Psoriasis
Conditions
Keywords
Double blind, Dose-finding, Vehicle-Controlled, GSK2894512, Plaque Psoriasis
Brief summary
This study will evaluate the efficacy and safety of two concentrations (0.5 percent \[%\] and 1%) and two application frequencies (once a day and twice a day) of GSK2894512 cream for the topical treatment in subjects with plaque psoriasis. Results from this study will be considered when selecting the most appropriate concentration of GSK2894512 cream and dosing frequency in future clinical safety and efficacy studies. This is a multicenter (United States, Canada, and Japan), randomized, double-blind (sponsor-unblind), vehicle-controlled, 6-arm, parallel-group, dose-finding study. Two concentrations of GSK2894512 cream (0.5% and 1%) and a vehicle control cream will be equally randomized and evaluated following application to all psoriasis lesions (except on the scalp) once daily (evening) or twice daily (morning and evening) for 12 weeks. This study will consist of 3 periods: up to 4 weeks screening, 12 weeks double-blind treatment, and 4 weeks post-treatment follow-up. The total duration of subject participation will be approximately 16 to 20 weeks. Approximately 270 adult males and females subjects with plaque psoriasis will be screened in order to have at least 228 randomized subjects (38 subjects for each of the 6 treatment groups) and approximately 204 evaluable subjects overall. Approximately 30 subjects will be randomized in Japan to achieve at least 24 evaluable Japanese subjects.
Interventions
1.0% (10 mg/g) GSK2894512 will be supplied as white to off-white cream to be applied topically
0.5% (5 mg/g) GSK2894512 will be supplied as white to off-white cream to be applied topically
DRUGVehicle cream
White to off-white vehicle cream base to be applied topically
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female between 18 to 65 years of age inclusive, at the time of signing the informed consent. * Confirmed clinical diagnosis of chronic stable plaque psoriasis for \>=6 months. * Body surface area involvement \>=1% and \<=15%, excluding scalp, at Screening and Baseline. * A PGA of psoriasis score \>=2 at Baseline. * One target plaque located on the trunk or proximal parts of extremities (excluding knees, elbows, and intertriginous areas) that is at least 3 (centimetre) cm х 3 cm in size at Screening and Baseline with a severity representative of the subject's overall disease. * A female subject is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin test), not lactating, and at least one of the following conditions applies: Non-reproductive potential defined as: 1) Pre-menopausal females with one of the following procedures documented: tubal ligation; hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; hysterectomy; bilateral oophorectomy. 2) Post-menopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone and estradiol levels consistent with menopause and falling into the central laboratory's postmenopausal reference range is confirmatory). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt are required to use one of the highly effective 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 enrolment; Reproductive potential and agrees to follow one of the options listed in the modified list of highly effective methods for avoiding pregnancy in females of reproductive potential from 30 days prior to the first dose of study medication and until (at least five terminal half-lives OR until any continuing pharmacologic effect has ended, whichever is longer) after the last dose of study medication and completion of the follow-up visit.
Exclusion criteria
* Any sign of infection of any of the psoriatic lesions. * A history or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, may interfere with the subject's completion of the study. * Known hypersensitivity to the study treatment excipients, or a history of drug or other allergy that, in the opinion of the investigator, contraindicates participation. * Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones), presence of hepatitis B surface antigen, or positive hepatitis C antibody test result within 3 months of screening. * Liver function tests: alanine aminotransferase \>=2x upper limit of normal (ULN); alkaline phosphatase and bilirubin \>1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%). * QTc \>=450 milliseconds (msec) or QTc \>=480 msec for subjects with bundle branch block. NOTES: The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF), with machine over-read. The QTc should be based on a single ECG obtained over a brief recording period. If QTc is outside of the threshold value, triplicate ECGs may be performed with the QTc values averaged. * Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation (eg, sunlight or tanning booth) within 4 weeks prior to the baseline visit and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the subject's psoriasis. * Used any of the following treatments within the indicated washout period before the baseline visit: 1) 12 weeks or 5 half-lives (whichever is longer) - biologic agents (eg, 24 weeks for alefacept, 12 weeks for etanercept, 15 weeks for ustekinumab); 2) 12 weeks - oral retinoids (eg, acitretin or isotretinoin); 3) 8 weeks - cyclosporin, interferon, methotrexate, other systemic immunosuppressive or immunomodulating agents, or psoralen plus UVA light treatment; 4) 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs; 5) 2 weeks - immunizations; drugs known to possibly worsen psoriasis, such as beta-blockers (eg, propranolol), lithium, iodides, angiotensin-converting enzyme inhibitors, and indomethacin, unless on a stable dose for \>12 weeks; 6) 2 weeks - topical treatments: corticosteroids, immunomodulators, anthralin (dithranol), Vitamin D derivatives, retinoids, or coal tar (used on the body). * Participated in a clinical study and received an investigational product within the following time period prior to the baseline visit: 4 weeks, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer). * History of alcohol or other substance abuse within the last 2 years. * Participated in a previous study using GSK2894512 (or WBI-1001).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Have a Physician Global Assessment (PGA) Score of 0 or 1 at Week 12 and a Minimum 2-grade Improvement in PGA Score From Baseline to Week 12 | Baseline and up to Week 12 | The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of responders that is, participants who achieved a PGA score of 0 or 1 and a minimum 2-grade improvement from Baseline were summarized. Baseline was defined as the latest assessment prior to the first dose. The analysis was performed on modified intent-to-treat (mITT) Population which comprised of all randomized participants except those enrolled at center ID 220008. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Baseline and up to Week 16 | The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of participants who achieved a minimum 2-grade improvement from Baseline for each study visit were summarized. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Up to Week 16 | The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of participants who achieved a PGA score of 0 or 1 from Baseline at each study visit was summarized. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Baseline and up to Week 16 | The extent of BSA affected by psoriasis is a general indicator of disease severity and was measured throughout the study. The extent of BSA to which study treatment was applied was also recorded. For the purpose of approximate clinical estimation, the total palmar surface of the palm plus 5 digits was assumed to be approximately equivalent to 1 percent BSA. Assessment of BSA affected with psoriasis was performed separately for four body surface regions: the head, the upper extremities, the trunk and the lower extremities, corresponding to 10, 20, 30 and 40 percent of the total body area, respectively. The mean change in percent BSA affected from Baseline was summarized for each study visit. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Mean Change in PASI Score From Baseline to Each Study Visit | Baseline and up to Week 16 | The PASI is a standard clinical tool for assessing the severity of psoriasis based on severity of erythema, thickness and scale, as well as the extent of BSA affected with psoriasis. The 3 clinical signs were graded on a 5 point scale (0=None to 4=Severe) and the percent of BSA affected is scored on a 7-point scale (0=0% involvement to 6=90-100%) for each of 4 specified body regions (head, upper extremities, trunk and lower extremities). The individual scores were multiplied by a weighted factor for each body region. The sum of these scores gave the overall PASI score. PASI score ranged from 0=no psoriasis to 72=worse psoriasis. The mean change in PASI score from Baseline was summarized for each study visit. Baseline was the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| PGA Scores at Each Study Visit | Up to Week 16 | The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The mean of PGA scores at each study visit was summarized. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Mean Change in PGA Score From Baseline to Each Study Visit | Baseline and up to Week 16 | The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The mean change in PGA scores from Baseline was summarized for each study visit. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Baseline and up to Week 16 | A single target lesion of at least 3 centimeter (cm) x 3 cm was selected at Baseline. For the selected lesion, the severity of erythema, scaling and plaque thickness (induration) was assessed by the investigator on a 5-point scale ranging from 0=none to 4=severe. The mean change in individual grading scores from Baseline was summarized for each study visit. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Baseline and up to Week 16 | The participant reported itch severity was obtained from the response of the participants to the itch NRS item in the psoriasis symptom diary (PSD). PSD was developed to assess daily self-reports of psoriasis symptoms and the functional impact related to the underlying pathophysiology of the disease. The participants answered questions related to the severity and impact of the signs and symptoms daily using a 11 point NRS with scores ranging from 0 (absent) to 10 (worst imaginable). Mean change in itch/pruritis NRS from Baseline to each study visit was presented. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the post dose weekly average value minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Baseline and up to Week 16 | The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of responders that is, participants who achieved a PGA score of 0 or 1 and a minimum 2-grade improvement from baseline were summarized. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | Up to Week 16 | An AE is defined as any untoward medical occurrence in a participant under clinical investigation, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. A TEAE is defined as an AE which occurred on or after study treatment start date and on or before the last visit. Number of participants with AEs and SAEs were presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment. |
| Number of Participants With Reported Local Tolerability Scores | Up to Week 14 | The assessment of the presence and degree of burning/stinging and itching at the application site following application of the study treatment was done at each specified study visit using a 5 point tolerability scale. The scores ranged from 0 to 4 where 0=None and 4=Strong/Severe. The score represented an average across all application sites. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Change From Baseline in Albumin and Protein Level | Baseline and up to Week 14 | Blood samples were collected for the evaluation of change in albumin and protein levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Baseline and up to Week 14 | Blood samples were collected for the evaluation of change in levels of alk phos, ALT, AST and GGT from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Baseline and up to Week 14 | Blood samples were collected for the evaluation of change in levels of direct bil, bil, creatinine and urate from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Baseline and up to Week 14 | Blood samples were collected for the evaluation of change in levels of calcium, chloride, CO2, glucose, potassium, sodium, and urea from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Baseline and up to Week 14 | Blood samples were collected for the evaluation of change in levels of basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocyte count from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Baseline and up to Week 16 | The PASI is a standard clinical tool for assessing the severity of psoriasis based on severity of erythema, thickness and scale, as well as the extent of body surface area (BSA) affected with psoriasis. The 3 clinical signs were graded on a 5 point scale (0 to 4) and the % BSA affected was scored on a 7-point scale (0 to 6) for each of the 4 specified body regions (head, upper extremities, trunk and lower extremities). The individual scores were multiplied by a weighted factor for each body region. The sum of these scores gave the overall PASI score. Higher scores indicated more severe disease. The percentage of participants with \>=75% improvement in PASI from Baseline were summarized. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Baseline and up to Week 14 | Blood samples were collected for the evaluation of change in Hgb levels and MCHC from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Baseline and up to Week 14 | Blood samples were collected for the evaluation of change in erythrocyte mean corpuscular hemoglobin level from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Change From Baseline in Erythrocyte Mean Corpuscular Volume | Baseline and up to Week 14 | Blood samples were collected for the evaluation of change in erythrocyte mean corpuscular volume from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Change From Baseline in Erythrocyte Count | Baseline and up to Week 14 | Blood samples were collected for the evaluation of change in erythrocyte count from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Number of Participants With Chemistry Data of Potential Clinical Importance | Up to Week 14 | Blood samples were collected for the evaluation of clinical chemistry parameters including alk phos, ALT, AST, bil, calcium, CO2, creatinine, glucose and potassium. The number of participants with chemistry data of potential clinical importance for the mentioned parameters was presented. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Number of Participants With Hematology Data of Clinical Importance | Up to Week 14 | Blood samples were collected for the evaluation of hematology parameters including hematocrit, Hgb, lymphocytes, neutrophils and platelets. The number of participants with clinically significant abnormal values of the mentioned hematology parameters was presented. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | Baseline and up to Week 12 | Blood samples were collected for the evaluation of change in IgA, IgG and IgM levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Number of Participants With Ig Data Outside the Reference Range | Up to Week 12 | Blood samples were collected for the evaluation of change in Ig levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Number of Participants With Immunophenotyping Data Outside the Reference Range | Up to Week 12 | Blood samples were collected for the evaluation of change in levels of cluster of differentiation (CD)19, CD3, CD3 Treg flow cytometry (CD3TFLC), CD3+CD8+, CD3+CD8+ TFLC, CD3+CD4+, CD3+CD4+ TFLC, CD16+CD56+, CD3+CD4+CD25+CD127 flow cytometry (CD3+CD4+CD25+CD127), CD3+CD4+foxP3+CD25+CD127 flow cytometry (CD3+CD4+fP3+CD25+CD127) and T Cell B Cell Natural Killer Lymphocytes flow cytometry (T-B cell NKL). Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Change From Baseline in Immunophenotype Data | Baseline and up to Week 12 | Blood samples were collected for the evaluation of change from Baseline in immunophenotype levels including CD19, CD3, CD3TFLC, CD3+CD8+, CD3+CD8+ TFLC, CD3+CD4+, CD3+CD4+ TFLC, CD16+CD56+, CD3+CD4+CD25+CD127 flow cytometry (CD3+CD4+CD25+CD127), CD3+CD4+foxP3+CD25+CD127 flow cytometry (CD3+CD4+fP3+CD25+CD127) and T-B cell NKL. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline and up to Week 14 | SBP and DBP were measured in semi-supine position after at least 5 minutes of rest. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Change From Baseline in Pulse Rate | Baseline and up to Week 14 | Pulse rate was measured in semi-supine position after at least 5 minutes of rest. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Change From Baseline in Temperature | Baseline and up to Week 14 | Temperature was measured in semi-supine position after at least 5 minutes of rest. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Number of Participants With Vital Signs of Clinical Importance | Up to Week 14 | The vital signs including SBP, DBP and pulse rate were measured from Baseline throughout the study. The number of participants with clinically significant abnormal vital signs were presented. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Up to Week 14 | Single 12-lead ECGs were obtained over a brief recording period at each specified time point during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. For multiple ECGs at one visit, or Any time post-screen, a participant is categorized as Abnormal if \>=1 assessment is abnormal. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
| Change From Baseline in Hematocrit Levels | Baseline and up to Week 14 | Blood samples were collected for the evaluation of change in hematocrit levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title). |
Countries
Canada, Japan, United States
Participant flow
Recruitment details
This was a randomized, double-blind, dose-finding study of GSK2894512 in adult participants with psoriasis. The study consisted of 3 periods: 4 weeks screening, 12 weeks double-blind treatment, and 4 weeks post-treatment follow-up. The total duration of study for a participant was 16-20 weeks.
Pre-assignment details
A total of 290 participants were screened of which 63 failed screening and 227 participants were randomized into the study. Participants in the treatment phase were randomized to receive GSK2894512 cream (0.5 or 1 percent) or vehicle control once daily (QD) or twice daily (BID).
Participants by arm
| Arm | Count |
|---|---|
| GSK2894512 1% BID The participants were topically administered GSK2894512 1% (10 milligrams per gram \[mg/g\]) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. | 38 |
| GSK2894512 1% QD The participants were topically administered GSK2894512 1% (10 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. | 38 |
| GSK2894512 0.5% BID The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. | 38 |
| GSK2894512 0.5% QD The participants were topically administered GSK2894512 0.5% (5 mg/g) cream applied QD approximately the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. | 38 |
| Vehicle BID The participants were topically administered vehicle applied BID approximately 12 hours apart at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. | 37 |
| Vehicle QD The participants were topically administered vehicle applied QD approximately at the same time each day for 12 weeks. The cream was applied as a thin layer to all psoriasis lesions except on the scalp. | 38 |
| Total | 227 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 4 | 4 | 3 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 | 1 | 0 | 1 | 1 |
| Overall Study | Physician Decision | 1 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 3 | 2 | 2 | 10 | 12 |
Baseline characteristics
| Characteristic | GSK2894512 1% BID | GSK2894512 1% QD | GSK2894512 0.5% BID | GSK2894512 0.5% QD | Vehicle BID | Vehicle QD | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 45.9 Years STANDARD_DEVIATION 11.93 | 48.5 Years STANDARD_DEVIATION 10.56 | 49.6 Years STANDARD_DEVIATION 10.93 | 48.7 Years STANDARD_DEVIATION 9.72 | 46.7 Years STANDARD_DEVIATION 12.62 | 46.4 Years STANDARD_DEVIATION 10.16 | 47.6 Years STANDARD_DEVIATION 10.99 |
| Race/Ethnicity, Customized Race, Customized American Indian (Amer Ind)/Alaska Native (Ala Nat) | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race, Customized Amer Ind/Ala Nat & Black/Afr Amer &White/Caucasian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race, Customized Asian/South East Asian Descent/Japanese Descent | 10 Participants | 9 Participants | 8 Participants | 6 Participants | 9 Participants | 6 Participants | 48 Participants |
| Race/Ethnicity, Customized Race, Customized Black/Afr Amer & White/Caucasian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race, Customized Black/African American (Afr Amer) | 1 Participants | 2 Participants | 3 Participants | 1 Participants | 3 Participants | 0 Participants | 10 Participants |
| Race/Ethnicity, Customized Race, Customized White/Caucasian | 26 Participants | 27 Participants | 26 Participants | 30 Participants | 25 Participants | 32 Participants | 166 Participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 14 Participants | 13 Participants | 14 Participants | 9 Participants | 74 Participants |
| Sex: Female, Male Male | 26 Participants | 26 Participants | 24 Participants | 25 Participants | 23 Participants | 29 Participants | 153 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 38 | 0 / 38 | 0 / 38 | 0 / 37 | 0 / 38 |
| other Total, other adverse events | 17 / 38 | 12 / 38 | 11 / 38 | 11 / 38 | 3 / 37 | 3 / 38 |
| serious Total, serious adverse events | 1 / 38 | 3 / 38 | 3 / 38 | 0 / 38 | 0 / 37 | 0 / 38 |
Outcome results
Primary
Percentage of Participants Who Have a Physician Global Assessment (PGA) Score of 0 or 1 at Week 12 and a Minimum 2-grade Improvement in PGA Score From Baseline to Week 12
The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of responders that is, participants who achieved a PGA score of 0 or 1 and a minimum 2-grade improvement from Baseline were summarized. Baseline was defined as the latest assessment prior to the first dose. The analysis was performed on modified intent-to-treat (mITT) Population which comprised of all randomized participants except those enrolled at center ID 220008.
Time frame: Baseline and up to Week 12
Population: mITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2894512 1% BID | Percentage of Participants Who Have a Physician Global Assessment (PGA) Score of 0 or 1 at Week 12 and a Minimum 2-grade Improvement in PGA Score From Baseline to Week 12 | 65 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants Who Have a Physician Global Assessment (PGA) Score of 0 or 1 at Week 12 and a Minimum 2-grade Improvement in PGA Score From Baseline to Week 12 | 56 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants Who Have a Physician Global Assessment (PGA) Score of 0 or 1 at Week 12 and a Minimum 2-grade Improvement in PGA Score From Baseline to Week 12 | 46 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants Who Have a Physician Global Assessment (PGA) Score of 0 or 1 at Week 12 and a Minimum 2-grade Improvement in PGA Score From Baseline to Week 12 | 36 Percentage of participants |
| Vehicle BID | Percentage of Participants Who Have a Physician Global Assessment (PGA) Score of 0 or 1 at Week 12 and a Minimum 2-grade Improvement in PGA Score From Baseline to Week 12 | 11 Percentage of participants |
| Vehicle QD | Percentage of Participants Who Have a Physician Global Assessment (PGA) Score of 0 or 1 at Week 12 and a Minimum 2-grade Improvement in PGA Score From Baseline to Week 12 | 5 Percentage of participants |
95% CI: [25.9, 76.6]
95% CI: [22.2, 73.2]
95% CI: [6.3, 60.5]
95% CI: [1.6, 55.9]
Secondary
Change From Baseline in Albumin and Protein Level
Blood samples were collected for the evaluation of change in albumin and protein levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Baseline and up to Week 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Albumin and Protein Level | Protein, Week 2, n=35, 36, 35, 37, 29, 34 | -1.1 grams/liter (g/L) | Standard Deviation 3.84 |
| GSK2894512 1% BID | Change From Baseline in Albumin and Protein Level | Albumin, Week 14, n=29, 31, 33, 34, 27, 24 | -1.3 grams/liter (g/L) | Standard Deviation 2.74 |
| GSK2894512 1% BID | Change From Baseline in Albumin and Protein Level | Protein, EW, n=10, 6, 3, 2, 10, 9 | -0.8 grams/liter (g/L) | Standard Deviation 2.66 |
| GSK2894512 1% BID | Change From Baseline in Albumin and Protein Level | Albumin, EW, n=10, 6, 3, 2, 10, 9 | -0.3 grams/liter (g/L) | Standard Deviation 2.06 |
| GSK2894512 1% BID | Change From Baseline in Albumin and Protein Level | Albumin, Week 4, n=32, 34, 33, 37, 29, 30 | -1.3 grams/liter (g/L) | Standard Deviation 2.1 |
| GSK2894512 1% BID | Change From Baseline in Albumin and Protein Level | Protein, Week 14, n=29, 31, 33, 34, 27, 24 | -2.1 grams/liter (g/L) | Standard Deviation 3.06 |
| GSK2894512 1% BID | Change From Baseline in Albumin and Protein Level | Protein, Week 12, n=27, 30, 32, 36, 26, 24 | -1.3 grams/liter (g/L) | Standard Deviation 2.73 |
| GSK2894512 1% BID | Change From Baseline in Albumin and Protein Level | Albumin, Week 8, n=30, 31, 32, 37, 27, 26 | -1.0 grams/liter (g/L) | Standard Deviation 1.65 |
| GSK2894512 1% BID | Change From Baseline in Albumin and Protein Level | Albumin, Week 2, n=35, 36, 35, 37, 29, 34 | -0.9 grams/liter (g/L) | Standard Deviation 2.11 |
| GSK2894512 1% BID | Change From Baseline in Albumin and Protein Level | Protein, Week 8, n=30, 31, 32, 37, 27, 26 | -2.1 grams/liter (g/L) | Standard Deviation 3.28 |
| GSK2894512 1% BID | Change From Baseline in Albumin and Protein Level | Albumin, Week 12, n=27, 30, 32, 36, 26, 24 | -0.8 grams/liter (g/L) | Standard Deviation 2.19 |
| GSK2894512 1% BID | Change From Baseline in Albumin and Protein Level | Protein, Week 4, n=32, 34, 33, 37, 29, 30 | -2.3 grams/liter (g/L) | Standard Deviation 3.23 |
| GSK2894512 1% QD | Change From Baseline in Albumin and Protein Level | Protein, Week 4, n=32, 34, 33, 37, 29, 30 | -2.9 grams/liter (g/L) | Standard Deviation 3.41 |
| GSK2894512 1% QD | Change From Baseline in Albumin and Protein Level | Protein, Week 2, n=35, 36, 35, 37, 29, 34 | -2.5 grams/liter (g/L) | Standard Deviation 3.95 |
| GSK2894512 1% QD | Change From Baseline in Albumin and Protein Level | Albumin, Week 14, n=29, 31, 33, 34, 27, 24 | -1.1 grams/liter (g/L) | Standard Deviation 2.72 |
| GSK2894512 1% QD | Change From Baseline in Albumin and Protein Level | Albumin, Week 8, n=30, 31, 32, 37, 27, 26 | -0.6 grams/liter (g/L) | Standard Deviation 2.33 |
| GSK2894512 1% QD | Change From Baseline in Albumin and Protein Level | Albumin, EW, n=10, 6, 3, 2, 10, 9 | -1.7 grams/liter (g/L) | Standard Deviation 2.5 |
| GSK2894512 1% QD | Change From Baseline in Albumin and Protein Level | Albumin, Week 12, n=27, 30, 32, 36, 26, 24 | -0.5 grams/liter (g/L) | Standard Deviation 3.31 |
| GSK2894512 1% QD | Change From Baseline in Albumin and Protein Level | Protein, Week 14, n=29, 31, 33, 34, 27, 24 | -2.9 grams/liter (g/L) | Standard Deviation 3.61 |
| GSK2894512 1% QD | Change From Baseline in Albumin and Protein Level | Protein, Week 8, n=30, 31, 32, 37, 27, 26 | -1.7 grams/liter (g/L) | Standard Deviation 3.74 |
| GSK2894512 1% QD | Change From Baseline in Albumin and Protein Level | Albumin, Week 4, n=32, 34, 33, 37, 29, 30 | -1.2 grams/liter (g/L) | Standard Deviation 2.52 |
| GSK2894512 1% QD | Change From Baseline in Albumin and Protein Level | Albumin, Week 2, n=35, 36, 35, 37, 29, 34 | -1.1 grams/liter (g/L) | Standard Deviation 2.7 |
| GSK2894512 1% QD | Change From Baseline in Albumin and Protein Level | Protein, EW, n=10, 6, 3, 2, 10, 9 | -3.5 grams/liter (g/L) | Standard Deviation 3.83 |
| GSK2894512 1% QD | Change From Baseline in Albumin and Protein Level | Protein, Week 12, n=27, 30, 32, 36, 26, 24 | -2.5 grams/liter (g/L) | Standard Deviation 3.72 |
| GSK2894512 0.5% BID | Change From Baseline in Albumin and Protein Level | Protein, EW, n=10, 6, 3, 2, 10, 9 | -3.0 grams/liter (g/L) | Standard Deviation 5 |
| GSK2894512 0.5% BID | Change From Baseline in Albumin and Protein Level | Albumin, Week 2, n=35, 36, 35, 37, 29, 34 | -0.9 grams/liter (g/L) | Standard Deviation 2.83 |
| GSK2894512 0.5% BID | Change From Baseline in Albumin and Protein Level | Albumin, Week 4, n=32, 34, 33, 37, 29, 30 | -1.0 grams/liter (g/L) | Standard Deviation 3.57 |
| GSK2894512 0.5% BID | Change From Baseline in Albumin and Protein Level | Albumin, Week 8, n=30, 31, 32, 37, 27, 26 | -1.0 grams/liter (g/L) | Standard Deviation 3.33 |
| GSK2894512 0.5% BID | Change From Baseline in Albumin and Protein Level | Albumin, Week 12, n=27, 30, 32, 36, 26, 24 | -1.3 grams/liter (g/L) | Standard Deviation 3.39 |
| GSK2894512 0.5% BID | Change From Baseline in Albumin and Protein Level | Albumin, Week 14, n=29, 31, 33, 34, 27, 24 | -1.5 grams/liter (g/L) | Standard Deviation 2.71 |
| GSK2894512 0.5% BID | Change From Baseline in Albumin and Protein Level | Albumin, EW, n=10, 6, 3, 2, 10, 9 | 0.0 grams/liter (g/L) | Standard Deviation 3.46 |
| GSK2894512 0.5% BID | Change From Baseline in Albumin and Protein Level | Protein, Week 2, n=35, 36, 35, 37, 29, 34 | -1.3 grams/liter (g/L) | Standard Deviation 4.25 |
| GSK2894512 0.5% BID | Change From Baseline in Albumin and Protein Level | Protein, Week 4, n=32, 34, 33, 37, 29, 30 | -0.9 grams/liter (g/L) | Standard Deviation 4.94 |
| GSK2894512 0.5% BID | Change From Baseline in Albumin and Protein Level | Protein, Week 8, n=30, 31, 32, 37, 27, 26 | -1.9 grams/liter (g/L) | Standard Deviation 4.88 |
| GSK2894512 0.5% BID | Change From Baseline in Albumin and Protein Level | Protein, Week 12, n=27, 30, 32, 36, 26, 24 | -2.4 grams/liter (g/L) | Standard Deviation 4.23 |
| GSK2894512 0.5% BID | Change From Baseline in Albumin and Protein Level | Protein, Week 14, n=29, 31, 33, 34, 27, 24 | -2.4 grams/liter (g/L) | Standard Deviation 4.34 |
| GSK2894512 0.5% QD | Change From Baseline in Albumin and Protein Level | Albumin, Week 12, n=27, 30, 32, 36, 26, 24 | -1.2 grams/liter (g/L) | Standard Deviation 1.67 |
| GSK2894512 0.5% QD | Change From Baseline in Albumin and Protein Level | Albumin, Week 4, n=32, 34, 33, 37, 29, 30 | -0.4 grams/liter (g/L) | Standard Deviation 1.99 |
| GSK2894512 0.5% QD | Change From Baseline in Albumin and Protein Level | Albumin, Week 2, n=35, 36, 35, 37, 29, 34 | -1.1 grams/liter (g/L) | Standard Deviation 2.33 |
| GSK2894512 0.5% QD | Change From Baseline in Albumin and Protein Level | Protein, Week 14, n=29, 31, 33, 34, 27, 24 | -1.9 grams/liter (g/L) | Standard Deviation 4.01 |
| GSK2894512 0.5% QD | Change From Baseline in Albumin and Protein Level | Protein, Week 4, n=32, 34, 33, 37, 29, 30 | -0.7 grams/liter (g/L) | Standard Deviation 3.37 |
| GSK2894512 0.5% QD | Change From Baseline in Albumin and Protein Level | Albumin, Week 14, n=29, 31, 33, 34, 27, 24 | -1.1 grams/liter (g/L) | Standard Deviation 2.81 |
| GSK2894512 0.5% QD | Change From Baseline in Albumin and Protein Level | Albumin, EW, n=10, 6, 3, 2, 10, 9 | -3.5 grams/liter (g/L) | Standard Deviation 3.54 |
| GSK2894512 0.5% QD | Change From Baseline in Albumin and Protein Level | Protein, Week 2, n=35, 36, 35, 37, 29, 34 | -1.5 grams/liter (g/L) | Standard Deviation 3.07 |
| GSK2894512 0.5% QD | Change From Baseline in Albumin and Protein Level | Albumin, Week 8, n=30, 31, 32, 37, 27, 26 | -1.0 grams/liter (g/L) | Standard Deviation 2.49 |
| GSK2894512 0.5% QD | Change From Baseline in Albumin and Protein Level | Protein, EW, n=10, 6, 3, 2, 10, 9 | -3.5 grams/liter (g/L) | Standard Deviation 2.12 |
| GSK2894512 0.5% QD | Change From Baseline in Albumin and Protein Level | Protein, Week 8, n=30, 31, 32, 37, 27, 26 | -1.3 grams/liter (g/L) | Standard Deviation 3.89 |
| GSK2894512 0.5% QD | Change From Baseline in Albumin and Protein Level | Protein, Week 12, n=27, 30, 32, 36, 26, 24 | -1.7 grams/liter (g/L) | Standard Deviation 3.27 |
| Vehicle BID | Change From Baseline in Albumin and Protein Level | Albumin, Week 12, n=27, 30, 32, 36, 26, 24 | -0.6 grams/liter (g/L) | Standard Deviation 3.14 |
| Vehicle BID | Change From Baseline in Albumin and Protein Level | Albumin, Week 8, n=30, 31, 32, 37, 27, 26 | -0.6 grams/liter (g/L) | Standard Deviation 3.19 |
| Vehicle BID | Change From Baseline in Albumin and Protein Level | Albumin, Week 2, n=35, 36, 35, 37, 29, 34 | -0.9 grams/liter (g/L) | Standard Deviation 3.37 |
| Vehicle BID | Change From Baseline in Albumin and Protein Level | Albumin, Week 4, n=32, 34, 33, 37, 29, 30 | -0.8 grams/liter (g/L) | Standard Deviation 3.53 |
| Vehicle BID | Change From Baseline in Albumin and Protein Level | Protein, EW, n=10, 6, 3, 2, 10, 9 | -1.2 grams/liter (g/L) | Standard Deviation 3.52 |
| Vehicle BID | Change From Baseline in Albumin and Protein Level | Protein, Week 14, n=29, 31, 33, 34, 27, 24 | -3.0 grams/liter (g/L) | Standard Deviation 4.32 |
| Vehicle BID | Change From Baseline in Albumin and Protein Level | Protein, Week 12, n=27, 30, 32, 36, 26, 24 | -1.8 grams/liter (g/L) | Standard Deviation 4.05 |
| Vehicle BID | Change From Baseline in Albumin and Protein Level | Albumin, Week 14, n=29, 31, 33, 34, 27, 24 | -1.6 grams/liter (g/L) | Standard Deviation 4.24 |
| Vehicle BID | Change From Baseline in Albumin and Protein Level | Protein, Week 8, n=30, 31, 32, 37, 27, 26 | -1.5 grams/liter (g/L) | Standard Deviation 4.42 |
| Vehicle BID | Change From Baseline in Albumin and Protein Level | Protein, Week 4, n=32, 34, 33, 37, 29, 30 | -1.9 grams/liter (g/L) | Standard Deviation 4.99 |
| Vehicle BID | Change From Baseline in Albumin and Protein Level | Protein, Week 2, n=35, 36, 35, 37, 29, 34 | -1.8 grams/liter (g/L) | Standard Deviation 4.21 |
| Vehicle BID | Change From Baseline in Albumin and Protein Level | Albumin, EW, n=10, 6, 3, 2, 10, 9 | -0.8 grams/liter (g/L) | Standard Deviation 1.99 |
| Vehicle QD | Change From Baseline in Albumin and Protein Level | Protein, Week 8, n=30, 31, 32, 37, 27, 26 | -1.4 grams/liter (g/L) | Standard Deviation 3.3 |
| Vehicle QD | Change From Baseline in Albumin and Protein Level | Albumin, Week 12, n=27, 30, 32, 36, 26, 24 | -1.1 grams/liter (g/L) | Standard Deviation 2.85 |
| Vehicle QD | Change From Baseline in Albumin and Protein Level | Protein, Week 2, n=35, 36, 35, 37, 29, 34 | -1.0 grams/liter (g/L) | Standard Deviation 4.25 |
| Vehicle QD | Change From Baseline in Albumin and Protein Level | Albumin, Week 8, n=30, 31, 32, 37, 27, 26 | -1.0 grams/liter (g/L) | Standard Deviation 2.36 |
| Vehicle QD | Change From Baseline in Albumin and Protein Level | Protein, Week 4, n=32, 34, 33, 37, 29, 30 | -0.3 grams/liter (g/L) | Standard Deviation 4.7 |
| Vehicle QD | Change From Baseline in Albumin and Protein Level | Albumin, EW, n=10, 6, 3, 2, 10, 9 | -0.2 grams/liter (g/L) | Standard Deviation 2.54 |
| Vehicle QD | Change From Baseline in Albumin and Protein Level | Albumin, Week 4, n=32, 34, 33, 37, 29, 30 | -0.2 grams/liter (g/L) | Standard Deviation 3.23 |
| Vehicle QD | Change From Baseline in Albumin and Protein Level | Protein, Week 12, n=27, 30, 32, 36, 26, 24 | -1.5 grams/liter (g/L) | Standard Deviation 3.84 |
| Vehicle QD | Change From Baseline in Albumin and Protein Level | Albumin, Week 2, n=35, 36, 35, 37, 29, 34 | -0.6 grams/liter (g/L) | Standard Deviation 2.76 |
| Vehicle QD | Change From Baseline in Albumin and Protein Level | Protein, EW, n=10, 6, 3, 2, 10, 9 | -0.2 grams/liter (g/L) | Standard Deviation 3.42 |
| Vehicle QD | Change From Baseline in Albumin and Protein Level | Albumin, Week 14, n=29, 31, 33, 34, 27, 24 | -2.0 grams/liter (g/L) | Standard Deviation 2.4 |
| Vehicle QD | Change From Baseline in Albumin and Protein Level | Protein, Week 14, n=29, 31, 33, 34, 27, 24 | -2.6 grams/liter (g/L) | Standard Deviation 2.81 |
Secondary
Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels.
