5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Direct bilirubin, Week 2 | 1.7 Micromol/L | Standard Deviation 1.5 |
| GSK1278863, 0.5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Indirect bilirubin, Day 1 | 4.4 Micromol/L | Standard Deviation 1.46 |
| GSK1278863, 0.5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Total bilirubin, Week 6 | 6.8 Micromol/L | Standard Deviation 3.19 |
| GSK1278863, 0.5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Indirect bilirubin, Week 6 | 5.0 Micromol/L | Standard Deviation 2.42 |
| GSK1278863, 0.5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Total bilirubin, Week 4 | 6.0 Micromol/L | Standard Deviation 1.15 |
| GSK1278863, 0.5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Indirect bilirubin, Week 2 | 4.5 Micromol/L | Standard Deviation 1.55 |
| GSK1278863, 0.5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Creatinine, Week 4 | 250.10 Micromol/L | Standard Deviation 101.583 |
| GSK1278863, 0.5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Indirect bilirubin, Week 4 | 4.2 Micromol/L | Standard Deviation 1.3 |
| GSK1278863, 0.5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Direct bilirubin, Day 1 | 2.1 Micromol/L | Standard Deviation 1.5 |
| GSK1278863, 0.5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Direct bilirubin, Week 4 | 1.8 Micromol/L | Standard Deviation 1.54 |
| GSK1278863, 0.5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Creatinine, Week 6 | 238.07 Micromol/L | Standard Deviation 99.771 |
| GSK1278863, 0.5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Creatinine, Week 2 | 245.16 Micromol/L | Standard Deviation 91.81 |
| GSK1278863, 0.5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Total bilirubin, Day 1 | 6.5 Micromol/L | Standard Deviation 0.87 |
| GSK1278863, 0.5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Direct bilirubin, Week 6 | 1.8 Micromol/L | Standard Deviation 1.61 |
| GSK1278863, 0.5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Total bilirubin, Week 2 | 6.1 Micromol/L | Standard Deviation 1.41 |
| GSK1278863, 0.5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Creatinine, Day 1 | 237.05 Micromol/L | Standard Deviation 91.762 |
| GSK1278863, 2 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Direct bilirubin, Week 2 | 1.8 Micromol/L | Standard Deviation 0.66 |
| GSK1278863, 2 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Direct bilirubin, Day 1 | 2.1 Micromol/L | Standard Deviation 1.11 |
| GSK1278863, 2 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Total bilirubin, Week 2 | 6.6 Micromol/L | Standard Deviation 1.97 |
| GSK1278863, 2 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Direct bilirubin, Week 4 | 1.9 Micromol/L | Standard Deviation 0.86 |
| GSK1278863, 2 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Direct bilirubin, Week 6 | 1.8 Micromol/L | Standard Deviation 0.68 |
| GSK1278863, 2 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Total bilirubin, Week 6 | 6.5 Micromol/L | Standard Deviation 1.37 |
| GSK1278863, 2 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Indirect bilirubin, Day 1 | 4.4 Micromol/L | Standard Deviation 1.46 |
| GSK1278863, 2 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Indirect bilirubin, Week 2 | 4.8 Micromol/L | Standard Deviation 1.74 |
| GSK1278863, 2 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Total bilirubin, Week 4 | 6.7 Micromol/L | Standard Deviation 1.99 |
| GSK1278863, 2 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Indirect bilirubin, Week 4 | 4.8 Micromol/L | Standard Deviation 1.74 |
| GSK1278863, 2 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Indirect bilirubin, Week 6 | 4.8 Micromol/L | Standard Deviation 1.24 |
| GSK1278863, 2 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Creatinine, Day 1 | 274.34 Micromol/L | Standard Deviation 146.092 |
| GSK1278863, 2 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Creatinine, Week 2 | 267.07 Micromol/L | Standard Deviation 166.48 |
| GSK1278863, 2 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Total bilirubin, Day 1 | 6.5 Micromol/L | Standard Deviation 1.94 |
| GSK1278863, 2 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Creatinine, Week 4 | 254.86 Micromol/L | Standard Deviation 149.148 |
| GSK1278863, 2 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Creatinine, Week 6 | 254.86 Micromol/L | Standard Deviation 171.772 |
| GSK1278863, 5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Total bilirubin, Week 6 | 5.9 Micromol/L | Standard Deviation 1.5 |
| GSK1278863, 5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Direct bilirubin, Week 6 | 2.1 Micromol/L | Standard Deviation 0.86 |
| GSK1278863, 5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Creatinine, Week 4 | 209.76 Micromol/L | Standard Deviation 109.374 |
| GSK1278863, 5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Creatinine, Day 1 | 237.43 Micromol/L | Standard Deviation 128.461 |
| GSK1278863, 5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Total bilirubin, Week 2 | 6.7 Micromol/L | Standard Deviation 2.34 |
| GSK1278863, 5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Direct bilirubin, Week 4 | 1.9 Micromol/L | Standard Deviation 1.11 |
| GSK1278863, 5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Total bilirubin, Day 1 | 6.2 Micromol/L | Standard Deviation 1.62 |
| GSK1278863, 5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Creatinine, Week 2 | 217.84 Micromol/L | Standard Deviation 112.543 |
| GSK1278863, 5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Direct bilirubin, Day 1 | 1.6 Micromol/L | Standard Deviation 1.07 |
| GSK1278863, 5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Indirect bilirubin, Week 2 | 4.6 Micromol/L | Standard Deviation 2.09 |
| GSK1278863, 5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Direct bilirubin, Week 2 | 2.1 Micromol/L | Standard Deviation 1.11 |
| GSK1278863, 5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Indirect bilirubin, Week 4 | 4.9 Micromol/L | Standard Deviation 1.75 |
| GSK1278863, 5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Total bilirubin, Week 4 | 6.8 Micromol/L | Standard Deviation 2.35 |
| GSK1278863, 5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Indirect bilirubin, Day 1 | 4.6 Micromol/L | Standard Deviation 1.34 |
| GSK1278863, 5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Creatinine, Week 6 | 219.50 Micromol/L | Standard Deviation 111.645 |
| GSK1278863, 5 mg | Absolute Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Baseline (Day 1), Week 2, 4, and 6 | Indirect bilirubin, Week 6 | 3.8 Micromol/L | Standard Deviation 0.97 |
Secondary
Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6
Absolute values of heart rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 were reported as vital parameter. Three measurements of heart rate were recorded from the participant in a supine position for at least 5 minutes (allowed enough time between measurement to completely deflate and loosen the inflatable cuff).
Time frame: Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Heart rate, Day 1 | 68.4 Beats per minute | Standard Deviation 10.78 |
| Placebo | Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Heart rate, Week 1 | 68.7 Beats per minute | Standard Deviation 10.33 |
| Placebo | Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Heart rate, Week 2 | 68.9 Beats per minute | Standard Deviation 8.95 |
| Placebo | Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Heart rate, Week 3 | 71.9 Beats per minute | Standard Deviation 9.92 |
| Placebo | Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Heart rate, Week 4 | 67.9 Beats per minute | Standard Deviation 9.5 |
| Placebo | Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Heart rate, Week 6 | 71.0 Beats per minute | Standard Deviation 10.63 |
| GSK1278863, 0.5 mg | Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Heart rate, Week 6 | 67.6 Beats per minute | Standard Deviation 9.27 |
| GSK1278863, 0.5 mg | Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Heart rate, Week 3 | 69.8 Beats per minute | Standard Deviation 10.51 |
| GSK1278863, 0.5 mg | Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Heart rate, Day 1 | 68.4 Beats per minute | Standard Deviation 8.07 |
| GSK1278863, 0.5 mg | Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Heart rate, Week 2 | 67.5 Beats per minute | Standard Deviation 7.6 |
| GSK1278863, 0.5 mg | Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Heart rate, Week 1 | 69.5 Beats per minute | Standard Deviation 8.71 |
| GSK1278863, 0.5 mg | Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Heart rate, Week 4 | 68.5 Beats per minute | Standard Deviation 9.55 |
| GSK1278863, 2 mg | Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Heart rate, Week 1 | 69.4 Beats per minute | Standard Deviation 12.89 |
| GSK1278863, 2 mg | Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Heart rate, Week 2 | 66.9 Beats per minute | Standard Deviation 13.03 |
| GSK1278863, 2 mg | Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Heart rate, Week 3 | 68.7 Beats per minute | Standard Deviation 14.43 |
| GSK1278863, 2 mg | Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Heart rate, Week 6 | 68.0 Beats per minute | Standard Deviation 10.55 |
| GSK1278863, 2 mg | Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Heart rate, Week 4 | 67.9 Beats per minute | Standard Deviation 16.29 |
| GSK1278863, 2 mg | Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Heart rate, Day 1 | 69.1 Beats per minute | Standard Deviation 14.58 |
| GSK1278863, 5 mg | Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Heart rate, Week 4 | 65.4 Beats per minute | Standard Deviation 11.97 |
| GSK1278863, 5 mg | Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Heart rate, Week 6 | 68.9 Beats per minute | Standard Deviation 13.01 |
| GSK1278863, 5 mg | Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Heart rate, Week 1 | 69.4 Beats per minute | Standard Deviation 9.8 |
| GSK1278863, 5 mg | Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Heart rate, Week 3 | 66.9 Beats per minute | Standard Deviation 11.96 |
| GSK1278863, 5 mg | Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Heart rate, Day 1 | 67.8 Beats per minute | Standard Deviation 7.53 |
| GSK1278863, 5 mg | Absolute Values of Heart Rate at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Heart rate, Week 2 | 67.6 Beats per minute | Standard Deviation 11.46 |
Secondary
Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6
Hematology parameter Mean Corpuscle Hgb Concentration was assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6).
Time frame: Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb, Day 1 | 328.6 G/L | Standard Deviation 8.98 |
| Placebo | Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb, Week 1 | 329.3 G/L | Standard Deviation 7.47 |
| Placebo | Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb, Week 2 | 327.3 G/L | Standard Deviation 7.72 |
| Placebo | Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb, Week 3 | 328.4 G/L | Standard Deviation 5.56 |
| Placebo | Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb, Week 4 | 329.6 G/L | Standard Deviation 5.81 |
| Placebo | Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb, Week 6 | 326.4 G/L | Standard Deviation 7.36 |
| GSK1278863, 0.5 mg | Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb, Week 6 | 330.7 G/L | Standard Deviation 8.7 |
| GSK1278863, 0.5 mg | Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb, Week 3 | 329.5 G/L | Standard Deviation 7.53 |
| GSK1278863, 0.5 mg | Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb, Day 1 | 330.9 G/L | Standard Deviation 5.85 |
| GSK1278863, 0.5 mg | Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb, Week 2 | 329.9 G/L | Standard Deviation 6.78 |
| GSK1278863, 0.5 mg | Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb, Week 1 | 330.1 G/L | Standard Deviation 7.9 |
| GSK1278863, 0.5 mg | Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb, Week 4 | 328.8 G/L | Standard Deviation 7.83 |
| GSK1278863, 2 mg | Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb, Week 1 | 330.8 G/L | Standard Deviation 6.69 |
| GSK1278863, 2 mg | Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb, Week 2 | 331.3 G/L | Standard Deviation 7.7 |
| GSK1278863, 2 mg | Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb, Week 3 | 331.2 G/L | Standard Deviation 6.12 |
| GSK1278863, 2 mg | Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb, Week 6 | 331.4 G/L | Standard Deviation 5.74 |
| GSK1278863, 2 mg | Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb, Week 4 | 329.6 G/L | Standard Deviation 3.95 |
| GSK1278863, 2 mg | Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb, Day 1 | 330.2 G/L | Standard Deviation 4.74 |
| GSK1278863, 5 mg | Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb, Week 4 | 326.1 G/L | Standard Deviation 7.52 |
| GSK1278863, 5 mg | Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb, Week 6 | 328.2 G/L | Standard Deviation 8.17 |
| GSK1278863, 5 mg | Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb, Week 1 | 328.0 G/L | Standard Deviation 8.46 |
| GSK1278863, 5 mg | Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb, Week 3 | 326.0 G/L | Standard Deviation 8.67 |
| GSK1278863, 5 mg | Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb, Day 1 | 328.4 G/L | Standard Deviation 7.87 |
| GSK1278863, 5 mg | Absolute Values of Mean Corpuscle Hgb Concentration at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb, Week 2 | 326.5 G/L | Standard Deviation 8.61 |
Secondary
Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6
Hematology parameter mean corpuscle volume was assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6).
Time frame: Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6 | Mean Corpuscle Volume, Day 1 | 93.8 Femtolitre (FL) | Standard Deviation 7.29 |
| Placebo | Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6 | Mean Corpuscle Volume, Week 1 | 93.6 Femtolitre (FL) | Standard Deviation 7.03 |
| Placebo | Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6 | Mean Corpuscle Volume, Week 2 | 93.9 Femtolitre (FL) | Standard Deviation 7.34 |
| Placebo | Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6 | Mean Corpuscle Volume, Week 3 | 93.6 Femtolitre (FL) | Standard Deviation 7.47 |
| Placebo | Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6 | Mean Corpuscle Volume, Week 4 | 93.9 Femtolitre (FL) | Standard Deviation 7.16 |
| Placebo | Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6 | Mean Corpuscle Volume, Week 6 | 94.1 Femtolitre (FL) | Standard Deviation 7.23 |
| GSK1278863, 0.5 mg | Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6 | Mean Corpuscle Volume, Week 6 | 94.1 Femtolitre (FL) | Standard Deviation 4.41 |
| GSK1278863, 0.5 mg | Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6 | Mean Corpuscle Volume, Week 3 | 93.1 Femtolitre (FL) | Standard Deviation 6.61 |
| GSK1278863, 0.5 mg | Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6 | Mean Corpuscle Volume, Day 1 | 92.4 Femtolitre (FL) | Standard Deviation 5.9 |
| GSK1278863, 0.5 mg | Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6 | Mean Corpuscle Volume, Week 2 | 92.8 Femtolitre (FL) | Standard Deviation 6.4 |
| GSK1278863, 0.5 mg | Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6 | Mean Corpuscle Volume, Week 1 | 92.7 Femtolitre (FL) | Standard Deviation 6.64 |
| GSK1278863, 0.5 mg | Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6 | Mean Corpuscle Volume, Week 4 | 93.4 Femtolitre (FL) | Standard Deviation 6.58 |
| GSK1278863, 2 mg | Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6 | Mean Corpuscle Volume, Week 1 | 94.6 Femtolitre (FL) | Standard Deviation 5.97 |
| GSK1278863, 2 mg | Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6 | Mean Corpuscle Volume, Week 2 | 95.5 Femtolitre (FL) | Standard Deviation 5.93 |
| GSK1278863, 2 mg | Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6 | Mean Corpuscle Volume, Week 3 | 95.6 Femtolitre (FL) | Standard Deviation 5.79 |
| GSK1278863, 2 mg | Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6 | Mean Corpuscle Volume, Week 6 | 95.8 Femtolitre (FL) | Standard Deviation 5.98 |
| GSK1278863, 2 mg | Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6 | Mean Corpuscle Volume, Week 4 | 96.1 Femtolitre (FL) | Standard Deviation 5.92 |
| GSK1278863, 2 mg | Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6 | Mean Corpuscle Volume, Day 1 | 94.8 Femtolitre (FL) | Standard Deviation 5.5 |
| GSK1278863, 5 mg | Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6 | Mean Corpuscle Volume, Week 4 | 95.7 Femtolitre (FL) | Standard Deviation 5.35 |
| GSK1278863, 5 mg | Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6 | Mean Corpuscle Volume, Week 6 | 95.1 Femtolitre (FL) | Standard Deviation 4.81 |
| GSK1278863, 5 mg | Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6 | Mean Corpuscle Volume, Week 1 | 95.3 Femtolitre (FL) | Standard Deviation 3.56 |
| GSK1278863, 5 mg | Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6 | Mean Corpuscle Volume, Week 3 | 95.9 Femtolitre (FL) | Standard Deviation 4.87 |
| GSK1278863, 5 mg | Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6 | Mean Corpuscle Volume, Day 1 | 94.2 Femtolitre (FL) | Standard Deviation 5.01 |
| GSK1278863, 5 mg | Absolute Values of Mean Corpuscle Volume at Baseline, Week 1, 2, 3, 4 and 6 | Mean Corpuscle Volume, Week 2 | 95.4 Femtolitre (FL) | Standard Deviation 4.78 |
Secondary
Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6
Hematology parameter reticulocyte were assessed at Baseline (Day 1 pre-dose), Week 2, 3, 4, and at follow-up visit (Week 6).
Time frame: Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Reticulocytes, Week 6 | 0.0154 Ratio | Standard Deviation 0.0049 |
| Placebo | Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Reticulocytes, Day 1 | 0.0183 Ratio | Standard Deviation 0.00584 |
| Placebo | Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Reticulocytes, Week 1 | 0.0185 Ratio | Standard Deviation 0.00667 |
| Placebo | Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Reticulocytes, Week 2 | 0.0178 Ratio | Standard Deviation 0.00558 |
| Placebo | Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Reticulocytes, Week 4 | 0.0174 Ratio | Standard Deviation 0.00486 |
| Placebo | Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Reticulocytes, Week 3 | 0.0191 Ratio | Standard Deviation 0.00641 |
| GSK1278863, 0.5 mg | Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Reticulocytes, Week 4 | 0.0187 Ratio | Standard Deviation 0.00615 |
| GSK1278863, 0.5 mg | Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Reticulocytes, Week 6 | 0.0196 Ratio | Standard Deviation 0.00681 |
| GSK1278863, 0.5 mg | Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Reticulocytes, Week 1 | 0.0198 Ratio | Standard Deviation 0.00446 |
| GSK1278863, 0.5 mg | Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Reticulocytes, Day 1 | 0.0179 Ratio | Standard Deviation 0.00494 |
| GSK1278863, 0.5 mg | Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Reticulocytes, Week 2 | 0.0201 Ratio | Standard Deviation 0.00432 |
| GSK1278863, 0.5 mg | Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Reticulocytes, Week 3 | 0.0189 Ratio | Standard Deviation 0.00388 |
| GSK1278863, 2 mg | Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Reticulocytes, Day 1 | 0.0208 Ratio | Standard Deviation 0.00747 |
| GSK1278863, 2 mg | Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Reticulocytes, Week 4 | 0.0203 Ratio | Standard Deviation 0.00905 |
| GSK1278863, 2 mg | Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Reticulocytes, Week 3 | 0.0229 Ratio | Standard Deviation 0.00943 |
| GSK1278863, 2 mg | Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Reticulocytes, Week 1 | 0.0256 Ratio | Standard Deviation 0.01086 |
| GSK1278863, 2 mg | Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Reticulocytes, Week 6 | 0.0161 Ratio | Standard Deviation 0.00889 |
| GSK1278863, 2 mg | Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Reticulocytes, Week 2 | 0.0224 Ratio | Standard Deviation 0.00993 |
| GSK1278863, 5 mg | Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Reticulocytes, Week 6 | 0.0142 Ratio | Standard Deviation 0.007 |
| GSK1278863, 5 mg | Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Reticulocytes, Day 1 | 0.0188 Ratio | Standard Deviation 0.00757 |
| GSK1278863, 5 mg | Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Reticulocytes, Week 1 | 0.0284 Ratio | Standard Deviation 0.00635 |
| GSK1278863, 5 mg | Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Reticulocytes, Week 2 | 0.0268 Ratio | Standard Deviation 0.00592 |
| GSK1278863, 5 mg | Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Reticulocytes, Week 3 | 0.0232 Ratio | Standard Deviation 0.0057 |
| GSK1278863, 5 mg | Absolute Values of Reticulocyte Count at Baseline (Day 1), Week 1, 2, 3, 4, and 6 | Reticulocytes, Week 4 | 0.0236 Ratio | Standard Deviation 0.0065 |
Secondary
Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6
Absolute values of systolic blood pressure and diastolic blood pressure Baseline (Day 1), Week 1, 2, 3, 4, and 6 as vital parameters were reported. Three measurements of systolic blood pressure and diastolic blood pressure were recorded from the participant in a supine position for at least 5 minutes (allowed enough time between measurement to completely deflate and loosen the inflatable cuff).
Time frame: Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Diastolic blood pressure, Week 3 | 67.7 Millimeter mercury (mmHg) | Standard Deviation 10.41 |
| Placebo | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Diastolic blood pressure, Week 6 | 70.3 Millimeter mercury (mmHg) | Standard Deviation 11.04 |
| Placebo | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Diastolic blood pressure, Week 1 | 66.9 Millimeter mercury (mmHg) | Standard Deviation 11.72 |
| Placebo | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Systolic blood pressure, Day 1 | 132.9 Millimeter mercury (mmHg) | Standard Deviation 14.57 |
| Placebo | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Diastolic blood pressure, Week 2 | 67.7 Millimeter mercury (mmHg) | Standard Deviation 13.04 |
| Placebo | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Systolic blood pressure, Week 2 | 128.4 Millimeter mercury (mmHg) | Standard Deviation 12.39 |
| Placebo | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Systolic blood pressure, Week 3 | 130.2 Millimeter mercury (mmHg) | Standard Deviation 13.2 |
| Placebo | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Systolic blood pressure, Week 1 | 132.3 Millimeter mercury (mmHg) | Standard Deviation 19.26 |
| Placebo | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Diastolic blood pressure, Week 4 | 68.9 Millimeter mercury (mmHg) | Standard Deviation 12.41 |
| Placebo | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Systolic blood pressure, Week 4 | 132.6 Millimeter mercury (mmHg) | Standard Deviation 13.94 |
| Placebo | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Systolic blood pressure, Week 6 | 134.3 Millimeter mercury (mmHg) | Standard Deviation 17.34 |
| Placebo | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Diastolic blood pressure, Day 1 | 69.9 Millimeter mercury (mmHg) | Standard Deviation 11.7 |
| GSK1278863, 0.5 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Systolic blood pressure, Week 1 | 136.0 Millimeter mercury (mmHg) | Standard Deviation 17.29 |
| GSK1278863, 0.5 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Diastolic blood pressure, Day 1 | 69.0 Millimeter mercury (mmHg) | Standard Deviation 9.48 |
| GSK1278863, 0.5 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Systolic blood pressure, Week 3 | 133.5 Millimeter mercury (mmHg) | Standard Deviation 17.28 |
| GSK1278863, 0.5 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Diastolic blood pressure, Week 2 | 68.6 Millimeter mercury (mmHg) | Standard Deviation 10.11 |
| GSK1278863, 0.5 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Diastolic blood pressure, Week 3 | 69.5 Millimeter mercury (mmHg) | Standard Deviation 11.39 |
| GSK1278863, 0.5 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Diastolic blood pressure, Week 1 | 68.8 Millimeter mercury (mmHg) | Standard Deviation 10.72 |
| GSK1278863, 0.5 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Systolic blood pressure, Day 1 | 135.5 Millimeter mercury (mmHg) | Standard Deviation 13.5 |
| GSK1278863, 0.5 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Systolic blood pressure, Week 6 | 131.7 Millimeter mercury (mmHg) | Standard Deviation 19.53 |
| GSK1278863, 0.5 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Systolic blood pressure, Week 4 | 133.1 Millimeter mercury (mmHg) | Standard Deviation 21.5 |
| GSK1278863, 0.5 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Systolic blood pressure, Week 2 | 129.4 Millimeter mercury (mmHg) | Standard Deviation 19.45 |
| GSK1278863, 0.5 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Diastolic blood pressure, Week 6 | 67.2 Millimeter mercury (mmHg) | Standard Deviation 8.33 |
| GSK1278863, 0.5 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Diastolic blood pressure, Week 4 | 68.2 Millimeter mercury (mmHg) | Standard Deviation 11.94 |
| GSK1278863, 2 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Diastolic blood pressure, Week 1 | 67.4 Millimeter mercury (mmHg) | Standard Deviation 9.72 |
| GSK1278863, 2 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Systolic blood pressure, Day 1 | 134.0 Millimeter mercury (mmHg) | Standard Deviation 16.96 |
| GSK1278863, 2 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Systolic blood pressure, Week 1 | 134.6 Millimeter mercury (mmHg) | Standard Deviation 20.52 |
| GSK1278863, 2 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Systolic blood pressure, Week 2 | 129.9 Millimeter mercury (mmHg) | Standard Deviation 17.18 |
| GSK1278863, 2 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Systolic blood pressure, Week 3 | 133.0 Millimeter mercury (mmHg) | Standard Deviation 19.06 |
| GSK1278863, 2 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Systolic blood pressure, Week 4 | 134.2 Millimeter mercury (mmHg) | Standard Deviation 14.21 |
| GSK1278863, 2 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Systolic blood pressure, Week 6 | 135.0 Millimeter mercury (mmHg) | Standard Deviation 22.79 |
| GSK1278863, 2 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Diastolic blood pressure, Day 1 | 68.2 Millimeter mercury (mmHg) | Standard Deviation 8.02 |
| GSK1278863, 2 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Diastolic blood pressure, Week 2 | 66.0 Millimeter mercury (mmHg) | Standard Deviation 8.71 |
| GSK1278863, 2 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Diastolic blood pressure, Week 3 | 66.5 Millimeter mercury (mmHg) | Standard Deviation 10.09 |
| GSK1278863, 2 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Diastolic blood pressure, Week 4 | 66.2 Millimeter mercury (mmHg) | Standard Deviation 7.24 |
| GSK1278863, 2 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Diastolic blood pressure, Week 6 | 66.6 Millimeter mercury (mmHg) | Standard Deviation 8.26 |
| GSK1278863, 5 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Systolic blood pressure, Week 6 | 130.4 Millimeter mercury (mmHg) | Standard Deviation 14.1 |
| GSK1278863, 5 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Systolic blood pressure, Week 4 | 135.4 Millimeter mercury (mmHg) | Standard Deviation 12.97 |
| GSK1278863, 5 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Systolic blood pressure, Day 1 | 140.1 Millimeter mercury (mmHg) | Standard Deviation 15.5 |
| GSK1278863, 5 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Diastolic blood pressure, Week 3 | 66.9 Millimeter mercury (mmHg) | Standard Deviation 11.35 |
| GSK1278863, 5 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Systolic blood pressure, Week 3 | 131.7 Millimeter mercury (mmHg) | Standard Deviation 12.78 |
| GSK1278863, 5 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Systolic blood pressure, Week 2 | 139.1 Millimeter mercury (mmHg) | Standard Deviation 14.69 |
| GSK1278863, 5 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Diastolic blood pressure, Week 6 | 70.1 Millimeter mercury (mmHg) | Standard Deviation 10.43 |
| GSK1278863, 5 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Diastolic blood pressure, Week 4 | 68.9 Millimeter mercury (mmHg) | Standard Deviation 10.68 |
| GSK1278863, 5 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Diastolic blood pressure, Week 1 | 71.5 Millimeter mercury (mmHg) | Standard Deviation 10.04 |
| GSK1278863, 5 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Diastolic blood pressure, Day 1 | 71.7 Millimeter mercury (mmHg) | Standard Deviation 10.03 |
| GSK1278863, 5 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Systolic blood pressure, Week 1 | 137.8 Millimeter mercury (mmHg) | Standard Deviation 13.29 |
| GSK1278863, 5 mg | Absolute Values of Systolic Blood Pressure and Diastolic Blood Pressure Baseline, Week 1, Week 2, Week 3, Week 4 and Week 6 | Diastolic blood pressure, Week 2 | 72.7 Millimeter mercury (mmHg) | Standard Deviation 12.65 |
Secondary
Absolute Values of Urine Total Protein/Creatinine Ratio at Baseline (Day 1), Week 2, 4, and 6
Absolute values of urine total protein/creatinine ratio at Baseline (Day 1), Week 2, 4, and follow-up (week 6) were reported.
Time frame: Baseline (Day 1), Week 2, 4, and 6
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Values of Urine Total Protein/Creatinine Ratio at Baseline (Day 1), Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Day 1 | 226.00 mg/MMOL | Standard Deviation 268.727 |
| Placebo | Absolute Values of Urine Total Protein/Creatinine Ratio at Baseline (Day 1), Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Week 2 | 170.41 mg/MMOL | Standard Deviation 194.898 |
| Placebo | Absolute Values of Urine Total Protein/Creatinine Ratio at Baseline (Day 1), Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Week 4 | 114.71 mg/MMOL | Standard Deviation 130.867 |
| Placebo | Absolute Values of Urine Total Protein/Creatinine Ratio at Baseline (Day 1), Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Week 6 | 232.80 mg/MMOL | Standard Deviation 381.556 |
| GSK1278863, 0.5 mg | Absolute Values of Urine Total Protein/Creatinine Ratio at Baseline (Day 1), Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Week 2 | 207.82 mg/MMOL | Standard Deviation 281.943 |
| GSK1278863, 0.5 mg | Absolute Values of Urine Total Protein/Creatinine Ratio at Baseline (Day 1), Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Week 4 | 169.31 mg/MMOL | Standard Deviation 262.401 |
| GSK1278863, 0.5 mg | Absolute Values of Urine Total Protein/Creatinine Ratio at Baseline (Day 1), Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Week 6 | 162.81 mg/MMOL | Standard Deviation 275.606 |
| GSK1278863, 0.5 mg | Absolute Values of Urine Total Protein/Creatinine Ratio at Baseline (Day 1), Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Day 1 | 205.73 mg/MMOL | Standard Deviation 366.1 |
| GSK1278863, 2 mg | Absolute Values of Urine Total Protein/Creatinine Ratio at Baseline (Day 1), Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Week 4 | 196.37 mg/MMOL | Standard Deviation 326.453 |
| GSK1278863, 2 mg | Absolute Values of Urine Total Protein/Creatinine Ratio at Baseline (Day 1), Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Week 2 | 194.14 mg/MMOL | Standard Deviation 314.152 |
| GSK1278863, 2 mg | Absolute Values of Urine Total Protein/Creatinine Ratio at Baseline (Day 1), Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Week 6 | 175.16 mg/MMOL | Standard Deviation 314.341 |
| GSK1278863, 2 mg | Absolute Values of Urine Total Protein/Creatinine Ratio at Baseline (Day 1), Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Day 1 | 342.39 mg/MMOL | Standard Deviation 518.396 |
| GSK1278863, 5 mg | Absolute Values of Urine Total Protein/Creatinine Ratio at Baseline (Day 1), Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Week 6 | 160.01 mg/MMOL | Standard Deviation 192.595 |
| GSK1278863, 5 mg | Absolute Values of Urine Total Protein/Creatinine Ratio at Baseline (Day 1), Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Week 2 | 149.08 mg/MMOL | Standard Deviation 135.788 |
| GSK1278863, 5 mg | Absolute Values of Urine Total Protein/Creatinine Ratio at Baseline (Day 1), Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Day 1 | 211.58 mg/MMOL | Standard Deviation 241.306 |
| GSK1278863, 5 mg | Absolute Values of Urine Total Protein/Creatinine Ratio at Baseline (Day 1), Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Week 4 | 219.47 mg/MMOL | Standard Deviation 280.924 |
Secondary
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6
Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet count, WBC count (absolute) at Week 1, 2, 3, 4, and 6 were reported.