Blood samples were collected for the evaluation of change in levels of alk phos, ALT, AST and GGT from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Baseline and up to Week 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 8, n=30, 31, 32, 37, 27, 26 | -4.1 International Units (IU)/L | Standard Deviation 17.59 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 12, n=27, 30, 32, 36, 26, 24 | -0.1 International Units (IU)/L | Standard Deviation 24.48 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 14, n=29, 31, 33, 34, 27, 24 | -1.9 International Units (IU)/L | Standard Deviation 16.31 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, EW, n=10, 6, 3, 2, 10, 9 | -2.0 International Units (IU)/L | Standard Deviation 6.25 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 2, n=35, 36, 35, 37, 29, 34 | -0.6 International Units (IU)/L | Standard Deviation 10.83 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 4, n=32, 34, 33, 37, 29, 30 | -0.2 International Units (IU)/L | Standard Deviation 20.5 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 8, n=30, 31, 32, 37, 27, 26 | 1.9 International Units (IU)/L | Standard Deviation 20.56 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 12, n=27, 30, 32, 36, 26, 24 | -5.7 International Units (IU)/L | Standard Deviation 18.74 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 14, n=29, 31, 33, 34, 27, 24 | -2.3 International Units (IU)/L | Standard Deviation 15.62 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, EW, n=10, 6, 3, 2, 10, 9 | -3.7 International Units (IU)/L | Standard Deviation 7.27 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 2, n=35, 36, 35, 37, 29, 34 | -2.1 International Units (IU)/L | Standard Deviation 7.98 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 4, n=32, 34, 33, 37, 29, 30 | 0.3 International Units (IU)/L | Standard Deviation 22.68 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 8, n=30, 31, 32, 37, 27, 26 | -1.5 International Units (IU)/L | Standard Deviation 10.37 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 12, n=27, 30, 32, 36, 26, 24 | -1.8 International Units (IU)/L | Standard Deviation 15.35 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 14, n=29, 31, 33, 34, 27, 24 | -3.8 International Units (IU)/L | Standard Deviation 17.42 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, EW, n=10, 6, 3, 2, 10, 9 | -1.1 International Units (IU)/L | Standard Deviation 5.02 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 2, n=35, 36, 35, 37, 29, 34 | -0.6 International Units (IU)/L | Standard Deviation 4.91 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 4, n=32, 34, 33, 37, 29, 30 | 0.2 International Units (IU)/L | Standard Deviation 9.76 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 8, n=30, 31, 32, 37, 27, 26 | -1.0 International Units (IU)/L | Standard Deviation 4.22 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 12, n=27, 30, 32, 36, 26, 24 | 0.6 International Units (IU)/L | Standard Deviation 9.09 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 14, n=29, 31, 33, 34, 27, 24 | -0.4 International Units (IU)/L | Standard Deviation 7.55 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, EW, n=10, 6, 3, 2, 10, 9 | -1.0 International Units (IU)/L | Standard Deviation 4.24 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 2, n=35, 36, 35, 37, 29, 34 | -1.0 International Units (IU)/L | Standard Deviation 6.63 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 4, n=32, 34, 33, 37, 29, 30 | 8.5 International Units (IU)/L | Standard Deviation 56.71 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 2, n=35, 36, 35, 37, 29, 34 | -0.9 International Units (IU)/L | Standard Deviation 8.44 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 8, n=30, 31, 32, 37, 27, 26 | -3.9 International Units (IU)/L | Standard Deviation 12.47 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 14, n=29, 31, 33, 34, 27, 24 | -2.5 International Units (IU)/L | Standard Deviation 11.69 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, EW, n=10, 6, 3, 2, 10, 9 | -2.2 International Units (IU)/L | Standard Deviation 7.31 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 2, n=35, 36, 35, 37, 29, 34 | -2.1 International Units (IU)/L | Standard Deviation 8.38 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 12, n=27, 30, 32, 36, 26, 24 | -2.2 International Units (IU)/L | Standard Deviation 8.25 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 14, n=29, 31, 33, 34, 27, 24 | -3.5 International Units (IU)/L | Standard Deviation 10.37 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 8, n=30, 31, 32, 37, 27, 26 | -1.2 International Units (IU)/L | Standard Deviation 11.06 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 12, n=27, 30, 32, 36, 26, 24 | -2.4 International Units (IU)/L | Standard Deviation 12.78 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, EW, n=10, 6, 3, 2, 10, 9 | 5.2 International Units (IU)/L | Standard Deviation 15.84 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 12, n=27, 30, 32, 36, 26, 24 | -3.1 International Units (IU)/L | Standard Deviation 10.45 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, EW, n=10, 6, 3, 2, 10, 9 | -5.3 International Units (IU)/L | Standard Deviation 7.42 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 14, n=29, 31, 33, 34, 27, 24 | -2.7 International Units (IU)/L | Standard Deviation 8.76 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 14, n=29, 31, 33, 34, 27, 24 | -4.1 International Units (IU)/L | Standard Deviation 10.56 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 8, n=30, 31, 32, 37, 27, 26 | -7.6 International Units (IU)/L | Standard Deviation 32.91 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, EW, n=10, 6, 3, 2, 10, 9 | 2.7 International Units (IU)/L | Standard Deviation 10.95 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 4, n=32, 34, 33, 37, 29, 30 | -0.6 International Units (IU)/L | Standard Deviation 7.03 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 12, n=27, 30, 32, 36, 26, 24 | -2.2 International Units (IU)/L | Standard Deviation 7.49 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 4, n=32, 34, 33, 37, 29, 30 | -3.5 International Units (IU)/L | Standard Deviation 17.84 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 2, n=35, 36, 35, 37, 29, 34 | -2.6 International Units (IU)/L | Standard Deviation 7.95 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 8, n=30, 31, 32, 37, 27, 26 | -2.2 International Units (IU)/L | Standard Deviation 6.32 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 4, n=32, 34, 33, 37, 29, 30 | -1.9 International Units (IU)/L | Standard Deviation 3.21 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 4, n=32, 34, 33, 37, 29, 30 | -2.7 International Units (IU)/L | Standard Deviation 5.99 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 2, n=35, 36, 35, 37, 29, 34 | -1.2 International Units (IU)/L | Standard Deviation 5.09 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, EW, n=10, 6, 3, 2, 10, 9 | 1.7 International Units (IU)/L | Standard Deviation 9.07 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 2, n=35, 36, 35, 37, 29, 34 | 0.5 International Units (IU)/L | Standard Deviation 3.71 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 8, n=30, 31, 32, 37, 27, 26 | 0.1 International Units (IU)/L | Standard Deviation 11.68 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 14, n=29, 31, 33, 34, 27, 24 | -3.1 International Units (IU)/L | Standard Deviation 12.34 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 14, n=29, 31, 33, 34, 27, 24 | -0.1 International Units (IU)/L | Standard Deviation 16.58 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 14, n=29, 31, 33, 34, 27, 24 | -1.8 International Units (IU)/L | Standard Deviation 12.99 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 2, n=35, 36, 35, 37, 29, 34 | -2.3 International Units (IU)/L | Standard Deviation 6.18 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 4, n=32, 34, 33, 37, 29, 30 | -4.6 International Units (IU)/L | Standard Deviation 22.06 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 12, n=27, 30, 32, 36, 26, 24 | -0.1 International Units (IU)/L | Standard Deviation 13.72 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 14, n=29, 31, 33, 34, 27, 24 | 0.7 International Units (IU)/L | Standard Deviation 8.39 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 12, n=27, 30, 32, 36, 26, 24 | 1.9 International Units (IU)/L | Standard Deviation 8.89 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 2, n=35, 36, 35, 37, 29, 34 | -0.4 International Units (IU)/L | Standard Deviation 17.64 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, EW, n=10, 6, 3, 2, 10, 9 | 5.0 International Units (IU)/L | Standard Deviation 16.64 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 4, n=32, 34, 33, 37, 29, 30 | 0.1 International Units (IU)/L | Standard Deviation 13.51 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 8, n=30, 31, 32, 37, 27, 26 | -0.1 International Units (IU)/L | Standard Deviation 9.53 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, EW, n=10, 6, 3, 2, 10, 9 | -2.0 International Units (IU)/L | Standard Deviation 6.56 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 12, n=27, 30, 32, 36, 26, 24 | 2.1 International Units (IU)/L | Standard Deviation 20.03 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, EW, n=10, 6, 3, 2, 10, 9 | 7.7 International Units (IU)/L | Standard Deviation 16.8 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 4, n=32, 34, 33, 37, 29, 30 | -3.7 International Units (IU)/L | Standard Deviation 13.21 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 4, n=32, 34, 33, 37, 29, 30 | -1.0 International Units (IU)/L | Standard Deviation 5.22 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 12, n=27, 30, 32, 36, 26, 24 | -1.7 International Units (IU)/L | Standard Deviation 9.29 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 2, n=35, 36, 35, 37, 29, 34 | -0.7 International Units (IU)/L | Standard Deviation 13.47 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 8, n=30, 31, 32, 37, 27, 26 | 2.6 International Units (IU)/L | Standard Deviation 11.6 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 8, n=30, 31, 32, 37, 27, 26 | -1.2 International Units (IU)/L | Standard Deviation 21.11 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, EW, n=10, 6, 3, 2, 10, 9 | -1.0 International Units (IU)/L | Standard Deviation 4.24 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 2, n=35, 36, 35, 37, 29, 34 | -2.9 International Units (IU)/L | Standard Deviation 10.93 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 4, n=32, 34, 33, 37, 29, 30 | 0.4 International Units (IU)/L | Standard Deviation 11.33 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 4, n=32, 34, 33, 37, 29, 30 | 0.3 International Units (IU)/L | Standard Deviation 15.4 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 8, n=30, 31, 32, 37, 27, 26 | -3.9 International Units (IU)/L | Standard Deviation 9.54 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 12, n=27, 30, 32, 36, 26, 24 | -2.3 International Units (IU)/L | Standard Deviation 8.3 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 14, n=29, 31, 33, 34, 27, 24 | -4.9 International Units (IU)/L | Standard Deviation 13.2 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, EW, n=10, 6, 3, 2, 10, 9 | -13.5 International Units (IU)/L | Standard Deviation 6.36 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 2, n=35, 36, 35, 37, 29, 34 | -2.9 International Units (IU)/L | Standard Deviation 9.75 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 4, n=32, 34, 33, 37, 29, 30 | -2.9 International Units (IU)/L | Standard Deviation 9.91 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 8, n=30, 31, 32, 37, 27, 26 | -4.4 International Units (IU)/L | Standard Deviation 10.88 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 12, n=27, 30, 32, 36, 26, 24 | -5.4 International Units (IU)/L | Standard Deviation 9.54 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 14, n=29, 31, 33, 34, 27, 24 | -6.5 International Units (IU)/L | Standard Deviation 10.33 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 2, n=35, 36, 35, 37, 29, 34 | -1.6 International Units (IU)/L | Standard Deviation 14.39 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, EW, n=10, 6, 3, 2, 10, 9 | -5.0 International Units (IU)/L | Standard Deviation 7.07 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 2, n=35, 36, 35, 37, 29, 34 | -1.8 International Units (IU)/L | Standard Deviation 11.91 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 4, n=32, 34, 33, 37, 29, 30 | -3.1 International Units (IU)/L | Standard Deviation 11.61 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 8, n=30, 31, 32, 37, 27, 26 | -4.2 International Units (IU)/L | Standard Deviation 11.5 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 12, n=27, 30, 32, 36, 26, 24 | -4.1 International Units (IU)/L | Standard Deviation 9.9 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 8, n=30, 31, 32, 37, 27, 26 | -3.2 International Units (IU)/L | Standard Deviation 20.11 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 12, n=27, 30, 32, 36, 26, 24 | -5.9 International Units (IU)/L | Standard Deviation 12.56 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 14, n=29, 31, 33, 34, 27, 24 | -5.9 International Units (IU)/L | Standard Deviation 17.67 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 14, n=29, 31, 33, 34, 27, 24 | -5.1 International Units (IU)/L | Standard Deviation 11.36 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, EW, n=10, 6, 3, 2, 10, 9 | -2.5 International Units (IU)/L | Standard Deviation 7.78 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 2, n=35, 36, 35, 37, 29, 34 | -2.7 International Units (IU)/L | Standard Deviation 13.45 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 14, n=29, 31, 33, 34, 27, 24 | -2.4 International Units (IU)/L | Standard Deviation 16.98 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, EW, n=10, 6, 3, 2, 10, 9 | -3.7 International Units (IU)/L | Standard Deviation 7.73 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 14, n=29, 31, 33, 34, 27, 24 | -0.5 International Units (IU)/L | Standard Deviation 38.93 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 8, n=30, 31, 32, 37, 27, 26 | -3.1 International Units (IU)/L | Standard Deviation 23.93 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 8, n=30, 31, 32, 37, 27, 26 | -0.3 International Units (IU)/L | Standard Deviation 10.52 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 12, n=27, 30, 32, 36, 26, 24 | -1.7 International Units (IU)/L | Standard Deviation 15.72 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 4, n=32, 34, 33, 37, 29, 30 | -1.9 International Units (IU)/L | Standard Deviation 9.05 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 8, n=30, 31, 32, 37, 27, 26 | 0.0 International Units (IU)/L | Standard Deviation 12.56 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 2, n=35, 36, 35, 37, 29, 34 | 0.7 International Units (IU)/L | Standard Deviation 18.06 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 12, n=27, 30, 32, 36, 26, 24 | -3.7 International Units (IU)/L | Standard Deviation 30.64 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 4, n=32, 34, 33, 37, 29, 30 | -2.4 International Units (IU)/L | Standard Deviation 11.83 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, EW, n=10, 6, 3, 2, 10, 9 | -3.4 International Units (IU)/L | Standard Deviation 10.51 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 12, n=27, 30, 32, 36, 26, 24 | -2.6 International Units (IU)/L | Standard Deviation 14.93 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 14, n=29, 31, 33, 34, 27, 24 | -1.3 International Units (IU)/L | Standard Deviation 13.4 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, EW, n=10, 6, 3, 2, 10, 9 | -2.6 International Units (IU)/L | Standard Deviation 4.65 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 14, n=29, 31, 33, 34, 27, 24 | -1.4 International Units (IU)/L | Standard Deviation 19.63 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 12, n=27, 30, 32, 36, 26, 24 | -1.6 International Units (IU)/L | Standard Deviation 12.75 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 4, n=32, 34, 33, 37, 29, 30 | -0.0 International Units (IU)/L | Standard Deviation 14.42 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 8, n=30, 31, 32, 37, 27, 26 | 0.3 International Units (IU)/L | Standard Deviation 14.28 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 4, n=32, 34, 33, 37, 29, 30 | -2.5 International Units (IU)/L | Standard Deviation 18.08 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 2, n=35, 36, 35, 37, 29, 34 | -2.3 International Units (IU)/L | Standard Deviation 10.76 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, EW, n=10, 6, 3, 2, 10, 9 | -8.2 International Units (IU)/L | Standard Deviation 12.16 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 2, n=35, 36, 35, 37, 29, 34 | -3.1 International Units (IU)/L | Standard Deviation 15.17 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, EW, n=10, 6, 3, 2, 10, 9 | -1.3 International Units (IU)/L | Standard Deviation 5.52 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 4, n=32, 34, 33, 37, 29, 30 | 2.3 International Units (IU)/L | Standard Deviation 9.1 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, EW, n=10, 6, 3, 2, 10, 9 | -10.1 International Units (IU)/L | Standard Deviation 25.73 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 2, n=35, 36, 35, 37, 29, 34 | -1.0 International Units (IU)/L | Standard Deviation 5.7 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 2, n=35, 36, 35, 37, 29, 34 | -4.5 International Units (IU)/L | Standard Deviation 9.92 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, EW, n=10, 6, 3, 2, 10, 9 | -0.3 International Units (IU)/L | Standard Deviation 7.48 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 2, n=35, 36, 35, 37, 29, 34 | -1.3 International Units (IU)/L | Standard Deviation 4.54 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 4, n=32, 34, 33, 37, 29, 30 | 0.5 International Units (IU)/L | Standard Deviation 6.66 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 4, n=32, 34, 33, 37, 29, 30 | -2.1 International Units (IU)/L | Standard Deviation 11.77 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 14, n=29, 31, 33, 34, 27, 24 | -1.3 International Units (IU)/L | Standard Deviation 11.15 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 8, n=30, 31, 32, 37, 27, 26 | -1.7 International Units (IU)/L | Standard Deviation 8.47 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, EW, n=10, 6, 3, 2, 10, 9 | -1.8 International Units (IU)/L | Standard Deviation 9.13 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 12, n=27, 30, 32, 36, 26, 24 | -0.3 International Units (IU)/L | Standard Deviation 8.45 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 14, n=29, 31, 33, 34, 27, 24 | -2.8 International Units (IU)/L | Standard Deviation 13.62 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 12, n=27, 30, 32, 36, 26, 24 | 1.2 International Units (IU)/L | Standard Deviation 13.29 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 2, n=35, 36, 35, 37, 29, 34 | -2.1 International Units (IU)/L | Standard Deviation 7.02 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 8, n=30, 31, 32, 37, 27, 26 | -0.4 International Units (IU)/L | Standard Deviation 13.61 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 8, n=30, 31, 32, 37, 27, 26 | 2.3 International Units (IU)/L | Standard Deviation 11.25 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | GGT, Week 12, n=27, 30, 32, 36, 26, 24 | 3.3 International Units (IU)/L | Standard Deviation 23.1 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 12, n=27, 30, 32, 36, 26, 24 | 1.5 International Units (IU)/L | Standard Deviation 20.39 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 8, n=30, 31, 32, 37, 27, 26 | -0.4 International Units (IU)/L | Standard Deviation 10.21 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | Alk. Phos, Week 4, n=32, 34, 33, 37, 29, 30 | -2.9 International Units (IU)/L | Standard Deviation 8.69 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | ALT, Week 14, n=29, 31, 33, 34, 27, 24 | -1.7 International Units (IU)/L | Standard Deviation 9.27 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk Phos), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma Glutamyl Transferase (GGT) Levels. | AST, Week 14, n=29, 31, 33, 34, 27, 24 | -1.0 International Units (IU)/L | Standard Deviation 6.92 |
Secondary
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count
Blood samples were collected for the evaluation of change in levels of basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocyte count from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Baseline and up to Week 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 2, n=35, 35, 36, 37, 29, 35 | 0.355 Giga unit/liter (GI/L) | Standard Deviation 1.7248 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 4, n=31, 34, 35, 37, 29, 31 | -0.083 Giga unit/liter (GI/L) | Standard Deviation 0.6201 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 4, n=31, 34, 35, 37, 29, 31 | 0.019 Giga unit/liter (GI/L) | Standard Deviation 0.138 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 2, n=35, 35, 36, 37, 29, 35 | 0.100 Giga unit/liter (GI/L) | Standard Deviation 0.469 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, EW, n=10, 6, 3, 2, 10, 9 | 0.029 Giga unit/liter (GI/L) | Standard Deviation 0.0841 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 8, n=30, 30, 32, 37, 27, 26 | 0.012 Giga unit/liter (GI/L) | Standard Deviation 0.1134 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 8, n=30, 30, 32, 37, 27, 26 | 0.49 Giga unit/liter (GI/L) | Standard Deviation 1.272 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 14, n=29, 30, 33, 34, 27, 23 | 0.033 Giga unit/liter (GI/L) | Standard Deviation 0.1084 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 12, n=27, 30, 31, 36, 26, 25 | 0.047 Giga unit/liter (GI/L) | Standard Deviation 0.2302 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 2, n=35, 35, 36, 37, 29, 35 | 0.004 Giga unit/liter (GI/L) | Standard Deviation 0.0213 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, EW, n=10, 6, 3, 2, 10, 9 | 0.21 Giga unit/liter (GI/L) | Standard Deviation 1.066 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 4, n=31, 34, 35, 37, 29, 31 | 0.13 Giga unit/liter (GI/L) | Standard Deviation 1.972 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 2, n=35, 35, 36, 37, 29, 35 | 0.50 Giga unit/liter (GI/L) | Standard Deviation 1.834 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 4, n=31, 34, 35, 37, 29, 31 | 0.003 Giga unit/liter (GI/L) | Standard Deviation 0.0176 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, EW, n=10, 5, 3, 2, 9, 9 | -2.1 Giga unit/liter (GI/L) | Standard Deviation 27.63 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 8, n=30, 30, 32, 37, 27, 26 | -0.001 Giga unit/liter (GI/L) | Standard Deviation 0.0167 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 14, n=29, 30, 33, 34, 27, 23 | 0.031 Giga unit/liter (GI/L) | Standard Deviation 0.1418 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 14, n=29, 30, 33, 34, 27, 23 | -2.9 Giga unit/liter (GI/L) | Standard Deviation 18.68 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 12, n=27, 30, 31, 36, 26, 25 | -10.3 Giga unit/liter (GI/L) | Standard Deviation 35.25 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 12, n=27, 30, 31, 36, 26, 25 | -0.003 Giga unit/liter (GI/L) | Standard Deviation 0.0151 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 8, n=30, 31, 32, 38, 27, 26 | -6.8 Giga unit/liter (GI/L) | Standard Deviation 34.57 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 14, n=29, 30, 33, 34, 27, 23 | -0.003 Giga unit/liter (GI/L) | Standard Deviation 0.0176 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 4, n=32, 34, 35, 37, 29, 31 | -12.3 Giga unit/liter (GI/L) | Standard Deviation 39.49 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 2, n=35, 35, 36, 37, 29, 35 | -0.3 Giga unit/liter (GI/L) | Standard Deviation 36.3 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, EW, n=10, 6, 3, 2, 10, 9 | -0.001 Giga unit/liter (GI/L) | Standard Deviation 0.0179 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 14, n=29, 30, 33, 34, 27, 23 | 0.47 Giga unit/liter (GI/L) | Standard Deviation 1.472 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, EW, n=10, 6, 3, 2, 10, 9 | 0.307 Giga unit/liter (GI/L) | Standard Deviation 1.1539 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 8, n=30, 30, 32, 37, 27, 26 | 0.034 Giga unit/liter (GI/L) | Standard Deviation 0.1468 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 4, n=31, 34, 35, 37, 29, 31 | 0.215 Giga unit/liter (GI/L) | Standard Deviation 1.5812 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 4, n=31, 34, 35, 37, 29, 31 | -0.017 Giga unit/liter (GI/L) | Standard Deviation 0.1241 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 12, n=27, 30, 31, 36, 26, 25 | -0.002 Giga unit/liter (GI/L) | Standard Deviation 0.1173 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 2, n=35, 35, 36, 37, 29, 35 | 0.029 Giga unit/liter (GI/L) | Standard Deviation 0.1833 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 8, n=30, 30, 32, 37, 27, 26 | 0.402 Giga unit/liter (GI/L) | Standard Deviation 1.1117 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 12, n=27, 30, 31, 36, 26, 25 | 0.36 Giga unit/liter (GI/L) | Standard Deviation 1.439 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, EW, n=10, 6, 3, 2, 10, 9 | -0.164 Giga unit/liter (GI/L) | Standard Deviation 0.6069 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 12, n=27, 30, 31, 36, 26, 25 | 0.277 Giga unit/liter (GI/L) | Standard Deviation 1.0785 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, EW, n=10, 6, 3, 2, 10, 9 | 0.046 Giga unit/liter (GI/L) | Standard Deviation 0.1959 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 14, n=29, 30, 33, 34, 27, 23 | 0.261 Giga unit/liter (GI/L) | Standard Deviation 0.9065 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 12, n=27, 30, 31, 36, 26, 25 | 0.050 Giga unit/liter (GI/L) | Standard Deviation 0.6354 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 14, n=29, 30, 33, 34, 27, 23 | 0.158 Giga unit/liter (GI/L) | Standard Deviation 1.0726 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 8, n=30, 30, 32, 37, 27, 26 | 0.048 Giga unit/liter (GI/L) | Standard Deviation 0.5656 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 2, n=35, 35, 36, 37, 29, 35 | 0.021 Giga unit/liter (GI/L) | Standard Deviation 0.1157 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 12, n=27, 30, 31, 36, 26, 25 | 0.099 Giga unit/liter (GI/L) | Standard Deviation 1.3124 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 4, n=31, 34, 35, 37, 29, 31 | -0.044 Giga unit/liter (GI/L) | Standard Deviation 0.4101 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 4, n=32, 34, 35, 37, 29, 31 | -4.1 Giga unit/liter (GI/L) | Standard Deviation 26.64 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 2, n=35, 35, 36, 37, 29, 35 | -0.002 Giga unit/liter (GI/L) | Standard Deviation 0.3827 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 2, n=35, 35, 36, 37, 29, 35 | -0.061 Giga unit/liter (GI/L) | Standard Deviation 0.1055 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 4, n=31, 34, 35, 37, 29, 31 | 0.034 Giga unit/liter (GI/L) | Standard Deviation 0.1371 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 8, n=30, 30, 32, 37, 27, 26 | 0.08 Giga unit/liter (GI/L) | Standard Deviation 1.167 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 14, n=29, 30, 33, 34, 27, 23 | -0.003 Giga unit/liter (GI/L) | Standard Deviation 0.0184 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, EW, n=10, 6, 3, 2, 10, 9 | 0.090 Giga unit/liter (GI/L) | Standard Deviation 0.1563 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 12, n=27, 30, 31, 36, 26, 25 | -0.050 Giga unit/liter (GI/L) | Standard Deviation 0.1036 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 14, n=29, 30, 33, 34, 27, 23 | 0.519 Giga unit/liter (GI/L) | Standard Deviation 1.4793 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 8, n=30, 30, 32, 37, 27, 26 | 0.024 Giga unit/liter (GI/L) | Standard Deviation 0.1015 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 2, n=35, 35, 36, 37, 29, 35 | 5.4 Giga unit/liter (GI/L) | Standard Deviation 40.5 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 14, n=29, 30, 33, 34, 27, 23 | 0.004 Giga unit/liter (GI/L) | Standard Deviation 0.0979 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, EW, n=10, 6, 3, 2, 10, 9 | -0.078 Giga unit/liter (GI/L) | Standard Deviation 0.3542 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 12, n=27, 30, 31, 36, 26, 25 | 0.000 Giga unit/liter (GI/L) | Standard Deviation 0.1002 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, EW, n=10, 6, 3, 2, 10, 9 | -0.015 Giga unit/liter (GI/L) | Standard Deviation 0.1299 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, EW, n=10, 6, 3, 2, 10, 9 | -0.017 Giga unit/liter (GI/L) | Standard Deviation 0.0294 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 2, n=35, 35, 36, 37, 29, 35 | -0.005 Giga unit/liter (GI/L) | Standard Deviation 0.0167 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 4, n=31, 34, 35, 37, 29, 31 | 0.12 Giga unit/liter (GI/L) | Standard Deviation 1.748 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, EW, n=10, 6, 3, 2, 10, 9 | -0.35 Giga unit/liter (GI/L) | Standard Deviation 1.395 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 2, n=35, 35, 36, 37, 29, 35 | 0.310 Giga unit/liter (GI/L) | Standard Deviation 1.3852 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 8, n=30, 30, 32, 37, 27, 26 | 0.140 Giga unit/liter (GI/L) | Standard Deviation 1.1014 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, EW, n=10, 6, 3, 2, 10, 9 | -0.305 Giga unit/liter (GI/L) | Standard Deviation 1.353 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 2, n=35, 35, 36, 37, 29, 