Time frame: Baseline (Day 1), Week 1, 2, 3, 4, and 6
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Basophils, Week 1 | -0.000 10^9 cells/L | Standard Deviation 0.0153 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Eosinophils, Week 6 | -0.012 10^9 cells/L | Standard Deviation 0.0638 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 3 | 0.014 10^9 cells/L | Standard Deviation 1.4591 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Monocytes, Week 6 | -0.012 10^9 cells/L | Standard Deviation 0.1245 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 3 | 0.018 10^9 cells/L | Standard Deviation 1.5653 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 1 | -0.002 10^9 cells/L | Standard Deviation 0.4362 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 6 | -0.229 10^9 cells/L | Standard Deviation 1.4571 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 4 | -0.394 10^9 cells/L | Standard Deviation 1.7757 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 1 | 0.422 10^9 cells/L | Standard Deviation 3.4155 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 2 | -0.234 10^9 cells/L | Standard Deviation 0.2874 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Monocytes, Week 4 | -0.039 10^9 cells/L | Standard Deviation 0.116 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Basophils, Week 4 | 0.005 10^9 cells/L | Standard Deviation 0.0241 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Eosinophils, Week 2 | -0.033 10^9 cells/L | Standard Deviation 0.0821 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 3 | -0.050 10^9 cells/L | Standard Deviation 0.286 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Platelet count, Week 1 | 4.833 10^9 cells/L | Standard Deviation 21.3906 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 6 | -0.443 10^9 cells/L | Standard Deviation 1.5994 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Platelet count, Week 6 | 8.933 10^9 cells/L | Standard Deviation 16.1973 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 4 | -0.137 10^9 cells/L | Standard Deviation 0.3011 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 2 | 0.155 10^9 cells/L | Standard Deviation 1.435 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Basophils, Week 2 | 0.004 10^9 cells/L | Standard Deviation 0.0145 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Eosinophils, Week 3 | -0.014 10^9 cells/L | Standard Deviation 0.0908 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 6 | -0.186 10^9 cells/L | Standard Deviation 0.351 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Eosinophils, Week 1 | -0.014 10^9 cells/L | Standard Deviation 0.0724 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 4 | -0.579 10^9 cells/L | Standard Deviation 1.7494 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Platelet count, Week 4 | -1.357 10^9 cells/L | Standard Deviation 12.9591 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Monocytes, Week 1 | 0.034 10^9 cells/L | Standard Deviation 0.1288 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Basophils, Week 3 | 0.004 10^9 cells/L | Standard Deviation 0.0229 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Basophils, Week 6 | -0.000 10^9 cells/L | Standard Deviation 0.0157 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 2 | -0.100 10^9 cells/L | Standard Deviation 1.5786 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Monocytes, Week 2 | 0.009 10^9 cells/L | Standard Deviation 0.1702 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Eosinophils, Week 4 | -0.020 10^9 cells/L | Standard Deviation 0.0855 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Platelet count, Week 2 | 16.375 10^9 cells/L | Standard Deviation 30.2189 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Platelet count, Week 3 | 14.118 10^9 cells/L | Standard Deviation 44.4324 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Monocytes, Week 3 | 0.060 10^9 cells/L | Standard Deviation 0.133 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 1 | 0.422 10^9 cells/L | Standard Deviation 3.6206 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Monocytes, Week 3 | 0.075 10^9 cells/L | Standard Deviation 0.0859 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Platelet count, Week 2 | -10.500 10^9 cells/L | Standard Deviation 26.3373 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Monocytes, Week 4 | 0.070 10^9 cells/L | Standard Deviation 0.0924 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 3 | 0.046 10^9 cells/L | Standard Deviation 0.8373 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Monocytes, Week 6 | 0.006 10^9 cells/L | Standard Deviation 0.1212 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Platelet count, Week 1 | -7.375 10^9 cells/L | Standard Deviation 23.5142 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 1 | 0.027 10^9 cells/L | Standard Deviation 0.6517 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Eosinophils, Week 1 | -0.014 10^9 cells/L | Standard Deviation 0.0896 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 2 | -0.217 10^9 cells/L | Standard Deviation 1.0644 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Basophils, Week 1 | -0.011 10^9 cells/L | Standard Deviation 0.0228 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 6 | -0.278 10^9 cells/L | Standard Deviation 0.6628 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 3 | -0.101 10^9 cells/L | Standard Deviation 0.7464 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 4 | 0.493 10^9 cells/L | Standard Deviation 0.8534 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Eosinophils, Week 2 | 0.021 10^9 cells/L | Standard Deviation 0.0914 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 2 | -0.136 10^9 cells/L | Standard Deviation 1.1972 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Eosinophils, Week 3 | 0.012 10^9 cells/L | Standard Deviation 0.0893 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Eosinophils, Week 4 | -0.004 10^9 cells/L | Standard Deviation 0.0971 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Basophils, Week 3 | -0.005 10^9 cells/L | Standard Deviation 0.0273 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Eosinophils, Week 6 | 0.034 10^9 cells/L | Standard Deviation 0.1241 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 6 | -0.336 10^9 cells/L | Standard Deviation 0.8409 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 1 | 0.050 10^9 cells/L | Standard Deviation 0.7598 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 1 | 0.024 10^9 cells/L | Standard Deviation 0.334 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 4 | 0.567 10^9 cells/L | Standard Deviation 0.8659 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 2 | 0.062 10^9 cells/L | Standard Deviation 0.2353 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Platelet count, Week 6 | -14.071 10^9 cells/L | Standard Deviation 44.0742 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 3 | 0.072 10^9 cells/L | Standard Deviation 0.3048 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Basophils, Week 4 | -0.000 10^9 cells/L | Standard Deviation 0.031 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 4 | 0.030 10^9 cells/L | Standard Deviation 0.4575 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Platelet count, Week 4 | 12.417 10^9 cells/L | Standard Deviation 34.3973 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 6 | -0.086 10^9 cells/L | Standard Deviation 0.3537 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Monocytes, Week 1 | 0.042 10^9 cells/L | Standard Deviation 0.1359 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Platelet count, Week 3 | -3.333 10^9 cells/L | Standard Deviation 21.8812 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Monocytes, Week 2 | 0.029 10^9 cells/L | Standard Deviation 0.0862 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Basophils, Week 6 | -0.003 10^9 cells/L | Standard Deviation 0.0276 |
| GSK1278863, 0.5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Basophils, Week 2 | -0.013 10^9 cells/L | Standard Deviation 0.03 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 1 | -0.211 10^9 cells/L | Standard Deviation 1.5885 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Basophils, Week 1 | 0.008 10^9 cells/L | Standard Deviation 0.026 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Basophils, Week 2 | -0.001 10^9 cells/L | Standard Deviation 0.0202 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Basophils, Week 3 | -0.001 10^9 cells/L | Standard Deviation 0.0218 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Basophils, Week 4 | -0.003 10^9 cells/L | Standard Deviation 0.0239 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Basophils, Week 6 | -0.003 10^9 cells/L | Standard Deviation 0.023 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Eosinophils, Week 1 | -0.029 10^9 cells/L | Standard Deviation 0.0841 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Eosinophils, Week 2 | -0.013 10^9 cells/L | Standard Deviation 0.0919 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Eosinophils, Week 3 | -0.040 10^9 cells/L | Standard Deviation 0.0553 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Eosinophils, Week 4 | -0.028 10^9 cells/L | Standard Deviation 0.0881 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Eosinophils, Week 6 | -0.018 10^9 cells/L | Standard Deviation 0.0871 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 1 | 0.126 10^9 cells/L | Standard Deviation 0.3811 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 2 | -0.176 10^9 cells/L | Standard Deviation 0.2424 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 3 | -0.028 10^9 cells/L | Standard Deviation 0.365 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 4 | -0.082 10^9 cells/L | Standard Deviation 0.4047 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 6 | -0.083 10^9 cells/L | Standard Deviation 0.3372 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Monocytes, Week 1 | 0.032 10^9 cells/L | Standard Deviation 0.1258 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Monocytes, Week 2 | -0.044 10^9 cells/L | Standard Deviation 0.1469 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Monocytes, Week 3 | 0.015 10^9 cells/L | Standard Deviation 0.1634 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Monocytes, Week 4 | 0.005 10^9 cells/L | Standard Deviation 0.112 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Monocytes, Week 6 | -0.010 10^9 cells/L | Standard Deviation 0.116 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 1 | -0.362 10^9 cells/L | Standard Deviation 1.2527 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 2 | -0.400 10^9 cells/L | Standard Deviation 0.947 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 3 | -0.373 10^9 cells/L | Standard Deviation 1.0319 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 4 | -0.239 10^9 cells/L | Standard Deviation 1.1614 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 6 | -0.428 10^9 cells/L | Standard Deviation 1.011 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Platelet count, Week 1 | 6.056 10^9 cells/L | Standard Deviation 31.6627 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Platelet count, Week 2 | 0.200 10^9 cells/L | Standard Deviation 23.6649 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Platelet count, Week 3 | -7.412 10^9 cells/L | Standard Deviation 26.8632 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Platelet count, Week 4 | -0.563 10^9 cells/L | Standard Deviation 47.3497 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Platelet count, Week 6 | 2.063 10^9 cells/L | Standard Deviation 21.3868 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 2 | -0.625 10^9 cells/L | Standard Deviation 1.0866 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 3 | -0.435 10^9 cells/L | Standard Deviation 1.0571 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 4 | -0.344 10^9 cells/L | Standard Deviation 1.4846 |
| GSK1278863, 2 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 6 | -0.538 10^9 cells/L | Standard Deviation 1.0893 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Monocytes, Week 3 | 0.054 10^9 cells/L | Standard Deviation 0.124 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Basophils, Week 4 | -0.001 10^9 cells/L | Standard Deviation 0.0232 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Platelet count, Week 2 | 12.941 10^9 cells/L | Standard Deviation 25.5721 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Monocytes, Week 2 | 0.025 10^9 cells/L | Standard Deviation 0.1182 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Monocytes, Week 1 | 0.096 10^9 cells/L | Standard Deviation 0.1305 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Basophils, Week 3 | 0.002 10^9 cells/L | Standard Deviation 0.0221 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Platelet count, Week 3 | 8.176 10^9 cells/L | Standard Deviation 29.1574 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 6 | 0.025 10^9 cells/L | Standard Deviation 0.3096 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 4 | -0.081 10^9 cells/L | Standard Deviation 0.3471 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 6 | 0.329 10^9 cells/L | Standard Deviation 1.4347 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Platelet count, Week 4 | 22.500 10^9 cells/L | Standard Deviation 46.0232 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 3 | 0.021 10^9 cells/L | Standard Deviation 0.3838 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 2 | -0.036 10^9 cells/L | Standard Deviation 0.3978 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 4 | -0.206 10^9 cells/L | Standard Deviation 1.1174 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Platelet count, Week 6 | 10.647 10^9 cells/L | Standard Deviation 31.0764 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Lymphocytes, Week 1 | 0.048 10^9 cells/L | Standard Deviation 0.366 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Eosinophils, Week 6 | 0.009 10^9 cells/L | Standard Deviation 0.1048 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Eosinophils, Week 4 | 0.011 10^9 cells/L | Standard Deviation 0.0818 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 1 | 0.639 10^9 cells/L | Standard Deviation 0.996 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Eosinophils, Week 3 | -0.018 10^9 cells/L | Standard Deviation 0.0695 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Eosinophils, Week 2 | -0.031 10^9 cells/L | Standard Deviation 0.0636 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Basophils, Week 2 | 0.004 10^9 cells/L | Standard Deviation 0.0336 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 2 | 0.050 10^9 cells/L | Standard Deviation 1.0377 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Eosinophils, Week 1 | 0.023 10^9 cells/L | Standard Deviation 0.0774 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Basophils, Week 6 | -0.001 10^9 cells/L | Standard Deviation 0.0169 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 4 | -0.148 10^9 cells/L | Standard Deviation 0.9234 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 3 | 0.335 10^9 cells/L | Standard Deviation 1.2442 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 2 | 0.086 10^9 cells/L | Standard Deviation 0.9817 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Basophils, Week 1 | 0.003 10^9 cells/L | Standard Deviation 0.0214 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 6 | 0.215 10^9 cells/L | Standard Deviation 1.4295 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Total Neutrophils, Week 1 | 0.457 10^9 cells/L | Standard Deviation 0.9942 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Monocytes, Week 6 | 0.066 10^9 cells/L | Standard Deviation 0.1579 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | WBC count (absolute), Week 3 | 0.394 10^9 cells/L | Standard Deviation 1.3908 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Platelet count, Week 1 | 14.500 10^9 cells/L | Standard Deviation 19.4672 |
| GSK1278863, 5 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet Count, WBC Count (Absolute) at Week 1, 2, 3, 4, and 6 | Monocytes, Week 4 | -0.007 10^9 cells/L | Standard Deviation 0.1223 |
Secondary
Change From Baseline in ECG Parameters at Week 2, 4 and 6
Full 12-lead ECGs were recorded in participants who were rested supine or seated for at least 10 minutes before each reading. All ECGs were transmitted to a central reviewer for blinded assessment. Full 12-lead ECGs were recorded on the provided ECG machine that automatically calculates heart rate, PR, QRS, QT and QTc intervals. Baseline ECG values were defined as measurements taken at screening. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values.
Time frame: Baseline (Screening), Week 2, 4, and 6
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QTc Interval (Bazett's), Week 6 | 11.4 msec | Standard Deviation 17.49 |
| Placebo | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QRS Duration, Week 4 | -0.4 msec | Standard Deviation 13.82 |
| Placebo | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QTc Interval (Bazett's), Week 2 | 7.9 msec | Standard Deviation 18.96 |
| Placebo | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QTc Interval (Bazett's), Week 4 | 2.5 msec | Standard Deviation 15.3 |
| Placebo | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | Uncorrected QT Interval, Week 2 | -10.8 msec | Standard Deviation 28.14 |
| Placebo | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QRS Duration, Week 6 | -0.3 msec | Standard Deviation 8.07 |
| Placebo | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QTc Interval (Fridericias's), Week 6 | 4.6 msec | Standard Deviation 12.04 |
| Placebo | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | PR Interval, Week 2 | -1.2 msec | Standard Deviation 9.22 |
| Placebo | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | PR Interval, Week 6 | -5.8 msec | Standard Deviation 10.7 |
| Placebo | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | Uncorrected QT Interval, Week 6 | -7.9 msec | Standard Deviation 20.94 |
| Placebo | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QTc Interval (Fridericias's), Week 4 | 1.0 msec | Standard Deviation 11.26 |
| Placebo | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | Uncorrected QT Interval, Week 4 | -2.9 msec | Standard Deviation 21.31 |
| Placebo | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QRS Duration, Week 2 | 2.5 msec | Standard Deviation 7.69 |
| Placebo | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | PR Interval, Week 4 | -2.6 msec | Standard Deviation 17.37 |
| Placebo | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QTc Interval (Fridericias's), Week 2 | 1.6 msec | Standard Deviation 12.03 |
| GSK1278863, 0.5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QTc Interval (Fridericias's), Week 4 | -4.2 msec | Standard Deviation 10.16 |
| GSK1278863, 0.5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | PR Interval, Week 2 | 3.6 msec | Standard Deviation 15.61 |
| GSK1278863, 0.5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | PR Interval, Week 4 | 1.8 msec | Standard Deviation 9.97 |
| GSK1278863, 0.5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | PR Interval, Week 6 | 0.5 msec | Standard Deviation 16.22 |
| GSK1278863, 0.5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QRS Duration, Week 2 | -0.0 msec | Standard Deviation 5.8 |
| GSK1278863, 0.5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QRS Duration, Week 4 | 1.8 msec | Standard Deviation 4.8 |
| GSK1278863, 0.5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QRS Duration, Week 6 | 0.2 msec | Standard Deviation 10.04 |
| GSK1278863, 0.5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QTc Interval (Bazett's), Week 2 | 3.4 msec | Standard Deviation 11.28 |
| GSK1278863, 0.5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QTc Interval (Bazett's), Week 4 | -0.8 msec | Standard Deviation 10.26 |
| GSK1278863, 0.5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QTc Interval (Bazett's), Week 6 | 2.9 msec | Standard Deviation 12.94 |
| GSK1278863, 0.5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QTc Interval (Fridericias's), Week 2 | 1.7 msec | Standard Deviation 7.8 |
| GSK1278863, 0.5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | Uncorrected QT Interval, Week 2 | -1.9 msec | Standard Deviation 12.25 |
| GSK1278863, 0.5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | Uncorrected QT Interval, Week 4 | -10.9 msec | Standard Deviation 18.75 |
| GSK1278863, 0.5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QTc Interval (Fridericias's), Week 6 | 1.0 msec | Standard Deviation 11.36 |
| GSK1278863, 0.5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | Uncorrected QT Interval, Week 6 | -2.4 msec | Standard Deviation 17.34 |
| GSK1278863, 2 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | Uncorrected QT Interval, Week 4 | 5.4 msec | Standard Deviation 17.87 |
| GSK1278863, 2 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QTc Interval (Bazett's), Week 4 | -1.8 msec | Standard Deviation 14.87 |
| GSK1278863, 2 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QTc Interval (Bazett's), Week 6 | 0.0 msec | Standard Deviation 20.99 |
| GSK1278863, 2 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QRS Duration, Week 2 | 0.4 msec | Standard Deviation 7.29 |
| GSK1278863, 2 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QTc Interval (Fridericias's), Week 2 | -1.7 msec | Standard Deviation 10.68 |
| GSK1278863, 2 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | PR Interval, Week 2 | 2.5 msec | Standard Deviation 9.88 |
| GSK1278863, 2 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | Uncorrected QT Interval, Week 2 | 3.1 msec | Standard Deviation 15.31 |
| GSK1278863, 2 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | PR Interval, Week 6 | -0.2 msec | Standard Deviation 16.83 |
| GSK1278863, 2 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QTc Interval (Fridericias's), Week 4 | 0.5 msec | Standard Deviation 13.54 |
| GSK1278863, 2 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | Uncorrected QT Interval, Week 6 | -6.7 msec | Standard Deviation 15.39 |
| GSK1278863, 2 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | PR Interval, Week 4 | 3.1 msec | Standard Deviation 12.35 |
| GSK1278863, 2 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QTc Interval (Fridericias's), Week 6 | -2.4 msec | Standard Deviation 15.05 |
| GSK1278863, 2 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QRS Duration, Week 6 | -1.9 msec | Standard Deviation 6.64 |
| GSK1278863, 2 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QTc Interval (Bazett's), Week 2 | -4.0 msec | Standard Deviation 12.98 |
| GSK1278863, 2 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QRS Duration, Week 4 | 1.3 msec | Standard Deviation 5.32 |
| GSK1278863, 5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | PR Interval, Week 4 | -2.0 msec | Standard Deviation 16.16 |
| GSK1278863, 5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QRS Duration, Week 6 | 3.5 msec | Standard Deviation 5.07 |
| GSK1278863, 5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QTc Interval (Bazett's), Week 4 | -1.9 msec | Standard Deviation 19.04 |
| GSK1278863, 5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QRS Duration, Week 2 | 4.6 msec | Standard Deviation 4.94 |
| GSK1278863, 5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | Uncorrected QT Interval, Week 4 | 8.8 msec | Standard Deviation 20.89 |
| GSK1278863, 5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QTc Interval (Fridericias's), Week 4 | 1.6 msec | Standard Deviation 17.45 |
| GSK1278863, 5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QTc Interval (Bazett's), Week 6 | 3.3 msec | Standard Deviation 19.38 |
| GSK1278863, 5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QRS Duration, Week 4 | 2.3 msec | Standard Deviation 8.15 |
| GSK1278863, 5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | PR Interval, Week 2 | -0.6 msec | Standard Deviation 10.8 |
| GSK1278863, 5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | Uncorrected QT Interval, Week 2 | 5.8 msec | Standard Deviation 22.23 |
| GSK1278863, 5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QTc Interval (Fridericias's), Week 2 | 3.0 msec | Standard Deviation 17.12 |
| GSK1278863, 5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | Uncorrected QT Interval, Week 6 | 3.2 msec | Standard Deviation 31.45 |
| GSK1278863, 5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QTc Interval (Fridericias's), Week 6 | 3.2 msec | Standard Deviation 18.08 |
| GSK1278863, 5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | PR Interval, Week 6 | 1.3 msec | Standard Deviation 15.67 |
| GSK1278863, 5 mg | Change From Baseline in ECG Parameters at Week 2, 4 and 6 | QTc Interval (Bazett's), Week 2 | 1.7 msec | Standard Deviation 17.77 |
Secondary
Change From Baseline in Erythropoietin at Week 2 and Week 4
Blood samples for erythropoietin were collected at Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1 and 3 h after this fist sample) and Week 4 (Pre-dose and 3 h post-dose). The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.
Time frame: Baseline (Day 1 Pre-dose), Week 2 and 4
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Erythropoietin at Week 2 and Week 4 | Week 2, 5-9 Hours, Post Dose | 1.541 Units per litre (U/L) | Standard Deviation 6.689 |
| Placebo | Change From Baseline in Erythropoietin at Week 2 and Week 4 | Week 2, 4-8 Hours Post-Dose | 0.721 Units per litre (U/L) | Standard Deviation 6.1773 |
| Placebo | Change From Baseline in Erythropoietin at Week 2 and Week 4 | Week 4, 3 Hour Post-Dose | 6.346 Units per litre (U/L) | Standard Deviation 18.2978 |
| Placebo | Change From Baseline in Erythropoietin at Week 2 and Week 4 | Week 4, Pre-dose | 6.644 Units per litre (U/L) | Standard Deviation 17.6483 |
| Placebo | Change From Baseline in Erythropoietin at Week 2 and Week 4 | Week 2, 7-11 Hours, Post Dose | 0.437 Units per litre (U/L) | Standard Deviation 5.4935 |
| GSK1278863, 0.5 mg | Change From Baseline in Erythropoietin at Week 2 and Week 4 | Week 4, Pre-dose | 0.014 Units per litre (U/L) | Standard Deviation 3.9986 |
| GSK1278863, 0.5 mg | Change From Baseline in Erythropoietin at Week 2 and Week 4 | Week 4, 3 Hour Post-Dose | 1.039 Units per litre (U/L) | Standard Deviation 5.1686 |
| GSK1278863, 0.5 mg | Change From Baseline in Erythropoietin at Week 2 and Week 4 | Week 2, 4-8 Hours Post-Dose | 1.022 Units per litre (U/L) | Standard Deviation 4.4319 |
| GSK1278863, 0.5 mg | Change From Baseline in Erythropoietin at Week 2 and Week 4 | Week 2, 5-9 Hours, Post Dose | 1.027 Units per litre (U/L) | Standard Deviation 4.3872 |
| GSK1278863, 0.5 mg | Change From Baseline in Erythropoietin at Week 2 and Week 4 | Week 2, 7-11 Hours, Post Dose | 0.538 Units per litre (U/L) | Standard Deviation 4.5382 |
| GSK1278863, 2 mg | Change From Baseline in Erythropoietin at Week 2 and Week 4 | Week 4, Pre-dose | 0.814 Units per litre (U/L) | Standard Deviation 6.8894 |
| GSK1278863, 2 mg | Change From Baseline in Erythropoietin at Week 2 and Week 4 | Week 2, 7-11 Hours, Post Dose | 6.630 Units per litre (U/L) | Standard Deviation 13.412 |
| GSK1278863, 2 mg | Change From Baseline in Erythropoietin at Week 2 and Week 4 | Week 2, 5-9 Hours, Post Dose | 4.612 Units per litre (U/L) | Standard Deviation 10.9494 |
| GSK1278863, 2 mg | Change From Baseline in Erythropoietin at Week 2 and Week 4 | Week 2, 4-8 Hours Post-Dose | 3.622 Units per litre (U/L) | Standard Deviation 10.0551 |
| GSK1278863, 2 mg | Change From Baseline in Erythropoietin at Week 2 and Week 4 | Week 4, 3 Hour Post-Dose | -0.075 Units per litre (U/L) | Standard Deviation 7.6779 |
| GSK1278863, 5 mg | Change From Baseline in Erythropoietin at Week 2 and Week 4 | Week 2, 4-8 Hours Post-Dose | 13.267 Units per litre (U/L) | Standard Deviation 17.858 |
| GSK1278863, 5 mg | Change From Baseline in Erythropoietin at Week 2 and Week 4 | Week 4, Pre-dose | 2.975 Units per litre (U/L) | Standard Deviation 7.5732 |
| GSK1278863, 5 mg | Change From Baseline in Erythropoietin at Week 2 and Week 4 | Week 2, 5-9 Hours, Post Dose | 15.800 Units per litre (U/L) | Standard Deviation 18.5065 |
| GSK1278863, 5 mg | Change From Baseline in Erythropoietin at Week 2 and Week 4 | Week 2, 7-11 Hours, Post Dose | 20.100 Units per litre (U/L) | Standard Deviation 18.5656 |
| GSK1278863, 5 mg | Change From Baseline in Erythropoietin at Week 2 and Week 4 | Week 4, 3 Hour Post-Dose | 2.102 Units per litre (U/L) | Standard Deviation 6.918 |
Secondary
Change From Baseline in Ferritin at Week 2 and Week 4
Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.
Time frame: Baseline (Day 1 Pre-dose), Week 2 and 4
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Ferritin at Week 2 and Week 4 | Week 4 | -24.3 mcg/L | Standard Deviation 38.61 |
| Placebo | Change From Baseline in Ferritin at Week 2 and Week 4 | Week 2 | 2.6 mcg/L | Standard Deviation 50.49 |
| GSK1278863, 0.5 mg | Change From Baseline in Ferritin at Week 2 and Week 4 | Week 2 | -20.0 mcg/L | Standard Deviation 40.02 |
| GSK1278863, 0.5 mg | Change From Baseline in Ferritin at Week 2 and Week 4 | Week 4 | -35.8 mcg/L | Standard Deviation 54.68 |
| GSK1278863, 2 mg | Change From Baseline in Ferritin at Week 2 and Week 4 | Week 4 | -8.2 mcg/L | Standard Deviation 268.77 |
| GSK1278863, 2 mg | Change From Baseline in Ferritin at Week 2 and Week 4 | Week 2 | -38.6 mcg/L | Standard Deviation 70.2 |
| GSK1278863, 5 mg | Change From Baseline in Ferritin at Week 2 and Week 4 | Week 4 | -101.8 mcg/L | Standard Deviation 91.07 |
| GSK1278863, 5 mg | Change From Baseline in Ferritin at Week 2 and Week 4 | Week 2 | -58.8 mcg/L | Standard Deviation 58.2 |
Secondary
Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6
Three measurements of heart rate were recorded from the participant in a supine position for at least 5 minutes (allowed enough time between measurement to completely deflate and loosen the inflatable cuff). Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. change from baseline in heart rate at Week 1, 2, 3, 4, and 6 were reported.
Time frame: Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6 | Heart rate, Week 4 | -1.167 Beats per minute | Standard Deviation 8.7271 |
| Placebo | Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6 | Heart rate, Week 2 | 0.412 Beats per minute | Standard Deviation 7.6771 |
| Placebo | Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6 | Heart rate, Week 6 | 1.854 Beats per minute | Standard Deviation 10.9029 |
| Placebo | Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6 | Heart rate, Week 3 | 3.392 Beats per minute | Standard Deviation 8.3543 |
| Placebo | Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6 | Heart rate, Week 1 | 0.296 Beats per minute | Standard Deviation 7.1005 |
| GSK1278863, 0.5 mg | Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6 | Heart rate, Week 3 | 0.976 Beats per minute | Standard Deviation 8.3179 |
| GSK1278863, 0.5 mg | Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6 | Heart rate, Week 4 | 1.111 Beats per minute | Standard Deviation 7.0801 |
| GSK1278863, 0.5 mg | Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6 | Heart rate, Week 6 | -0.167 Beats per minute | Standard Deviation 7.7993 |
| GSK1278863, 0.5 mg | Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6 | Heart rate, Week 2 | -1.310 Beats per minute | Standard Deviation 7.6051 |
| GSK1278863, 0.5 mg | Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6 | Heart rate, Week 1 | 1.375 Beats per minute | Standard Deviation 6.9088 |
| GSK1278863, 2 mg | Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6 | Heart rate, Week 3 | 0.412 Beats per minute | Standard Deviation 6.6558 |
| GSK1278863, 2 mg | Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6 | Heart rate, Week 1 | 0.315 Beats per minute | Standard Deviation 12.5898 |
| GSK1278863, 2 mg | Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6 | Heart rate, Week 2 | -1.333 Beats per minute | Standard Deviation 5.5777 |
| GSK1278863, 2 mg | Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6 | Heart rate, Week 4 | -0.500 Beats per minute | Standard Deviation 7.0889 |
| GSK1278863, 2 mg | Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6 | Heart rate, Week 6 | -0.458 Beats per minute | Standard Deviation 8.2846 |
| GSK1278863, 5 mg | Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6 | Heart rate, Week 4 | -2.020 Beats per minute | Standard Deviation 7.8391 |
| GSK1278863, 5 mg | Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6 | Heart rate, Week 2 | -0.500 Beats per minute | Standard Deviation 6.8716 |
| GSK1278863, 5 mg | Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6 | Heart rate, Week 1 | 1.632 Beats per minute | Standard Deviation 7.1258 |
| GSK1278863, 5 mg | Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6 | Heart rate, Week 3 | -0.510 Beats per minute | Standard Deviation 6.9802 |
| GSK1278863, 5 mg | Change From Baseline in Heart Rate at Week 1, 2, 3, 4, and 6 | Heart rate, Week 6 | 0.917 Beats per minute | Standard Deviation 7.5134 |
Secondary
Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks
Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.
Time frame: Baseline (Day 1 pre-dose), Week 1, 2, 3, and 4
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Hematocrit, Week 1 | -0.15 Ratio | Standard Deviation 1.385 |
| Placebo | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Hematocrit, Week 2 | 0.35 Ratio | Standard Deviation 1.854 |
| Placebo | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Hematocrit, Week 3 | -0.24 Ratio | Standard Deviation 1.752 |
| Placebo | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Hematocrit, Week 4 | -0.50 Ratio | Standard Deviation 1.958 |
| Placebo | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Reticulocyte, Week 1 | 0.05 Ratio | Standard Deviation 0.494 |
| Placebo | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Reticulocyte, Week 2 | 0.01 Ratio | Standard Deviation 0.474 |
| Placebo | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Reticulocyte, Week 3 | 0.13 Ratio | Standard Deviation 0.479 |
| Placebo | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Reticulocyte, Week 4 | -0.07 Ratio | Standard Deviation 0.39 |
| GSK1278863, 0.5 mg | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Reticulocyte, Week 2 | 0.32 Ratio | Standard Deviation 0.458 |
| GSK1278863, 0.5 mg | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Reticulocyte, Week 1 | 0.24 Ratio | Standard Deviation 0.443 |
| GSK1278863, 0.5 mg | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Hematocrit, Week 2 | 0.11 Ratio | Standard Deviation 1.57 |
| GSK1278863, 0.5 mg | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Reticulocyte, Week 4 | 0.11 Ratio | Standard Deviation 0.375 |
| GSK1278863, 0.5 mg | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Reticulocyte, Week 3 | 0.23 Ratio | Standard Deviation 0.308 |
| GSK1278863, 0.5 mg | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Hematocrit, Week 4 | -0.14 Ratio | Standard Deviation 1.204 |
| GSK1278863, 0.5 mg | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Hematocrit, Week 3 | -0.56 Ratio | Standard Deviation 1.148 |
| GSK1278863, 0.5 mg | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Hematocrit, Week 1 | -0.29 Ratio | Standard Deviation 1.976 |
| GSK1278863, 2 mg | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Reticulocyte, Week 3 | 0.15 Ratio | Standard Deviation 0.634 |
| GSK1278863, 2 mg | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Hematocrit, Week 3 | 0.08 Ratio | Standard Deviation 1.406 |
| GSK1278863, 2 mg | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Hematocrit, Week 4 | 1.16 Ratio | Standard Deviation 2.566 |
| GSK1278863, 2 mg | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Reticulocyte, Week 1 | 0.46 Ratio | Standard Deviation 0.725 |
| GSK1278863, 2 mg | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Reticulocyte, Week 2 | 0.12 Ratio | Standard Deviation 0.685 |
| GSK1278863, 2 mg | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Reticulocyte, Week 4 | -0.07 Ratio | Standard Deviation 0.66 |
| GSK1278863, 2 mg | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Hematocrit, Week 1 | -0.35 Ratio | Standard Deviation 0.941 |
| GSK1278863, 2 mg | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Hematocrit, Week 2 | 0.24 Ratio | Standard Deviation 1.683 |
| GSK1278863, 5 mg | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Hematocrit, Week 3 | 2.11 Ratio | Standard Deviation 2.257 |
| GSK1278863, 5 mg | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Hematocrit, Week 4 | 3.38 Ratio | Standard Deviation 2.052 |
| GSK1278863, 5 mg | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Hematocrit, Week 2 | 1.64 Ratio | Standard Deviation 2.103 |
| GSK1278863, 5 mg | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Hematocrit, Week 1 | 0.39 Ratio | Standard Deviation 1.616 |
| GSK1278863, 5 mg | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Reticulocyte, Week 1 | 0.95 Ratio | Standard Deviation 0.626 |
| GSK1278863, 5 mg | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Reticulocyte, Week 4 | 0.49 Ratio | Standard Deviation 0.532 |
| GSK1278863, 5 mg | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Reticulocyte, Week 3 | 0.45 Ratio | Standard Deviation 0.525 |
| GSK1278863, 5 mg | Change From Baseline in Hematocrit and Reticulocytes Over 4 Weeks | Reticulocyte, Week 2 | 0.85 Ratio | Standard Deviation 0.633 |
Secondary
Change From Baseline in Hepcidin at Week 2 and Week 4
Blood samples for hepcidin were collected at Day 1 (pre-dose), Week 2 (approximately between 4 to 8 h) and Week 4 (pre-dose). Hepcidin is a regulator of iron metabolism. Baseline was the last pre-dose value on Day 1. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. Where hepcidin values were missing because the value was below the quantification limit (BQL), the BQL value was imputed.
Time frame: Baseline (Pre-dose on Day 1), Week 2 and 4
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hepcidin at Week 2 and Week 4 | Week 2 | 10.19 Microgram per Litre (mcg/L) | Standard Deviation 88.535 |
| Placebo | Change From Baseline in Hepcidin at Week 2 and Week 4 | Week 4 | -2.62 Microgram per Litre (mcg/L) | Standard Deviation 96.176 |
| GSK1278863, 0.5 mg | Change From Baseline in Hepcidin at Week 2 and Week 4 | Week 4 | -22.16 Microgram per Litre (mcg/L) | Standard Deviation 120.138 |
| GSK1278863, 0.5 mg | Change From Baseline in Hepcidin at Week 2 and Week 4 | Week 2 | -23.46 Microgram per Litre (mcg/L) | Standard Deviation 58.809 |
| GSK1278863, 2 mg | Change From Baseline in Hepcidin at Week 2 and Week 4 | Week 2 | -75.24 Microgram per Litre (mcg/L) | Standard Deviation 88.862 |
| GSK1278863, 2 mg | Change From Baseline in Hepcidin at Week 2 and Week 4 | Week 4 | -77.34 Microgram per Litre (mcg/L) | Standard Deviation 96.843 |
| GSK1278863, 5 mg | Change From Baseline in Hepcidin at Week 2 and Week 4 | Week 2 | -120.31 Microgram per Litre (mcg/L) | Standard Deviation 113.653 |
| GSK1278863, 5 mg | Change From Baseline in Hepcidin at Week 2 and Week 4 | Week 4 | -143.09 Microgram per Litre (mcg/L) | Standard Deviation 119.617 |
Secondary
Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 2 and Week 4
Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.
Time frame: Baseline (Day 1 Pre-dose), Week 2 and 4
Population: ITT population. Only those participants available at the specified time points were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 2 and Week 4 | Week 2 | 6.13 miligram per litre (mg/L) | Standard Deviation 32.236 |
| Placebo | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 2 and Week 4 | Week 4 | 0.21 miligram per litre (mg/L) | Standard Deviation 2.212 |
| GSK1278863, 0.5 mg | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 2 and Week 4 | Week 4 | 0.65 miligram per litre (mg/L) | Standard Deviation 3.383 |
| GSK1278863, 0.5 mg | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 2 and Week 4 | Week 2 | 2.35 miligram per litre (mg/L) | Standard Deviation 6.973 |
| GSK1278863, 2 mg | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 2 and Week 4 | Week 2 | -1.00 miligram per litre (mg/L) | Standard Deviation 13.878 |
| GSK1278863, 2 mg | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 2 and Week 4 | Week 4 | -2.09 miligram per litre (mg/L) | Standard Deviation 11.708 |
| GSK1278863, 5 mg | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 2 and Week 4 | Week 2 | 4.32 miligram per litre (mg/L) | Standard Deviation 12.337 |
| GSK1278863, 5 mg | Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Week 2 and Week 4 | Week 4 | 1.76 miligram per litre (mg/L) | Standard Deviation 9.378 |
Secondary
Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6
Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 were reported.