35 | 0.28 Giga unit/liter (GI/L) | Standard Deviation 1.381 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 12, n=27, 30, 31, 36, 26, 25 | 0.052 Giga unit/liter (GI/L) | Standard Deviation 0.4589 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 12, n=27, 30, 31, 36, 26, 25 | 0.12 Giga unit/liter (GI/L) | Standard Deviation 1.359 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 4, n=31, 34, 35, 37, 29, 31 | -0.002 Giga unit/liter (GI/L) | Standard Deviation 0.0285 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 14, n=29, 30, 33, 34, 27, 23 | 0.54 Giga unit/liter (GI/L) | Standard Deviation 1.757 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, EW, n=10, 5, 3, 2, 9, 9 | -7.6 Giga unit/liter (GI/L) | Standard Deviation 13.89 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 8, n=30, 30, 32, 37, 27, 26 | -0.071 Giga unit/liter (GI/L) | Standard Deviation 0.1258 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 14, n=29, 30, 33, 34, 27, 23 | -9.6 Giga unit/liter (GI/L) | Standard Deviation 29.12 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 8, n=30, 30, 32, 37, 27, 26 | -0.009 Giga unit/liter (GI/L) | Standard Deviation 0.3778 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 8, n=30, 30, 32, 37, 27, 26 | -0.001 Giga unit/liter (GI/L) | Standard Deviation 0.0181 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 4, n=31, 34, 35, 37, 29, 31 | -0.014 Giga unit/liter (GI/L) | Standard Deviation 0.1706 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 14, n=29, 30, 33, 34, 27, 23 | 0.021 Giga unit/liter (GI/L) | Standard Deviation 0.6397 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 12, n=27, 30, 31, 36, 26, 25 | -7.9 Giga unit/liter (GI/L) | Standard Deviation 24.25 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 2, n=35, 35, 36, 37, 29, 35 | 0.043 Giga unit/liter (GI/L) | Standard Deviation 0.1356 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 4, n=31, 34, 35, 37, 29, 31 | 0.139 Giga unit/liter (GI/L) | Standard Deviation 1.6995 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 12, n=27, 30, 31, 36, 26, 25 | 0.004 Giga unit/liter (GI/L) | Standard Deviation 0.0233 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 14, n=29, 30, 33, 34, 27, 23 | -0.009 Giga unit/liter (GI/L) | Standard Deviation 0.1341 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 8, n=30, 31, 32, 38, 27, 26 | -1.0 Giga unit/liter (GI/L) | Standard Deviation 23.87 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 4, n=31, 34, 35, 37, 29, 31 | 0.291 Giga unit/liter (GI/L) | Standard Deviation 1.2083 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 12, n=27, 30, 31, 36, 26, 25 | -0.055 Giga unit/liter (GI/L) | Standard Deviation 0.1399 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 14, n=29, 30, 33, 34, 27, 23 | -0.057 Giga unit/liter (GI/L) | Standard Deviation 0.1378 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, EW, n=10, 6, 3, 2, 10, 9 | -0.243 Giga unit/liter (GI/L) | Standard Deviation 0.2593 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 2, n=35, 35, 36, 37, 29, 35 | -0.005 Giga unit/liter (GI/L) | Standard Deviation 0.0178 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 4, n=31, 34, 35, 37, 29, 31 | -0.002 Giga unit/liter (GI/L) | Standard Deviation 0.0166 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 8, n=30, 30, 32, 37, 27, 26 | -0.004 Giga unit/liter (GI/L) | Standard Deviation 0.015 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 12, n=27, 30, 31, 36, 26, 25 | -0.007 Giga unit/liter (GI/L) | Standard Deviation 0.017 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 14, n=29, 30, 33, 34, 27, 23 | -0.003 Giga unit/liter (GI/L) | Standard Deviation 0.0188 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, EW, n=10, 6, 3, 2, 10, 9 | -0.010 Giga unit/liter (GI/L) | Standard Deviation 0.01 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 2, n=35, 35, 36, 37, 29, 35 | 0.341 Giga unit/liter (GI/L) | Standard Deviation 1.3914 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 8, n=30, 30, 32, 37, 27, 26 | -0.049 Giga unit/liter (GI/L) | Standard Deviation 1.4021 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 12, n=27, 30, 31, 36, 26, 25 | -0.015 Giga unit/liter (GI/L) | Standard Deviation 1.4752 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 14, n=29, 30, 33, 34, 27, 23 | -0.053 Giga unit/liter (GI/L) | Standard Deviation 1.0828 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 2, n=35, 35, 36, 37, 29, 35 | -0.017 Giga unit/liter (GI/L) | Standard Deviation 0.1857 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 4, n=31, 34, 35, 37, 29, 31 | -0.005 Giga unit/liter (GI/L) | Standard Deviation 0.1554 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 8, n=30, 30, 32, 37, 27, 26 | -0.008 Giga unit/liter (GI/L) | Standard Deviation 0.1495 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 12, n=27, 30, 31, 36, 26, 25 | -0.032 Giga unit/liter (GI/L) | Standard Deviation 0.1714 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 14, n=29, 30, 33, 34, 27, 23 | -0.011 Giga unit/liter (GI/L) | Standard Deviation 0.2186 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, EW, n=10, 6, 3, 2, 10, 9 | -0.233 Giga unit/liter (GI/L) | Standard Deviation 0.3955 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 2, n=35, 35, 36, 37, 29, 35 | 0.097 Giga unit/liter (GI/L) | Standard Deviation 0.3995 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 4, n=31, 34, 35, 37, 29, 31 | 0.041 Giga unit/liter (GI/L) | Standard Deviation 0.3875 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 8, n=30, 30, 32, 37, 27, 26 | -0.048 Giga unit/liter (GI/L) | Standard Deviation 0.4379 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 12, n=27, 30, 31, 36, 26, 25 | 0.120 Giga unit/liter (GI/L) | Standard Deviation 0.58 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 14, n=29, 30, 33, 34, 27, 23 | 0.075 Giga unit/liter (GI/L) | Standard Deviation 0.5712 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, EW, n=10, 6, 3, 2, 10, 9 | -0.113 Giga unit/liter (GI/L) | Standard Deviation 0.3502 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 2, n=35, 35, 36, 37, 29, 35 | 0.012 Giga unit/liter (GI/L) | Standard Deviation 0.1314 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 4, n=31, 34, 35, 37, 29, 31 | -0.014 Giga unit/liter (GI/L) | Standard Deviation 0.1226 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 8, n=30, 30, 32, 37, 27, 26 | -0.036 Giga unit/liter (GI/L) | Standard Deviation 0.1252 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, EW, n=10, 6, 3, 2, 10, 9 | 2.727 Giga unit/liter (GI/L) | Standard Deviation 3.3561 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 2, n=35, 35, 36, 37, 29, 35 | 2.3 Giga unit/liter (GI/L) | Standard Deviation 26.06 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 4, n=32, 34, 35, 37, 29, 31 | 1.9 Giga unit/liter (GI/L) | Standard Deviation 26.97 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 8, n=30, 31, 32, 38, 27, 26 | -1.8 Giga unit/liter (GI/L) | Standard Deviation 25.81 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 12, n=27, 30, 31, 36, 26, 25 | -4.9 Giga unit/liter (GI/L) | Standard Deviation 26.54 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 14, n=29, 30, 33, 34, 27, 23 | -2.9 Giga unit/liter (GI/L) | Standard Deviation 20.21 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, EW, n=10, 5, 3, 2, 9, 9 | 37.0 Giga unit/liter (GI/L) | Standard Deviation 37.8 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 2, n=35, 35, 36, 37, 29, 35 | 0.42 Giga unit/liter (GI/L) | Standard Deviation 1.686 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 4, n=31, 34, 35, 37, 29, 31 | 0.31 Giga unit/liter (GI/L) | Standard Deviation 1.374 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 8, n=30, 30, 32, 37, 27, 26 | -0.14 Giga unit/liter (GI/L) | Standard Deviation 1.516 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 12, n=27, 30, 31, 36, 26, 25 | 0.02 Giga unit/liter (GI/L) | Standard Deviation 1.46 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 14, n=29, 30, 33, 34, 27, 23 | -0.05 Giga unit/liter (GI/L) | Standard Deviation 1.256 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, EW, n=10, 6, 3, 2, 10, 9 | 2.13 Giga unit/liter (GI/L) | Standard Deviation 2.94 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 8, n=30, 30, 32, 37, 27, 26 | -0.02 Giga unit/liter (GI/L) | Standard Deviation 1.604 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 4, n=31, 34, 35, 37, 29, 31 | 0.228 Giga unit/liter (GI/L) | Standard Deviation 0.5664 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 14, n=29, 30, 33, 34, 27, 23 | -0.225 Giga unit/liter (GI/L) | Standard Deviation 1.5059 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 8, n=30, 30, 32, 37, 27, 26 | 0.075 Giga unit/liter (GI/L) | Standard Deviation 0.5255 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 12, n=27, 30, 31, 36, 26, 25 | 0.148 Giga unit/liter (GI/L) | Standard Deviation 0.4774 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 12, n=27, 30, 31, 36, 26, 25 | -0.008 Giga unit/liter (GI/L) | Standard Deviation 1.4329 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 14, n=29, 30, 33, 34, 27, 23 | 0.174 Giga unit/liter (GI/L) | Standard Deviation 0.7327 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 8, n=30, 30, 32, 37, 27, 26 | -0.075 Giga unit/liter (GI/L) | Standard Deviation 1.4243 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, EW, n=10, 6, 3, 2, 10, 9 | -0.185 Giga unit/liter (GI/L) | Standard Deviation 0.1061 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 4, n=31, 34, 35, 37, 29, 31 | 0.267 Giga unit/liter (GI/L) | Standard Deviation 1.331 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, EW, n=10, 6, 3, 2, 10, 9 | -0.85 Giga unit/liter (GI/L) | Standard Deviation 0.354 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 2, n=35, 35, 36, 37, 29, 35 | -0.035 Giga unit/liter (GI/L) | Standard Deviation 0.1117 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 12, n=27, 30, 31, 36, 26, 25 | 0.10 Giga unit/liter (GI/L) | Standard Deviation 1.538 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 4, n=31, 34, 35, 37, 29, 31 | -0.049 Giga unit/liter (GI/L) | Standard Deviation 0.1119 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 2, n=35, 35, 36, 37, 29, 35 | 0.009 Giga unit/liter (GI/L) | Standard Deviation 1.3107 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 8, n=30, 30, 32, 37, 27, 26 | -0.043 Giga unit/liter (GI/L) | Standard Deviation 0.1579 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, EW, n=10, 6, 3, 2, 10, 9 | 0.000 Giga unit/liter (GI/L) | Standard Deviation 0 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, EW, n=10, 6, 3, 2, 10, 9 | -0.735 Giga unit/liter (GI/L) | Standard Deviation 0.2899 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 14, n=29, 30, 33, 34, 27, 23 | -0.054 Giga unit/liter (GI/L) | Standard Deviation 0.1609 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 2, n=35, 35, 36, 37, 29, 35 | -5.6 Giga unit/liter (GI/L) | Standard Deviation 47.57 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 14, n=29, 30, 33, 34, 27, 23 | 0.002 Giga unit/liter (GI/L) | Standard Deviation 0.025 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 4, n=32, 34, 35, 37, 29, 31 | -1.0 Giga unit/liter (GI/L) | Standard Deviation 38.16 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 12, n=27, 30, 31, 36, 26, 25 | 0.000 Giga unit/liter (GI/L) | Standard Deviation 0.0161 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 8, n=30, 31, 32, 38, 27, 26 | -11.5 Giga unit/liter (GI/L) | Standard Deviation 50.01 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 14, n=29, 30, 33, 34, 27, 23 | -0.11 Giga unit/liter (GI/L) | Standard Deviation 1.38 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 12, n=27, 30, 31, 36, 26, 25 | -15.7 Giga unit/liter (GI/L) | Standard Deviation 38.39 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 8, n=30, 30, 32, 37, 27, 26 | -0.002 Giga unit/liter (GI/L) | Standard Deviation 0.0195 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 14, n=29, 30, 33, 34, 27, 23 | -18.5 Giga unit/liter (GI/L) | Standard Deviation 41.03 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 4, n=31, 34, 35, 37, 29, 31 | -0.003 Giga unit/liter (GI/L) | Standard Deviation 0.0184 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, EW, n=10, 5, 3, 2, 9, 9 | -30.5 Giga unit/liter (GI/L) | Standard Deviation 48.79 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 2, n=35, 35, 36, 37, 29, 35 | 0.12 Giga unit/liter (GI/L) | Standard Deviation 1.391 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 2, n=35, 35, 36, 37, 29, 35 | 0.006 Giga unit/liter (GI/L) | Standard Deviation 0.0243 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 12, n=27, 30, 31, 36, 26, 25 | -0.043 Giga unit/liter (GI/L) | Standard Deviation 0.1578 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 4, n=31, 34, 35, 37, 29, 31 | 0.44 Giga unit/liter (GI/L) | Standard Deviation 1.398 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 12, n=27, 30, 31, 36, 26, 25 | 0.026 Giga unit/liter (GI/L) | Standard Deviation 0.0934 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 8, n=30, 30, 32, 37, 27, 26 | 0.037 Giga unit/liter (GI/L) | Standard Deviation 0.1001 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 14, n=29, 30, 33, 34, 27, 23 | 0.002 Giga unit/liter (GI/L) | Standard Deviation 0.1053 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, EW, n=10, 6, 3, 2, 10, 9 | -0.045 Giga unit/liter (GI/L) | Standard Deviation 0.1061 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, EW, n=10, 6, 3, 2, 10, 9 | 0.095 Giga unit/liter (GI/L) | Standard Deviation 0.0071 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 4, n=31, 34, 35, 37, 29, 31 | 0.005 Giga unit/liter (GI/L) | Standard Deviation 0.0954 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 2, n=35, 35, 36, 37, 29, 35 | 0.145 Giga unit/liter (GI/L) | Standard Deviation 0.3966 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 2, n=35, 35, 36, 37, 29, 35 | 0.011 Giga unit/liter (GI/L) | Standard Deviation 0.0972 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 12, n=27, 30, 31, 36, 26, 25 | -0.07 Giga unit/liter (GI/L) | Standard Deviation 1.301 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 8, n=30, 30, 32, 37, 27, 26 | -0.048 Giga unit/liter (GI/L) | Standard Deviation 0.1692 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 14, n=29, 30, 33, 34, 27, 23 | 0.267 Giga unit/liter (GI/L) | Standard Deviation 2.2299 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, EW, n=10, 6, 3, 2, 10, 9 | -0.005 Giga unit/liter (GI/L) | Standard Deviation 0.0151 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 4, n=31, 34, 35, 37, 29, 31 | -0.14 Giga unit/liter (GI/L) | Standard Deviation 1.798 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, EW, n=10, 6, 3, 2, 10, 9 | -0.285 Giga unit/liter (GI/L) | Standard Deviation 1.2029 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 14, n=29, 30, 33, 34, 27, 23 | -0.001 Giga unit/liter (GI/L) | Standard Deviation 0.0188 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 2, n=35, 35, 36, 37, 29, 35 | 0.5 Giga unit/liter (GI/L) | Standard Deviation 29.07 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 12, n=27, 30, 31, 36, 26, 25 | 0.001 Giga unit/liter (GI/L) | Standard Deviation 0.1375 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 4, n=32, 34, 35, 37, 29, 31 | 2.6 Giga unit/liter (GI/L) | Standard Deviation 26 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 12, n=27, 30, 31, 36, 26, 25 | 0.006 Giga unit/liter (GI/L) | Standard Deviation 0.025 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 8, n=30, 30, 32, 37, 27, 26 | -0.008 Giga unit/liter (GI/L) | Standard Deviation 0.1142 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, EW, n=10, 6, 3, 2, 10, 9 | -0.21 Giga unit/liter (GI/L) | Standard Deviation 1.26 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 8, n=30, 31, 32, 38, 27, 26 | 0.2 Giga unit/liter (GI/L) | Standard Deviation 28.94 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 8, n=30, 30, 32, 37, 27, 26 | 0.002 Giga unit/liter (GI/L) | Standard Deviation 0.0233 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, EW, n=10, 6, 3, 2, 10, 9 | 0.006 Giga unit/liter (GI/L) | Standard Deviation 0.1179 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 12, n=27, 30, 31, 36, 26, 25 | -5.5 Giga unit/liter (GI/L) | Standard Deviation 38.31 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 14, n=29, 30, 33, 34, 27, 23 | 0.004 Giga unit/liter (GI/L) | Standard Deviation 0.1469 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 14, n=29, 30, 33, 34, 27, 23 | 0.22 Giga unit/liter (GI/L) | Standard Deviation 2.172 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 14, n=29, 30, 33, 34, 27, 23 | -1.7 Giga unit/liter (GI/L) | Standard Deviation 37.21 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 4, n=31, 34, 35, 37, 29, 31 | 0.002 Giga unit/liter (GI/L) | Standard Deviation 0.0175 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 4, n=31, 34, 35, 37, 29, 31 | -0.142 Giga unit/liter (GI/L) | Standard Deviation 0.4421 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 8, n=30, 30, 32, 37, 27, 26 | -0.35 Giga unit/liter (GI/L) | Standard Deviation 1.392 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 4, n=31, 34, 35, 37, 29, 31 | -0.019 Giga unit/liter (GI/L) | Standard Deviation 0.1205 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 8, n=30, 30, 32, 37, 27, 26 | -0.110 Giga unit/liter (GI/L) | Standard Deviation 0.6406 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 12, n=27, 30, 31, 36, 26, 25 | 0.043 Giga unit/liter (GI/L) | Standard Deviation 1.347 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, EW, n=10, 5, 3, 2, 9, 9 | 1.6 Giga unit/liter (GI/L) | Standard Deviation 22.36 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 12, n=27, 30, 31, 36, 26, 25 | -0.110 Giga unit/liter (GI/L) | Standard Deviation 0.6003 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 8, n=30, 30, 32, 37, 27, 26 | -0.181 Giga unit/liter (GI/L) | Standard Deviation 1.4359 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 14, n=29, 30, 33, 34, 27, 23 | -0.031 Giga unit/liter (GI/L) | Standard Deviation 0.6712 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 2, n=35, 35, 36, 37, 29, 35 | 0.003 Giga unit/liter (GI/L) | Standard Deviation 0.0248 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 14, n=29, 30, 33, 34, 27, 23 | -0.025 Giga unit/liter (GI/L) | Standard Deviation 0.213 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 12, n=27, 30, 31, 36, 26, 25 | -0.015 Giga unit/liter (GI/L) | Standard Deviation 0.1964 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, EW, n=10, 6, 3, 2, 10, 9 | 0.032 Giga unit/liter (GI/L) | Standard Deviation 0.2862 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 4, n=31, 34, 35, 37, 29, 31 | 0.049 Giga unit/liter (GI/L) | Standard Deviation 1.7831 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 2, n=35, 35, 36, 37, 29, 35 | -0.021 Giga unit/liter (GI/L) | Standard Deviation 0.1363 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 2, n=35, 35, 36, 37, 29, 35 | -0.21 Giga unit/liter (GI/L) | Standard Deviation 1.892 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 2, n=35, 35, 36, 37, 29, 35 | -0.007 Giga unit/liter (GI/L) | Standard Deviation 0.1583 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 2, n=35, 35, 36, 37, 29, 35 | -0.138 Giga unit/liter (GI/L) | Standard Deviation 0.4764 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 4, n=31, 34, 35, 37, 29, 31 | -0.032 Giga unit/liter (GI/L) | Standard Deviation 0.1972 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 2, n=35, 35, 36, 37, 29, 35 | -0.058 Giga unit/liter (GI/L) | Standard Deviation 1.8094 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, EW, n=10, 6, 3, 2, 10, 9 | 0.053 Giga unit/liter (GI/L) | Standard Deviation 0.2675 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 2, n=35, 35, 36, 37, 29, 35 | 0.107 Giga unit/liter (GI/L) | Standard Deviation 1.1007 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, EW, n=10, 6, 3, 2, 10, 9 | -0.047 Giga unit/liter (GI/L) | Standard Deviation 0.1775 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 4, n=31, 34, 35, 37, 29, 31 | -0.005 Giga unit/liter (GI/L) | Standard Deviation 0.1522 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 8, n=30, 30, 32, 37, 27, 26 | -0.025 Giga unit/liter (GI/L) | Standard Deviation 0.177 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 14, n=29, 30, 33, 34, 27, 23 | 0.109 Giga unit/liter (GI/L) | Standard Deviation 0.4985 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 14, n=29, 30, 33, 34, 27, 23 | -0.052 Giga unit/liter (GI/L) | Standard Deviation 0.864 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 4, n=31, 34, 35, 37, 29, 31 | -0.077 Giga unit/liter (GI/L) | Standard Deviation 0.4524 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, EW, n=10, 6, 3, 2, 10, 9 | 0.012 Giga unit/liter (GI/L) | Standard Deviation 0.0217 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 12, n=27, 30, 31, 36, 26, 25 | -0.19 Giga unit/liter (GI/L) | Standard Deviation 1.221 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 8, n=30, 30, 32, 37, 27, 26 | -0.048 Giga unit/liter (GI/L) | Standard Deviation 0.1258 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 14, n=29, 30, 33, 34, 27, 23 | -0.00 Giga unit/liter (GI/L) | Standard Deviation 1.207 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, EW, n=10, 6, 3, 2, 10, 9 | -0.019 Giga unit/liter (GI/L) | Standard Deviation 0.9601 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 14, n=29, 30, 33, 34, 27, 23 | -0.001 Giga unit/liter (GI/L) | Standard Deviation 0.0216 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 4, n=31, 34, 35, 37, 29, 31 | -0.011 Giga unit/liter (GI/L) | Standard Deviation 0.1464 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 4, n=31, 34, 35, 37, 29, 31 | -0.03 Giga unit/liter (GI/L) | Standard Deviation 1.059 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 2, n=35, 35, 36, 37, 29, 35 | -0.018 Giga unit/liter (GI/L) | Standard Deviation 0.4774 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 4, n=31, 34, 35, 37, 29, 31 | 0.059 Giga unit/liter (GI/L) | Standard Deviation 1.0011 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 2, n=35, 35, 36, 37, 29, 35 | -6.1 Giga unit/liter (GI/L) | Standard Deviation 23.7 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 2, n=35, 35, 36, 37, 29, 35 | 0.08 Giga unit/liter (GI/L) | Standard Deviation 1.166 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 12, n=27, 30, 31, 36, 26, 25 | -0.003 Giga unit/liter (GI/L) | Standard Deviation 0.0151 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 12, n=27, 30, 31, 36, 26, 25 | -0.026 Giga unit/liter (GI/L) | Standard Deviation 0.1323 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 12, n=27, 30, 31, 36, 26, 25 | -0.027 Giga unit/liter (GI/L) | Standard Deviation 0.1322 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 8, n=30, 30, 32, 37, 27, 26 | 0.032 Giga unit/liter (GI/L) | Standard Deviation 0.4913 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 4, n=32, 34, 35, 37, 29, 31 | -0.7 Giga unit/liter (GI/L) | Standard Deviation 28.81 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 12, n=27, 30, 31, 36, 26, 25 | 0.008 Giga unit/liter (GI/L) | Standard Deviation 1.0432 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, EW, n=10, 6, 3, 2, 10, 9 | -0.084 Giga unit/liter (GI/L) | Standard Deviation 0.2625 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, Week 8, n=30, 30, 32, 37, 27, 26 | 0.23 Giga unit/liter (GI/L) | Standard Deviation 1.527 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 2, n=35, 35, 36, 37, 29, 35 | -0.015 Giga unit/liter (GI/L) | Standard Deviation 0.1295 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 2, n=35, 35, 36, 37, 29, 35 | -0.013 Giga unit/liter (GI/L) | Standard Deviation 0.1083 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 8, n=30, 31, 32, 38, 27, 26 | -1.5 Giga unit/liter (GI/L) | Standard Deviation 23.61 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 8, n=30, 30, 32, 37, 27, 26 | -0.008 Giga unit/liter (GI/L) | Standard Deviation 0.0145 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, EW, n=10, 6, 3, 2, 10, 9 | 0.246 Giga unit/liter (GI/L) | Standard Deviation 0.4375 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Lymphocytes, Week 12, n=27, 30, 31, 36, 26, 25 | -0.145 Giga unit/liter (GI/L) | Standard Deviation 0.4177 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Leukocytes, EW, n=10, 6, 3, 2, 10, 9 | 0.10 Giga unit/liter (GI/L) | Standard Deviation 0.505 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, EW, n=10, 5, 3, 2, 9, 9 | 23.1 Giga unit/liter (GI/L) | Standard Deviation 25.21 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 12, n=27, 30, 31, 36, 26, 25 | -8.9 Giga unit/liter (GI/L) | Standard Deviation 26.72 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Neutrophils, Week 8, n=30, 30, 32, 37, 27, 26 | 0.285 Giga unit/liter (GI/L) | Standard Deviation 1.3332 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 4, n=31, 34, 35, 37, 29, 31 | -0.000 Giga unit/liter (GI/L) | Standard Deviation 0.0143 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Monocytes, Week 14, n=29, 30, 33, 34, 27, 23 | -0.017 Giga unit/liter (GI/L) | Standard Deviation 0.1202 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Eosinophils, Week 14, n=29, 30, 33, 34, 27, 23 | -0.053 Giga unit/liter (GI/L) | Standard Deviation 0.1867 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Basophils, Week 2, n=35, 35, 36, 37, 29, 35 | 0.003 Giga unit/liter (GI/L) | Standard Deviation 0.0172 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelets and Leukocyte Count | Platelets, Week 14, n=29, 30, 33, 34, 27, 23 | 1.2 Giga unit/liter (GI/L) | Standard Deviation 18.69 |
Secondary
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels
Blood samples were collected for the evaluation of change in levels of calcium, chloride, CO2, glucose, potassium, sodium, and urea from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Baseline and up to Week 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 4, n=32, 34, 33, 37, 29, 30 | -0.1 millimoles (mmol)/L | Standard Deviation 1.66 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, EW, n=10, 6, 3, 2, 10, 9 | 0.25 millimoles (mmol)/L | Standard Deviation 1.007 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 4, n=32, 34, 33, 37, 29, 30 | -1.0 millimoles (mmol)/L | Standard Deviation 2.21 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 2, n=35, 36, 35, 37, 29, 34 | -1.6 millimoles (mmol)/L | Standard Deviation 2.13 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, EW, n=10, 6, 3, 2, 10, 9 | -0.8 millimoles (mmol)/L | Standard Deviation 3.19 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 14, n=29, 31, 33, 34, 27, 24 | 0.4 millimoles (mmol)/L | Standard Deviation 2.24 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 8, n=30, 31, 32, 37, 27, 26 | 0.3 millimoles (mmol)/L | Standard Deviation 1.73 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 4, n=32, 34, 33, 37, 29, 30 | -0.23 millimoles (mmol)/L | Standard Deviation 0.907 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 12, n=27, 30, 32, 36, 26, 24 | -0.4 millimoles (mmol)/L | Standard Deviation 2.62 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 2, n=35, 36, 35, 37, 29, 34 | 0.17 millimoles (mmol)/L | Standard Deviation 1.317 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, EW, n=10, 6, 3, 2, 10, 9 | -1.4 millimoles (mmol)/L | Standard Deviation 2.17 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 14, n=29, 31, 33, 34, 27, 24 | -0.3 millimoles (mmol)/L | Standard Deviation 2.17 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 8, n=30, 31, 32, 37, 27, 26 | -0.034 millimoles (mmol)/L | Standard Deviation 0.1205 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 14, n=29, 31, 33, 34, 27, 24 | -0.10 millimoles (mmol)/L | Standard Deviation 1.105 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 12, n=27, 30, 32, 36, 26, 24 | -0.6 millimoles (mmol)/L | Standard Deviation 2.75 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 8, n=30, 31, 32, 37, 27, 26 | -0.3 millimoles (mmol)/L | Standard Deviation 1.86 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 4, n=32, 34, 33, 37, 29, 30 | -0.6 millimoles (mmol)/L | Standard Deviation 1.52 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 2, n=35, 36, 35, 37, 29, 34 | -0.7 millimoles (mmol)/L | Standard Deviation 2.19 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 12, n=27, 30, 32, 36, 26, 24 | -0.019 millimoles (mmol)/L | Standard Deviation 0.091 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 12, n=27, 30, 32, 36, 26, 24 | -0.17 millimoles (mmol)/L | Standard Deviation 0.888 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, EW, n=10, 6, 3, 2, 10, 9 | -0.05 millimoles (mmol)/L | Standard Deviation 0.217 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 14, n=29, 31, 33, 34, 27, 24 | -0.01 millimoles (mmol)/L | Standard Deviation 0.274 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 12, n=27, 30, 32, 36, 26, 24 | -0.07 millimoles (mmol)/L | Standard Deviation 0.321 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 8, n=30, 31, 32, 37, 27, 26 | 0.10 millimoles (mmol)/L | Standard Deviation 0.365 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 14, n=29, 31, 33, 34, 27, 24 | -0.028 millimoles (mmol)/L | Standard Deviation 0.0912 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 8, n=30, 31, 32, 37, 27, 26 | -0.07 millimoles (mmol)/L | Standard Deviation 1.158 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 4, n=32, 34, 33, 37, 29, 30 | 0.07 millimoles (mmol)/L | Standard Deviation 0.382 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 2, n=35, 36, 35, 37, 29, 34 | 0.07 millimoles (mmol)/L | Standard Deviation 0.412 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, EW, n=10, 6, 3, 2, 10, 9 | 0.00 millimoles (mmol)/L | Standard Deviation 1.524 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 14, n=29, 31, 33, 34, 27, 24 | 0.03 millimoles (mmol)/L | Standard Deviation 1.708 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, EW, n=10, 6, 3, 2, 10, 9 | -0.024 millimoles (mmol)/L | Standard Deviation 0.0717 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 2, n=35, 36, 35, 37, 29, 34 | -0.036 millimoles (mmol)/L | Standard Deviation 0.1241 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 12, n=27, 30, 32, 36, 26, 24 | 0.26 millimoles (mmol)/L | Standard Deviation 2.223 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 8, n=30, 31, 32, 37, 27, 26 | 0.32 millimoles (mmol)/L | Standard Deviation 1.571 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 4, n=32, 34, 33, 37, 29, 30 | 0.84 millimoles (mmol)/L | Standard Deviation 1.75 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 2, n=35, 36, 35, 37, 29, 34 | 0.35 millimoles (mmol)/L | Standard Deviation 1.147 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 2, n=35, 36, 35, 37, 29, 34 | -0.1 millimoles (mmol)/L | Standard Deviation 2.3 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 4, n=32, 34, 33, 37, 29, 30 | -0.037 millimoles (mmol)/L | Standard Deviation 0.1003 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, EW, n=10, 6, 3, 2, 10, 9 | -1.7 millimoles (mmol)/L | Standard Deviation 1.57 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 14, n=29, 31, 33, 34, 27, 24 | -0.7 millimoles (mmol)/L | Standard Deviation 2.02 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 12, n=27, 30, 32, 36, 26, 24 | -1.0 millimoles (mmol)/L | Standard Deviation 1.58 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 8, n=30, 31, 32, 37, 27, 26 | -1.6 millimoles (mmol)/L | Standard Deviation 2.19 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, EW, n=10, 6, 3, 2, 10, 9 | -0.020 millimoles (mmol)/L | Standard Deviation 0.0632 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 2, n=35, 36, 35, 37, 29, 34 | -0.036 millimoles (mmol)/L | Standard Deviation 0.0935 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 4, n=32, 34, 33, 37, 29, 30 | -0.045 millimoles (mmol)/L | Standard Deviation 0.0788 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 8, n=30, 31, 32, 37, 27, 26 | -0.015 millimoles (mmol)/L | Standard Deviation 0.0853 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 12, n=27, 30, 32, 36, 26, 24 | -0.013 millimoles (mmol)/L | Standard Deviation 0.0934 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 14, n=29, 31, 33, 34, 27, 24 | -0.030 millimoles (mmol)/L | Standard Deviation 0.1067 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 2, n=35, 36, 35, 37, 29, 34 | 0.3 millimoles (mmol)/L | Standard Deviation 2 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 4, n=32, 34, 33, 37, 29, 30 | 0.5 millimoles (mmol)/L | Standard Deviation 1.97 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 8, n=30, 31, 32, 37, 27, 26 | 0.6 millimoles (mmol)/L | Standard Deviation 1.89 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 12, n=27, 30, 32, 36, 26, 24 | 0.7 millimoles (mmol)/L | Standard Deviation 2 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 14, n=29, 31, 33, 34, 27, 24 | 0.5 millimoles (mmol)/L | Standard Deviation 2.23 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, EW, n=10, 6, 3, 2, 10, 9 | -1.5 millimoles (mmol)/L | Standard Deviation 0.84 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 2, n=35, 36, 35, 37, 29, 34 | -1.1 millimoles (mmol)/L | Standard Deviation 2.48 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 4, n=32, 34, 33, 37, 29, 30 | -1.4 millimoles (mmol)/L | Standard Deviation 2.57 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 8, n=30, 31, 32, 37, 27, 26 | -1.5 millimoles (mmol)/L | Standard Deviation 2.49 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 12, n=27, 30, 32, 36, 26, 24 | -1.1 millimoles (mmol)/L | Standard Deviation 1.87 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 14, n=29, 31, 33, 34, 27, 24 | -0.7 millimoles (mmol)/L | Standard Deviation 2.55 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, EW, n=10, 6, 3, 2, 10, 9 | 0.5 millimoles (mmol)/L | Standard Deviation 1.52 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 2, n=35, 36, 35, 37, 29, 34 | 0.59 millimoles (mmol)/L | Standard Deviation 1.445 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 4, n=32, 34, 33, 37, 29, 30 | 0.53 millimoles (mmol)/L | Standard Deviation 1.656 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 8, n=30, 31, 32, 37, 27, 26 | 0.29 millimoles (mmol)/L | Standard Deviation 1.34 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 12, n=27, 30, 32, 36, 26, 24 | -0.33 millimoles (mmol)/L | Standard Deviation 1.099 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 14, n=29, 31, 33, 34, 27, 24 | 0.15 millimoles (mmol)/L | Standard Deviation 1.628 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, EW, n=10, 6, 3, 2, 10, 9 | 0.58 millimoles (mmol)/L | Standard Deviation 2.185 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 2, n=35, 36, 35, 37, 29, 34 | 0.03 millimoles (mmol)/L | Standard Deviation 0.322 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 4, n=32, 34, 33, 37, 29, 30 | 0.09 millimoles (mmol)/L | Standard Deviation 0.37 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 8, n=30, 31, 32, 37, 27, 26 | 0.09 millimoles (mmol)/L | Standard Deviation 0.576 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 12, n=27, 30, 32, 36, 26, 24 | 0.02 millimoles (mmol)/L | Standard Deviation 0.228 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 14, n=29, 31, 33, 34, 27, 24 | 0.02 millimoles (mmol)/L | Standard Deviation 0.268 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, EW, n=10, 6, 3, 2, 10, 9 | -0.02 millimoles (mmol)/L | Standard Deviation 0.605 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 2, n=35, 36, 35, 37, 29, 34 | -0.2 millimoles (mmol)/L | Standard Deviation 2.04 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 4, n=32, 34, 33, 37, 29, 30 | -0.1 millimoles (mmol)/L | Standard Deviation 1.81 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 8, n=30, 31, 32, 37, 27, 26 | -0.2 millimoles (mmol)/L | Standard Deviation 1.93 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 12, n=27, 30, 32, 36, 26, 24 | 0.1 millimoles (mmol)/L | Standard Deviation 1.93 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 14, n=29, 31, 33, 34, 27, 24 | -0.2 millimoles (mmol)/L | Standard Deviation 1.51 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, EW, n=10, 6, 3, 2, 10, 9 | -0.5 millimoles (mmol)/L | Standard Deviation 1.52 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 2, n=35, 36, 35, 37, 29, 34 | 0.44 millimoles (mmol)/L | Standard Deviation 2.242 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 4, n=32, 34, 33, 37, 29, 30 | 0.41 millimoles (mmol)/L | Standard Deviation 1.469 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 8, n=30, 31, 32, 37, 27, 26 | -0.13 millimoles (mmol)/L | Standard Deviation 1.049 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 12, n=27, 30, 32, 36, 26, 24 | 0.28 millimoles (mmol)/L | Standard Deviation 1.201 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 14, n=29, 31, 33, 34, 27, 24 | 0.55 millimoles (mmol)/L | Standard Deviation 1.485 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, EW, n=10, 6, 3, 2, 10, 9 | -0.83 millimoles (mmol)/L | Standard Deviation 0.983 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, EW, n=10, 6, 3, 2, 10, 9 | 0.007 millimoles (mmol)/L | Standard Deviation 0.1286 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 4, n=32, 34, 33, 37, 29, 30 | -0.033 millimoles (mmol)/L | Standard Deviation 0.1306 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 12, n=27, 30, 32, 36, 26, 24 | 0.42 millimoles (mmol)/L | Standard Deviation 2.704 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, EW, n=10, 6, 3, 2, 10, 9 | -1.0 millimoles (mmol)/L | Standard Deviation 2 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 12, n=27, 30, 32, 36, 26, 24 | 0.13 millimoles (mmol)/L | Standard Deviation 0.395 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 8, n=30, 31, 32, 37, 27, 26 | 0.06 millimoles (mmol)/L | Standard Deviation 0.312 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 12, n=27, 30, 32, 36, 26, 24 | -0.27 millimoles (mmol)/L | Standard Deviation 1.344 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 4, n=32, 34, 33, 37, 29, 30 | 0.05 millimoles (mmol)/L | Standard Deviation 0.281 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 14, n=29, 31, 33, 34, 27, 24 | 0.79 millimoles (mmol)/L | Standard Deviation 2.608 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 4, n=32, 34, 33, 37, 29, 30 | -2.0 millimoles (mmol)/L | Standard Deviation 2.81 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 14, n=29, 31, 33, 34, 27, 24 | -0.029 millimoles (mmol)/L | Standard Deviation 0.093 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 2, n=35, 36, 35, 37, 29, 34 | 0.10 millimoles (mmol)/L | Standard Deviation 0.45 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, EW, n=10, 6, 3, 2, 10, 9 | 0.43 millimoles (mmol)/L | Standard Deviation 1.361 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 14, n=29, 31, 33, 34, 27, 24 | -0.3 millimoles (mmol)/L | Standard Deviation 2.31 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 14, n=29, 31, 33, 34, 27, 24 | -1.0 millimoles (mmol)/L | Standard Deviation 2.38 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 4, n=32, 34, 33, 37, 29, 30 | -0.4 millimoles (mmol)/L | Standard Deviation 2.56 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 12, n=27, 30, 32, 36, 26, 24 | 0.1 millimoles (mmol)/L | Standard Deviation 2.29 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 8, n=30, 31, 32, 37, 27, 26 | -0.3 millimoles (mmol)/L | Standard Deviation 2.02 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 2, n=35, 36, 35, 37, 29, 34 | -0.3 millimoles (mmol)/L | Standard Deviation 1.98 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 2, n=35, 36, 35, 37, 29, 34 | 0.06 millimoles (mmol)/L | Standard Deviation 1.193 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, EW, n=10, 6, 3, 2, 10, 9 | 0.0 millimoles (mmol)/L | Standard Deviation 3.46 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 2, n=35, 36, 35, 37, 29, 34 | -0.041 millimoles (mmol)/L | Standard Deviation 0.1411 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, EW, n=10, 6, 3, 2, 10, 9 | -1.0 millimoles (mmol)/L | Standard Deviation 2.65 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 14, n=29, 31, 33, 34, 27, 24 | -0.6 millimoles (mmol)/L | Standard Deviation 2.18 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 12, n=27, 30, 32, 36, 26, 24 | -0.3 millimoles (mmol)/L | Standard Deviation 2.43 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 8, n=30, 31, 32, 37, 27, 26 | -0.036 millimoles (mmol)/L | Standard Deviation 0.0951 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 2, n=35, 36, 35, 37, 29, 34 | -0.09 millimoles (mmol)/L | Standard Deviation 1.852 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 2, n=35, 36, 35, 37, 29, 34 | -1.2 millimoles (mmol)/L | Standard Deviation 2.64 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 8, n=30, 31, 32, 37, 27, 26 | -0.9 millimoles (mmol)/L | Standard Deviation 2.01 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 14, n=29, 31, 33, 34, 27, 24 | -0.08 millimoles (mmol)/L | Standard Deviation 1.442 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 4, n=32, 34, 33, 37, 29, 30 | -1.1 millimoles (mmol)/L | Standard Deviation 2.28 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, EW, n=10, 6, 3, 2, 10, 9 | 1.83 millimoles (mmol)/L | Standard Deviation 3.884 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 4, n=32, 34, 33, 37, 29, 30 | 0.40 millimoles (mmol)/L | Standard Deviation 3.059 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 8, n=30, 31, 32, 37, 27, 26 | -1.3 millimoles (mmol)/L | Standard Deviation 1.89 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 2, n=35, 36, 35, 37, 29, 34 | -0.2 millimoles (mmol)/L | Standard Deviation 2.13 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, EW, n=10, 6, 3, 2, 10, 9 | 0.23 millimoles (mmol)/L | Standard Deviation 0.493 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 12, n=27, 30, 32, 36, 26, 24 | -1.2 millimoles (mmol)/L | Standard Deviation 2.55 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 8, n=30, 31, 32, 37, 27, 26 | -0.45 millimoles (mmol)/L | Standard Deviation 1.31 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 8, n=30, 31, 32, 37, 27, 26 | 0.63 millimoles (mmol)/L | Standard Deviation 2.604 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 4, n=32, 34, 33, 37, 29, 30 | 0.05 millimoles (mmol)/L | Standard Deviation 1.195 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 12, n=27, 30, 32, 36, 26, 24 | -0.034 millimoles (mmol)/L | Standard Deviation 0.0845 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 14, n=29, 31, 33, 34, 27, 24 | 0.05 millimoles (mmol)/L | Standard Deviation 0.361 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, EW, n=10, 6, 3, 2, 10, 9 | 0.0 millimoles (mmol)/L | Standard Deviation 1.41 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 8, n=30, 31, 32, 37, 27, 26 | -1.0 millimoles (mmol)/L | Standard Deviation 2.25 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 4, n=32, 34, 33, 37, 29, 30 | 0.36 millimoles (mmol)/L | Standard Deviation 0.991 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 12, n=27, 30, 32, 36, 26, 24 | -1.1 millimoles (mmol)/L | Standard Deviation 2.31 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 2, n=35, 36, 35, 37, 29, 34 | 0.1 millimoles (mmol)/L | Standard Deviation 2.05 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 14, n=29, 31, 33, 34, 27, 24 | -1.1 millimoles (mmol)/L | Standard Deviation 2.32 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 2, n=35, 36, 35, 37, 29, 34 | 0.05 millimoles (mmol)/L | Standard Deviation 1.864 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 4, n=32, 34, 33, 37, 29, 30 | 0.42 millimoles (mmol)/L | Standard Deviation 2.842 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, EW, n=10, 6, 3, 2, 10, 9 | -0.030 millimoles (mmol)/L | Standard Deviation 0.099 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 8, n=30, 31, 32, 37, 27, 26 | 0.35 millimoles (mmol)/L | Standard Deviation 1.376 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 8, n=30, 31, 32, 37, 27, 26 | 0.32 millimoles (mmol)/L | Standard Deviation 0.876 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 12, n=27, 30, 32, 36, 26, 24 | -0.02 millimoles (mmol)/L | Standard Deviation 1.977 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 14, n=29, 31, 33, 34, 27, 24 | 0.12 millimoles (mmol)/L | Standard Deviation 2.224 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, EW, n=10, 6, 3, 2, 10, 9 | -0.25 millimoles (mmol)/L | Standard Deviation 0.212 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 14, n=29, 31, 33, 34, 27, 24 | -0.025 millimoles (mmol)/L | Standard Deviation 0.0935 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 2, n=35, 36, 35, 37, 29, 34 | 0.12 millimoles (mmol)/L | Standard Deviation 0.349 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, EW, n=10, 6, 3, 2, 10, 9 | 0.00 millimoles (mmol)/L | Standard Deviation 1.414 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 4, n=32, 34, 33, 37, 29, 30 | -0.01 millimoles (mmol)/L | Standard Deviation 0.307 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 8, n=30, 31, 32, 37, 27, 26 | -0.04 millimoles (mmol)/L | Standard Deviation 0.302 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 12, n=27, 30, 32, 36, 26, 24 | 0.43 millimoles (mmol)/L | Standard Deviation 1.22 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 12, n=27, 30, 32, 36, 26, 24 | 0.00 millimoles (mmol)/L | Standard Deviation 0.359 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 12, n=27, 30, 32, 36, 26, 24 | -0.021 millimoles (mmol)/L | Standard Deviation 0.1129 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 14, n=29, 31, 33, 34, 27, 24 | -0.06 millimoles (mmol)/L | Standard Deviation 0.319 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, EW, n=10, 6, 3, 2, 10, 9 | 0.35 millimoles (mmol)/L | Standard Deviation 0.071 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 2, n=35, 36, 35, 37, 29, 34 | -0.036 millimoles (mmol)/L | Standard Deviation 0.0967 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 2, n=35, 36, 35, 37, 29, 34 | -0.6 millimoles (mmol)/L | Standard Deviation 2.09 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 4, n=32, 34, 33, 37, 29, 30 | -0.8 millimoles (mmol)/L | Standard Deviation 2.07 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 8, n=30, 31, 32, 37, 27, 26 | -0.010 millimoles (mmol)/L | Standard Deviation 0.1 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 8, n=30, 31, 32, 37, 27, 26 | -0.2 millimoles (mmol)/L | Standard Deviation 2.25 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 14, n=29, 31, 33, 34, 27, 24 | 0.07 millimoles (mmol)/L | Standard Deviation 1.303 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 12, n=27, 30, 32, 36, 26, 24 | -0.5 millimoles (mmol)/L | Standard Deviation 1.9 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 14, n=29, 31, 33, 34, 27, 24 | -0.7 millimoles (mmol)/L | Standard Deviation 2.29 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, EW, n=10, 6, 3, 2, 10, 9 | 1.0 millimoles (mmol)/L | Standard Deviation 1.41 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 4, n=32, 34, 33, 37, 29, 30 | -0.014 millimoles (mmol)/L | Standard Deviation 0.0899 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 8, n=30, 31, 32, 37, 27, 26 | 0.3 millimoles (mmol)/L | Standard Deviation 2.03 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 2, n=35, 36, 35, 37, 29, 34 | 0.38 millimoles (mmol)/L | Standard Deviation 1.187 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 12, n=27, 30, 32, 36, 26, 24 | -0.2 millimoles (mmol)/L | Standard Deviation 2.35 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 14, n=29, 31, 33, 34, 27, 24 | 0.5 millimoles (mmol)/L | Standard Deviation 2.3 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, EW, n=10, 6, 3, 2, 10, 9 | 1.0 millimoles (mmol)/L | Standard Deviation 1.41 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 4, n=32, 34, 33, 37, 29, 30 | -0.5 millimoles (mmol)/L | Standard Deviation 1.83 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 2, n=35, 36, 35, 37, 29, 34 | -1.2 millimoles (mmol)/L | Standard Deviation 1.96 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 4, n=32, 34, 33, 37, 29, 30 | -0.8 millimoles (mmol)/L | Standard Deviation 2.12 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, EW, n=10, 6, 3, 2, 10, 9 | -0.014 millimoles (mmol)/L | Standard Deviation 0.0366 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 12, n=27, 30, 32, 36, 26, 24 | -0.19 millimoles (mmol)/L | Standard Deviation 0.861 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 14, n=29, 31, 33, 34, 27, 24 | -0.3 millimoles (mmol)/L | Standard Deviation 2.84 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 14, n=29, 31, 33, 34, 27, 24 | -0.01 millimoles (mmol)/L | Standard Deviation 0.372 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 8, n=30, 31, 32, 37, 27, 26 | 0.18 millimoles (mmol)/L | Standard Deviation 1.505 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, EW, n=10, 6, 3, 2, 10, 9 | -0.15 millimoles (mmol)/L | Standard Deviation 0.357 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 4, n=32, 34, 33, 37, 29, 30 | 0.1 millimoles (mmol)/L | Standard Deviation 2.62 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 4, n=32, 34, 33, 37, 29, 30 | 0.01 millimoles (mmol)/L | Standard Deviation 1.299 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 2, n=35, 36, 35, 37, 29, 34 | -0.0 millimoles (mmol)/L | Standard Deviation 2.21 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 8, n=30, 31, 32, 37, 27, 26 | -0.039 millimoles (mmol)/L | Standard Deviation 0.1131 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, EW, n=10, 6, 3, 2, 10, 9 | -0.05 millimoles (mmol)/L | Standard Deviation 1.012 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 4, n=32, 34, 33, 37, 29, 30 | 0.1 millimoles (mmol)/L | Standard Deviation 2.47 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 8, n=30, 31, 32, 37, 27, 26 | -1.0 millimoles (mmol)/L | Standard Deviation 1.85 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 2, n=35, 36, 35, 37, 29, 34 | -0.01 millimoles (mmol)/L | Standard Deviation 1.168 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, EW, n=10, 6, 3, 2, 10, 9 | 0.0 millimoles (mmol)/L | Standard Deviation 2.31 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 8, n=30, 31, 32, 37, 27, 26 | -1.1 millimoles (mmol)/L | Standard Deviation 2.21 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 12, n=27, 30, 32, 36, 26, 24 | -0.2 millimoles (mmol)/L | Standard Deviation 2.6 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 14, n=29, 31, 33, 34, 27, 24 | 0.35 millimoles (mmol)/L | Standard Deviation 1.199 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 12, n=27, 30, 32, 36, 26, 24 | -0.9 millimoles (mmol)/L | Standard Deviation 2.66 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 14, n=29, 31, 33, 34, 27, 24 | -0.8 millimoles (mmol)/L | Standard Deviation 2.33 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 4, n=32, 34, 33, 37, 29, 30 | -0.036 millimoles (mmol)/L | Standard Deviation 0.1451 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, EW, n=10, 6, 3, 2, 10, 9 | -0.6 millimoles (mmol)/L | Standard Deviation 1.65 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 2, n=35, 36, 35, 37, 29, 34 | 0.3 millimoles (mmol)/L | Standard Deviation 2.44 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, EW, n=10, 6, 3, 2, 10, 9 | -0.8 millimoles (mmol)/L | Standard Deviation 2.15 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 4, n=32, 34, 33, 37, 29, 30 | -0.5 millimoles (mmol)/L | Standard Deviation 1.99 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 2, n=35, 36, 35, 37, 29, 34 | -0.6 millimoles (mmol)/L | Standard Deviation 2.37 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 8, n=30, 31, 32, 37, 27, 26 | -0.1 millimoles (mmol)/L | Standard Deviation 2.13 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 14, n=29, 31, 33, 34, 27, 24 | -0.045 millimoles (mmol)/L | Standard Deviation 0.127 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, EW, n=10, 6, 3, 2, 10, 9 | 0.35 millimoles (mmol)/L | Standard Deviation 0.357 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 14, n=29, 31, 33, 34, 27, 24 | -0.3 millimoles (mmol)/L | Standard Deviation 2.31 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 2, n=35, 36, 35, 37, 29, 34 | -0.048 millimoles (mmol)/L | Standard Deviation 0.1239 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 2, n=35, 36, 35, 37, 29, 34 | 0.20 millimoles (mmol)/L | Standard Deviation 0.408 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 14, n=29, 31, 33, 34, 27, 24 | -0.02 millimoles (mmol)/L | Standard Deviation 2.104 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 12, n=27, 30, 32, 36, 26, 24 | 0.7 millimoles (mmol)/L | Standard Deviation 2.37 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 8, n=30, 31, 32, 37, 27, 26 | -0.22 millimoles (mmol)/L | Standard Deviation 1.022 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 4, n=32, 34, 33, 37, 29, 30 | 0.13 millimoles (mmol)/L | Standard Deviation 0.48 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 8, n=30, 31, 32, 37, 27, 26 | 0.05 millimoles (mmol)/L | Standard Deviation 0.377 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 12, n=27, 30, 32, 36, 26, 24 | -0.032 millimoles (mmol)/L | Standard Deviation 0.0988 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 2, n=35, 36, 35, 37, 29, 34 | -0.09 millimoles (mmol)/L | Standard Deviation 1.044 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 12, n=27, 30, 32, 36, 26, 24 | -0.24 millimoles (mmol)/L | Standard Deviation 0.966 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 4, n=32, 34, 33, 37, 29, 30 | -0.19 millimoles (mmol)/L | Standard Deviation 1.198 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 12, n=27, 30, 32, 36, 26, 24 | 0.02 millimoles (mmol)/L | Standard Deviation 0.376 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 14, n=29, 31, 33, 34, 27, 24 | 0.13 millimoles (mmol)/L | Standard Deviation 1.696 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 14, n=29, 31, 33, 34, 27, 24 | -0.15 millimoles (mmol)/L | Standard Deviation 1.272 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 8, n=30, 31, 32, 37, 27, 26 | 0.55 millimoles (mmol)/L | Standard Deviation 2.392 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 8, n=30, 31, 32, 37, 27, 26 | -1.5 millimoles (mmol)/L | Standard Deviation 2.47 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 14, n=29, 31, 33, 34, 27, 24 | -0.020 millimoles (mmol)/L | Standard Deviation 0.1052 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 14, n=29, 31, 33, 34, 27, 24 | 0.01 millimoles (mmol)/L | Standard Deviation 0.372 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 2, n=35, 36, 35, 37, 29, 34 | -0.00 millimoles (mmol)/L | Standard Deviation 0.306 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 12, n=27, 30, 32, 36, 26, 24 | -0.15 millimoles (mmol)/L | Standard Deviation 1.485 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 4, n=32, 34, 33, 37, 29, 30 | 0.73 millimoles (mmol)/L | Standard Deviation 2.436 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 14, n=29, 31, 33, 34, 27, 24 | 0.2 millimoles (mmol)/L | Standard Deviation 2.55 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, EW, n=10, 6, 3, 2, 10, 9 | -2.0 millimoles (mmol)/L | Standard Deviation 2.06 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, EW, n=10, 6, 3, 2, 10, 9 | -0.08 millimoles (mmol)/L | Standard Deviation 0.291 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 8, n=30, 31, 32, 37, 27, 26 | -0.017 millimoles (mmol)/L | Standard Deviation 0.0948 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 12, n=27, 30, 32, 36, 26, 24 | 0.45 millimoles (mmol)/L | Standard Deviation 1.703 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 2, n=35, 36, 35, 37, 29, 34 | -0.0 millimoles (mmol)/L | Standard Deviation 2.29 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 2, n=35, 36, 35, 37, 29, 34 | 0.10 millimoles (mmol)/L | Standard Deviation 1.347 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 4, n=32, 34, 33, 37, 29, 30 | 0.28 millimoles (mmol)/L | Standard Deviation 1.501 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 2, n=35, 36, 35, 37, 29, 34 | -0.5 millimoles (mmol)/L | Standard Deviation 1.94 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 4, n=32, 34, 33, 37, 29, 30 | -0.7 millimoles (mmol)/L | Standard Deviation 2.74 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 12, n=27, 30, 32, 36, 26, 24 | 0.02 millimoles (mmol)/L | Standard Deviation 0.298 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, EW, n=10, 6, 3, 2, 10, 9 | 0.28 millimoles (mmol)/L | Standard Deviation 1.46 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 12, n=27, 30, 32, 36, 26, 24 | -1.1 millimoles (mmol)/L | Standard Deviation 2.23 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 8, n=30, 31, 32, 37, 27, 26 | -0.3 millimoles (mmol)/L | Standard Deviation 3.07 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 4, n=32, 34, 33, 37, 29, 30 | -1.2 millimoles (mmol)/L | Standard Deviation 2.06 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 14, n=29, 31, 33, 34, 27, 24 | -1.2 millimoles (mmol)/L | Standard Deviation 2.19 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, Week 2, n=35, 36, 35, 37, 29, 34 | 0.28 millimoles (mmol)/L | Standard Deviation 1.398 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Urea, Week 8, n=30, 31, 32, 37, 27, 26 | -0.13 millimoles (mmol)/L | Standard Deviation 1.179 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, Week 12, n=27, 30, 32, 36, 26, 24 | -0.7 millimoles (mmol)/L | Standard Deviation 2.8 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 2, n=35, 36, 35, 37, 29, 34 | -0.9 millimoles (mmol)/L | Standard Deviation 2.04 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 8, n=30, 31, 32, 37, 27, 26 | -0.8 millimoles (mmol)/L | Standard Deviation 2.43 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 2, n=35, 36, 35, 37, 29, 34 | -0.006 millimoles (mmol)/L | Standard Deviation 0.0887 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Chloride, EW, n=10, 6, 3, 2, 10, 9 | -1.9 millimoles (mmol)/L | Standard Deviation 2.98 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, EW, n=10, 6, 3, 2, 10, 9 | 0.004 millimoles (mmol)/L | Standard Deviation 0.0691 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, Week 4, n=32, 34, 33, 37, 29, 30 | -1.5 millimoles (mmol)/L | Standard Deviation 2.5 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 8, n=30, 31, 32, 37, 27, 26 | 0.10 millimoles (mmol)/L | Standard Deviation 0.6 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 12, n=27, 30, 32, 36, 26, 24 | -1.2 millimoles (mmol)/L | Standard Deviation 2.08 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 4, n=32, 34, 33, 37, 29, 30 | 0.003 millimoles (mmol)/L | Standard Deviation 0.083 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Glucose, EW, n=10, 6, 3, 2, 10, 9 | 0.37 millimoles (mmol)/L | Standard Deviation 1.665 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | CO2, EW, n=10, 6, 3, 2, 10, 9 | -0.1 millimoles (mmol)/L | Standard Deviation 1.27 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Potassium, Week 4, n=32, 34, 33, 37, 29, 30 | 0.01 millimoles (mmol)/L | Standard Deviation 0.38 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Calcium, Week 12, n=27, 30, 32, 36, 26, 24 | 0.011 millimoles (mmol)/L | Standard Deviation 0.1127 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium and Urea Levels | Sodium, Week 14, n=29, 31, 33, 34, 27, 24 | -1.0 millimoles (mmol)/L | Standard Deviation 2.3 |
Secondary
Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate.