Time frame: Baseline (Day 1), Week 1, 2, 3, 4, and 6
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb Concentration, Week 4 | 2.429 G/L | Standard Deviation 8.2808 |
| Placebo | Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb Concentration, Week 2 | -0.875 G/L | Standard Deviation 8.8835 |
| Placebo | Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb Concentration, Week 6 | -1.200 G/L | Standard Deviation 7.1534 |
| Placebo | Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb Concentration, Week 3 | 0.647 G/L | Standard Deviation 7.7938 |
| Placebo | Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb Concentration, Week 1 | 0.667 G/L | Standard Deviation 6.9367 |
| GSK1278863, 0.5 mg | Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb Concentration, Week 3 | -0.462 G/L | Standard Deviation 6.4371 |
| GSK1278863, 0.5 mg | Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb Concentration, Week 4 | -1.417 G/L | Standard Deviation 5.0355 |
| GSK1278863, 0.5 mg | Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb Concentration, Week 6 | -1.714 G/L | Standard Deviation 8.3245 |
| GSK1278863, 0.5 mg | Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb Concentration, Week 2 | -0.214 G/L | Standard Deviation 5.9249 |
| GSK1278863, 0.5 mg | Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb Concentration, Week 1 | -0.688 G/L | Standard Deviation 5.3631 |
| GSK1278863, 2 mg | Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb Concentration, Week 3 | 0.294 G/L | Standard Deviation 8.6658 |
| GSK1278863, 2 mg | Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb Concentration, Week 1 | 0.222 G/L | Standard Deviation 5.8767 |
| GSK1278863, 2 mg | Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb Concentration, Week 2 | 0.750 G/L | Standard Deviation 8.2341 |
| GSK1278863, 2 mg | Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb Concentration, Week 4 | -1.375 G/L | Standard Deviation 6.7318 |
| GSK1278863, 2 mg | Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb Concentration, Week 6 | 0.438 G/L | Standard Deviation 7.8568 |
| GSK1278863, 5 mg | Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb Concentration, Week 4 | -2.625 G/L | Standard Deviation 5.5121 |
| GSK1278863, 5 mg | Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb Concentration, Week 2 | -2.111 G/L | Standard Deviation 5.7792 |
| GSK1278863, 5 mg | Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb Concentration, Week 1 | -0.389 G/L | Standard Deviation 6.3165 |
| GSK1278863, 5 mg | Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb Concentration, Week 3 | -2.588 G/L | Standard Deviation 8.5225 |
| GSK1278863, 5 mg | Change From Baseline in Mean Corpuscle Hgb Concentration at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Hgb Concentration, Week 6 | -0.353 G/L | Standard Deviation 8.162 |
Secondary
Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6
Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 were reported.
Time frame: Baseline (Day 1), Week 1, 2, 3, 4, and 6
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Volume, Week 4 | -0.143 FL | Standard Deviation 1.9945 |
| Placebo | Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Volume, Week 1 | -0.222 FL | Standard Deviation 1.3956 |
| Placebo | Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Volume, Week 6 | -0.133 FL | Standard Deviation 1.5523 |
| Placebo | Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Volume, Week 3 | -0.235 FL | Standard Deviation 1.6405 |
| Placebo | Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Volume, Week 2 | 0.188 FL | Standard Deviation 1.4705 |
| GSK1278863, 0.5 mg | Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Volume, Week 3 | -0.231 FL | Standard Deviation 1.0127 |
| GSK1278863, 0.5 mg | Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Volume, Week 4 | 0.083 FL | Standard Deviation 1.1645 |
| GSK1278863, 0.5 mg | Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Volume, Week 6 | -0.071 FL | Standard Deviation 1.2688 |
| GSK1278863, 0.5 mg | Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Volume, Week 2 | -0.214 FL | Standard Deviation 1.1217 |
| GSK1278863, 0.5 mg | Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Volume, Week 1 | 0.125 FL | Standard Deviation 1.3601 |
| GSK1278863, 2 mg | Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Volume, Week 1 | -0.222 FL | Standard Deviation 1.5551 |
| GSK1278863, 2 mg | Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Volume, Week 2 | 0.125 FL | Standard Deviation 1.4549 |
| GSK1278863, 2 mg | Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Volume, Week 3 | 0.118 FL | Standard Deviation 1.9327 |
| GSK1278863, 2 mg | Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Volume, Week 4 | 0.188 FL | Standard Deviation 1.9397 |
| GSK1278863, 2 mg | Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Volume, Week 6 | -0.125 FL | Standard Deviation 2.2174 |
| GSK1278863, 5 mg | Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Volume, Week 4 | 1.188 FL | Standard Deviation 1.5152 |
| GSK1278863, 5 mg | Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Volume, Week 2 | 0.944 FL | Standard Deviation 0.8726 |
| GSK1278863, 5 mg | Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Volume, Week 1 | 0.278 FL | Standard Deviation 1.1275 |
| GSK1278863, 5 mg | Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Volume, Week 3 | 1.176 FL | Standard Deviation 0.8828 |
| GSK1278863, 5 mg | Change From Baseline in Mean Corpuscle Volume at Week 1, 2, 3, 4, and 6 | Mean Corpuscle Volume, Week 6 | 0.353 FL | Standard Deviation 1.2719 |
Secondary
Change From Baseline in Red Blood Cells Count Over 4 Weeks
Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.
Time frame: Baseline (Day 1 pre-dose), week 1, 2, 3, 4
Population: ITT population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Red Blood Cells Count Over 4 Weeks | Week 1 | -0.01 10^12 cells /L | Standard Deviation 0.137 |
| Placebo | Change From Baseline in Red Blood Cells Count Over 4 Weeks | Week 2 | 0.02 10^12 cells /L | Standard Deviation 0.181 |
| Placebo | Change From Baseline in Red Blood Cells Count Over 4 Weeks | Week 3 | -0.03 10^12 cells /L | Standard Deviation 0.193 |
| Placebo | Change From Baseline in Red Blood Cells Count Over 4 Weeks | Week 4 | -0.05 10^12 cells /L | Standard Deviation 0.181 |
| GSK1278863, 0.5 mg | Change From Baseline in Red Blood Cells Count Over 4 Weeks | Week 2 | 0.03 10^12 cells /L | Standard Deviation 0.16 |
| GSK1278863, 0.5 mg | Change From Baseline in Red Blood Cells Count Over 4 Weeks | Week 3 | -0.02 10^12 cells /L | Standard Deviation 0.136 |
| GSK1278863, 0.5 mg | Change From Baseline in Red Blood Cells Count Over 4 Weeks | Week 4 | 0.01 10^12 cells /L | Standard Deviation 0.145 |
| GSK1278863, 0.5 mg | Change From Baseline in Red Blood Cells Count Over 4 Weeks | Week 1 | -0.03 10^12 cells /L | Standard Deviation 0.181 |
| GSK1278863, 2 mg | Change From Baseline in Red Blood Cells Count Over 4 Weeks | Week 3 | -0.02 10^12 cells /L | Standard Deviation 0.147 |
| GSK1278863, 2 mg | Change From Baseline in Red Blood Cells Count Over 4 Weeks | Week 2 | 0.01 10^12 cells /L | Standard Deviation 0.165 |
| GSK1278863, 2 mg | Change From Baseline in Red Blood Cells Count Over 4 Weeks | Week 4 | 0.09 10^12 cells /L | Standard Deviation 0.254 |
| GSK1278863, 2 mg | Change From Baseline in Red Blood Cells Count Over 4 Weeks | Week 1 | -0.03 10^12 cells /L | Standard Deviation 0.113 |
| GSK1278863, 5 mg | Change From Baseline in Red Blood Cells Count Over 4 Weeks | Week 4 | 0.33 10^12 cells /L | Standard Deviation 0.209 |
| GSK1278863, 5 mg | Change From Baseline in Red Blood Cells Count Over 4 Weeks | Week 2 | 0.14 10^12 cells /L | Standard Deviation 0.225 |
| GSK1278863, 5 mg | Change From Baseline in Red Blood Cells Count Over 4 Weeks | Week 1 | 0.04 10^12 cells /L | Standard Deviation 0.162 |
| GSK1278863, 5 mg | Change From Baseline in Red Blood Cells Count Over 4 Weeks | Week 3 | 0.16 10^12 cells /L | Standard Deviation 0.223 |
Secondary
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6
Three measurements of SBP and DBP were recorded from the participant in a supine position for at least 5 minutes (allowed enough time between measurement to completely deflate and loosen the inflatable cuff). Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline in systolic blood pressure and diastolic blood pressure at Week 1, 2, 3, 4, and 6 were reported.
Time frame: Baseline (Day 1 pre-dose), Week 1, 2, 3, 4, and 6
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Systolic blood pressure, Week 1 | -0.519 mmHg | Standard Deviation 12.4024 |
| Placebo | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Systolic blood pressure, Week 2 | -3.373 mmHg | Standard Deviation 9.6414 |
| Placebo | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Systolic blood pressure, Week 3 | -1.529 mmHg | Standard Deviation 13.8349 |
| Placebo | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Systolic blood pressure, Week 4 | 0.854 mmHg | Standard Deviation 10.1463 |
| Placebo | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Systolic blood pressure, Week 6 | 0.125 mmHg | Standard Deviation 15.6446 |
| Placebo | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Diastolic blood pressure, Week 1 | -3.037 mmHg | Standard Deviation 8.6409 |
| Placebo | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Diastolic blood pressure, Week 2 | -1.608 mmHg | Standard Deviation 12.0348 |
| Placebo | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Diastolic blood pressure, Week 3 | -1.647 mmHg | Standard Deviation 8.7998 |
| Placebo | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Diastolic blood pressure, Week 4 | -0.625 mmHg | Standard Deviation 5.959 |
| Placebo | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Diastolic blood pressure, Week 6 | 1.396 mmHg | Standard Deviation 7.9807 |
| GSK1278863, 0.5 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Systolic blood pressure, Week 3 | -1.643 mmHg | Standard Deviation 9.4312 |
| GSK1278863, 0.5 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Diastolic blood pressure, Week 4 | -0.111 mmHg | Standard Deviation 8.8299 |
| GSK1278863, 0.5 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Systolic blood pressure, Week 4 | -0.944 mmHg | Standard Deviation 13.7693 |
| GSK1278863, 0.5 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Systolic blood pressure, Week 6 | -2.458 mmHg | Standard Deviation 15.852 |
| GSK1278863, 0.5 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Diastolic blood pressure, Week 1 | 0.521 mmHg | Standard Deviation 7.5933 |
| GSK1278863, 0.5 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Diastolic blood pressure, Week 2 | -0.024 mmHg | Standard Deviation 8.0133 |
| GSK1278863, 0.5 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Diastolic blood pressure, Week 6 | -1.312 mmHg | Standard Deviation 10.6795 |
| GSK1278863, 0.5 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Diastolic blood pressure, Week 3 | 0.857 mmHg | Standard Deviation 8.1531 |
| GSK1278863, 0.5 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Systolic blood pressure, Week 1 | 1.167 mmHg | Standard Deviation 7.1874 |
| GSK1278863, 0.5 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Systolic blood pressure, Week 2 | -5.786 mmHg | Standard Deviation 15.4381 |
| GSK1278863, 2 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Diastolic blood pressure, Week 3 | -1.755 mmHg | Standard Deviation 7.8329 |
| GSK1278863, 2 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Diastolic blood pressure, Week 2 | -2.206 mmHg | Standard Deviation 9.0633 |
| GSK1278863, 2 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Diastolic blood pressure, Week 6 | -1.281 mmHg | Standard Deviation 7.7741 |
| GSK1278863, 2 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Systolic blood pressure, Week 1 | 0.565 mmHg | Standard Deviation 13.6685 |
| GSK1278863, 2 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Systolic blood pressure, Week 4 | 0.844 mmHg | Standard Deviation 9.8529 |
| GSK1278863, 2 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Diastolic blood pressure, Week 1 | -0.750 mmHg | Standard Deviation 7.5737 |
| GSK1278863, 2 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Diastolic blood pressure, Week 4 | -1.615 mmHg | Standard Deviation 7.8894 |
| GSK1278863, 2 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Systolic blood pressure, Week 2 | -5.284 mmHg | Standard Deviation 11.6117 |
| GSK1278863, 2 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Systolic blood pressure, Week 6 | 1.656 mmHg | Standard Deviation 17.5153 |
| GSK1278863, 2 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Systolic blood pressure, Week 3 | -2.206 mmHg | Standard Deviation 13.4641 |
| GSK1278863, 5 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Systolic blood pressure, Week 6 | -6.451 mmHg | Standard Deviation 15.9295 |
| GSK1278863, 5 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Diastolic blood pressure, Week 3 | -2.627 mmHg | Standard Deviation 7.5414 |
| GSK1278863, 5 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Diastolic blood pressure, Week 1 | -0.193 mmHg | Standard Deviation 6.9711 |
| GSK1278863, 5 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Diastolic blood pressure, Week 6 | 0.529 mmHg | Standard Deviation 8.083 |
| GSK1278863, 5 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Diastolic blood pressure, Week 2 | 1.963 mmHg | Standard Deviation 7.1189 |
| GSK1278863, 5 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Systolic blood pressure, Week 2 | 1.241 mmHg | Standard Deviation 15.2259 |
| GSK1278863, 5 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Systolic blood pressure, Week 3 | -5.216 mmHg | Standard Deviation 13.0309 |
| GSK1278863, 5 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Systolic blood pressure, Week 4 | -1.510 mmHg | Standard Deviation 14.4554 |
| GSK1278863, 5 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Systolic blood pressure, Week 1 | -2.368 mmHg | Standard Deviation 8.9062 |
| GSK1278863, 5 mg | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at Week 1, 2, 3, 4, and 6 | Diastolic blood pressure, Week 4 | -0.667 mmHg | Standard Deviation 7.2024 |
Secondary
Change From Baseline in Total Iron at Week 2 and Week 4
Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.
Time frame: Baseline (Day 1 Pre-dose), Week 2 and 4
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Total Iron at Week 2 and Week 4 | Week 2 | 0.4 micromol/L | Standard Deviation 3.71 |
| Placebo | Change From Baseline in Total Iron at Week 2 and Week 4 | Week 4 | 0.6 micromol/L | Standard Deviation 2.82 |
| GSK1278863, 0.5 mg | Change From Baseline in Total Iron at Week 2 and Week 4 | Week 4 | -1.7 micromol/L | Standard Deviation 3.31 |
| GSK1278863, 0.5 mg | Change From Baseline in Total Iron at Week 2 and Week 4 | Week 2 | -1.1 micromol/L | Standard Deviation 1.7 |
| GSK1278863, 2 mg | Change From Baseline in Total Iron at Week 2 and Week 4 | Week 2 | -1.3 micromol/L | Standard Deviation 2.97 |
| GSK1278863, 2 mg | Change From Baseline in Total Iron at Week 2 and Week 4 | Week 4 | -0.4 micromol/L | Standard Deviation 3.33 |
| GSK1278863, 5 mg | Change From Baseline in Total Iron at Week 2 and Week 4 | Week 2 | 0.4 micromol/L | Standard Deviation 4.14 |
| GSK1278863, 5 mg | Change From Baseline in Total Iron at Week 2 and Week 4 | Week 4 | -0.4 micromol/L | Standard Deviation 6.1 |
Secondary
Change From Baseline in Total Iron Binding Capacity at Week 2 and Week 4
Total iron-binding capacity is a medical laboratory test that measures the blood's capacity to bind iron with transferrin. Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.
Time frame: Baseline (Day 1 Pre-dose), Week 2 and 4
Population: ITT population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Total Iron Binding Capacity at Week 2 and Week 4 | Week 2 | 0.6 Micromol per litre (micromol/L) | Standard Deviation 5.63 |
| Placebo | Change From Baseline in Total Iron Binding Capacity at Week 2 and Week 4 | Week 4 | -0.5 Micromol per litre (micromol/L) | Standard Deviation 3.72 |
| GSK1278863, 0.5 mg | Change From Baseline in Total Iron Binding Capacity at Week 2 and Week 4 | Week 4 | 0.3 Micromol per litre (micromol/L) | Standard Deviation 6.34 |
| GSK1278863, 0.5 mg | Change From Baseline in Total Iron Binding Capacity at Week 2 and Week 4 | Week 2 | -1.6 Micromol per litre (micromol/L) | Standard Deviation 5.08 |
| GSK1278863, 2 mg | Change From Baseline in Total Iron Binding Capacity at Week 2 and Week 4 | Week 2 | 2.9 Micromol per litre (micromol/L) | Standard Deviation 3.3 |
| GSK1278863, 2 mg | Change From Baseline in Total Iron Binding Capacity at Week 2 and Week 4 | Week 4 | 5.1 Micromol per litre (micromol/L) | Standard Deviation 4.12 |
| GSK1278863, 5 mg | Change From Baseline in Total Iron Binding Capacity at Week 2 and Week 4 | Week 2 | 5.9 Micromol per litre (micromol/L) | Standard Deviation 6.85 |
| GSK1278863, 5 mg | Change From Baseline in Total Iron Binding Capacity at Week 2 and Week 4 | Week 4 | 8.3 Micromol per litre (micromol/L) | Standard Deviation 5.54 |
Secondary
Change From Baseline in Transferrin at Week 2 and Week 4
Baseline was the Day 1 pre-dose value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.