Blood samples were collected for the evaluation of change in levels of direct bil, bil, creatinine and urate from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Baseline and up to Week 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 2, n=35, 36, 35, 37, 29, 34 | -0.7 micromoles (µmol)/L | Standard Deviation 3.03 |
| GSK2894512 1% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 4, n=32, 34, 33, 37, 29, 30 | -0.3 micromoles (µmol)/L | Standard Deviation 0.67 |
| GSK2894512 1% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 8, n=30, 31, 32, 37, 27, 26 | -0.4 micromoles (µmol)/L | Standard Deviation 0.97 |
| GSK2894512 1% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 12, n=27, 30, 32, 36, 26, 24 | -0.2 micromoles (µmol)/L | Standard Deviation 0.64 |
| GSK2894512 1% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 14, n=29, 31, 33, 34, 27, 24 | 0.1 micromoles (µmol)/L | Standard Deviation 1.19 |
| GSK2894512 1% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, EW, n=10, 6, 3, 2, 10, 9 | 0.2 micromoles (µmol)/L | Standard Deviation 1.14 |
| GSK2894512 1% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 2, n=35, 36, 35, 37, 29, 34 | -0.2 micromoles (µmol)/L | Standard Deviation 0.81 |
| GSK2894512 1% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 4, n=32, 34, 33, 37, 29, 30 | -0.4 micromoles (µmol)/L | Standard Deviation 3.5 |
| GSK2894512 1% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 8, n=30, 31, 32, 37, 27, 26 | -0.3 micromoles (µmol)/L | Standard Deviation 2.86 |
| GSK2894512 1% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 12, n=27, 30, 32, 36, 26, 24 | -0.2 micromoles (µmol)/L | Standard Deviation 2.1 |
| GSK2894512 1% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 14, n=29, 31, 33, 34, 27, 24 | 0.6 micromoles (µmol)/L | Standard Deviation 3.7 |
| GSK2894512 1% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, EW, n=10, 6, 3, 2, 10, 9 | -0.8 micromoles (µmol)/L | Standard Deviation 2.53 |
| GSK2894512 1% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 2, n=35, 36, 35, 37, 29, 34 | -0.26 micromoles (µmol)/L | Standard Deviation 7.565 |
| GSK2894512 1% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 4, n=32, 34, 33, 37, 29, 30 | -2.27 micromoles (µmol)/L | Standard Deviation 6.493 |
| GSK2894512 1% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 8, n=30, 31, 32, 37, 27, 26 | -0.09 micromoles (µmol)/L | Standard Deviation 6.792 |
| GSK2894512 1% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 12, n=27, 30, 32, 36, 26, 24 | 2.39 micromoles (µmol)/L | Standard Deviation 7.526 |
| GSK2894512 1% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 14, n=29, 31, 33, 34, 27, 24 | 1.74 micromoles (µmol)/L | Standard Deviation 5.748 |
| GSK2894512 1% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, EW, n=10, 6, 3, 2, 10, 9 | -0.80 micromoles (µmol)/L | Standard Deviation 8.57 |
| GSK2894512 1% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 2, n=35, 36, 35, 37, 29, 34 | -6.0 micromoles (µmol)/L | Standard Deviation 55.26 |
| GSK2894512 1% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 4, n=32, 34, 33, 37, 29, 30 | -12.5 micromoles (µmol)/L | Standard Deviation 34.36 |
| GSK2894512 1% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 8, n=30, 31, 32, 37, 27, 26 | -5.0 micromoles (µmol)/L | Standard Deviation 37.3 |
| GSK2894512 1% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 12, n=27, 30, 32, 36, 26, 24 | -6.3 micromoles (µmol)/L | Standard Deviation 28.44 |
| GSK2894512 1% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 14, n=29, 31, 33, 34, 27, 24 | 3.1 micromoles (µmol)/L | Standard Deviation 41.15 |
| GSK2894512 1% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, EW, n=10, 6, 3, 2, 10, 9 | -2.0 micromoles (µmol)/L | Standard Deviation 35.21 |
| GSK2894512 1% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 14, n=29, 31, 33, 34, 27, 24 | -0.3 micromoles (µmol)/L | Standard Deviation 1.28 |
| GSK2894512 1% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 2, n=35, 36, 35, 37, 29, 34 | 0.86 micromoles (µmol)/L | Standard Deviation 9.588 |
| GSK2894512 1% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 8, n=30, 31, 32, 37, 27, 26 | -0.3 micromoles (µmol)/L | Standard Deviation 1.24 |
| GSK2894512 1% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 12, n=27, 30, 32, 36, 26, 24 | 0.14 micromoles (µmol)/L | Standard Deviation 6.543 |
| GSK2894512 1% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 14, n=29, 31, 33, 34, 27, 24 | 19.4 micromoles (µmol)/L | Standard Deviation 71.04 |
| GSK2894512 1% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 4, n=32, 34, 33, 37, 29, 30 | 0.12 micromoles (µmol)/L | Standard Deviation 8.469 |
| GSK2894512 1% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 8, n=30, 31, 32, 37, 27, 26 | 0.55 micromoles (µmol)/L | Standard Deviation 7.03 |
| GSK2894512 1% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 2, n=35, 36, 35, 37, 29, 34 | -1.4 micromoles (µmol)/L | Standard Deviation 3.24 |
| GSK2894512 1% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 4, n=32, 34, 33, 37, 29, 30 | -0.5 micromoles (µmol)/L | Standard Deviation 1.5 |
| GSK2894512 1% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 12, n=27, 30, 32, 36, 26, 24 | 5.7 micromoles (µmol)/L | Standard Deviation 34.51 |
| GSK2894512 1% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 4, n=32, 34, 33, 37, 29, 30 | -1.2 micromoles (µmol)/L | Standard Deviation 3.42 |
| GSK2894512 1% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 12, n=27, 30, 32, 36, 26, 24 | -0.3 micromoles (µmol)/L | Standard Deviation 1.26 |
| GSK2894512 1% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 8, n=30, 31, 32, 37, 27, 26 | -8.7 micromoles (µmol)/L | Standard Deviation 37.13 |
| GSK2894512 1% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 8, n=30, 31, 32, 37, 27, 26 | 0.1 micromoles (µmol)/L | Standard Deviation 2.73 |
| GSK2894512 1% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 2, n=35, 36, 35, 37, 29, 34 | -0.4 micromoles (µmol)/L | Standard Deviation 1.36 |
| GSK2894512 1% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 12, n=27, 30, 32, 36, 26, 24 | -0.7 micromoles (µmol)/L | Standard Deviation 2.7 |
| GSK2894512 1% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, EW, n=10, 6, 3, 2, 10, 9 | 0.0 micromoles (µmol)/L | Standard Deviation 0 |
| GSK2894512 1% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 4, n=32, 34, 33, 37, 29, 30 | -7.9 micromoles (µmol)/L | Standard Deviation 43.82 |
| GSK2894512 1% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, EW, n=10, 6, 3, 2, 10, 9 | -38.3 micromoles (µmol)/L | Standard Deviation 31.89 |
| GSK2894512 1% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 14, n=29, 31, 33, 34, 27, 24 | -0.7 micromoles (µmol)/L | Standard Deviation 4.34 |
| GSK2894512 1% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 2, n=35, 36, 35, 37, 29, 34 | -7.8 micromoles (µmol)/L | Standard Deviation 40.29 |
| GSK2894512 1% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, EW, n=10, 6, 3, 2, 10, 9 | -5.02 micromoles (µmol)/L | Standard Deviation 9.374 |
| GSK2894512 1% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, EW, n=10, 6, 3, 2, 10, 9 | 0.0 micromoles (µmol)/L | Standard Deviation 2.19 |
| GSK2894512 1% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 14, n=29, 31, 33, 34, 27, 24 | 1.67 micromoles (µmol)/L | Standard Deviation 7.316 |
| GSK2894512 0.5% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 12, n=27, 30, 32, 36, 26, 24 | 1.6 micromoles (µmol)/L | Standard Deviation 35.21 |
| GSK2894512 0.5% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 14, n=29, 31, 33, 34, 27, 24 | 3.41 micromoles (µmol)/L | Standard Deviation 7.309 |
| GSK2894512 0.5% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 2, n=35, 36, 35, 37, 29, 34 | 1.14 micromoles (µmol)/L | Standard Deviation 7.202 |
| GSK2894512 0.5% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 8, n=30, 31, 32, 37, 27, 26 | -0.8 micromoles (µmol)/L | Standard Deviation 2.48 |
| GSK2894512 0.5% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 8, n=30, 31, 32, 37, 27, 26 | -0.2 micromoles (µmol)/L | Standard Deviation 0.93 |
| GSK2894512 0.5% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 8, n=30, 31, 32, 37, 27, 26 | 0.48 micromoles (µmol)/L | Standard Deviation 7.086 |
| GSK2894512 0.5% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 14, n=29, 31, 33, 34, 27, 24 | -0.9 micromoles (µmol)/L | Standard Deviation 2.74 |
| GSK2894512 0.5% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, EW, n=10, 6, 3, 2, 10, 9 | 76.7 micromoles (µmol)/L | Standard Deviation 98.15 |
| GSK2894512 0.5% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 4, n=32, 34, 33, 37, 29, 30 | 0.97 micromoles (µmol)/L | Standard Deviation 7.802 |
| GSK2894512 0.5% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 8, n=30, 31, 32, 37, 27, 26 | -3.8 micromoles (µmol)/L | Standard Deviation 32.3 |
| GSK2894512 0.5% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 4, n=32, 34, 33, 37, 29, 30 | 11.2 micromoles (µmol)/L | Standard Deviation 48.01 |
| GSK2894512 0.5% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 14, n=29, 31, 33, 34, 27, 24 | 16.4 micromoles (µmol)/L | Standard Deviation 48.98 |
| GSK2894512 0.5% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 12, n=27, 30, 32, 36, 26, 24 | 0.34 micromoles (µmol)/L | Standard Deviation 6.852 |
| GSK2894512 0.5% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, EW, n=10, 6, 3, 2, 10, 9 | 0.0 micromoles (µmol)/L | Standard Deviation 0 |
| GSK2894512 0.5% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 2, n=35, 36, 35, 37, 29, 34 | -0.6 micromoles (µmol)/L | Standard Deviation 2.98 |
| GSK2894512 0.5% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 12, n=27, 30, 32, 36, 26, 24 | -0.2 micromoles (µmol)/L | Standard Deviation 1.18 |
| GSK2894512 0.5% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 4, n=32, 34, 33, 37, 29, 30 | -0.1 micromoles (µmol)/L | Standard Deviation 1.17 |
| GSK2894512 0.5% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 12, n=27, 30, 32, 36, 26, 24 | -0.9 micromoles (µmol)/L | Standard Deviation 3.13 |
| GSK2894512 0.5% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, EW, n=10, 6, 3, 2, 10, 9 | 2.7 micromoles (µmol)/L | Standard Deviation 3.06 |
| GSK2894512 0.5% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, EW, n=10, 6, 3, 2, 10, 9 | 21.77 micromoles (µmol)/L | Standard Deviation 31.832 |
| GSK2894512 0.5% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 4, n=32, 34, 33, 37, 29, 30 | 0.4 micromoles (µmol)/L | Standard Deviation 4.34 |
| GSK2894512 0.5% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 14, n=29, 31, 33, 34, 27, 24 | -0.1 micromoles (µmol)/L | Standard Deviation 1.06 |
| GSK2894512 0.5% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 2, n=35, 36, 35, 37, 29, 34 | 15.4 micromoles (µmol)/L | Standard Deviation 41.96 |
| GSK2894512 0.5% BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 2, n=35, 36, 35, 37, 29, 34 | 0.0 micromoles (µmol)/L | Standard Deviation 1.08 |
| GSK2894512 0.5% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 12, n=27, 30, 32, 36, 26, 24 | -1.7 micromoles (µmol)/L | Standard Deviation 55.01 |
| GSK2894512 0.5% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 14, n=29, 31, 33, 34, 27, 24 | -0.1 micromoles (µmol)/L | Standard Deviation 1.04 |
| GSK2894512 0.5% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, EW, n=10, 6, 3, 2, 10, 9 | 2.0 micromoles (µmol)/L | Standard Deviation 0 |
| GSK2894512 0.5% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, EW, n=10, 6, 3, 2, 10, 9 | -10.0 micromoles (µmol)/L | Standard Deviation 14.14 |
| GSK2894512 0.5% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 2, n=35, 36, 35, 37, 29, 34 | -0.3 micromoles (µmol)/L | Standard Deviation 2.56 |
| GSK2894512 0.5% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 4, n=32, 34, 33, 37, 29, 30 | -0.6 micromoles (µmol)/L | Standard Deviation 2.87 |
| GSK2894512 0.5% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 8, n=30, 31, 32, 37, 27, 26 | -0.3 micromoles (µmol)/L | Standard Deviation 3.06 |
| GSK2894512 0.5% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 12, n=27, 30, 32, 36, 26, 24 | -0.4 micromoles (µmol)/L | Standard Deviation 3.13 |
| GSK2894512 0.5% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 14, n=29, 31, 33, 34, 27, 24 | -0.5 micromoles (µmol)/L | Standard Deviation 3.56 |
| GSK2894512 0.5% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, EW, n=10, 6, 3, 2, 10, 9 | -1.0 micromoles (µmol)/L | Standard Deviation 1.41 |
| GSK2894512 0.5% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 2, n=35, 36, 35, 37, 29, 34 | 0.27 micromoles (µmol)/L | Standard Deviation 9.708 |
| GSK2894512 0.5% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 4, n=32, 34, 33, 37, 29, 30 | 1.81 micromoles (µmol)/L | Standard Deviation 7.51 |
| GSK2894512 0.5% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 8, n=30, 31, 32, 37, 27, 26 | 2.82 micromoles (µmol)/L | Standard Deviation 11.713 |
| GSK2894512 0.5% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 14, n=29, 31, 33, 34, 27, 24 | -5.9 micromoles (µmol)/L | Standard Deviation 54.72 |
| GSK2894512 0.5% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 12, n=27, 30, 32, 36, 26, 24 | 0.37 micromoles (µmol)/L | Standard Deviation 11.501 |
| GSK2894512 0.5% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 14, n=29, 31, 33, 34, 27, 24 | 1.67 micromoles (µmol)/L | Standard Deviation 14.096 |
| GSK2894512 0.5% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, EW, n=10, 6, 3, 2, 10, 9 | -1.80 micromoles (µmol)/L | Standard Deviation 0 |
| GSK2894512 0.5% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 2, n=35, 36, 35, 37, 29, 34 | 6.2 micromoles (µmol)/L | Standard Deviation 61.07 |
| GSK2894512 0.5% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 4, n=32, 34, 33, 37, 29, 30 | 5.7 micromoles (µmol)/L | Standard Deviation 49.36 |
| GSK2894512 0.5% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 2, n=35, 36, 35, 37, 29, 34 | -0.1 micromoles (µmol)/L | Standard Deviation 1.24 |
| GSK2894512 0.5% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 4, n=32, 34, 33, 37, 29, 30 | -0.2 micromoles (µmol)/L | Standard Deviation 0.99 |
| GSK2894512 0.5% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 8, n=30, 31, 32, 37, 27, 26 | -0.2 micromoles (µmol)/L | Standard Deviation 1.03 |
| GSK2894512 0.5% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 8, n=30, 31, 32, 37, 27, 26 | -0.3 micromoles (µmol)/L | Standard Deviation 45.43 |
| GSK2894512 0.5% QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 12, n=27, 30, 32, 36, 26, 24 | -0.4 micromoles (µmol)/L | Standard Deviation 1.15 |
| Vehicle BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 14, n=29, 31, 33, 34, 27, 24 | -0.8 micromoles (µmol)/L | Standard Deviation 4.84 |
| Vehicle BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 8, n=30, 31, 32, 37, 27, 26 | -0.9 micromoles (µmol)/L | Standard Deviation 4.27 |
| Vehicle BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 12, n=27, 30, 32, 36, 26, 24 | 0.4 micromoles (µmol)/L | Standard Deviation 88.79 |
| Vehicle BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 8, n=30, 31, 32, 37, 27, 26 | -0.1 micromoles (µmol)/L | Standard Deviation 1.35 |
| Vehicle BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 2, n=35, 36, 35, 37, 29, 34 | -0.1 micromoles (µmol)/L | Standard Deviation 1.51 |
| Vehicle BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 2, n=35, 36, 35, 37, 29, 34 | -8.3 micromoles (µmol)/L | Standard Deviation 62.91 |
| Vehicle BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 4, n=32, 34, 33, 37, 29, 30 | -0.6 micromoles (µmol)/L | Standard Deviation 4.84 |
| Vehicle BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, EW, n=10, 6, 3, 2, 10, 9 | -1.58 micromoles (µmol)/L | Standard Deviation 6.009 |
| Vehicle BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 2, n=35, 36, 35, 37, 29, 34 | -0.3 micromoles (µmol)/L | Standard Deviation 4.4 |
| Vehicle BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 14, n=29, 31, 33, 34, 27, 24 | 0.1 micromoles (µmol)/L | Standard Deviation 1.52 |
| Vehicle BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 4, n=32, 34, 33, 37, 29, 30 | -0.1 micromoles (µmol)/L | Standard Deviation 1.36 |
| Vehicle BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, EW, n=10, 6, 3, 2, 10, 9 | 0.4 micromoles (µmol)/L | Standard Deviation 3.1 |
| Vehicle BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 12, n=27, 30, 32, 36, 26, 24 | -0.4 micromoles (µmol)/L | Standard Deviation 4.93 |
| Vehicle BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 4, n=32, 34, 33, 37, 29, 30 | -2.38 micromoles (µmol)/L | Standard Deviation 6.095 |
| Vehicle BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 8, n=30, 31, 32, 37, 27, 26 | -6.3 micromoles (µmol)/L | Standard Deviation 73.54 |
| Vehicle BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 12, n=27, 30, 32, 36, 26, 24 | 0.0 micromoles (µmol)/L | Standard Deviation 1.26 |
| Vehicle BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 8, n=30, 31, 32, 37, 27, 26 | -2.89 micromoles (µmol)/L | Standard Deviation 7.566 |
| Vehicle BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 4, n=32, 34, 33, 37, 29, 30 | -10.7 micromoles (µmol)/L | Standard Deviation 54.11 |
| Vehicle BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, EW, n=10, 6, 3, 2, 10, 9 | -0.4 micromoles (µmol)/L | Standard Deviation 1.26 |
| Vehicle BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 2, n=35, 36, 35, 37, 29, 34 | -1.65 micromoles (µmol)/L | Standard Deviation 5.812 |
| Vehicle BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, EW, n=10, 6, 3, 2, 10, 9 | -13.0 micromoles (µmol)/L | Standard Deviation 33.68 |
| Vehicle BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 14, n=29, 31, 33, 34, 27, 24 | -2.33 micromoles (µmol)/L | Standard Deviation 9.715 |
| Vehicle BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 12, n=27, 30, 32, 36, 26, 24 | -4.35 micromoles (µmol)/L | Standard Deviation 10.528 |
| Vehicle BID | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 14, n=29, 31, 33, 34, 27, 24 | -14.1 micromoles (µmol)/L | Standard Deviation 59.37 |
| Vehicle QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 12, n=27, 30, 32, 36, 26, 24 | 1.49 micromoles (µmol)/L | Standard Deviation 7.718 |
| Vehicle QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, EW, n=10, 6, 3, 2, 10, 9 | -0.2 micromoles (µmol)/L | Standard Deviation 3.23 |
| Vehicle QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 12, n=27, 30, 32, 36, 26, 24 | -0.1 micromoles (µmol)/L | Standard Deviation 1.1 |
| Vehicle QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 14, n=29, 31, 33, 34, 27, 24 | 3.06 micromoles (µmol)/L | Standard Deviation 8.97 |
| Vehicle QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 14, n=29, 31, 33, 34, 27, 24 | -2.5 micromoles (µmol)/L | Standard Deviation 65.62 |
| Vehicle QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 12, n=27, 30, 32, 36, 26, 24 | 15.4 micromoles (µmol)/L | Standard Deviation 66.27 |
| Vehicle QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 14, n=29, 31, 33, 34, 27, 24 | 0.5 micromoles (µmol)/L | Standard Deviation 2.96 |
| Vehicle QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, EW, n=10, 6, 3, 2, 10, 9 | -2.36 micromoles (µmol)/L | Standard Deviation 5.544 |
| Vehicle QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, EW, n=10, 6, 3, 2, 10, 9 | -13.3 micromoles (µmol)/L | Standard Deviation 52.92 |
| Vehicle QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 8, n=30, 31, 32, 37, 27, 26 | -0.5 micromoles (µmol)/L | Standard Deviation 1.33 |
| Vehicle QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 2, n=35, 36, 35, 37, 29, 34 | -0.3 micromoles (µmol)/L | Standard Deviation 62.06 |
| Vehicle QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 12, n=27, 30, 32, 36, 26, 24 | 0.6 micromoles (µmol)/L | Standard Deviation 4.02 |
| Vehicle QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 4, n=32, 34, 33, 37, 29, 30 | 2.7 micromoles (µmol)/L | Standard Deviation 52.06 |
| Vehicle QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 8, n=30, 31, 32, 37, 27, 26 | 0.2 micromoles (µmol)/L | Standard Deviation 3.81 |
| Vehicle QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 4, n=32, 34, 33, 37, 29, 30 | 1.7 micromoles (µmol)/L | Standard Deviation 4.29 |
| Vehicle QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 14, n=29, 31, 33, 34, 27, 24 | -0.2 micromoles (µmol)/L | Standard Deviation 0.82 |
| Vehicle QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 2, n=35, 36, 35, 37, 29, 34 | 0.0 micromoles (µmol)/L | Standard Deviation 0.85 |
| Vehicle QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Bil, Week 2, n=35, 36, 35, 37, 29, 34 | 0.8 micromoles (µmol)/L | Standard Deviation 4.15 |
| Vehicle QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, Week 4, n=32, 34, 33, 37, 29, 30 | -0.1 micromoles (µmol)/L | Standard Deviation 1.17 |
| Vehicle QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 4, n=32, 34, 33, 37, 29, 30 | 1.57 micromoles (µmol)/L | Standard Deviation 10.282 |
| Vehicle QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 2, n=35, 36, 35, 37, 29, 34 | 1.22 micromoles (µmol)/L | Standard Deviation 6.632 |
| Vehicle QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Direct bil, EW, n=10, 6, 3, 2, 10, 9 | -0.2 micromoles (µmol)/L | Standard Deviation 1.2 |
| Vehicle QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Creatinine, Week 8, n=30, 31, 32, 37, 27, 26 | 1.40 micromoles (µmol)/L | Standard Deviation 8.515 |
| Vehicle QD | Change From Baseline in Direct Bilirubin (Bil), Bilirubin (Bil), Creatinine and Urate. | Urate, Week 8, n=30, 31, 32, 37, 27, 26 | -4.2 micromoles (µmol)/L | Standard Deviation 75.8 |
Secondary
Change From Baseline in Erythrocyte Count
Blood samples were collected for the evaluation of change in erythrocyte count from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Baseline and up to Week 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Erythrocyte Count | Week 2, n=35, 35, 36, 37, 29, 35 | -0.01 Tetra unit/L (TI/L) | Standard Deviation 0.18 |
| GSK2894512 1% BID | Change From Baseline in Erythrocyte Count | Week 4, n=32, 34, 35, 37, 29, 31 | -0.03 Tetra unit/L (TI/L) | Standard Deviation 0.213 |
| GSK2894512 1% BID | Change From Baseline in Erythrocyte Count | Week 8, n=30, 31, 32, 38, 27, 26 | -0.09 Tetra unit/L (TI/L) | Standard Deviation 0.273 |
| GSK2894512 1% BID | Change From Baseline in Erythrocyte Count | Week 12, n=27, 30, 31, 36, 26, 25 | -0.07 Tetra unit/L (TI/L) | Standard Deviation 0.237 |
| GSK2894512 1% BID | Change From Baseline in Erythrocyte Count | Week 14, n=29, 30, 33, 34, 27, 23 | -0.13 Tetra unit/L (TI/L) | Standard Deviation 0.334 |
| GSK2894512 1% BID | Change From Baseline in Erythrocyte Count | EW, n=10, 6, 3, 2, 10, 9 | -0.03 Tetra unit/L (TI/L) | Standard Deviation 0.25 |
| GSK2894512 1% QD | Change From Baseline in Erythrocyte Count | Week 4, n=32, 34, 35, 37, 29, 31 | -0.06 Tetra unit/L (TI/L) | Standard Deviation 0.22 |
| GSK2894512 1% QD | Change From Baseline in Erythrocyte Count | Week 12, n=27, 30, 31, 36, 26, 25 | 0.00 Tetra unit/L (TI/L) | Standard Deviation 0.257 |
| GSK2894512 1% QD | Change From Baseline in Erythrocyte Count | EW, n=10, 6, 3, 2, 10, 9 | -0.30 Tetra unit/L (TI/L) | Standard Deviation 0.268 |
| GSK2894512 1% QD | Change From Baseline in Erythrocyte Count | Week 2, n=35, 35, 36, 37, 29, 35 | -0.06 Tetra unit/L (TI/L) | Standard Deviation 0.243 |
| GSK2894512 1% QD | Change From Baseline in Erythrocyte Count | Week 8, n=30, 31, 32, 38, 27, 26 | -0.05 Tetra unit/L (TI/L) | Standard Deviation 0.468 |
| GSK2894512 1% QD | Change From Baseline in Erythrocyte Count | Week 14, n=29, 30, 33, 34, 27, 23 | -0.09 Tetra unit/L (TI/L) | Standard Deviation 0.252 |
| GSK2894512 0.5% BID | Change From Baseline in Erythrocyte Count | EW, n=10, 6, 3, 2, 10, 9 | -0.13 Tetra unit/L (TI/L) | Standard Deviation 0.153 |
| GSK2894512 0.5% BID | Change From Baseline in Erythrocyte Count | Week 14, n=29, 30, 33, 34, 27, 23 | -0.07 Tetra unit/L (TI/L) | Standard Deviation 0.374 |
| GSK2894512 0.5% BID | Change From Baseline in Erythrocyte Count | Week 12, n=27, 30, 31, 36, 26, 25 | -0.05 Tetra unit/L (TI/L) | Standard Deviation 0.356 |
| GSK2894512 0.5% BID | Change From Baseline in Erythrocyte Count | Week 8, n=30, 31, 32, 38, 27, 26 | -0.07 Tetra unit/L (TI/L) | Standard Deviation 0.306 |
| GSK2894512 0.5% BID | Change From Baseline in Erythrocyte Count | Week 2, n=35, 35, 36, 37, 29, 35 | -0.04 Tetra unit/L (TI/L) | Standard Deviation 0.315 |
| GSK2894512 0.5% BID | Change From Baseline in Erythrocyte Count | Week 4, n=32, 34, 35, 37, 29, 31 | 0.02 Tetra unit/L (TI/L) | Standard Deviation 0.358 |
| GSK2894512 0.5% QD | Change From Baseline in Erythrocyte Count | Week 12, n=27, 30, 31, 36, 26, 25 | -0.08 Tetra unit/L (TI/L) | Standard Deviation 0.228 |
| GSK2894512 0.5% QD | Change From Baseline in Erythrocyte Count | Week 4, n=32, 34, 35, 37, 29, 31 | -0.01 Tetra unit/L (TI/L) | Standard Deviation 0.269 |
| GSK2894512 0.5% QD | Change From Baseline in Erythrocyte Count | Week 8, n=30, 31, 32, 38, 27, 26 | -0.07 Tetra unit/L (TI/L) | Standard Deviation 0.257 |
| GSK2894512 0.5% QD | Change From Baseline in Erythrocyte Count | EW, n=10, 6, 3, 2, 10, 9 | -0.10 Tetra unit/L (TI/L) | Standard Deviation 0 |
| GSK2894512 0.5% QD | Change From Baseline in Erythrocyte Count | Week 14, n=29, 30, 33, 34, 27, 23 | -0.18 Tetra unit/L (TI/L) | Standard Deviation 0.343 |
| GSK2894512 0.5% QD | Change From Baseline in Erythrocyte Count | Week 2, n=35, 35, 36, 37, 29, 35 | -0.05 Tetra unit/L (TI/L) | Standard Deviation 0.21 |
| Vehicle BID | Change From Baseline in Erythrocyte Count | Week 2, n=35, 35, 36, 37, 29, 35 | -0.03 Tetra unit/L (TI/L) | Standard Deviation 0.363 |
| Vehicle BID | Change From Baseline in Erythrocyte Count | Week 14, n=29, 30, 33, 34, 27, 23 | -0.06 Tetra unit/L (TI/L) | Standard Deviation 0.37 |
| Vehicle BID | Change From Baseline in Erythrocyte Count | Week 4, n=32, 34, 35, 37, 29, 31 | 0.01 Tetra unit/L (TI/L) | Standard Deviation 0.421 |
| Vehicle BID | Change From Baseline in Erythrocyte Count | Week 8, n=30, 31, 32, 38, 27, 26 | 0.06 Tetra unit/L (TI/L) | Standard Deviation 0.356 |
| Vehicle BID | Change From Baseline in Erythrocyte Count | Week 12, n=27, 30, 31, 36, 26, 25 | 0.00 Tetra unit/L (TI/L) | Standard Deviation 0.328 |
| Vehicle BID | Change From Baseline in Erythrocyte Count | EW, n=10, 6, 3, 2, 10, 9 | -0.07 Tetra unit/L (TI/L) | Standard Deviation 0.2 |
| Vehicle QD | Change From Baseline in Erythrocyte Count | Week 12, n=27, 30, 31, 36, 26, 25 | 0.04 Tetra unit/L (TI/L) | Standard Deviation 0.229 |
| Vehicle QD | Change From Baseline in Erythrocyte Count | Week 8, n=30, 31, 32, 38, 27, 26 | 0.03 Tetra unit/L (TI/L) | Standard Deviation 0.317 |
| Vehicle QD | Change From Baseline in Erythrocyte Count | Week 14, n=29, 30, 33, 34, 27, 23 | -0.07 Tetra unit/L (TI/L) | Standard Deviation 0.194 |
| Vehicle QD | Change From Baseline in Erythrocyte Count | EW, n=10, 6, 3, 2, 10, 9 | 0.00 Tetra unit/L (TI/L) | Standard Deviation 0.212 |
| Vehicle QD | Change From Baseline in Erythrocyte Count | Week 4, n=32, 34, 35, 37, 29, 31 | 0.05 Tetra unit/L (TI/L) | Standard Deviation 0.294 |
| Vehicle QD | Change From Baseline in Erythrocyte Count | Week 2, n=35, 35, 36, 37, 29, 35 | 0.01 Tetra unit/L (TI/L) | Standard Deviation 0.269 |
Secondary
Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level
Blood samples were collected for the evaluation of change in erythrocyte mean corpuscular hemoglobin level from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Baseline and up to Week 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 2, n=35, 35, 36, 37, 29, 35 | 0.10 Picogram (pg) | Standard Deviation 0.493 |
| GSK2894512 1% BID | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 4, n=32, 34, 35, 37, 29, 31 | 0.01 Picogram (pg) | Standard Deviation 0.562 |
| GSK2894512 1% BID | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 8, n=30, 31, 32, 38, 27, 26 | 0.13 Picogram (pg) | Standard Deviation 0.608 |
| GSK2894512 1% BID | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 12, n=27, 30, 31, 36, 26, 25 | 0.20 Picogram (pg) | Standard Deviation 0.804 |
| GSK2894512 1% BID | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 14, n=29, 30, 33, 34, 27, 23 | 0.39 Picogram (pg) | Standard Deviation 0.671 |
| GSK2894512 1% BID | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | EW, n=10, 6, 3, 2, 10, 9 | 0.10 Picogram (pg) | Standard Deviation 0.371 |
| GSK2894512 1% QD | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 4, n=32, 34, 35, 37, 29, 31 | -0.06 Picogram (pg) | Standard Deviation 0.517 |
| GSK2894512 1% QD | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 12, n=27, 30, 31, 36, 26, 25 | -0.07 Picogram (pg) | Standard Deviation 0.672 |
| GSK2894512 1% QD | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | EW, n=10, 6, 3, 2, 10, 9 | 0.15 Picogram (pg) | Standard Deviation 0.734 |
| GSK2894512 1% QD | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 2, n=35, 35, 36, 37, 29, 35 | 0.05 Picogram (pg) | Standard Deviation 0.408 |
| GSK2894512 1% QD | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 8, n=30, 31, 32, 38, 27, 26 | 0.31 Picogram (pg) | Standard Deviation 2.22 |
| GSK2894512 1% QD | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 14, n=29, 30, 33, 34, 27, 23 | 0.02 Picogram (pg) | Standard Deviation 0.406 |
| GSK2894512 0.5% BID | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | EW, n=10, 6, 3, 2, 10, 9 | -0.50 Picogram (pg) | Standard Deviation 0.52 |
| GSK2894512 0.5% BID | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 14, n=29, 30, 33, 34, 27, 23 | -0.19 Picogram (pg) | Standard Deviation 0.685 |
| GSK2894512 0.5% BID | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 12, n=27, 30, 31, 36, 26, 25 | -0.15 Picogram (pg) | Standard Deviation 0.532 |
| GSK2894512 0.5% BID | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 8, n=30, 31, 32, 38, 27, 26 | -0.20 Picogram (pg) | Standard Deviation 0.805 |
| GSK2894512 0.5% BID | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 2, n=35, 35, 36, 37, 29, 35 | -0.08 Picogram (pg) | Standard Deviation 0.59 |
| GSK2894512 0.5% BID | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 4, n=32, 34, 35, 37, 29, 31 | -0.19 Picogram (pg) | Standard Deviation 0.75 |
| GSK2894512 0.5% QD | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 12, n=27, 30, 31, 36, 26, 25 | -0.00 Picogram (pg) | Standard Deviation 0.837 |
| GSK2894512 0.5% QD | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 4, n=32, 34, 35, 37, 29, 31 | 0.08 Picogram (pg) | Standard Deviation 0.774 |
| GSK2894512 0.5% QD | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 8, n=30, 31, 32, 38, 27, 26 | -0.04 Picogram (pg) | Standard Deviation 0.803 |
| GSK2894512 0.5% QD | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | EW, n=10, 6, 3, 2, 10, 9 | 0.05 Picogram (pg) | Standard Deviation 0.071 |
| GSK2894512 0.5% QD | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 14, n=29, 30, 33, 34, 27, 23 | 0.07 Picogram (pg) | Standard Deviation 0.785 |
| GSK2894512 0.5% QD | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 2, n=35, 35, 36, 37, 29, 35 | 0.11 Picogram (pg) | Standard Deviation 0.733 |
| Vehicle BID | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 2, n=35, 35, 36, 37, 29, 35 | -0.10 Picogram (pg) | Standard Deviation 1.519 |
| Vehicle BID | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 14, n=29, 30, 33, 34, 27, 23 | -0.23 Picogram (pg) | Standard Deviation 1.396 |
| Vehicle BID | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 4, n=32, 34, 35, 37, 29, 31 | -0.15 Picogram (pg) | Standard Deviation 1.257 |
| Vehicle BID | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 8, n=30, 31, 32, 38, 27, 26 | -0.13 Picogram (pg) | Standard Deviation 1.286 |
| Vehicle BID | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 12, n=27, 30, 31, 36, 26, 25 | -0.30 Picogram (pg) | Standard Deviation 1.265 |
| Vehicle BID | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | EW, n=10, 6, 3, 2, 10, 9 | -0.02 Picogram (pg) | Standard Deviation 0.181 |
| Vehicle QD | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 12, n=27, 30, 31, 36, 26, 25 | -0.21 Picogram (pg) | Standard Deviation 0.764 |
| Vehicle QD | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 8, n=30, 31, 32, 38, 27, 26 | -0.09 Picogram (pg) | Standard Deviation 0.753 |
| Vehicle QD | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 14, n=29, 30, 33, 34, 27, 23 | 0.01 Picogram (pg) | Standard Deviation 0.557 |
| Vehicle QD | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | EW, n=10, 6, 3, 2, 10, 9 | -0.12 Picogram (pg) | Standard Deviation 0.533 |
| Vehicle QD | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 4, n=32, 34, 35, 37, 29, 31 | -0.15 Picogram (pg) | Standard Deviation 0.863 |
| Vehicle QD | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin Level | Week 2, n=35, 35, 36, 37, 29, 35 | -0.01 Picogram (pg) | Standard Deviation 0.605 |
Secondary
Change From Baseline in Erythrocyte Mean Corpuscular Volume
Blood samples were collected for the evaluation of change in erythrocyte mean corpuscular volume from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Baseline and up to Week 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 2, n=35, 35, 36, 37, 29, 35 | 0.7 Femtoliter (fL) | Standard Deviation 2.38 |
| GSK2894512 1% BID | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 4, n=32, 34, 35, 37, 29, 31 | 0.8 Femtoliter (fL) | Standard Deviation 2.21 |
| GSK2894512 1% BID | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 8, n=30, 31, 32, 38, 27, 26 | 2.0 Femtoliter (fL) | Standard Deviation 2.39 |
| GSK2894512 1% BID | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 12, n=27, 30, 31, 36, 26, 25 | 2.4 Femtoliter (fL) | Standard Deviation 2.27 |
| GSK2894512 1% BID | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 14, n=29, 30, 33, 34, 27, 23 | 2.7 Femtoliter (fL) | Standard Deviation 2.87 |
| GSK2894512 1% BID | Change From Baseline in Erythrocyte Mean Corpuscular Volume | EW, n=10, 6, 3, 2, 10, 9 | 0.6 Femtoliter (fL) | Standard Deviation 3.41 |
| GSK2894512 1% QD | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 4, n=32, 34, 35, 37, 29, 31 | 0.4 Femtoliter (fL) | Standard Deviation 1.94 |
| GSK2894512 1% QD | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 12, n=27, 30, 31, 36, 26, 25 | 1.6 Femtoliter (fL) | Standard Deviation 1.94 |
| GSK2894512 1% QD | Change From Baseline in Erythrocyte Mean Corpuscular Volume | EW, n=10, 6, 3, 2, 10, 9 | 0.0 Femtoliter (fL) | Standard Deviation 2.19 |
| GSK2894512 1% QD | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 2, n=35, 35, 36, 37, 29, 35 | 0.6 Femtoliter (fL) | Standard Deviation 2.07 |
| GSK2894512 1% QD | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 8, n=30, 31, 32, 38, 27, 26 | 2.0 Femtoliter (fL) | Standard Deviation 5.05 |
| GSK2894512 1% QD | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 14, n=29, 30, 33, 34, 27, 23 | 1.6 Femtoliter (fL) | Standard Deviation 2.08 |
| GSK2894512 0.5% BID | Change From Baseline in Erythrocyte Mean Corpuscular Volume | EW, n=10, 6, 3, 2, 10, 9 | -0.3 Femtoliter (fL) | Standard Deviation 0.58 |
| GSK2894512 0.5% BID | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 14, n=29, 30, 33, 34, 27, 23 | 1.5 Femtoliter (fL) | Standard Deviation 3.04 |
| GSK2894512 0.5% BID | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 12, n=27, 30, 31, 36, 26, 25 | 1.9 Femtoliter (fL) | Standard Deviation 3.41 |
| GSK2894512 0.5% BID | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 8, n=30, 31, 32, 38, 27, 26 | 1.1 Femtoliter (fL) | Standard Deviation 3.57 |
| GSK2894512 0.5% BID | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 2, n=35, 35, 36, 37, 29, 35 | 0.6 Femtoliter (fL) | Standard Deviation 2.39 |
| GSK2894512 0.5% BID | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 4, n=32, 34, 35, 37, 29, 31 | 0.4 Femtoliter (fL) | Standard Deviation 2.65 |
| GSK2894512 0.5% QD | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 12, n=27, 30, 31, 36, 26, 25 | 1.4 Femtoliter (fL) | Standard Deviation 3.72 |
| GSK2894512 0.5% QD | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 4, n=32, 34, 35, 37, 29, 31 | 0.2 Femtoliter (fL) | Standard Deviation 2.39 |
| GSK2894512 0.5% QD | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 8, n=30, 31, 32, 38, 27, 26 | 0.6 Femtoliter (fL) | Standard Deviation 3.41 |
| GSK2894512 0.5% QD | Change From Baseline in Erythrocyte Mean Corpuscular Volume | EW, n=10, 6, 3, 2, 10, 9 | -0.5 Femtoliter (fL) | Standard Deviation 0.71 |
| GSK2894512 0.5% QD | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 14, n=29, 30, 33, 34, 27, 23 | 0.9 Femtoliter (fL) | Standard Deviation 3.27 |
| GSK2894512 0.5% QD | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 2, n=35, 35, 36, 37, 29, 35 | 0.1 Femtoliter (fL) | Standard Deviation 2.11 |
| Vehicle BID | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 2, n=35, 35, 36, 37, 29, 35 | -0.5 Femtoliter (fL) | Standard Deviation 4.05 |
| Vehicle BID | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 14, n=29, 30, 33, 34, 27, 23 | 0.9 Femtoliter (fL) | Standard Deviation 3.95 |
| Vehicle BID | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 4, n=32, 34, 35, 37, 29, 31 | 0.7 Femtoliter (fL) | Standard Deviation 3.73 |
| Vehicle BID | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 8, n=30, 31, 32, 38, 27, 26 | 0.9 Femtoliter (fL) | Standard Deviation 3.8 |
| Vehicle BID | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 12, n=27, 30, 31, 36, 26, 25 | 0.8 Femtoliter (fL) | Standard Deviation 3.98 |
| Vehicle BID | Change From Baseline in Erythrocyte Mean Corpuscular Volume | EW, n=10, 6, 3, 2, 10, 9 | 1.1 Femtoliter (fL) | Standard Deviation 1.6 |
| Vehicle QD | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 12, n=27, 30, 31, 36, 26, 25 | 0.9 Femtoliter (fL) | Standard Deviation 2.93 |
| Vehicle QD | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 8, n=30, 31, 32, 38, 27, 26 | 0.9 Femtoliter (fL) | Standard Deviation 3.1 |
| Vehicle QD | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 14, n=29, 30, 33, 34, 27, 23 | 1.9 Femtoliter (fL) | Standard Deviation 2.36 |
| Vehicle QD | Change From Baseline in Erythrocyte Mean Corpuscular Volume | EW, n=10, 6, 3, 2, 10, 9 | 0.1 Femtoliter (fL) | Standard Deviation 2.42 |
| Vehicle QD | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 4, n=32, 34, 35, 37, 29, 31 | 0.0 Femtoliter (fL) | Standard Deviation 3.1 |
| Vehicle QD | Change From Baseline in Erythrocyte Mean Corpuscular Volume | Week 2, n=35, 35, 36, 37, 29, 35 | 0.2 Femtoliter (fL) | Standard Deviation 1.96 |
Secondary
Change From Baseline in Hematocrit Levels
Blood samples were collected for the evaluation of change in hematocrit levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Baseline and up to Week 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Hematocrit Levels | Week 2, n=35, 35, 36, 37, 29, 35 | 0.0029 Proportion of red blood cells in blood | Standard Deviation 0.0198 |
| GSK2894512 1% BID | Change From Baseline in Hematocrit Levels | Week 4, n=32, 34, 35, 37, 29, 31 | 0.0007 Proportion of red blood cells in blood | Standard Deviation 0.0227 |
| GSK2894512 1% BID | Change From Baseline in Hematocrit Levels | Week 8, n=30, 31, 32, 38, 27, 26 | 0.0020 Proportion of red blood cells in blood | Standard Deviation 0.0273 |
| GSK2894512 1% BID | Change From Baseline in Hematocrit Levels | Week 12, n=27, 30, 31, 36, 26, 25 | 0.0045 Proportion of red blood cells in blood | Standard Deviation 0.0238 |
| GSK2894512 1% BID | Change From Baseline in Hematocrit Levels | Week 14, n=29, 30, 33, 34, 27, 23 | 0.0017 Proportion of red blood cells in blood | Standard Deviation 0.0259 |
| GSK2894512 1% BID | Change From Baseline in Hematocrit Levels | EW, n=10, 6, 3, 2, 10, 9 | 0.0014 Proportion of red blood cells in blood | Standard Deviation 0.0185 |
| GSK2894512 1% QD | Change From Baseline in Hematocrit Levels | Week 4, n=32, 34, 35, 37, 29, 31 | -0.0049 Proportion of red blood cells in blood | Standard Deviation 0.0238 |
| GSK2894512 1% QD | Change From Baseline in Hematocrit Levels | Week 12, n=27, 30, 31, 36, 26, 25 | 0.0059 Proportion of red blood cells in blood | Standard Deviation 0.0275 |
| GSK2894512 1% QD | Change From Baseline in Hematocrit Levels | EW, n=10, 6, 3, 2, 10, 9 | -0.0273 Proportion of red blood cells in blood | Standard Deviation 0.0221 |
| GSK2894512 1% QD | Change From Baseline in Hematocrit Levels | Week 2, n=35, 35, 36, 37, 29, 35 | -0.0036 Proportion of red blood cells in blood | Standard Deviation 0.0243 |
| GSK2894512 1% QD | Change From Baseline in Hematocrit Levels | Week 8, n=30, 31, 32, 38, 27, 26 | 0.0047 Proportion of red blood cells in blood | Standard Deviation 0.0274 |
| GSK2894512 1% QD | Change From Baseline in Hematocrit Levels | Week 14, n=29, 30, 33, 34, 27, 23 | -0.0010 Proportion of red blood cells in blood | Standard Deviation 0.0274 |
| GSK2894512 0.5% BID | Change From Baseline in Hematocrit Levels | EW, n=10, 6, 3, 2, 10, 9 | -0.0093 Proportion of red blood cells in blood | Standard Deviation 0.0134 |
| GSK2894512 0.5% BID | Change From Baseline in Hematocrit Levels | Week 14, n=29, 30, 33, 34, 27, 23 | 0.0021 Proportion of red blood cells in blood | Standard Deviation 0.0288 |
| GSK2894512 0.5% BID | Change From Baseline in Hematocrit Levels | Week 12, n=27, 30, 31, 36, 26, 25 | 0.0059 Proportion of red blood cells in blood | Standard Deviation 0.0235 |
| GSK2894512 0.5% BID | Change From Baseline in Hematocrit Levels | Week 8, n=30, 31, 32, 38, 27, 26 | -0.0004 Proportion of red blood cells in blood | Standard Deviation 0.0288 |
| GSK2894512 0.5% BID | Change From Baseline in Hematocrit Levels | Week 2, n=35, 35, 36, 37, 29, 35 | -0.0002 Proportion of red blood cells in blood | Standard Deviation 0.0251 |
| GSK2894512 0.5% BID | Change From Baseline in Hematocrit Levels | Week 4, n=32, 34, 35, 37, 29, 31 | 0.0058 Proportion of red blood cells in blood | Standard Deviation 0.0283 |
| GSK2894512 0.5% QD | Change From Baseline in Hematocrit Levels | Week 12, n=27, 30, 31, 36, 26, 25 | -0.0013 Proportion of red blood cells in blood | Standard Deviation 0.0202 |
| GSK2894512 0.5% QD | Change From Baseline in Hematocrit Levels | Week 4, n=32, 34, 35, 37, 29, 31 | -0.0008 Proportion of red blood cells in blood | Standard Deviation 0.0269 |
| GSK2894512 0.5% QD | Change From Baseline in Hematocrit Levels | Week 8, n=30, 31, 32, 38, 27, 26 | -0.0036 Proportion of red blood cells in blood | Standard Deviation 0.0342 |
| GSK2894512 0.5% QD | Change From Baseline in Hematocrit Levels | EW, n=10, 6, 3, 2, 10, 9 | -0.0050 Proportion of red blood cells in blood | Standard Deviation 0.0014 |
| GSK2894512 0.5% QD | Change From Baseline in Hematocrit Levels | Week 14, n=29, 30, 33, 34, 27, 23 | -0.0120 Proportion of red blood cells in blood | Standard Deviation 0.0348 |
| GSK2894512 0.5% QD | Change From Baseline in Hematocrit Levels | Week 2, n=35, 35, 36, 37, 29, 35 | -0.0038 Proportion of red blood cells in blood | Standard Deviation 0.0193 |
| Vehicle BID | Change From Baseline in Hematocrit Levels | Week 2, n=35, 35, 36, 37, 29, 35 | -0.0063 Proportion of red blood cells in blood | Standard Deviation 0.0243 |
| Vehicle BID | Change From Baseline in Hematocrit Levels | Week 14, n=29, 30, 33, 34, 27, 23 | -0.0021 Proportion of red blood cells in blood | Standard Deviation 0.0336 |
| Vehicle BID | Change From Baseline in Hematocrit Levels | Week 4, n=32, 34, 35, 37, 29, 31 | 0.0028 Proportion of red blood cells in blood | Standard Deviation 0.0291 |
| Vehicle BID | Change From Baseline in Hematocrit Levels | Week 8, n=30, 31, 32, 38, 27, 26 | 0.0084 Proportion of red blood cells in blood | Standard Deviation 0.0284 |
| Vehicle BID | Change From Baseline in Hematocrit Levels | Week 12, n=27, 30, 31, 36, 26, 25 | 0.0045 Proportion of red blood cells in blood | Standard Deviation 0.0225 |
| Vehicle BID | Change From Baseline in Hematocrit Levels | EW, n=10, 6, 3, 2, 10, 9 | -0.0017 Proportion of red blood cells in blood | Standard Deviation 0.0161 |
| Vehicle QD | Change From Baseline in Hematocrit Levels | Week 12, n=27, 30, 31, 36, 26, 25 | 0.0084 Proportion of red blood cells in blood | Standard Deviation 0.0286 |
| Vehicle QD | Change From Baseline in Hematocrit Levels | Week 8, n=30, 31, 32, 38, 27, 26 | 0.0092 Proportion of red blood cells in blood | Standard Deviation 0.0319 |
| Vehicle QD | Change From Baseline in Hematocrit Levels | Week 14, n=29, 30, 33, 34, 27, 23 | 0.0035 Proportion of red blood cells in blood | Standard Deviation 0.0186 |
| Vehicle QD | Change From Baseline in Hematocrit Levels | EW, n=10, 6, 3, 2, 10, 9 | 0.0014 Proportion of red blood cells in blood | Standard Deviation 0.0268 |
| Vehicle QD | Change From Baseline in Hematocrit Levels | Week 4, n=32, 34, 35, 37, 29, 31 | 0.0054 Proportion of red blood cells in blood | Standard Deviation 0.0239 |
| Vehicle QD | Change From Baseline in Hematocrit Levels | Week 2, n=35, 35, 36, 37, 29, 35 | 0.0011 Proportion of red blood cells in blood | Standard Deviation 0.0217 |
Secondary
Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC)
Blood samples were collected for the evaluation of change in Hgb levels and MCHC from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Baseline and up to Week 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 8, n=30, 31, 32, 38, 27, 26 | -5.4 G/L | Standard Deviation 11.25 |
| GSK2894512 1% BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 2, n=35, 35, 36, 37, 29, 35 | 0.3 G/L | Standard Deviation 5.84 |
| GSK2894512 1% BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 4, n=32, 34, 35, 37, 29, 31 | -3.1 G/L | Standard Deviation 11.45 |
| GSK2894512 1% BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, EW, n=10, 6, 3, 2, 10, 9 | -1.1 G/L | Standard Deviation 11.57 |
| GSK2894512 1% BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 8, n=30, 31, 32, 38, 27, 26 | -1.8 G/L | Standard Deviation 6.18 |
| GSK2894512 1% BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 14, n=29, 30, 33, 34, 27, 23 | -5.4 G/L | Standard Deviation 8.55 |
| GSK2894512 1% BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 12, n=27, 30, 31, 36, 26, 25 | -1.3 G/L | Standard Deviation 5.74 |
| GSK2894512 1% BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 14, n=29, 30, 33, 34, 27, 23 | -1.9 G/L | Standard Deviation 7.85 |
| GSK2894512 1% BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 12, n=27, 30, 31, 36, 26, 25 | -6.1 G/L | Standard Deviation 12.65 |
| GSK2894512 1% BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, EW, n=10, 6, 3, 2, 10, 9 | 0.0 G/L | Standard Deviation 7.26 |
| GSK2894512 1% BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 4, n=32, 34, 35, 37, 29, 31 | -1.0 G/L | Standard Deviation 6.02 |
| GSK2894512 1% BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 2, n=35, 35, 36, 37, 29, 35 | -1.5 G/L | Standard Deviation 8.77 |
| GSK2894512 1% QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, EW, n=10, 6, 3, 2, 10, 9 | -7.8 G/L | Standard Deviation 8.73 |
| GSK2894512 1% QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 2, n=35, 35, 36, 37, 29, 35 | -1.3 G/L | Standard Deviation 9.44 |
| GSK2894512 1% QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 8, n=30, 31, 32, 38, 27, 26 | -3.2 G/L | Standard Deviation 12.76 |
| GSK2894512 1% QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 4, n=32, 34, 35, 37, 29, 31 | -2.5 G/L | Standard Deviation 5.86 |
| GSK2894512 1% QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 14, n=29, 30, 33, 34, 27, 23 | -2.7 G/L | Standard Deviation 7.54 |
| GSK2894512 1% QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 12, n=27, 30, 31, 36, 26, 25 | -0.8 G/L | Standard Deviation 6.86 |
| GSK2894512 1% QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 2, n=35, 35, 36, 37, 29, 35 | -1.6 G/L | Standard Deviation 6.98 |
| GSK2894512 1% QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 4, n=32, 34, 35, 37, 29, 31 | -2.1 G/L | Standard Deviation 9.88 |
| GSK2894512 1% QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 14, n=29, 30, 33, 34, 27, 23 | -5.5 G/L | Standard Deviation 9.15 |
| GSK2894512 1% QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 8, n=30, 31, 32, 38, 27, 26 | 0.1 G/L | Standard Deviation 6.78 |
| GSK2894512 1% QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, EW, n=10, 6, 3, 2, 10, 9 | 1.5 G/L | Standard Deviation 8.5 |
| GSK2894512 1% QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 12, n=27, 30, 31, 36, 26, 25 | -6.1 G/L | Standard Deviation 11.25 |
| GSK2894512 0.5% BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 14, n=29, 30, 33, 34, 27, 23 | -7.4 G/L | Standard Deviation 10.74 |
| GSK2894512 0.5% BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 8, n=30, 31, 32, 38, 27, 26 | -2.8 G/L | Standard Deviation 9.06 |
| GSK2894512 0.5% BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 8, n=30, 31, 32, 38, 27, 26 | -5.9 G/L | Standard Deviation 13.41 |
| GSK2894512 0.5% BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 12, n=27, 30, 31, 36, 26, 25 | -1.9 G/L | Standard Deviation 8.76 |
| GSK2894512 0.5% BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, EW, n=10, 6, 3, 2, 10, 9 | -6.3 G/L | Standard Deviation 9.07 |
| GSK2894512 0.5% BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 12, n=27, 30, 31, 36, 26, 25 | -8.6 G/L | Standard Deviation 11.49 |
| GSK2894512 0.5% BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 2, n=35, 35, 36, 37, 29, 35 | -3.0 G/L | Standard Deviation 10.32 |
| GSK2894512 0.5% BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 4, n=32, 34, 35, 37, 29, 31 | -3.6 G/L | Standard Deviation 10.6 |
| GSK2894512 0.5% BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 14, n=29, 30, 33, 34, 27, 23 | -2.6 G/L | Standard Deviation 8.64 |
| GSK2894512 0.5% BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 4, n=32, 34, 35, 37, 29, 31 | 0.3 G/L | Standard Deviation 8.74 |
| GSK2894512 0.5% BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 2, n=35, 35, 36, 37, 29, 35 | -1.4 G/L | Standard Deviation 7.51 |
| GSK2894512 0.5% BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, EW, n=10, 6, 3, 2, 10, 9 | -5.7 G/L | Standard Deviation 3.79 |
| GSK2894512 0.5% QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 4, n=32, 34, 35, 37, 29, 31 | 0.4 G/L | Standard Deviation 8.36 |
| GSK2894512 0.5% QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 2, n=35, 35, 36, 37, 29, 35 | -0.6 G/L | Standard Deviation 6.29 |
| GSK2894512 0.5% QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 4, n=32, 34, 35, 37, 29, 31 | -0.1 G/L | Standard Deviation 8.82 |
| GSK2894512 0.5% QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 8, n=30, 31, 32, 38, 27, 26 | -2.1 G/L | Standard Deviation 9.17 |
| GSK2894512 0.5% QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 12, n=27, 30, 31, 36, 26, 25 | -2.4 G/L | Standard Deviation 5.94 |
| GSK2894512 0.5% QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 14, n=29, 30, 33, 34, 27, 23 | -5.0 G/L | Standard Deviation 10.24 |
| GSK2894512 0.5% QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, EW, n=10, 6, 3, 2, 10, 9 | -1.5 G/L | Standard Deviation 0.71 |
| GSK2894512 0.5% QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 2, n=35, 35, 36, 37, 29, 35 | 1.0 G/L | Standard Deviation 7.15 |
| GSK2894512 0.5% QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 8, n=30, 31, 32, 38, 27, 26 | -2.3 G/L | Standard Deviation 11.29 |
| GSK2894512 0.5% QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 12, n=27, 30, 31, 36, 26, 25 | -4.8 G/L | Standard Deviation 10.39 |
| GSK2894512 0.5% QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 14, n=29, 30, 33, 34, 27, 23 | -2.7 G/L | Standard Deviation 9.4 |
| GSK2894512 0.5% QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, EW, n=10, 6, 3, 2, 10, 9 | 0.0 G/L | Standard Deviation 0 |
| Vehicle BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 14, n=29, 30, 33, 34, 27, 23 | -2.8 G/L | Standard Deviation 8.82 |
| Vehicle BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 8, n=30, 31, 32, 38, 27, 26 | 1.0 G/L | Standard Deviation 8.82 |
| Vehicle BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 2, n=35, 35, 36, 37, 29, 35 | -1.3 G/L | Standard Deviation 7.79 |
| Vehicle BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, EW, n=10, 6, 3, 2, 10, 9 | -4.1 G/L | Standard Deviation 4.12 |
| Vehicle BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 14, n=29, 30, 33, 34, 27, 23 | -5.3 G/L | Standard Deviation 9.27 |
| Vehicle BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 12, n=27, 30, 31, 36, 26, 25 | -1.0 G/L | Standard Deviation 7.65 |
| Vehicle BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 4, n=32, 34, 35, 37, 29, 31 | -0.7 G/L | Standard Deviation 8.77 |
| Vehicle BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 8, n=30, 31, 32, 38, 27, 26 | -4.4 G/L | Standard Deviation 10.65 |
| Vehicle BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 12, n=27, 30, 31, 36, 26, 25 | -5.9 G/L | Standard Deviation 10.14 |
| Vehicle BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 2, n=35, 35, 36, 37, 29, 35 | 0.9 G/L | Standard Deviation 7.99 |
| Vehicle BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 4, n=32, 34, 35, 37, 29, 31 | -3.8 G/L | Standard Deviation 9.19 |
| Vehicle BID | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, EW, n=10, 6, 3, 2, 10, 9 | -2.3 G/L | Standard Deviation 4.99 |
| Vehicle QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 4, n=32, 34, 35, 37, 29, 31 | -1.6 G/L | Standard Deviation 10.02 |
| Vehicle QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 14, n=29, 30, 33, 34, 27, 23 | -1.6 G/L | Standard Deviation 5.94 |
| Vehicle QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 8, n=30, 31, 32, 38, 27, 26 | -3.8 G/L | Standard Deviation 11.4 |
| Vehicle QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 12, n=27, 30, 31, 36, 26, 25 | 0.2 G/L | Standard Deviation 6.27 |
| Vehicle QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, EW, n=10, 6, 3, 2, 10, 9 | -1.3 G/L | Standard Deviation 9.1 |
| Vehicle QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 12, n=27, 30, 31, 36, 26, 25 | -5.0 G/L | Standard Deviation 10.74 |
| Vehicle QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 8, n=30, 31, 32, 38, 27, 26 | 1.2 G/L | Standard Deviation 7.73 |
| Vehicle QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 4, n=32, 34, 35, 37, 29, 31 | 1.0 G/L | Standard Deviation 5.68 |
| Vehicle QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 14, n=29, 30, 33, 34, 27, 23 | -5.9 G/L | Standard Deviation 9.79 |
| Vehicle QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, Week 2, n=35, 35, 36, 37, 29, 35 | 0.1 G/L | Standard Deviation 6.18 |
| Vehicle QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | MCHC, Week 2, n=35, 35, 36, 37, 29, 35 | -0.5 G/L | Standard Deviation 7.1 |
| Vehicle QD | Change From Baseline in Hemoglobin (Hgb) Level and Erythrocyte Mean Corpuscular Hgb Concentration (MCHC) | Hgb, EW, n=10, 6, 3, 2, 10, 9 | -0.1 G/L | Standard Deviation 6.13 |
Secondary
Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels
Blood samples were collected for the evaluation of change in IgA, IgG and IgM levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Baseline and up to Week 12
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgA, Week 4, n=32, 34, 35, 38, 29, 31 | -0.035 g/L | Standard Deviation 0.2151 |