Time frame: Baseline (Day 1 Pre-dose), Week 2 and 4
Population: ITT population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Transferrin at Week 2 and Week 4 | Week 2 | -0.017 Grams per litre (G/L) | Standard Deviation 0.2551 |
| Placebo | Change From Baseline in Transferrin at Week 2 and Week 4 | Week 4 | 0.011 Grams per litre (G/L) | Standard Deviation 0.2646 |
| GSK1278863, 0.5 mg | Change From Baseline in Transferrin at Week 2 and Week 4 | Week 4 | 0.028 Grams per litre (G/L) | Standard Deviation 0.2743 |
| GSK1278863, 0.5 mg | Change From Baseline in Transferrin at Week 2 and Week 4 | Week 2 | -0.100 Grams per litre (G/L) | Standard Deviation 0.2194 |
| GSK1278863, 2 mg | Change From Baseline in Transferrin at Week 2 and Week 4 | Week 2 | 0.153 Grams per litre (G/L) | Standard Deviation 0.4556 |
| GSK1278863, 2 mg | Change From Baseline in Transferrin at Week 2 and Week 4 | Week 4 | 0.294 Grams per litre (G/L) | Standard Deviation 0.3442 |
| GSK1278863, 5 mg | Change From Baseline in Transferrin at Week 2 and Week 4 | Week 2 | 0.141 Grams per litre (G/L) | Standard Deviation 0.7335 |
| GSK1278863, 5 mg | Change From Baseline in Transferrin at Week 2 and Week 4 | Week 4 | 0.388 Grams per litre (G/L) | Standard Deviation 0.355 |
Secondary
Change From Baseline in Transferrin Saturation at Week 2 and Week 4
Transferrin saturation was measured as a percentage, and is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Baseline value for transferrin saturation was the pre-dose value on Day 1. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values.
Time frame: Baseline (Day 1 Pre-dose), Week 2 and 4
Population: ITT Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Transferrin Saturation at Week 2 and Week 4 | Week 2 | 0.7 Percentage of transferrin saturation | Standard Deviation 7.18 |
| Placebo | Change From Baseline in Transferrin Saturation at Week 2 and Week 4 | Week 4 | 1.5 Percentage of transferrin saturation | Standard Deviation 6.08 |
| GSK1278863, 0.5 mg | Change From Baseline in Transferrin Saturation at Week 2 and Week 4 | Week 4 | -3.1 Percentage of transferrin saturation | Standard Deviation 4.85 |
| GSK1278863, 0.5 mg | Change From Baseline in Transferrin Saturation at Week 2 and Week 4 | Week 2 | -1.5 Percentage of transferrin saturation | Standard Deviation 4.16 |
| GSK1278863, 2 mg | Change From Baseline in Transferrin Saturation at Week 2 and Week 4 | Week 2 | -3.7 Percentage of transferrin saturation | Standard Deviation 4.59 |
| GSK1278863, 2 mg | Change From Baseline in Transferrin Saturation at Week 2 and Week 4 | Week 4 | -2.6 Percentage of transferrin saturation | Standard Deviation 6.18 |
| GSK1278863, 5 mg | Change From Baseline in Transferrin Saturation at Week 2 and Week 4 | Week 2 | -2.1 Percentage of transferrin saturation | Standard Deviation 6.51 |
| GSK1278863, 5 mg | Change From Baseline in Transferrin Saturation at Week 2 and Week 4 | Week 4 | -3.4 Percentage of transferrin saturation | Standard Deviation 11.27 |
Secondary
Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4
Blood samples for VEGF were collected at Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1 and 3 h after this fist sample) and Week 4 (Pre-dose and 3 h post-dose). Baseline was the Day 1 pre-dose value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values.
Time frame: Baseline (Pre-dose), week 2 and 4
Population: ITT population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4 | WEEK 4, PRE-DOSE | -39.69 Nanogram per litre (ng/L) | Standard Deviation 114.265 |
| Placebo | Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4 | WEEK 2, 5-9 HOURS, POST DOSE | -23.04 Nanogram per litre (ng/L) | Standard Deviation 104.309 |
| Placebo | Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4 | WEEK 4, 3 HOUR POST-DOSE | -43.33 Nanogram per litre (ng/L) | Standard Deviation 136.048 |
| Placebo | Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4 | WEEK 2, 7-11 HOURS, POST DOSE | -41.40 Nanogram per litre (ng/L) | Standard Deviation 133.098 |
| Placebo | Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4 | WEEK 2, 4-8 HOURS POST-DOSE | -12.09 Nanogram per litre (ng/L) | Standard Deviation 62.267 |
| GSK1278863, 0.5 mg | Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4 | WEEK 2, 7-11 HOURS, POST DOSE | -30.56 Nanogram per litre (ng/L) | Standard Deviation 58.602 |
| GSK1278863, 0.5 mg | Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4 | WEEK 4, PRE-DOSE | 65.89 Nanogram per litre (ng/L) | Standard Deviation 161.068 |
| GSK1278863, 0.5 mg | Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4 | WEEK 4, 3 HOUR POST-DOSE | 0.77 Nanogram per litre (ng/L) | Standard Deviation 37.861 |
| GSK1278863, 0.5 mg | Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4 | WEEK 2, 5-9 HOURS, POST DOSE | -18.21 Nanogram per litre (ng/L) | Standard Deviation 33.258 |
| GSK1278863, 0.5 mg | Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4 | WEEK 2, 4-8 HOURS POST-DOSE | -17.23 Nanogram per litre (ng/L) | Standard Deviation 56.519 |
| GSK1278863, 2 mg | Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4 | WEEK 2, 7-11 HOURS, POST DOSE | -17.88 Nanogram per litre (ng/L) | Standard Deviation 89.793 |
| GSK1278863, 2 mg | Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4 | WEEK 2, 4-8 HOURS POST-DOSE | -19.55 Nanogram per litre (ng/L) | Standard Deviation 88.167 |
| GSK1278863, 2 mg | Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4 | WEEK 2, 5-9 HOURS, POST DOSE | -11.80 Nanogram per litre (ng/L) | Standard Deviation 100.745 |
| GSK1278863, 2 mg | Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4 | WEEK 4, PRE-DOSE | -7.47 Nanogram per litre (ng/L) | Standard Deviation 29.058 |
| GSK1278863, 2 mg | Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4 | WEEK 4, 3 HOUR POST-DOSE | -3.87 Nanogram per litre (ng/L) | Standard Deviation 36.521 |
| GSK1278863, 5 mg | Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4 | WEEK 4, PRE-DOSE | -1.48 Nanogram per litre (ng/L) | Standard Deviation 30.874 |
| GSK1278863, 5 mg | Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4 | WEEK 2, 5-9 HOURS, POST DOSE | 8.38 Nanogram per litre (ng/L) | Standard Deviation 39.975 |
| GSK1278863, 5 mg | Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4 | WEEK 2, 4-8 HOURS POST-DOSE | 20.38 Nanogram per litre (ng/L) | Standard Deviation 60.84 |
| GSK1278863, 5 mg | Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4 | WEEK 2, 7-11 HOURS, POST DOSE | 14.40 Nanogram per litre (ng/L) | Standard Deviation 41.786 |
| GSK1278863, 5 mg | Change From Baseline in Vascular Endothelial Growth Factor (VEGF) at Week 2 and Week 4 | WEEK 4, 3 HOUR POST-DOSE | 5.56 Nanogram per litre (ng/L) | Standard Deviation 41.4 |
Secondary
Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6
Baseline values were recorded on Day 1 (Pre dose). If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of albumin, apolipoprotein A1, apolipoprotein total, total protein at Week 2, 4, and 6 were reported.
Time frame: Baseline (Day 1), Week 2, 4, and 6
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Total protein, Week 2 | 1.1 G/L | Standard Deviation 3.04 |
| Placebo | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Total protein, Week 6 | 0.4 G/L | Standard Deviation 2.73 |
| Placebo | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Apolipoprotein total, Week 4 | -0.036 G/L | Standard Deviation 0.0954 |
| Placebo | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Albumin, Week 2 | 0.7 G/L | Standard Deviation 1.86 |
| Placebo | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Apolipoprotein total, Week 6 | -0.007 G/L | Standard Deviation 0.0952 |
| Placebo | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Albumin, Week 6 | 0.2 G/L | Standard Deviation 2.01 |
| Placebo | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Apolipoprotein A1, Week 2 | -0.045 G/L | Standard Deviation 0.0887 |
| Placebo | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Albumin, Week 4 | 0.4 G/L | Standard Deviation 2.03 |
| Placebo | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Total protein, Week 4 | 0.5 G/L | Standard Deviation 3.18 |
| Placebo | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Apolipoprotein A1, Week 4 | -0.011 G/L | Standard Deviation 0.1144 |
| Placebo | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Apolipoprotein A1, Week 6 | -0.009 G/L | Standard Deviation 0.1287 |
| Placebo | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Apolipoprotein total, Week 2 | -0.016 G/L | Standard Deviation 0.0775 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Albumin, Week 4 | -0.2 G/L | Standard Deviation 2.08 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Apolipoprotein total, Week 2 | -0.067 G/L | Standard Deviation 0.1254 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Apolipoprotein A1, Week 2 | -0.063 G/L | Standard Deviation 0.1386 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Apolipoprotein total, Week 6 | -0.077 G/L | Standard Deviation 0.1685 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Total protein, Week 2 | -0.7 G/L | Standard Deviation 3.03 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Apolipoprotein total, Week 4 | -0.051 G/L | Standard Deviation 0.091 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Albumin, Week 2 | -0.5 G/L | Standard Deviation 1.92 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Apolipoprotein A1, Week 6 | -0.026 G/L | Standard Deviation 0.1408 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Apolipoprotein A1, Week 4 | -0.061 G/L | Standard Deviation 0.1198 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Albumin, Week 6 | -1.2 G/L | Standard Deviation 2.08 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Total protein, Week 6 | -1.5 G/L | Standard Deviation 3.2 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Total protein, Week 4 | -0.1 G/L | Standard Deviation 3.64 |
| GSK1278863, 2 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Apolipoprotein total, Week 4 | -0.055 G/L | Standard Deviation 0.1852 |
| GSK1278863, 2 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Albumin, Week 2 | -0.9 G/L | Standard Deviation 2.12 |
| GSK1278863, 2 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Albumin, Week 4 | -0.6 G/L | Standard Deviation 0.87 |
| GSK1278863, 2 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Albumin, Week 6 | 0.1 G/L | Standard Deviation 1.89 |
| GSK1278863, 2 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Apolipoprotein A1, Week 2 | -0.023 G/L | Standard Deviation 0.1754 |
| GSK1278863, 2 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Apolipoprotein A1, Week 4 | -0.025 G/L | Standard Deviation 0.1932 |
| GSK1278863, 2 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Apolipoprotein A1, Week 6 | -0.011 G/L | Standard Deviation 0.1618 |
| GSK1278863, 2 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Apolipoprotein total, Week 2 | -0.051 G/L | Standard Deviation 0.1312 |
| GSK1278863, 2 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Apolipoprotein total, Week 6 | 0.014 G/L | Standard Deviation 0.2147 |
| GSK1278863, 2 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Total protein, Week 2 | -1.3 G/L | Standard Deviation 3.64 |
| GSK1278863, 2 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Total protein, Week 4 | -0.8 G/L | Standard Deviation 2.65 |
| GSK1278863, 2 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Total protein, Week 6 | -0.3 G/L | Standard Deviation 2.44 |
| GSK1278863, 5 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Apolipoprotein A1, Week 6 | -0.076 G/L | Standard Deviation 0.2743 |
| GSK1278863, 5 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Apolipoprotein A1, Week 4 | -0.163 G/L | Standard Deviation 0.2133 |
| GSK1278863, 5 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Albumin, Week 2 | -0.4 G/L | Standard Deviation 2.12 |
| GSK1278863, 5 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Total protein, Week 2 | -0.2 G/L | Standard Deviation 2.79 |
| GSK1278863, 5 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Apolipoprotein A1, Week 2 | -0.197 G/L | Standard Deviation 0.1641 |
| GSK1278863, 5 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Albumin, Week 6 | -1.0 G/L | Standard Deviation 2.65 |
| GSK1278863, 5 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Total protein, Week 6 | -0.6 G/L | Standard Deviation 2.92 |
| GSK1278863, 5 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Total protein, Week 4 | 0.2 G/L | Standard Deviation 4.5 |
| GSK1278863, 5 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Apolipoprotein total, Week 4 | -0.024 G/L | Standard Deviation 0.2123 |
| GSK1278863, 5 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Apolipoprotein total, Week 2 | -0.048 G/L | Standard Deviation 0.1488 |
| GSK1278863, 5 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Albumin, Week 4 | -0.6 G/L | Standard Deviation 2.71 |
| GSK1278863, 5 mg | Change From Baseline Values of Albumin, Apolipoprotein A1, Apolipoprotein Total, Total Protein at Week 2, 4, and 6 | Apolipoprotein total, Week 6 | 0.009 G/L | Standard Deviation 0.2194 |
Secondary
Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6
Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the Baseline value. The change from Baseline was calculated by subtracting the Baseline value from the individual post-dose visit values. Change from Baseline values of ALT, AST, ALP and CK at Week 2, 4, and 6
Time frame: Baseline (Day 1), Week 2, 4, and 6
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | CK, Week 2 | -18.7 IU/L | Standard Deviation 34.45 |
| Placebo | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | CK, Week 6 | -19.1 IU/L | Standard Deviation 37.64 |
| Placebo | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | AST, Week 4 | -1.3 IU/L | Standard Deviation 3.24 |
| Placebo | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | ALT, Week 2 | -1.1 IU/L | Standard Deviation 2.89 |
| Placebo | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | AST, Week 6 | -1.6 IU/L | Standard Deviation 3.03 |
| Placebo | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | ALT, Week 6 | -1.3 IU/L | Standard Deviation 3.09 |
| Placebo | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | ALP, Week 2 | 0.8 IU/L | Standard Deviation 10.25 |
| Placebo | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | ALT, Week 4 | 0.1 IU/L | Standard Deviation 3.38 |
| Placebo | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | CK, Week 4 | -21.4 IU/L | Standard Deviation 57.79 |
| Placebo | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | ALP, Week 4 | 1.1 IU/L | Standard Deviation 8.92 |
| Placebo | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | ALP, Week 6 | -1.9 IU/L | Standard Deviation 11.51 |
| Placebo | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | AST, Week 2 | -0.9 IU/L | Standard Deviation 2.66 |
| GSK1278863, 0.5 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | ALT, Week 4 | 0.7 IU/L | Standard Deviation 6.79 |
| GSK1278863, 0.5 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | AST, Week 2 | -1.7 IU/L | Standard Deviation 3.51 |
| GSK1278863, 0.5 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | ALP, Week 2 | -2.8 IU/L | Standard Deviation 12.11 |
| GSK1278863, 0.5 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | AST, Week 6 | -0.1 IU/L | Standard Deviation 5.92 |
| GSK1278863, 0.5 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | CK, Week 2 | 7.9 IU/L | Standard Deviation 137.74 |
| GSK1278863, 0.5 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | AST, Week 4 | -0.5 IU/L | Standard Deviation 4.37 |
| GSK1278863, 0.5 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | ALT, Week 2 | -1.2 IU/L | Standard Deviation 3.32 |
| GSK1278863, 0.5 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | ALP, Week 6 | -6.4 IU/L | Standard Deviation 14.19 |
| GSK1278863, 0.5 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | ALP, Week 4 | -4.8 IU/L | Standard Deviation 10.49 |
| GSK1278863, 0.5 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | ALT, Week 6 | 0.7 IU/L | Standard Deviation 4.19 |
| GSK1278863, 0.5 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | CK, Week 6 | -9.4 IU/L | Standard Deviation 97 |
| GSK1278863, 0.5 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | CK, Week 4 | -8.5 IU/L | Standard Deviation 90.9 |
| GSK1278863, 2 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | AST, Week 4 | 5.1 IU/L | Standard Deviation 28.99 |
| GSK1278863, 2 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | ALT, Week 2 | 3.9 IU/L | Standard Deviation 21.85 |
| GSK1278863, 2 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | ALT, Week 4 | 6.0 IU/L | Standard Deviation 29.33 |
| GSK1278863, 2 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | ALT, Week 6 | 0.4 IU/L | Standard Deviation 7.51 |
| GSK1278863, 2 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | ALP, Week 2 | -1.2 IU/L | Standard Deviation 12.31 |
| GSK1278863, 2 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | ALP, Week 4 | -0.8 IU/L | Standard Deviation 18.42 |
| GSK1278863, 2 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | ALP, Week 6 | -5.7 IU/L | Standard Deviation 19.41 |
| GSK1278863, 2 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | AST, Week 2 | 4.7 IU/L | Standard Deviation 21.33 |
| GSK1278863, 2 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | AST, Week 6 | -0.3 IU/L | Standard Deviation 7.89 |
| GSK1278863, 2 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | CK, Week 2 | 1.2 IU/L | Standard Deviation 61.44 |
| GSK1278863, 2 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | CK, Week 4 | -12.6 IU/L | Standard Deviation 66.4 |
| GSK1278863, 2 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | CK, Week 6 | -5.1 IU/L | Standard Deviation 63.93 |
| GSK1278863, 5 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | ALP, Week 6 | 4.9 IU/L | Standard Deviation 13.4 |
| GSK1278863, 5 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | ALP, Week 4 | 2.6 IU/L | Standard Deviation 8.15 |
| GSK1278863, 5 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | ALT, Week 2 | -1.9 IU/L | Standard Deviation 4.16 |
| GSK1278863, 5 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | CK, Week 2 | 4.4 IU/L | Standard Deviation 53 |
| GSK1278863, 5 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | ALP, Week 2 | 2.7 IU/L | Standard Deviation 10.52 |
| GSK1278863, 5 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | ALT, Week 6 | 0.5 IU/L | Standard Deviation 9.02 |
| GSK1278863, 5 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | CK, Week 6 | 40.4 IU/L | Standard Deviation 240.54 |
| GSK1278863, 5 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | CK, Week 4 | -7.5 IU/L | Standard Deviation 39.31 |
| GSK1278863, 5 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | AST, Week 4 | -1.1 IU/L | Standard Deviation 4.7 |
| GSK1278863, 5 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | AST, Week 2 | 0.1 IU/L | Standard Deviation 3.92 |
| GSK1278863, 5 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | ALT, Week 4 | -2.8 IU/L | Standard Deviation 7.68 |
| GSK1278863, 5 mg | Change From Baseline Values of ALT, ALP, AST, CK at Week 2, 4, and 6 | AST, Week 6 | 1.4 IU/L | Standard Deviation 4.66 |
Secondary
Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6
Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of calcium, chloride, cholesterol, glucose, inorganic phosphorus, potassium, sodium at Week 2, 4, and 6 were reported.
Time frame: Baseline (Day 1), Week 2, 4, and 6
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Glucose, Week 4 | 0.01 MMOL/L | Standard Deviation 2.893 |
| Placebo | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Calcium, Week 2 | 0.044 MMOL/L | Standard Deviation 0.0686 |
| Placebo | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Glucose, Week 6 | 1.89 MMOL/L | Standard Deviation 3.913 |
| Placebo | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Sodium, Week 4 | 0.5 MMOL/L | Standard Deviation 3.78 |
| Placebo | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Potassium, Week 2 | 0.10 MMOL/L | Standard Deviation 0.42 |
| Placebo | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Inorganic phosphorus, Week 2 | 0.012 MMOL/L | Standard Deviation 0.142 |
| Placebo | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Chloride, Week 2 | 0.0 MMOL/L | Standard Deviation 3.59 |
| Placebo | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Inorganic phosphorus, Week 4 | 0.025 MMOL/L | Standard Deviation 0.1718 |
| Placebo | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Inorganic phosphorus, Week 6 | 0.003 MMOL/L | Standard Deviation 0.3041 |
| Placebo | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Chloride, Week 4 | 1.4 MMOL/L | Standard Deviation 2.84 |
| Placebo | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Calcium, Week 4 | 0.021 MMOL/L | Standard Deviation 0.1088 |
| Placebo | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Sodium, Week 2 | -0.3 MMOL/L | Standard Deviation 2.42 |
| Placebo | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Chloride, Week 6 | 1.1 MMOL/L | Standard Deviation 2.95 |
| Placebo | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Cholesterol, Week 1 | 0.050 MMOL/L | — |
| Placebo | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Cholesterol, Week 2 | -0.029 MMOL/L | Standard Deviation 0.2948 |
| Placebo | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Potassium, Week 6 | 0.05 MMOL/L | Standard Deviation 0.601 |
| Placebo | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Cholesterol, Week 4 | -0.136 MMOL/L | Standard Deviation 0.306 |
| Placebo | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Sodium, Week 6 | -0.2 MMOL/L | Standard Deviation 2.29 |
| Placebo | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Cholesterol, Week 6 | -0.134 MMOL/L | Standard Deviation 0.4704 |
| Placebo | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Calcium, Week 6 | 0.000 MMOL/L | Standard Deviation 0.1073 |
| Placebo | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Potassium, Week 4 | 0.05 MMOL/L | Standard Deviation 0.47 |
| Placebo | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Glucose, Week 2 | 0.35 MMOL/L | Standard Deviation 3.025 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Chloride, Week 6 | 1.9 MMOL/L | Standard Deviation 3.51 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Potassium, Week 2 | 0.01 MMOL/L | Standard Deviation 0.5 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Calcium, Week 4 | 0.008 MMOL/L | Standard Deviation 0.087 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Glucose, Week 6 | 0.53 MMOL/L | Standard Deviation 3.725 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Potassium, Week 6 | -0.05 MMOL/L | Standard Deviation 0.385 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Glucose, Week 2 | -0.59 MMOL/L | Standard Deviation 5.94 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Cholesterol, Week 6 | -0.223 MMOL/L | Standard Deviation 0.7452 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Inorganic phosphorus, Week 2 | 0.065 MMOL/L | Standard Deviation 0.1536 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Cholesterol, Week 2 | -0.150 MMOL/L | Standard Deviation 0.5398 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Inorganic phosphorus, Week 6 | -0.031 MMOL/L | Standard Deviation 0.1345 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Calcium, Week 2 | 0.017 MMOL/L | Standard Deviation 0.0767 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Inorganic phosphorus, Week 4 | 0.015 MMOL/L | Standard Deviation 0.1784 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Chloride, Week 2 | 0.9 MMOL/L | Standard Deviation 3.34 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Calcium, Week 6 | 0.019 MMOL/L | Standard Deviation 0.1192 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Sodium, Week 6 | 1.3 MMOL/L | Standard Deviation 2.87 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Sodium, Week 2 | 0.1 MMOL/L | Standard Deviation 2.53 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Sodium, Week 4 | 1.6 MMOL/L | Standard Deviation 2.84 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Chloride, Week 4 | 1.8 MMOL/L | Standard Deviation 3.26 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Cholesterol, Week 4 | -0.195 MMOL/L | Standard Deviation 0.431 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Glucose, Week 4 | -0.21 MMOL/L | Standard Deviation 3.809 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Potassium, Week 4 | -0.02 MMOL/L | Standard Deviation 0.559 |
| GSK1278863, 2 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Potassium, Week 2 | 0.08 MMOL/L | Standard Deviation 0.558 |
| GSK1278863, 2 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Calcium, Week 2 | 0.032 MMOL/L | Standard Deviation 0.0977 |
| GSK1278863, 2 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Calcium, Week 4 | -0.000 MMOL/L | Standard Deviation 0.0641 |
| GSK1278863, 2 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Calcium, Week 6 | -0.001 MMOL/L | Standard Deviation 0.0959 |
| GSK1278863, 2 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Chloride, Week 2 | -0.5 MMOL/L | Standard Deviation 4.95 |
| GSK1278863, 2 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Chloride, Week 4 | -0.1 MMOL/L | Standard Deviation 3.43 |
| GSK1278863, 2 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Chloride, Week 6 | -0.1 MMOL/L | Standard Deviation 3.94 |
| GSK1278863, 2 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Cholesterol, Week 2 | -0.256 MMOL/L | Standard Deviation 0.3907 |
| GSK1278863, 2 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Cholesterol, Week 4 | -0.288 MMOL/L | Standard Deviation 0.6412 |
| GSK1278863, 2 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Cholesterol, Week 6 | -0.040 MMOL/L | Standard Deviation 0.8412 |
| GSK1278863, 2 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Glucose, Week 2 | 0.13 MMOL/L | Standard Deviation 4.375 |
| GSK1278863, 2 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Glucose, Week 4 | -0.88 MMOL/L | Standard Deviation 3.968 |
| GSK1278863, 2 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Glucose, Week 6 | -0.57 MMOL/L | Standard Deviation 5.339 |
| GSK1278863, 2 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Inorganic phosphorus, Week 2 | 0.032 MMOL/L | Standard Deviation 0.2277 |
| GSK1278863, 2 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Inorganic phosphorus, Week 4 | 0.000 MMOL/L | Standard Deviation 0.243 |
| GSK1278863, 2 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Inorganic phosphorus, Week 6 | -0.009 MMOL/L | Standard Deviation 0.2478 |
| GSK1278863, 2 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Potassium, Week 4 | -0.04 MMOL/L | Standard Deviation 0.488 |
| GSK1278863, 2 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Potassium, Week 6 | 0.06 MMOL/L | Standard Deviation 0.346 |
| GSK1278863, 2 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Sodium, Week 2 | 0.3 MMOL/L | Standard Deviation 2.8 |
| GSK1278863, 2 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Sodium, Week 4 | 0.6 MMOL/L | Standard Deviation 2.96 |
| GSK1278863, 2 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Sodium, Week 6 | 0.1 MMOL/L | Standard Deviation 3.04 |
| GSK1278863, 5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Glucose, Week 2 | 1.67 MMOL/L | Standard Deviation 5.073 |
| GSK1278863, 5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Potassium, Week 2 | -0.02 MMOL/L | Standard Deviation 0.437 |
| GSK1278863, 5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Cholesterol, Week 6 | 0.029 MMOL/L | Standard Deviation 0.7814 |
| GSK1278863, 5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Cholesterol, Week 4 | -0.285 MMOL/L | Standard Deviation 0.8511 |
| GSK1278863, 5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Sodium, Week 4 | 1.3 MMOL/L | Standard Deviation 3.72 |
| GSK1278863, 5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Potassium, Week 4 | -0.23 MMOL/L | Standard Deviation 0.541 |
| GSK1278863, 5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Cholesterol, Week 2 | -0.244 MMOL/L | Standard Deviation 0.629 |
| GSK1278863, 5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Chloride, Week 6 | -1.3 MMOL/L | Standard Deviation 3.37 |
| GSK1278863, 5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Calcium, Week 4 | 0.010 MMOL/L | Standard Deviation 0.0719 |
| GSK1278863, 5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Potassium, Week 6 | 0.01 MMOL/L | Standard Deviation 0.439 |
| GSK1278863, 5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Chloride, Week 4 | 0.9 MMOL/L | Standard Deviation 3.69 |
| GSK1278863, 5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Chloride, Week 2 | -1.5 MMOL/L | Standard Deviation 3.54 |
| GSK1278863, 5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Calcium, Week 2 | 0.014 MMOL/L | Standard Deviation 0.0717 |
| GSK1278863, 5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Sodium, Week 2 | -0.9 MMOL/L | Standard Deviation 2.86 |
| GSK1278863, 5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Calcium, Week 6 | -0.014 MMOL/L | Standard Deviation 0.0514 |
| GSK1278863, 5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Inorganic phosphorus, Week 4 | -0.032 MMOL/L | Standard Deviation 0.1828 |
| GSK1278863, 5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Inorganic phosphorus, Week 2 | 0.026 MMOL/L | Standard Deviation 0.2122 |
| GSK1278863, 5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Sodium, Week 6 | -0.1 MMOL/L | Standard Deviation 2.83 |
| GSK1278863, 5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Inorganic phosphorus, Week 6 | -0.074 MMOL/L | Standard Deviation 0.1161 |
| GSK1278863, 5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Glucose, Week 6 | 0.59 MMOL/L | Standard Deviation 2.585 |
| GSK1278863, 5 mg | Change From Baseline Values of Calcium, Chloride, Cholesterol, Glucose, Inorganic Phosphorus, Potassium, Sodium at Week 2, 4, and 6 | Glucose, Week 4 | -0.51 MMOL/L | Standard Deviation 1.957 |
Secondary
Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6
Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of creatinine, direct bilirubin, indirect bilirubin, total bilirubin at Week 2, 4, and 6 were reported.
Time frame: Baseline (Day 1), Week 2, 4, and 6
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Total bilirubin, Week 2 | 0.7 Micromol/L | Standard Deviation 1.72 |
| Placebo | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Total bilirubin, Week 6 | 0.0 Micromol/L | Standard Deviation 1.79 |
| Placebo | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Indirect bilirubin, Week 4 | 0.4 Micromol/L | Standard Deviation 1.6 |
| Placebo | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Creatinine, Week 2 | -1.41 Micromol/L | Standard Deviation 22.366 |
| Placebo | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Indirect bilirubin, Week 6 | 0.4 Micromol/L | Standard Deviation 2.09 |
| Placebo | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Creatinine, Week 6 | 0.71 Micromol/L | Standard Deviation 46.295 |
| Placebo | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Direct bilirubin, Week 2 | -0.5 Micromol/L | Standard Deviation 1.66 |
| Placebo | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Creatinine, Week 4 | 11.79 Micromol/L | Standard Deviation 20.853 |
| Placebo | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Total bilirubin, Week 4 | -0.1 Micromol/L | Standard Deviation 1.23 |
| Placebo | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Direct bilirubin, Week 4 | -0.6 Micromol/L | Standard Deviation 1.65 |
| Placebo | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Direct bilirubin, Week 6 | -0.4 Micromol/L | Standard Deviation 1.67 |
| Placebo | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Indirect bilirubin, Week 2 | 1.2 Micromol/L | Standard Deviation 2.13 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Creatinine, Week 4 | 1.65 Micromol/L | Standard Deviation 18.8 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Indirect bilirubin, Week 2 | 0.1 Micromol/L | Standard Deviation 2.4 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Direct bilirubin, Week 2 | -0.3 Micromol/L | Standard Deviation 1.99 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Indirect bilirubin, Week 6 | 0.9 Micromol/L | Standard Deviation 2.17 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Total bilirubin, Week 2 | -0.3 Micromol/L | Standard Deviation 1.03 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Indirect bilirubin, Week 4 | -0.2 Micromol/L | Standard Deviation 2.17 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Creatinine, Week 2 | -0.99 Micromol/L | Standard Deviation 29.854 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Direct bilirubin, Week 6 | -0.5 Micromol/L | Standard Deviation 1.13 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Direct bilirubin, Week 4 | -0.2 Micromol/L | Standard Deviation 1.74 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Creatinine, Week 6 | -5.01 Micromol/L | Standard Deviation 41.477 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Total bilirubin, Week 6 | 0.4 Micromol/L | Standard Deviation 2.53 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Total bilirubin, Week 4 | -0.5 Micromol/L | Standard Deviation 0.88 |
| GSK1278863, 2 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Indirect bilirubin, Week 4 | 0.5 Micromol/L | Standard Deviation 1.66 |
| GSK1278863, 2 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Creatinine, Week 2 | 10.78 Micromol/L | Standard Deviation 51.17 |
| GSK1278863, 2 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Creatinine, Week 4 | -1.44 Micromol/L | Standard Deviation 37 |
| GSK1278863, 2 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Creatinine, Week 6 | 7.24 Micromol/L | Standard Deviation 58.581 |
| GSK1278863, 2 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Direct bilirubin, Week 2 | -0.4 Micromol/L | Standard Deviation 1.06 |
| GSK1278863, 2 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Direct bilirubin, Week 4 | -0.2 Micromol/L | Standard Deviation 0.97 |
| GSK1278863, 2 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Direct bilirubin, Week 6 | -0.4 Micromol/L | Standard Deviation 1.31 |
| GSK1278863, 2 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Indirect bilirubin, Week 2 | 0.5 Micromol/L | Standard Deviation 1.33 |
| GSK1278863, 2 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Indirect bilirubin, Week 6 | 0.3 Micromol/L | Standard Deviation 1.61 |
| GSK1278863, 2 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Total bilirubin, Week 2 | 0.1 Micromol/L | Standard Deviation 1.32 |
| GSK1278863, 2 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Total bilirubin, Week 4 | 0.2 Micromol/L | Standard Deviation 1.86 |
| GSK1278863, 2 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Total bilirubin, Week 6 | -0.1 Micromol/L | Standard Deviation 1.86 |
| GSK1278863, 5 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Direct bilirubin, Week 6 | 0.5 Micromol/L | Standard Deviation 0.87 |
| GSK1278863, 5 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Direct bilirubin, Week 4 | 0.2 Micromol/L | Standard Deviation 1.2 |
| GSK1278863, 5 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Creatinine, Week 2 | -2.60 Micromol/L | Standard Deviation 18.802 |
| GSK1278863, 5 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Total bilirubin, Week 2 | 0.2 Micromol/L | Standard Deviation 2.33 |
| GSK1278863, 5 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Direct bilirubin, Week 2 | 0.4 Micromol/L | Standard Deviation 1.27 |
| GSK1278863, 5 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Creatinine, Week 6 | -7.23 Micromol/L | Standard Deviation 29.816 |
| GSK1278863, 5 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Total bilirubin, Week 6 | -0.2 Micromol/L | Standard Deviation 0.66 |
| GSK1278863, 5 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Total bilirubin, Week 4 | 0.7 Micromol/L | Standard Deviation 1.21 |
| GSK1278863, 5 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Indirect bilirubin, Week 4 | 0.5 Micromol/L | Standard Deviation 1.66 |
| GSK1278863, 5 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Indirect bilirubin, Week 2 | -0.1 Micromol/L | Standard Deviation 2.39 |
| GSK1278863, 5 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Creatinine, Week 4 | -16.96 Micromol/L | Standard Deviation 23.293 |
| GSK1278863, 5 mg | Change From Baseline Values of Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin at Week 2, 4, and 6 | Indirect bilirubin, Week 6 | -0.7 Micromol/L | Standard Deviation 0.99 |
Secondary
Change From Baseline Values of Urine Total Protein/Creatinine Ratio at Week 2, 4, and 6
Baseline values were recorded on Day 1. If the Day 1 value was missing, the last non-missing value from week -1 or week-2 was represented as the baseline value. The change from baseline was calculated by subtracting the baseline value from the individual post-dose visit values. Change from Baseline values of urine total protein/creatinine ratio at Week 2, 4, and 6 were reported.