| GSK2894512 1% BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgG, Week 8, n=30, 31, 33, 38, 27, 26 | -0.098 g/L | Standard Deviation 1.1559 |
| GSK2894512 1% BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgG, Week 12, n=27, 30, 32, 36, 26, 24 | 0.248 g/L | Standard Deviation 0.8937 |
| GSK2894512 1% BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgM, Week 8, n=30, 31, 33, 38, 27, 26 | -0.103 g/L | Standard Deviation 0.1649 |
| GSK2894512 1% BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgM, Week 12, n=27, 30, 32, 36, 26, 24 | -0.072 g/L | Standard Deviation 0.0992 |
| GSK2894512 1% BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgA, Week 8, n=30, 31, 33, 38, 27, 26 | 0.021 g/L | Standard Deviation 0.3615 |
| GSK2894512 1% BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgG, Week 4, n=32, 34, 35, 38, 29, 31 | 0.130 g/L | Standard Deviation 0.815 |
| GSK2894512 1% BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgA, Week 12, n=27, 30, 32, 36, 26, 24 | -0.028 g/L | Standard Deviation 0.2806 |
| GSK2894512 1% BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgM, Week 4, n=32, 34, 35, 38, 29, 31 | -0.077 g/L | Standard Deviation 0.1215 |
| GSK2894512 1% QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgM, Week 4, n=32, 34, 35, 38, 29, 31 | -0.050 g/L | Standard Deviation 0.0797 |
| GSK2894512 1% QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgA, Week 12, n=27, 30, 32, 36, 26, 24 | -0.138 g/L | Standard Deviation 0.2461 |
| GSK2894512 1% QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgM, Week 8, n=30, 31, 33, 38, 27, 26 | -0.030 g/L | Standard Deviation 0.1737 |
| GSK2894512 1% QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgG, Week 12, n=27, 30, 32, 36, 26, 24 | 0.029 g/L | Standard Deviation 1.1145 |
| GSK2894512 1% QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgM, Week 12, n=27, 30, 32, 36, 26, 24 | -0.082 g/L | Standard Deviation 0.1264 |
| GSK2894512 1% QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgA, Week 4, n=32, 34, 35, 38, 29, 31 | -0.138 g/L | Standard Deviation 0.3147 |
| GSK2894512 1% QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgG, Week 4, n=32, 34, 35, 38, 29, 31 | -0.223 g/L | Standard Deviation 1.0422 |
| GSK2894512 1% QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgA, Week 8, n=30, 31, 33, 38, 27, 26 | -0.151 g/L | Standard Deviation 0.3497 |
| GSK2894512 1% QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgG, Week 8, n=30, 31, 33, 38, 27, 26 | -0.055 g/L | Standard Deviation 1.1243 |
| GSK2894512 0.5% BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgG, Week 4, n=32, 34, 35, 38, 29, 31 | 0.117 g/L | Standard Deviation 1.4003 |
| GSK2894512 0.5% BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgG, Week 8, n=30, 31, 33, 38, 27, 26 | -0.016 g/L | Standard Deviation 1.4066 |
| GSK2894512 0.5% BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgM, Week 8, n=30, 31, 33, 38, 27, 26 | -0.005 g/L | Standard Deviation 0.4892 |
| GSK2894512 0.5% BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgA, Week 4, n=32, 34, 35, 38, 29, 31 | -0.153 g/L | Standard Deviation 0.5744 |
| GSK2894512 0.5% BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgM, Week 4, n=32, 34, 35, 38, 29, 31 | -0.023 g/L | Standard Deviation 0.3524 |
| GSK2894512 0.5% BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgA, Week 8, n=30, 31, 33, 38, 27, 26 | -0.239 g/L | Standard Deviation 0.6447 |
| GSK2894512 0.5% BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgA, Week 12, n=27, 30, 32, 36, 26, 24 | -0.271 g/L | Standard Deviation 0.6764 |
| GSK2894512 0.5% BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgM, Week 12, n=27, 30, 32, 36, 26, 24 | -0.047 g/L | Standard Deviation 0.5307 |
| GSK2894512 0.5% BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgG, Week 12, n=27, 30, 32, 36, 26, 24 | -0.360 g/L | Standard Deviation 1.3683 |
| GSK2894512 0.5% QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgA, Week 8, n=30, 31, 33, 38, 27, 26 | -0.064 g/L | Standard Deviation 0.6353 |
| GSK2894512 0.5% QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgA, Week 4, n=32, 34, 35, 38, 29, 31 | -0.024 g/L | Standard Deviation 0.615 |
| GSK2894512 0.5% QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgA, Week 12, n=27, 30, 32, 36, 26, 24 | -0.037 g/L | Standard Deviation 1.0705 |
| GSK2894512 0.5% QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgG, Week 4, n=32, 34, 35, 38, 29, 31 | 0.028 g/L | Standard Deviation 1.7157 |
| GSK2894512 0.5% QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgG, Week 8, n=30, 31, 33, 38, 27, 26 | 0.195 g/L | Standard Deviation 1.433 |
| GSK2894512 0.5% QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgG, Week 12, n=27, 30, 32, 36, 26, 24 | 0.251 g/L | Standard Deviation 1.4115 |
| GSK2894512 0.5% QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgM, Week 4, n=32, 34, 35, 38, 29, 31 | -0.017 g/L | Standard Deviation 0.1434 |
| GSK2894512 0.5% QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgM, Week 8, n=30, 31, 33, 38, 27, 26 | -0.012 g/L | Standard Deviation 0.1213 |
| GSK2894512 0.5% QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgM, Week 12, n=27, 30, 32, 36, 26, 24 | -0.017 g/L | Standard Deviation 0.1495 |
| Vehicle BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgG, Week 12, n=27, 30, 32, 36, 26, 24 | 0.377 g/L | Standard Deviation 2.0539 |
| Vehicle BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgA, Week 8, n=30, 31, 33, 38, 27, 26 | 0.086 g/L | Standard Deviation 0.6911 |
| Vehicle BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgM, Week 4, n=32, 34, 35, 38, 29, 31 | -0.004 g/L | Standard Deviation 0.1951 |
| Vehicle BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgA, Week 4, n=32, 34, 35, 38, 29, 31 | 0.125 g/L | Standard Deviation 0.5462 |
| Vehicle BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgM, Week 12, n=27, 30, 32, 36, 26, 24 | -0.023 g/L | Standard Deviation 0.2431 |
| Vehicle BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgM, Week 8, n=30, 31, 33, 38, 27, 26 | -0.011 g/L | Standard Deviation 0.1951 |
| Vehicle BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgG, Week 8, n=30, 31, 33, 38, 27, 26 | 0.634 g/L | Standard Deviation 1.4913 |
| Vehicle BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgA, Week 12, n=27, 30, 32, 36, 26, 24 | -0.023 g/L | Standard Deviation 0.8912 |
| Vehicle BID | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgG, Week 4, n=32, 34, 35, 38, 29, 31 | 0.441 g/L | Standard Deviation 1.6655 |
| Vehicle QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgG, Week 4, n=32, 34, 35, 38, 29, 31 | 0.218 g/L | Standard Deviation 1.1025 |
| Vehicle QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgA, Week 8, n=30, 31, 33, 38, 27, 26 | -0.050 g/L | Standard Deviation 0.4347 |
| Vehicle QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgA, Week 12, n=27, 30, 32, 36, 26, 24 | -0.018 g/L | Standard Deviation 0.2355 |
| Vehicle QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgA, Week 4, n=32, 34, 35, 38, 29, 31 | 0.006 g/L | Standard Deviation 0.235 |
| Vehicle QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgM, Week 12, n=27, 30, 32, 36, 26, 24 | -0.033 g/L | Standard Deviation 0.19 |
| Vehicle QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgM, Week 8, n=30, 31, 33, 38, 27, 26 | -0.006 g/L | Standard Deviation 0.1802 |
| Vehicle QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgG, Week 12, n=27, 30, 32, 36, 26, 24 | 0.283 g/L | Standard Deviation 1.0979 |
| Vehicle QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgM, Week 4, n=32, 34, 35, 38, 29, 31 | -0.016 g/L | Standard Deviation 0.1371 |
| Vehicle QD | Change From Baseline in Immunoglobulin (Ig) A, IgG and IgM Levels | IgG, Week 8, n=30, 31, 33, 38, 27, 26 | 0.299 g/L | Standard Deviation 1.3855 |
Secondary
Change From Baseline in Immunophenotype Data
Blood samples were collected for the evaluation of change from Baseline in immunophenotype levels including CD19, CD3, CD3TFLC, CD3+CD8+, CD3+CD8+ TFLC, CD3+CD4+, CD3+CD4+ TFLC, CD16+CD56+, CD3+CD4+CD25+CD127 flow cytometry (CD3+CD4+CD25+CD127), CD3+CD4+foxP3+CD25+CD127 flow cytometry (CD3+CD4+fP3+CD25+CD127) and T-B cell NKL. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Baseline and up to Week 12
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD3+CD4+fP3+CD25+CD127 Week12,n=25,24,30,34,24,24 | 0.0063 GI/L | Standard Deviation 0.0115 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD3+CD4+ TFLC, Week 12, n=25, 24, 30, 34, 24, 24 | -0.0511 GI/L | Standard Deviation 0.2835 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD19, Week 8, n=30, 31, 33, 38, 27, 26 | 0.0367 GI/L | Standard Deviation 0.1284 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD3+CD4+, Week 4, n=30, 32, 35, 38, 29, 30 | -0.0750 GI/L | Standard Deviation 0.2756 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD3 TFLC, Week 8, n=29, 27, 31, 34, 25, 22 | 0.0187 GI/L | Standard Deviation 0.4749 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD3+CD4+, Week 8, n=30, 31, 33, 38, 27, 26 | 0.0296 GI/L | Standard Deviation 0.3006 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD3+CD4+CD25+CD127, Week 12, n=25,24,30,34,24,24 | 0.0060 GI/L | Standard Deviation 0.0121 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD3, Week 4, n=30, 32, 35, 38, 29, 30 | -0.1067 GI/L | Standard Deviation 0.3964 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD3+CD4+, Week 12, n=27, 29, 32, 36, 26, 24 | -0.0228 GI/L | Standard Deviation 0.2928 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | T-B cell NKL, Week 12, n=27,29,32,36,26,24 | -0.063 GI/L | Standard Deviation 0.5793 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD3 TFLC, Week 12, n=25,24,30, 34, 24, 24 | -0.0916 GI/L | Standard Deviation 0.4466 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD3+CD8+ TFLC, Week 12, n=25, 24, 30, 34, 24, 24 | -0.0306 GI/L | Standard Deviation 0.1284 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD16+CD56+, Week 8, n=30, 31, 33, 38, 27, 26 | 0.002 GI/L | Standard Deviation 0.0699 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD3+CD4+fP3+CD25+CD127, Week4,n=27,29,32,36,28,26 | -0.0019 GI/L | Standard Deviation 0.0118 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD3, Week 12, n=27, 29, 32, 36, 26, 24 | -0.0511 GI/L | Standard Deviation 0.4225 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD3+CD4+ TFLC, Week 8, n=29, 27, 31, 34, 25, 22 | 0.0268 GI/L | Standard Deviation 0.3134 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD3+CD8+ TFLC, Week 8, n=29, 27, 31, 34, 25, 22 | -0.0066 GI/L | Standard Deviation 0.142 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD3+CD8+, Week 4, n=30, 32, 35, 38, 29, 30 | -0.0297 GI/L | Standard Deviation 0.1394 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD3+CD8+ TFLC, Week 4, n=27, 29, 32, 36, 28, 26 | -0.0203 GI/L | Standard Deviation 0.1264 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | T-B cell NKL, Week 4, n=30,32,35,38,29,30 | -0.157 GI/L | Standard Deviation 0.5537 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD3+CD4+fP3+CD25+CD127, Week 8,n=29,27,31,34,25,22 | -0.0006 GI/L | Standard Deviation 0.017 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD3+CD4+ TFLC, Week 4, n=27, 29, 32, 36, 28, 26 | -0.0512 GI/L | Standard Deviation 0.2493 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD3+CD4+CD25+CD127, Week 8, n=29,27,31,34,25,22 | 0.0002 GI/L | Standard Deviation 0.0141 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD3+CD8+, Week 8, n=30, 31, 33, 38, 27, 26 | 0.0001 GI/L | Standard Deviation 0.1582 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD19, Week 12, n=27, 29, 32, 36, 26, 24 | 0.0059 GI/L | Standard Deviation 0.1178 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD3, Week 8, n=30, 31, 33, 38, 27, 26 | 0.0227 GI/L | Standard Deviation 0.4318 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD3+CD4+CD25+CD127, Week 4, n=27,29,32,36,28,26 | 0.0016 GI/L | Standard Deviation 0.0109 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD16+CD56+, Week 12, n=27, 29, 32, 36, 26, 24 | -0.010 GI/L | Standard Deviation 0.0861 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD3 TFLC, Week 4, n=27, 29, 32, 36, 28, 26 | -0.0829 GI/L | Standard Deviation 0.4002 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD3+CD8+, Week 12, n=27, 29, 32, 36, 26, 24 | -0.0174 GI/L | Standard Deviation 0.1417 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | T-B cell NKL, Week 8, n=30,31,33,38,27,26 | 0.057 GI/L | Standard Deviation 0.5699 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD16+CD56+, Week 4, n=30, 32, 35, 38, 29, 30 | -0.023 GI/L | Standard Deviation 0.091 |
| GSK2894512 1% BID | Change From Baseline in Immunophenotype Data | CD19, Week 4, n=30, 32, 35, 38, 29, 30 | -0.0182 GI/L | Standard Deviation 0.106 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD3+CD8+, Week 8, n=30, 31, 33, 38, 27, 26 | 0.0683 GI/L | Standard Deviation 0.1697 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD3+CD8+ TFLC, Week 4, n=27, 29, 32, 36, 28, 26 | 0.0359 GI/L | Standard Deviation 0.1719 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD3, Week 4, n=30, 32, 35, 38, 29, 30 | 0.1044 GI/L | Standard Deviation 0.3945 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD3+CD4+, Week 8, n=30, 31, 33, 38, 27, 26 | 0.0758 GI/L | Standard Deviation 0.2036 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD3+CD8+ TFLC, Week 8, n=29, 27, 31, 34, 25, 22 | 0.0375 GI/L | Standard Deviation 0.1628 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD3+CD4+CD25+CD127, Week 12, n=25,24,30,34,24,24 | 0.0035 GI/L | Standard Deviation 0.0279 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD3+CD8+ TFLC, Week 12, n=25, 24, 30, 34, 24, 24 | 0.0260 GI/L | Standard Deviation 0.176 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD16+CD56+, Week 8, n=30, 31, 33, 38, 27, 26 | 0.011 GI/L | Standard Deviation 0.1312 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD19, Week 12, n=27, 29, 32, 36, 26, 24 | 0.0362 GI/L | Standard Deviation 0.0968 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | T-B cell NKL, Week 4, n=30,32,35,38,29,30 | 0.152 GI/L | Standard Deviation 0.5655 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD3+CD4+, Week 4, n=30, 32, 35, 38, 29, 30 | 0.0525 GI/L | Standard Deviation 0.2577 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD3, Week 8, n=30, 31, 33, 38, 27, 26 | 0.1426 GI/L | Standard Deviation 0.365 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD3, Week 12, n=27, 29, 32, 36, 26, 24 | 0.1327 GI/L | Standard Deviation 0.423 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD19, Week 4, n=30, 32, 35, 38, 29, 30 | 0.0318 GI/L | Standard Deviation 0.1046 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD3+CD4+fP3+CD25+CD127, Week4,n=27,29,32,36,28,26 | 0.0057 GI/L | Standard Deviation 0.011 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD3+CD4+fP3+CD25+CD127, Week 8,n=29,27,31,34,25,22 | 0.0055 GI/L | Standard Deviation 0.0121 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD3+CD4+ TFLC, Week 12, n=25, 24, 30, 34, 24, 24 | 0.1196 GI/L | Standard Deviation 0.2891 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD3 TFLC, Week 4, n=27, 29, 32, 36, 28, 26 | 0.1270 GI/L | Standard Deviation 0.4233 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD3+CD4+CD25+CD127, Week 4, n=27,29,32,36,28,26 | 0.0021 GI/L | Standard Deviation 0.0195 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | T-B cell NKL, Week 12, n=27,29,32,36,26,24 | 0.163 GI/L | Standard Deviation 0.6093 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD3 TFLC, Week 8, n=29, 27, 31, 34, 25, 22 | 0.1296 GI/L | Standard Deviation 0.3352 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD16+CD56+, Week 12, n=27, 29, 32, 36, 26, 24 | -0.001 GI/L | Standard Deviation 0.1283 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD3+CD4+fP3+CD25+CD127 Week12,n=25,24,30,34,24,24 | 0.0041 GI/L | Standard Deviation 0.0147 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD19, Week 8, n=30, 31, 33, 38, 27, 26 | 0.0491 GI/L | Standard Deviation 0.0984 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD3 TFLC, Week 12, n=25,24,30, 34, 24, 24 | 0.1494 GI/L | Standard Deviation 0.4745 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD3+CD4+ TFLC, Week 8, n=29, 27, 31, 34, 25, 22 | 0.0857 GI/L | Standard Deviation 0.1814 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD16+CD56+, Week 4, n=30, 32, 35, 38, 29, 30 | 0.014 GI/L | Standard Deviation 0.1031 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD3+CD4+ TFLC, Week 4, n=27, 29, 32, 36, 28, 26 | 0.0764 GI/L | Standard Deviation 0.2613 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD3+CD8+, Week 4, n=30, 32, 35, 38, 29, 30 | 0.0524 GI/L | Standard Deviation 0.1516 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD3+CD4+CD25+CD127, Week 8, n=29,27,31,34,25,22 | 0.0040 GI/L | Standard Deviation 0.0228 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD3+CD4+, Week 12, n=27, 29, 32, 36, 26, 24 | 0.0936 GI/L | Standard Deviation 0.2664 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | T-B cell NKL, Week 8, n=30,31,33,38,27,26 | 0.195 GI/L | Standard Deviation 0.5345 |
| GSK2894512 1% QD | Change From Baseline in Immunophenotype Data | CD3+CD8+, Week 12, n=27, 29, 32, 36, 26, 24 | 0.0477 GI/L | Standard Deviation 0.1642 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD3+CD4+, Week 12, n=27, 29, 32, 36, 26, 24 | -0.0225 GI/L | Standard Deviation 0.2149 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD16+CD56+, Week 12, n=27, 29, 32, 36, 26, 24 | -0.015 GI/L | Standard Deviation 0.0861 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD3+CD4+CD25+CD127, Week 4, n=27,29,32,36,28,26 | 0.0019 GI/L | Standard Deviation 0.0147 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD3+CD4+CD25+CD127, Week 8, n=29,27,31,34,25,22 | 0.0027 GI/L | Standard Deviation 0.0133 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD3+CD4+CD25+CD127, Week 12, n=25,24,30,34,24,24 | 0.0029 GI/L | Standard Deviation 0.0164 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD3+CD4+fP3+CD25+CD127, Week4,n=27,29,32,36,28,26 | 0.0018 GI/L | Standard Deviation 0.0107 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD3, Week 12, n=27, 29, 32, 36, 26, 24 | -0.0248 GI/L | Standard Deviation 0.314 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | T-B cell NKL, Week 12, n=27,29,32,36,26,24 | -0.081 GI/L | Standard Deviation 0.4282 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD3 TFLC, Week 4, n=27, 29, 32, 36, 28, 26 | 0.0196 GI/L | Standard Deviation 0.3104 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD3 TFLC, Week 8, n=29, 27, 31, 34, 25, 22 | -0.0158 GI/L | Standard Deviation 0.3503 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD3 TFLC, Week 12, n=25,24,30, 34, 24, 24 | -0.0266 GI/L | Standard Deviation 0.3227 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD19, Week 8, n=30, 31, 33, 38, 27, 26 | -0.0288 GI/L | Standard Deviation 0.0953 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD3+CD8+, Week 4, n=30, 32, 35, 38, 29, 30 | 0.0094 GI/L | Standard Deviation 0.1279 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | T-B cell NKL, Week 8, n=30,31,33,38,27,26 | -0.028 GI/L | Standard Deviation 0.4384 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD3+CD8+, Week 8, n=30, 31, 33, 38, 27, 26 | 0.0100 GI/L | Standard Deviation 0.1006 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD19, Week 12, n=27, 29, 32, 36, 26, 24 | -0.0334 GI/L | Standard Deviation 0.0968 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD3+CD8+, Week 12, n=27, 29, 32, 36, 26, 24 | 0.0106 GI/L | Standard Deviation 0.1253 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD3+CD8+ TFLC, Week 4, n=27, 29, 32, 36, 28, 26 | 0.0083 GI/L | Standard Deviation 0.098 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD3+CD8+ TFLC, Week 8, n=29, 27, 31, 34, 25, 22 | 0.0091 GI/L | Standard Deviation 0.092 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD19, Week 4, n=30, 32, 35, 38, 29, 30 | -0.0261 GI/L | Standard Deviation 0.1177 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | T-B cell NKL, Week 4, n=30,32,35,38,29,30 | -0.051 GI/L | Standard Deviation 0.4505 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD3+CD8+ TFLC, Week 12, n=25, 24, 30, 34, 24, 24 | -0.0042 GI/L | Standard Deviation 0.1113 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD3+CD4+, Week 4, n=30, 32, 35, 38, 29, 30 | -0.0374 GI/L | Standard Deviation 0.2429 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD3+CD4+, Week 8, n=30, 31, 33, 38, 27, 26 | -0.0042 GI/L | Standard Deviation 0.2396 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD3+CD4+fP3+CD25+CD127, Week 8,n=29,27,31,34,25,22 | 0.0004 GI/L | Standard Deviation 0.0118 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD3, Week 4, n=30, 32, 35, 38, 29, 30 | -0.0360 GI/L | Standard Deviation 0.3419 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD3+CD4+ TFLC, Week 4, n=27, 29, 32, 36, 28, 26 | 0.0009 GI/L | Standard Deviation 0.2121 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD3+CD4+fP3+CD25+CD127 Week12,n=25,24,30,34,24,24 | 0.0005 GI/L | Standard Deviation 0.0127 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD3+CD4+ TFLC, Week 8, n=29, 27, 31, 34, 25, 22 | -0.0075 GI/L | Standard Deviation 0.2525 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD3+CD4+ TFLC, Week 12, n=25, 24, 30, 34, 24, 24 | -0.0159 GI/L | Standard Deviation 0.2244 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD16+CD56+, Week 4, n=30, 32, 35, 38, 29, 30 | 0.011 GI/L | Standard Deviation 0.0897 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD3, Week 8, n=30, 31, 33, 38, 27, 26 | -0.0101 GI/L | Standard Deviation 0.3231 |
| GSK2894512 0.5% BID | Change From Baseline in Immunophenotype Data | CD16+CD56+, Week 8, n=30, 31, 33, 38, 27, 26 | 0.009 GI/L | Standard Deviation 0.0867 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD3, Week 8, n=30, 31, 33, 38, 27, 26 | -0.0053 GI/L | Standard Deviation 0.3463 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD3+CD4+, Week 12, n=27, 29, 32, 36, 26, 24 | -0.0249 GI/L | Standard Deviation 0.2005 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD16+CD56+, Week 4, n=30, 32, 35, 38, 29, 30 | -0.009 GI/L | Standard Deviation 0.0821 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD3+CD4+fP3+CD25+CD127 Week12,n=25,24,30,34,24,24 | -0.0001 GI/L | Standard Deviation 0.0125 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD3+CD8+, Week 4, n=30, 32, 35, 38, 29, 30 | 0.0095 GI/L | Standard Deviation 0.1217 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD19, Week 8, n=30, 31, 33, 38, 27, 26 | -0.0464 GI/L | Standard Deviation 0.222 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD16+CD56+, Week 8, n=30, 31, 33, 38, 27, 26 | -0.002 GI/L | Standard Deviation 0.0713 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD3+CD4+ TFLC, Week 4, n=27, 29, 32, 36, 28, 26 | 0.0280 GI/L | Standard Deviation 0.2521 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD3, Week 4, n=30, 32, 35, 38, 29, 30 | 0.0186 GI/L | Standard Deviation 0.3417 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD3+CD4+fP3+CD25+CD127, Week 8,n=29,27,31,34,25,22 | 0.0055 GI/L | Standard Deviation 0.0134 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | T-B cell NKL, Week 8, n=30,31,33,38,27,26 | -0.064 GI/L | Standard Deviation 0.4563 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD3 TFLC, Week 12, n=25,24,30, 34, 24, 24 | -0.0342 GI/L | Standard Deviation 0.3157 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD3+CD4+CD25+CD127, Week 4, n=27,29,32,36,28,26 | -0.0036 GI/L | Standard Deviation 0.0218 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD3+CD4+ TFLC, Week 8, n=29, 27, 31, 34, 25, 22 | 0.0138 GI/L | Standard Deviation 0.2066 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD19, Week 4, n=30, 32, 35, 38, 29, 30 | -0.0184 GI/L | Standard Deviation 0.246 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD3 TFLC, Week 8, n=29, 27, 31, 34, 25, 22 | 0.0053 GI/L | Standard Deviation 0.2782 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD3 TFLC, Week 4, n=27, 29, 32, 36, 28, 26 | 0.0320 GI/L | Standard Deviation 0.3412 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD3, Week 12, n=27, 29, 32, 36, 26, 24 | -0.0315 GI/L | Standard Deviation 0.3259 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD16+CD56+, Week 12, n=27, 29, 32, 36, 26, 24 | -0.022 GI/L | Standard Deviation 0.1082 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD3+CD4+ TFLC, Week 12, n=25, 24, 30, 34, 24, 24 | 0.0044 GI/L | Standard Deviation 0.173 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD3+CD4+CD25+CD127, Week 12, n=25,24,30,34,24,24 | -0.0035 GI/L | Standard Deviation 0.0229 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD3+CD4+fP3+CD25+CD127, Week4,n=27,29,32,36,28,26 | -0.0024 GI/L | Standard Deviation 0.013 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD3+CD4+CD25+CD127, Week 8, n=29,27,31,34,25,22 | -0.0019 GI/L | Standard Deviation 0.02 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD3+CD4+, Week 4, n=30, 32, 35, 38, 29, 30 | 0.0210 GI/L | Standard Deviation 0.2475 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD3+CD8+ TFLC, Week 12, n=25, 24, 30, 34, 24, 24 | 0.0010 GI/L | Standard Deviation 0.1518 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD3+CD8+ TFLC, Week 8, n=29, 27, 31, 34, 25, 22 | 0.0035 GI/L | Standard Deviation 0.1194 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | T-B cell NKL, Week 4, n=30,32,35,38,29,30 | -0.009 GI/L | Standard Deviation 0.4837 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | T-B cell NKL, Week 12, n=27,29,32,36,26,24 | -0.094 GI/L | Standard Deviation 0.5229 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD19, Week 12, n=27, 29, 32, 36, 26, 24 | -0.0305 GI/L | Standard Deviation 0.2591 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD3+CD4+, Week 8, n=30, 31, 33, 38, 27, 26 | -0.0164 GI/L | Standard Deviation 0.2338 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD3+CD8+ TFLC, Week 4, n=27, 29, 32, 36, 28, 26 | -0.0069 GI/L | Standard Deviation 0.148 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD3+CD8+, Week 12, n=27, 29, 32, 36, 26, 24 | 0.0151 GI/L | Standard Deviation 0.1594 |