Time frame: Baseline (Day 1), Week 2, 4, and 6
Population: Safety population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline Values of Urine Total Protein/Creatinine Ratio at Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Week 2 | 3.44 MG/MMOL | Standard Deviation 39.792 |
| Placebo | Change From Baseline Values of Urine Total Protein/Creatinine Ratio at Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Week 6 | 47.22 MG/MMOL | Standard Deviation 185.115 |
| Placebo | Change From Baseline Values of Urine Total Protein/Creatinine Ratio at Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Week 4 | -20.56 MG/MMOL | Standard Deviation 50.953 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Urine Total Protein/Creatinine Ratio at Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Week 2 | -38.83 MG/MMOL | Standard Deviation 97.814 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Urine Total Protein/Creatinine Ratio at Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Week 6 | -26.73 MG/MMOL | Standard Deviation 67.464 |
| GSK1278863, 0.5 mg | Change From Baseline Values of Urine Total Protein/Creatinine Ratio at Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Week 4 | 17.43 MG/MMOL | Standard Deviation 58.837 |
| GSK1278863, 2 mg | Change From Baseline Values of Urine Total Protein/Creatinine Ratio at Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Week 4 | -99.40 MG/MMOL | Standard Deviation 209.678 |
| GSK1278863, 2 mg | Change From Baseline Values of Urine Total Protein/Creatinine Ratio at Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Week 2 | -115.28 MG/MMOL | Standard Deviation 265.028 |
| GSK1278863, 2 mg | Change From Baseline Values of Urine Total Protein/Creatinine Ratio at Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Week 6 | -72.19 MG/MMOL | Standard Deviation 187.792 |
| GSK1278863, 5 mg | Change From Baseline Values of Urine Total Protein/Creatinine Ratio at Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Week 2 | -77.98 MG/MMOL | Standard Deviation 173.654 |
| GSK1278863, 5 mg | Change From Baseline Values of Urine Total Protein/Creatinine Ratio at Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Week 6 | -41.40 MG/MMOL | Standard Deviation 191.418 |
| GSK1278863, 5 mg | Change From Baseline Values of Urine Total Protein/Creatinine Ratio at Week 2, 4, and 6 | Urine Total Protein/Creatinine ratio, Week 4 | 39.90 MG/MMOL | Standard Deviation 86.729 |
Secondary
Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites
Cmax of GSK1278863 and GSK1278863 metabolites (M1, M2, M3, M4, M5 and M6) were reported. For assessment of Pharmacokinetics parameters blood samples were collected at Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this first sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose).
Time frame: Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this first sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose).
Population: All participants from whom a pharmacokinetic sample had been obtained and analyzed were included in the pharmacokinetic population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites | GSK1278863 | 2.68 nanogram per millilitre (ng/mL) | Geometric Coefficient of Variation 92.6 |
| Placebo | Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites | M2 | 1.03 nanogram per millilitre (ng/mL) | Geometric Coefficient of Variation 27.9 |
| Placebo | Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites | M3 | 1.23 nanogram per millilitre (ng/mL) | Geometric Coefficient of Variation 25.1 |
| Placebo | Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites | M4 | 0.721 nanogram per millilitre (ng/mL) | Geometric Coefficient of Variation 29.7 |
| Placebo | Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites | M5 | 0.296 nanogram per millilitre (ng/mL) | Geometric Coefficient of Variation 23.7 |
| Placebo | Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites | M6 | 0.455 nanogram per millilitre (ng/mL) | Geometric Coefficient of Variation 21.9 |
| GSK1278863, 0.5 mg | Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites | M6 | 1.74 nanogram per millilitre (ng/mL) | Geometric Coefficient of Variation 56.1 |
| GSK1278863, 0.5 mg | Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites | GSK1278863 | 12.8 nanogram per millilitre (ng/mL) | Geometric Coefficient of Variation 121 |
| GSK1278863, 0.5 mg | Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites | M4 | 2.74 nanogram per millilitre (ng/mL) | Geometric Coefficient of Variation 84.7 |
| GSK1278863, 0.5 mg | Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites | M5 | 1.08 nanogram per millilitre (ng/mL) | Geometric Coefficient of Variation 49 |
| GSK1278863, 0.5 mg | Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites | M2 | 3.83 nanogram per millilitre (ng/mL) | Geometric Coefficient of Variation 61.4 |
| GSK1278863, 0.5 mg | Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites | M3 | 4.45 nanogram per millilitre (ng/mL) | Geometric Coefficient of Variation 54.4 |
| GSK1278863, 2 mg | Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites | M2 | 10.3 nanogram per millilitre (ng/mL) | Geometric Coefficient of Variation 61.1 |
| GSK1278863, 2 mg | Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites | M3 | 11.8 nanogram per millilitre (ng/mL) | Geometric Coefficient of Variation 64.8 |
| GSK1278863, 2 mg | Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites | M6 | 4.43 nanogram per millilitre (ng/mL) | Geometric Coefficient of Variation 83.1 |
| GSK1278863, 2 mg | Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites | M4 | 7.29 nanogram per millilitre (ng/mL) | Geometric Coefficient of Variation 116 |
| GSK1278863, 2 mg | Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites | GSK1278863 | 35.7 nanogram per millilitre (ng/mL) | Geometric Coefficient of Variation 143 |
| GSK1278863, 2 mg | Mean Maximum Plasma Concentration (Cmax) of GSK1278863 and GSK1278863 Metabolites | M5 | 2.81 nanogram per millilitre (ng/mL) | Geometric Coefficient of Variation 79.8 |
Secondary
Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites
Mean Steady state AUC of GSK1278863 and GSK1278863 metabolites (M1, M2, M3, M4, M5 and M6) were reported. For pharmacokinetic parameter assessment blood samples were collected at Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this fist sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose).
Time frame: Day 1 (pre-dose), Week 2 (first samples was collected approximately between 4 to 8 h and then 1, 2 and 3 h after this first sample) and Week 4 (Pre-dose 1, 2 and 3 h post-dose)
Population: Pharmacokinetic population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites | GSK1278863 | 10.3 ng*hour/mL | Geometric Coefficient of Variation 119 |
| Placebo | Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites | M2 | 13.0 ng*hour/mL | Geometric Coefficient of Variation 38.8 |
| Placebo | Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites | M6 | 5.34 ng*hour/mL | Geometric Coefficient of Variation 36.3 |
| Placebo | Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites | M3 | 17.8 ng*hour/mL | Geometric Coefficient of Variation 33.4 |
| Placebo | Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites | M4 | 5.54 ng*hour/mL | Geometric Coefficient of Variation 60 |
| Placebo | Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites | M5 | 4.64 ng*hour/mL | Geometric Coefficient of Variation 27.7 |
| GSK1278863, 0.5 mg | Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites | M5 | 17.3 ng*hour/mL | Geometric Coefficient of Variation 66.7 |
| GSK1278863, 0.5 mg | Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites | M3 | 67.1 ng*hour/mL | Geometric Coefficient of Variation 74.2 |
| GSK1278863, 0.5 mg | Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites | M6 | 21.5 ng*hour/mL | Geometric Coefficient of Variation 71.4 |
| GSK1278863, 0.5 mg | Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites | GSK1278863 | 51.1 ng*hour/mL | Geometric Coefficient of Variation 159 |
| GSK1278863, 0.5 mg | Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites | M4 | 22.0 ng*hour/mL | Geometric Coefficient of Variation 99 |
| GSK1278863, 0.5 mg | Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites | M2 | 51.9 ng*hour/mL | Geometric Coefficient of Variation 81.3 |
| GSK1278863, 2 mg | Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites | GSK1278863 | 148 ng*hour/mL | Geometric Coefficient of Variation 167 |
| GSK1278863, 2 mg | Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites | M5 | 43.5 ng*hour/mL | Geometric Coefficient of Variation 86 |
| GSK1278863, 2 mg | Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites | M4 | 63.4 ng*hour/mL | Geometric Coefficient of Variation 105 |
| GSK1278863, 2 mg | Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites | M6 | 56.3 ng*hour/mL | Geometric Coefficient of Variation 85.8 |
| GSK1278863, 2 mg | Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites | M2 | 140 ng*hour/mL | Geometric Coefficient of Variation 65.4 |
| GSK1278863, 2 mg | Mean Steady State Area Under the Curve (AUC) of GSK1278863 and GSK1278863 Metabolites | M3 | 175 ng*hour/mL | Geometric Coefficient of Variation 71.6 |
Secondary
Model-Adjusted Maximum Hgb Changes Over 4 Weeks
Maximum Hgb change over 4 weeks was analyzed using an ANCOVA model with terms included for treatment and baseline Hgb value. Least square mean estimates and 95% CI for each treatment group were reported. Baseline was the average of Week -2 , Week -1 and Day 1 visits. The change from Baseline was calculated by subtracting the baseline value from the individual post-dose visit values.
Time frame: Baseline (average of Week -2 , -1 and Day 1 visits) and 4 weeks
Population: ITT population.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Model-Adjusted Maximum Hgb Changes Over 4 Weeks | 0.153 g/dL | Standard Error 0.1476 |
| GSK1278863, 0.5 mg | Model-Adjusted Maximum Hgb Changes Over 4 Weeks | 0.137 g/dL | Standard Error 0.1609 |
| GSK1278863, 2 mg | Model-Adjusted Maximum Hgb Changes Over 4 Weeks | 0.474 g/dL | Standard Error 0.1532 |
| GSK1278863, 5 mg | Model-Adjusted Maximum Hgb Changes Over 4 Weeks | 1.069 g/dL | Standard Error 0.1527 |
Secondary
Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb
Number of participants achieving an increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb from baseline were reported. Entry into the study required a target stable Hgb of 8.5-11.0 g/dL. A stable Hgb value was confirmed from three Hgb values taken during the screening period at Week -2, Week -1 and Day 1 (randomization). The average of these three values was used for Baseline Hgb.
Time frame: Up to 4 weeks
Population: ITT Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=1 g/dL | 1 Participants |
| Placebo | Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=1.5 g/dL | 0 Participants |
| Placebo | Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Decrease/increase of < 0.5 g/dL | 16 Participants |
| Placebo | Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=0.5 g/dL | 3 Participants |
| Placebo | Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=2 g/dL | 0 Participants |
| GSK1278863, 0.5 mg | Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=1 g/dL | 1 Participants |
| GSK1278863, 0.5 mg | Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=1.5 g/dL | 0 Participants |
| GSK1278863, 0.5 mg | Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=0.5 g/dL | 4 Participants |
| GSK1278863, 0.5 mg | Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Decrease/increase of < 0.5 g/dL | 12 Participants |
| GSK1278863, 0.5 mg | Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=2 g/dL | 0 Participants |
| GSK1278863, 2 mg | Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=1 g/dL | 2 Participants |
| GSK1278863, 2 mg | Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Decrease/increase of < 0.5 g/dL | 12 Participants |
| GSK1278863, 2 mg | Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=0.5 g/dL | 6 Participants |
| GSK1278863, 2 mg | Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=1.5 g/dL | 0 Participants |
| GSK1278863, 2 mg | Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=2 g/dL | 0 Participants |
| GSK1278863, 5 mg | Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=1.5 g/dL | 5 Participants |
| GSK1278863, 5 mg | Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=0.5 g/dL | 14 Participants |
| GSK1278863, 5 mg | Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Decrease/increase of < 0.5 g/dL | 4 Participants |
| GSK1278863, 5 mg | Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=1 g/dL | 9 Participants |
| GSK1278863, 5 mg | Number of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=2 g/dL | 1 Participants |
Secondary
Number of Participants Discontinuing the Study Treatment Due to AEs
AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. number of participants discontinuing the study treatment due to AEs.
Time frame: Up to 6 weeks
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Discontinuing the Study Treatment Due to AEs | 1 Participants |
| GSK1278863, 0.5 mg | Number of Participants Discontinuing the Study Treatment Due to AEs | 1 Participants |
| GSK1278863, 2 mg | Number of Participants Discontinuing the Study Treatment Due to AEs | 0 Participants |
| GSK1278863, 5 mg | Number of Participants Discontinuing the Study Treatment Due to AEs | 0 Participants |
Secondary
Number of Participants Who Reached Hgb Stopping Criteria
The Hgb stopping criteria was defined as reaching to value \<8.0 g/dL, \>=8.0 - \<13.0 (\>= 2g/dL absolute Hgb change over 1 week ) or \>=13.0 g/dL. The number of participants who reached the Hgb stopping criteria of Hgb concentration were presented.
Time frame: Up to Week 4
Population: ITT Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants Who Reached Hgb Stopping Criteria | <8.0 | 0 Participants |
| Placebo | Number of Participants Who Reached Hgb Stopping Criteria | >=8.0-<13.0 and >=2.0 increase | 0 Participants |
| Placebo | Number of Participants Who Reached Hgb Stopping Criteria | >=8.0-<13.0 and >=2.0 decrease | 1 Participants |
| GSK1278863, 0.5 mg | Number of Participants Who Reached Hgb Stopping Criteria | <8.0 | 0 Participants |
| GSK1278863, 0.5 mg | Number of Participants Who Reached Hgb Stopping Criteria | >=8.0-<13.0 and >=2.0 increase | 1 Participants |
| GSK1278863, 0.5 mg | Number of Participants Who Reached Hgb Stopping Criteria | >=8.0-<13.0 and >=2.0 decrease | 0 Participants |
| GSK1278863, 2 mg | Number of Participants Who Reached Hgb Stopping Criteria | >=8.0-<13.0 and >=2.0 decrease | 0 Participants |
| GSK1278863, 2 mg | Number of Participants Who Reached Hgb Stopping Criteria | <8.0 | 1 Participants |
| GSK1278863, 2 mg | Number of Participants Who Reached Hgb Stopping Criteria | >=8.0-<13.0 and >=2.0 increase | 1 Participants |
| GSK1278863, 5 mg | Number of Participants Who Reached Hgb Stopping Criteria | <8.0 | 0 Participants |
| GSK1278863, 5 mg | Number of Participants Who Reached Hgb Stopping Criteria | >=8.0-<13.0 and >=2.0 increase | 0 Participants |
| GSK1278863, 5 mg | Number of Participants Who Reached Hgb Stopping Criteria | >=8.0-<13.0 and >=2.0 decrease | 0 Participants |
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE was defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include AEs those result in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Time frame: Up to 6 weeks
Population: The Safety Population comprised of all participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 9 Participants |
| Placebo | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 1 Participants |
| GSK1278863, 0.5 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 0 Participants |
| GSK1278863, 0.5 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 10 Participants |
| GSK1278863, 2 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 5 Participants |
| GSK1278863, 2 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 2 Participants |
| GSK1278863, 5 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any AEs | 6 Participants |
| GSK1278863, 5 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Any SAEs | 1 Participants |
Secondary
Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb
Percentage of participants achieving an increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb from baseline were reported. Entry into the study requires a target stable Hgb of 8.5-11.0 g/dL. A stable Hgb value was confirmed from three Hgb values taken during the screening period at Week -2, Week -1 and Day 1 (randomization). The average of these three values was used for Baseline Hgb.
Time frame: Up to 4 weeks
Population: ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=1.5 g/dL | 0 Percentage of participants |
| Placebo | Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=0.5 g/dL | 16 Percentage of participants |
| Placebo | Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=2 g/dL | 0 Percentage of participants |
| Placebo | Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=1 g/dL | 5 Percentage of participants |
| Placebo | Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Decrease/increase of < 0.5 g/dL | 84 Percentage of participants |
| GSK1278863, 0.5 mg | Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=1 g/dL | 6 Percentage of participants |
| GSK1278863, 0.5 mg | Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=1.5 g/dL | 0 Percentage of participants |
| GSK1278863, 0.5 mg | Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=2 g/dL | 0 Percentage of participants |
| GSK1278863, 0.5 mg | Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=0.5 g/dL | 25 Percentage of participants |
| GSK1278863, 0.5 mg | Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Decrease/increase of < 0.5 g/dL | 75 Percentage of participants |
| GSK1278863, 2 mg | Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=1 g/dL | 11 Percentage of participants |
| GSK1278863, 2 mg | Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Decrease/increase of < 0.5 g/dL | 67 Percentage of participants |
| GSK1278863, 2 mg | Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=0.5 g/dL | 33 Percentage of participants |
| GSK1278863, 2 mg | Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=1.5 g/dL | 0 Percentage of participants |
| GSK1278863, 2 mg | Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=2 g/dL | 0 Percentage of participants |
| GSK1278863, 5 mg | Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=1.5 g/dL | 28 Percentage of participants |
| GSK1278863, 5 mg | Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=0.5 g/dL | 78 Percentage of participants |
| GSK1278863, 5 mg | Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Decrease/increase of < 0.5 g/dL | 22 Percentage of participants |
| GSK1278863, 5 mg | Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=1 g/dL | 50 Percentage of participants |
| GSK1278863, 5 mg | Percentage of Participants Achieving an Increase of 0.5, 1.0, 1.5 and 2.0 g/dL in Hgb | Increase of >=2 g/dL | 6 Percentage of participants |