| GSK2894512 0.5% QD | Change From Baseline in Immunophenotype Data | CD3+CD8+, Week 8, n=30, 31, 33, 38, 27, 26 | 0.0219 GI/L | Standard Deviation 0.155 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD3+CD4+fP3+CD25+CD127 Week12,n=25,24,30,34,24,24 | 0.0001 GI/L | Standard Deviation 0.0099 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD19, Week 4, n=30, 32, 35, 38, 29, 30 | -0.0241 GI/L | Standard Deviation 0.321 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD19, Week 12, n=27, 29, 32, 36, 26, 24 | -0.0443 GI/L | Standard Deviation 0.2863 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD3, Week 4, n=30, 32, 35, 38, 29, 30 | -0.0842 GI/L | Standard Deviation 0.2888 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD3, Week 8, n=30, 31, 33, 38, 27, 26 | -0.1063 GI/L | Standard Deviation 0.4996 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD3, Week 12, n=27, 29, 32, 36, 26, 24 | -0.0822 GI/L | Standard Deviation 0.3222 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD3 TFLC, Week 4, n=27, 29, 32, 36, 28, 26 | -0.0937 GI/L | Standard Deviation 0.3115 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD3 TFLC, Week 8, n=29, 27, 31, 34, 25, 22 | -0.1393 GI/L | Standard Deviation 0.5368 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD3 TFLC, Week 12, n=25,24,30, 34, 24, 24 | -0.1220 GI/L | Standard Deviation 0.301 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD3+CD8+, Week 4, n=30, 32, 35, 38, 29, 30 | -0.0009 GI/L | Standard Deviation 0.1871 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD3+CD8+, Week 8, n=30, 31, 33, 38, 27, 26 | -0.0189 GI/L | Standard Deviation 0.2073 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD3+CD8+, Week 12, n=27, 29, 32, 36, 26, 24 | 0.0081 GI/L | Standard Deviation 0.192 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD3+CD8+ TFLC, Week 4, n=27, 29, 32, 36, 28, 26 | -0.0107 GI/L | Standard Deviation 0.1759 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD3+CD8+ TFLC, Week 8, n=29, 27, 31, 34, 25, 22 | -0.0254 GI/L | Standard Deviation 0.2065 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD3+CD8+ TFLC, Week 12, n=25, 24, 30, 34, 24, 24 | -0.0112 GI/L | Standard Deviation 0.1493 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD3+CD4+, Week 4, n=30, 32, 35, 38, 29, 30 | -0.0857 GI/L | Standard Deviation 0.1802 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD3+CD4+, Week 8, n=30, 31, 33, 38, 27, 26 | -0.0821 GI/L | Standard Deviation 0.3158 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD3+CD4+, Week 12, n=27, 29, 32, 36, 26, 24 | -0.0798 GI/L | Standard Deviation 0.1817 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD3+CD4+ TFLC, Week 4, n=27, 29, 32, 36, 28, 26 | -0.0729 GI/L | Standard Deviation 0.1786 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD3+CD4+ TFLC, Week 8, n=29, 27, 31, 34, 25, 22 | -0.0784 GI/L | Standard Deviation 0.3136 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD3+CD4+ TFLC, Week 12, n=25, 24, 30, 34, 24, 24 | -0.0679 GI/L | Standard Deviation 0.174 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD16+CD56+, Week 4, n=30, 32, 35, 38, 29, 30 | -0.013 GI/L | Standard Deviation 0.1134 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD16+CD56+, Week 8, n=30, 31, 33, 38, 27, 26 | -0.000 GI/L | Standard Deviation 0.18 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD16+CD56+, Week 12, n=27, 29, 32, 36, 26, 24 | -0.035 GI/L | Standard Deviation 0.1168 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD3+CD4+CD25+CD127, Week 4, n=27,29,32,36,28,26 | -0.0016 GI/L | Standard Deviation 0.0172 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD3+CD4+CD25+CD127, Week 8, n=29,27,31,34,25,22 | -0.0034 GI/L | Standard Deviation 0.0205 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD3+CD4+CD25+CD127, Week 12, n=25,24,30,34,24,24 | -0.0037 GI/L | Standard Deviation 0.0141 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD3+CD4+fP3+CD25+CD127, Week4,n=27,29,32,36,28,26 | -0.0005 GI/L | Standard Deviation 0.0115 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD3+CD4+fP3+CD25+CD127, Week 8,n=29,27,31,34,25,22 | 0.0003 GI/L | Standard Deviation 0.0107 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | T-B cell NKL, Week 4, n=30,32,35,38,29,30 | -0.137 GI/L | Standard Deviation 0.4446 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | T-B cell NKL, Week 8, n=30,31,33,38,27,26 | -0.186 GI/L | Standard Deviation 0.4999 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | T-B cell NKL, Week 12, n=27,29,32,36,26,24 | -0.193 GI/L | Standard Deviation 0.4038 |
| Vehicle BID | Change From Baseline in Immunophenotype Data | CD19, Week 8, n=30, 31, 33, 38, 27, 26 | -0.0533 GI/L | Standard Deviation 0.2878 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD16+CD56+, Week 8, n=30, 31, 33, 38, 27, 26 | 0.013 GI/L | Standard Deviation 0.1339 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD16+CD56+, Week 4, n=30, 32, 35, 38, 29, 30 | 0.001 GI/L | Standard Deviation 0.0876 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD19, Week 4, n=30, 32, 35, 38, 29, 30 | -0.0109 GI/L | Standard Deviation 0.0659 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD3+CD4+fP3+CD25+CD127, Week 8,n=29,27,31,34,25,22 | -0.0000 GI/L | Standard Deviation 0.01 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD3+CD4+ TFLC, Week 12, n=25, 24, 30, 34, 24, 24 | -0.0386 GI/L | Standard Deviation 0.1832 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD3+CD4+ TFLC, Week 8, n=29, 27, 31, 34, 25, 22 | -0.0298 GI/L | Standard Deviation 0.2089 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD3+CD4+ TFLC, Week 4, n=27, 29, 32, 36, 28, 26 | -0.0621 GI/L | Standard Deviation 0.2216 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD3+CD4+, Week 12, n=27, 29, 32, 36, 26, 24 | -0.0458 GI/L | Standard Deviation 0.196 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD3+CD4+, Week 8, n=30, 31, 33, 38, 27, 26 | -0.0715 GI/L | Standard Deviation 0.2205 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD3+CD4+fP3+CD25+CD127 Week12,n=25,24,30,34,24,24 | 0.0001 GI/L | Standard Deviation 0.0124 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD3+CD4+, Week 4, n=30, 32, 35, 38, 29, 30 | -0.0775 GI/L | Standard Deviation 0.2286 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD3+CD8+ TFLC, Week 12, n=25, 24, 30, 34, 24, 24 | 0.0193 GI/L | Standard Deviation 0.1535 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD3+CD8+ TFLC, Week 8, n=29, 27, 31, 34, 25, 22 | 0.0139 GI/L | Standard Deviation 0.1195 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD3+CD8+ TFLC, Week 4, n=27, 29, 32, 36, 28, 26 | -0.0180 GI/L | Standard Deviation 0.1055 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD19, Week 12, n=27, 29, 32, 36, 26, 24 | -0.0097 GI/L | Standard Deviation 0.0774 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | T-B cell NKL, Week 4, n=30,32,35,38,29,30 | -0.083 GI/L | Standard Deviation 0.4134 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD3+CD8+, Week 12, n=27, 29, 32, 36, 26, 24 | 0.0326 GI/L | Standard Deviation 0.169 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD3+CD8+, Week 8, n=30, 31, 33, 38, 27, 26 | 0.0566 GI/L | Standard Deviation 0.1508 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD3+CD8+, Week 4, n=30, 32, 35, 38, 29, 30 | 0.0179 GI/L | Standard Deviation 0.1504 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD3 TFLC, Week 12, n=25,24,30, 34, 24, 24 | -0.0280 GI/L | Standard Deviation 0.363 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD19, Week 8, n=30, 31, 33, 38, 27, 26 | 0.0150 GI/L | Standard Deviation 0.1099 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | T-B cell NKL, Week 8, n=30,31,33,38,27,26 | 0.006 GI/L | Standard Deviation 0.4809 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD3 TFLC, Week 8, n=29, 27, 31, 34, 25, 22 | -0.0383 GI/L | Standard Deviation 0.3471 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD3 TFLC, Week 4, n=27, 29, 32, 36, 28, 26 | -0.1031 GI/L | Standard Deviation 0.3504 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD3, Week 12, n=27, 29, 32, 36, 26, 24 | -0.0142 GI/L | Standard Deviation 0.3345 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD3, Week 8, n=30, 31, 33, 38, 27, 26 | -0.0213 GI/L | Standard Deviation 0.2936 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD3, Week 4, n=30, 32, 35, 38, 29, 30 | -0.0584 GI/L | Standard Deviation 0.3175 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD3+CD4+CD25+CD127, Week 12, n=25,24,30,34,24,24 | -0.0010 GI/L | Standard Deviation 0.0106 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD3+CD4+CD25+CD127, Week 8, n=29,27,31,34,25,22 | 0.0020 GI/L | Standard Deviation 0.0122 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | T-B cell NKL, Week 12, n=27,29,32,36,26,24 | 0.008 GI/L | Standard Deviation 0.4342 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD3+CD4+fP3+CD25+CD127, Week4,n=27,29,32,36,28,26 | -0.0003 GI/L | Standard Deviation 0.0104 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD3+CD4+CD25+CD127, Week 4, n=27,29,32,36,28,26 | -0.0008 GI/L | Standard Deviation 0.0097 |
| Vehicle QD | Change From Baseline in Immunophenotype Data | CD16+CD56+, Week 12, n=27, 29, 32, 36, 26, 24 | 0.024 GI/L | Standard Deviation 0.0792 |
Secondary
Change From Baseline in Pulse Rate
Pulse rate was measured in semi-supine position after at least 5 minutes of rest. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Baseline and up to Week 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Pulse Rate | Week 4, n=32, 34, 35, 38, 29, 31 | 1.2 beats per minute | Standard Deviation 8.08 |
| GSK2894512 1% BID | Change From Baseline in Pulse Rate | Week 8, n=30, 31, 33, 38, 27, 26 | -0.4 beats per minute | Standard Deviation 8.06 |
| GSK2894512 1% BID | Change From Baseline in Pulse Rate | Week 1, n=36, 38, 37, 38, 35, 37 | 0.5 beats per minute | Standard Deviation 8.82 |
| GSK2894512 1% BID | Change From Baseline in Pulse Rate | EW, n=10, 7, 4, 2, 10, 9 | -2.2 beats per minute | Standard Deviation 4.54 |
| GSK2894512 1% BID | Change From Baseline in Pulse Rate | Week 2, n=36, 36, 36, 38, 31, 35 | 0.9 beats per minute | Standard Deviation 10.33 |
| GSK2894512 1% BID | Change From Baseline in Pulse Rate | Week 14, n=29, 31, 33, 34, 27, 26 | -0.6 beats per minute | Standard Deviation 8.52 |
| GSK2894512 1% BID | Change From Baseline in Pulse Rate | Week 12, n=26, 30, 32, 36, 26, 25 | 0.1 beats per minute | Standard Deviation 9.16 |
| GSK2894512 1% QD | Change From Baseline in Pulse Rate | Week 12, n=26, 30, 32, 36, 26, 25 | -2.2 beats per minute | Standard Deviation 10.18 |
| GSK2894512 1% QD | Change From Baseline in Pulse Rate | Week 4, n=32, 34, 35, 38, 29, 31 | -0.9 beats per minute | Standard Deviation 8.08 |
| GSK2894512 1% QD | Change From Baseline in Pulse Rate | Week 2, n=36, 36, 36, 38, 31, 35 | -3.2 beats per minute | Standard Deviation 9.77 |
| GSK2894512 1% QD | Change From Baseline in Pulse Rate | Week 8, n=30, 31, 33, 38, 27, 26 | -0.9 beats per minute | Standard Deviation 7.59 |
| GSK2894512 1% QD | Change From Baseline in Pulse Rate | EW, n=10, 7, 4, 2, 10, 9 | -2.7 beats per minute | Standard Deviation 9.25 |
| GSK2894512 1% QD | Change From Baseline in Pulse Rate | Week 1, n=36, 38, 37, 38, 35, 37 | -0.4 beats per minute | Standard Deviation 9.4 |
| GSK2894512 1% QD | Change From Baseline in Pulse Rate | Week 14, n=29, 31, 33, 34, 27, 26 | -0.8 beats per minute | Standard Deviation 8.27 |
| GSK2894512 0.5% BID | Change From Baseline in Pulse Rate | Week 4, n=32, 34, 35, 38, 29, 31 | 0.8 beats per minute | Standard Deviation 7.13 |
| GSK2894512 0.5% BID | Change From Baseline in Pulse Rate | Week 1, n=36, 38, 37, 38, 35, 37 | 1.7 beats per minute | Standard Deviation 7.07 |
| GSK2894512 0.5% BID | Change From Baseline in Pulse Rate | Week 2, n=36, 36, 36, 38, 31, 35 | 1.4 beats per minute | Standard Deviation 7.73 |
| GSK2894512 0.5% BID | Change From Baseline in Pulse Rate | Week 8, n=30, 31, 33, 38, 27, 26 | 0.2 beats per minute | Standard Deviation 8.02 |
| GSK2894512 0.5% BID | Change From Baseline in Pulse Rate | Week 12, n=26, 30, 32, 36, 26, 25 | 1.4 beats per minute | Standard Deviation 8.18 |
| GSK2894512 0.5% BID | Change From Baseline in Pulse Rate | Week 14, n=29, 31, 33, 34, 27, 26 | 0.2 beats per minute | Standard Deviation 9.2 |
| GSK2894512 0.5% BID | Change From Baseline in Pulse Rate | EW, n=10, 7, 4, 2, 10, 9 | -2.5 beats per minute | Standard Deviation 5.8 |
| GSK2894512 0.5% QD | Change From Baseline in Pulse Rate | EW, n=10, 7, 4, 2, 10, 9 | -4.5 beats per minute | Standard Deviation 3.54 |
| GSK2894512 0.5% QD | Change From Baseline in Pulse Rate | Week 1, n=36, 38, 37, 38, 35, 37 | -0.1 beats per minute | Standard Deviation 9.18 |
| GSK2894512 0.5% QD | Change From Baseline in Pulse Rate | Week 4, n=32, 34, 35, 38, 29, 31 | 1.5 beats per minute | Standard Deviation 9.78 |
| GSK2894512 0.5% QD | Change From Baseline in Pulse Rate | Week 12, n=26, 30, 32, 36, 26, 25 | 0.6 beats per minute | Standard Deviation 9.8 |
| GSK2894512 0.5% QD | Change From Baseline in Pulse Rate | Week 8, n=30, 31, 33, 38, 27, 26 | 1.3 beats per minute | Standard Deviation 9.38 |
| GSK2894512 0.5% QD | Change From Baseline in Pulse Rate | Week 14, n=29, 31, 33, 34, 27, 26 | -0.1 beats per minute | Standard Deviation 8.48 |
| GSK2894512 0.5% QD | Change From Baseline in Pulse Rate | Week 2, n=36, 36, 36, 38, 31, 35 | 1.7 beats per minute | Standard Deviation 9.76 |
| Vehicle BID | Change From Baseline in Pulse Rate | Week 14, n=29, 31, 33, 34, 27, 26 | -0.1 beats per minute | Standard Deviation 11.14 |
| Vehicle BID | Change From Baseline in Pulse Rate | Week 1, n=36, 38, 37, 38, 35, 37 | -0.0 beats per minute | Standard Deviation 7.65 |
| Vehicle BID | Change From Baseline in Pulse Rate | Week 4, n=32, 34, 35, 38, 29, 31 | 2.4 beats per minute | Standard Deviation 11.14 |
| Vehicle BID | Change From Baseline in Pulse Rate | Week 12, n=26, 30, 32, 36, 26, 25 | 1.2 beats per minute | Standard Deviation 11.75 |
| Vehicle BID | Change From Baseline in Pulse Rate | Week 8, n=30, 31, 33, 38, 27, 26 | 2.8 beats per minute | Standard Deviation 10.54 |
| Vehicle BID | Change From Baseline in Pulse Rate | Week 2, n=36, 36, 36, 38, 31, 35 | -1.5 beats per minute | Standard Deviation 11.51 |
| Vehicle BID | Change From Baseline in Pulse Rate | EW, n=10, 7, 4, 2, 10, 9 | 2.4 beats per minute | Standard Deviation 11.99 |
| Vehicle QD | Change From Baseline in Pulse Rate | EW, n=10, 7, 4, 2, 10, 9 | -2.1 beats per minute | Standard Deviation 7.36 |
| Vehicle QD | Change From Baseline in Pulse Rate | Week 8, n=30, 31, 33, 38, 27, 26 | 0.2 beats per minute | Standard Deviation 10.28 |
| Vehicle QD | Change From Baseline in Pulse Rate | Week 12, n=26, 30, 32, 36, 26, 25 | 2.6 beats per minute | Standard Deviation 8.04 |
| Vehicle QD | Change From Baseline in Pulse Rate | Week 1, n=36, 38, 37, 38, 35, 37 | -0.6 beats per minute | Standard Deviation 9.96 |
| Vehicle QD | Change From Baseline in Pulse Rate | Week 14, n=29, 31, 33, 34, 27, 26 | 1.3 beats per minute | Standard Deviation 6.24 |
| Vehicle QD | Change From Baseline in Pulse Rate | Week 4, n=32, 34, 35, 38, 29, 31 | -1.7 beats per minute | Standard Deviation 7.59 |
| Vehicle QD | Change From Baseline in Pulse Rate | Week 2, n=36, 36, 36, 38, 31, 35 | 1.6 beats per minute | Standard Deviation 10.4 |
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were measured in semi-supine position after at least 5 minutes of rest. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Baseline and up to Week 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, EW, n=10, 7, 4, 2, 10, 9 | 5.3 Millimeter of mercury (mmHg) | Standard Deviation 14.73 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 14, n=29, 31, 33, 34, 27, 26 | 0.3 Millimeter of mercury (mmHg) | Standard Deviation 8.8 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 8, n=30, 31, 33, 38, 27, 26 | 0.1 Millimeter of mercury (mmHg) | Standard Deviation 6.44 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 2, n=36, 36, 36, 38, 31, 35 | -2.0 Millimeter of mercury (mmHg) | Standard Deviation 11.61 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 8, n=30, 31, 33, 38, 27, 26 | 4.0 Millimeter of mercury (mmHg) | Standard Deviation 12.11 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 12, n=26, 30, 32, 36, 26, 25 | 2.4 Millimeter of mercury (mmHg) | Standard Deviation 9.98 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 1, n=36, 38, 37, 38, 35, 37 | -1.4 Millimeter of mercury (mmHg) | Standard Deviation 10.54 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 4, n=32, 34, 35, 38, 29, 31 | 1.0 Millimeter of mercury (mmHg) | Standard Deviation 8.04 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 4, n=32, 34, 35, 38, 29, 31 | 0.4 Millimeter of mercury (mmHg) | Standard Deviation 12.4 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 2, n=36, 36, 36, 38, 31, 35 | 0.5 Millimeter of mercury (mmHg) | Standard Deviation 8.13 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 12, n=26, 30, 32, 36, 26, 25 | 3.4 Millimeter of mercury (mmHg) | Standard Deviation 14.09 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 14, n=29, 31, 33, 34, 27, 26 | -0.3 Millimeter of mercury (mmHg) | Standard Deviation 13.1 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, EW, n=10, 7, 4, 2, 10, 9 | 3.4 Millimeter of mercury (mmHg) | Standard Deviation 6.22 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 1, n=36, 38, 37, 38, 35, 37 | 0.9 Millimeter of mercury (mmHg) | Standard Deviation 7.7 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 1, n=36, 38, 37, 38, 35, 37 | -0.2 Millimeter of mercury (mmHg) | Standard Deviation 7.64 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, EW, n=10, 7, 4, 2, 10, 9 | 0.4 Millimeter of mercury (mmHg) | Standard Deviation 17.22 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 14, n=29, 31, 33, 34, 27, 26 | -0.9 Millimeter of mercury (mmHg) | Standard Deviation 14.44 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 14, n=29, 31, 33, 34, 27, 26 | 2.5 Millimeter of mercury (mmHg) | Standard Deviation 8.27 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 2, n=36, 36, 36, 38, 31, 35 | -1.0 Millimeter of mercury (mmHg) | Standard Deviation 11.45 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 1, n=36, 38, 37, 38, 35, 37 | -0.8 Millimeter of mercury (mmHg) | Standard Deviation 10.54 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 12, n=26, 30, 32, 36, 26, 25 | 1.3 Millimeter of mercury (mmHg) | Standard Deviation 9 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 4, n=32, 34, 35, 38, 29, 31 | -2.0 Millimeter of mercury (mmHg) | Standard Deviation 12.68 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, EW, n=10, 7, 4, 2, 10, 9 | 1.4 Millimeter of mercury (mmHg) | Standard Deviation 7.32 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 8, n=30, 31, 33, 38, 27, 26 | 1.4 Millimeter of mercury (mmHg) | Standard Deviation 9.17 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 4, n=32, 34, 35, 38, 29, 31 | 0.7 Millimeter of mercury (mmHg) | Standard Deviation 7.53 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 8, n=30, 31, 33, 38, 27, 26 | -1.6 Millimeter of mercury (mmHg) | Standard Deviation 14.25 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 2, n=36, 36, 36, 38, 31, 35 | 0.3 Millimeter of mercury (mmHg) | Standard Deviation 7.55 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 12, n=26, 30, 32, 36, 26, 25 | -1.5 Millimeter of mercury (mmHg) | Standard Deviation 14.88 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 8, n=30, 31, 33, 38, 27, 26 | 4.0 Millimeter of mercury (mmHg) | Standard Deviation 14.69 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 1, n=36, 38, 37, 38, 35, 37 | 1.6 Millimeter of mercury (mmHg) | Standard Deviation 10.08 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 2, n=36, 36, 36, 38, 31, 35 | 3.0 Millimeter of mercury (mmHg) | Standard Deviation 10.73 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 4, n=32, 34, 35, 38, 29, 31 | 2.6 Millimeter of mercury (mmHg) | Standard Deviation 11.54 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 12, n=26, 30, 32, 36, 26, 25 | 1.1 Millimeter of mercury (mmHg) | Standard Deviation 12.97 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 14, n=29, 31, 33, 34, 27, 26 | 2.6 Millimeter of mercury (mmHg) | Standard Deviation 11.66 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, EW, n=10, 7, 4, 2, 10, 9 | 1.3 Millimeter of mercury (mmHg) | Standard Deviation 8.73 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 1, n=36, 38, 37, 38, 35, 37 | 0.4 Millimeter of mercury (mmHg) | Standard Deviation 6.61 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 2, n=36, 36, 36, 38, 31, 35 | 2.3 Millimeter of mercury (mmHg) | Standard Deviation 6.52 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 4, n=32, 34, 35, 38, 29, 31 | 1.2 Millimeter of mercury (mmHg) | Standard Deviation 6.79 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 8, n=30, 31, 33, 38, 27, 26 | 2.1 Millimeter of mercury (mmHg) | Standard Deviation 7.26 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 12, n=26, 30, 32, 36, 26, 25 | 1.0 Millimeter of mercury (mmHg) | Standard Deviation 8.28 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 14, n=29, 31, 33, 34, 27, 26 | 2.2 Millimeter of mercury (mmHg) | Standard Deviation 5.56 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, EW, n=10, 7, 4, 2, 10, 9 | 3.5 Millimeter of mercury (mmHg) | Standard Deviation 5.97 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 1, n=36, 38, 37, 38, 35, 37 | 2.1 Millimeter of mercury (mmHg) | Standard Deviation 6.97 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 4, n=32, 34, 35, 38, 29, 31 | -0.2 Millimeter of mercury (mmHg) | Standard Deviation 5.77 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 14, n=29, 31, 33, 34, 27, 26 | -1.1 Millimeter of mercury (mmHg) | Standard Deviation 9.7 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, EW, n=10, 7, 4, 2, 10, 9 | 3.5 Millimeter of mercury (mmHg) | Standard Deviation 16.26 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 14, n=29, 31, 33, 34, 27, 26 | -0.1 Millimeter of mercury (mmHg) | Standard Deviation 7.64 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 4, n=32, 34, 35, 38, 29, 31 | -1.4 Millimeter of mercury (mmHg) | Standard Deviation 8.35 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 8, n=30, 31, 33, 38, 27, 26 | 0.9 Millimeter of mercury (mmHg) | Standard Deviation 9.66 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, EW, n=10, 7, 4, 2, 10, 9 | -10.5 Millimeter of mercury (mmHg) | Standard Deviation 2.12 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 1, n=36, 38, 37, 38, 35, 37 | 1.5 Millimeter of mercury (mmHg) | Standard Deviation 7.48 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 2, n=36, 36, 36, 38, 31, 35 | 0.3 Millimeter of mercury (mmHg) | Standard Deviation 7.11 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 12, n=26, 30, 32, 36, 26, 25 | -0.6 Millimeter of mercury (mmHg) | Standard Deviation 9.51 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 2, n=36, 36, 36, 38, 31, 35 | -0.1 Millimeter of mercury (mmHg) | Standard Deviation 9.79 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 8, n=30, 31, 33, 38, 27, 26 | 0.3 Millimeter of mercury (mmHg) | Standard Deviation 13.42 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 12, n=26, 30, 32, 36, 26, 25 | 0.3 Millimeter of mercury (mmHg) | Standard Deviation 8.02 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 12, n=26, 30, 32, 36, 26, 25 | 2.0 Millimeter of mercury (mmHg) | Standard Deviation 11.16 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 1, n=36, 38, 37, 38, 35, 37 | 1.5 Millimeter of mercury (mmHg) | Standard Deviation 10.14 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 8, n=30, 31, 33, 38, 27, 26 | 0.4 Millimeter of mercury (mmHg) | Standard Deviation 13.34 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 1, n=36, 38, 37, 38, 35, 37 | 1.4 Millimeter of mercury (mmHg) | Standard Deviation 11.18 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 2, n=36, 36, 36, 38, 31, 35 | 1.2 Millimeter of mercury (mmHg) | Standard Deviation 9.51 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 4, n=32, 34, 35, 38, 29, 31 | -1.8 Millimeter of mercury (mmHg) | Standard Deviation 9.32 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 4, n=32, 34, 35, 38, 29, 31 | -0.3 Millimeter of mercury (mmHg) | Standard Deviation 13.35 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 8, n=30, 31, 33, 38, 27, 26 | 0.6 Millimeter of mercury (mmHg) | Standard Deviation 8.42 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 2, n=36, 36, 36, 38, 31, 35 | 0.6 Millimeter of mercury (mmHg) | Standard Deviation 13.73 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 12, n=26, 30, 32, 36, 26, 25 | 0.1 Millimeter of mercury (mmHg) | Standard Deviation 8.6 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, EW, n=10, 7, 4, 2, 10, 9 | 1.2 Millimeter of mercury (mmHg) | Standard Deviation 11.49 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 14, n=29, 31, 33, 34, 27, 26 | -2.4 Millimeter of mercury (mmHg) | Standard Deviation 15.05 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 14, n=29, 31, 33, 34, 27, 26 | -1.1 Millimeter of mercury (mmHg) | Standard Deviation 9.45 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, EW, n=10, 7, 4, 2, 10, 9 | -1.3 Millimeter of mercury (mmHg) | Standard Deviation 16.15 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 12, n=26, 30, 32, 36, 26, 25 | 1.2 Millimeter of mercury (mmHg) | Standard Deviation 12.02 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 12, n=26, 30, 32, 36, 26, 25 | -0.1 Millimeter of mercury (mmHg) | Standard Deviation 7.98 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 2, n=36, 36, 36, 38, 31, 35 | 0.0 Millimeter of mercury (mmHg) | Standard Deviation 7.94 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 1, n=36, 38, 37, 38, 35, 37 | 1.1 Millimeter of mercury (mmHg) | Standard Deviation 11.16 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, EW, n=10, 7, 4, 2, 10, 9 | -4.0 Millimeter of mercury (mmHg) | Standard Deviation 13.19 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 8, n=30, 31, 33, 38, 27, 26 | 2.4 Millimeter of mercury (mmHg) | Standard Deviation 13.81 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 14, n=29, 31, 33, 34, 27, 26 | 0.2 Millimeter of mercury (mmHg) | Standard Deviation 9.85 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, EW, n=10, 7, 4, 2, 10, 9 | -1.1 Millimeter of mercury (mmHg) | Standard Deviation 6.13 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 14, n=29, 31, 33, 34, 27, 26 | 2.2 Millimeter of mercury (mmHg) | Standard Deviation 10.97 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 8, n=30, 31, 33, 38, 27, 26 | 0.6 Millimeter of mercury (mmHg) | Standard Deviation 8.18 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 2, n=36, 36, 36, 38, 31, 35 | -1.1 Millimeter of mercury (mmHg) | Standard Deviation 13.15 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 1, n=36, 38, 37, 38, 35, 37 | -0.8 Millimeter of mercury (mmHg) | Standard Deviation 8.27 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP, Week 4, n=32, 34, 35, 38, 29, 31 | -0.2 Millimeter of mercury (mmHg) | Standard Deviation 7.54 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP, Week 4, n=32, 34, 35, 38, 29, 31 | -0.3 Millimeter of mercury (mmHg) | Standard Deviation 13.22 |
Secondary
Change From Baseline in Temperature
Temperature was measured in semi-supine position after at least 5 minutes of rest. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Baseline and up to Week 14
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Temperature | Week 1, n=36, 38, 37, 38, 35, 37 | 0.01 degree Celsius | Standard Deviation 0.356 |
| GSK2894512 1% BID | Change From Baseline in Temperature | Week 12, n=26, 30, 32, 36, 26, 25 | 0.02 degree Celsius | Standard Deviation 0.343 |
| GSK2894512 1% BID | Change From Baseline in Temperature | Week 2, n=36, 36, 36, 38, 31, 35 | 0.03 degree Celsius | Standard Deviation 0.395 |
| GSK2894512 1% BID | Change From Baseline in Temperature | EW, n=10, 7, 4, 2, 10, 9 | 0.12 degree Celsius | Standard Deviation 0.466 |
| GSK2894512 1% BID | Change From Baseline in Temperature | Week 4, n=31, 34, 35, 38, 29, 31 | 0.05 degree Celsius | Standard Deviation 0.445 |
| GSK2894512 1% BID | Change From Baseline in Temperature | Week 14, n=29, 31, 33, 34, 27, 26 | -0.04 degree Celsius | Standard Deviation 0.372 |
| GSK2894512 1% BID | Change From Baseline in Temperature | Week 8, n=29, 31, 32, 38, 27, 26 | -0.02 degree Celsius | Standard Deviation 0.503 |
| GSK2894512 1% QD | Change From Baseline in Temperature | Week 2, n=36, 36, 36, 38, 31, 35 | -0.01 degree Celsius | Standard Deviation 0.41 |
| GSK2894512 1% QD | Change From Baseline in Temperature | Week 8, n=29, 31, 32, 38, 27, 26 | 0.17 degree Celsius | Standard Deviation 0.334 |
| GSK2894512 1% QD | Change From Baseline in Temperature | Week 4, n=31, 34, 35, 38, 29, 31 | 0.11 degree Celsius | Standard Deviation 0.385 |
| GSK2894512 1% QD | Change From Baseline in Temperature | Week 12, n=26, 30, 32, 36, 26, 25 | 0.14 degree Celsius | Standard Deviation 0.423 |
| GSK2894512 1% QD | Change From Baseline in Temperature | Week 1, n=36, 38, 37, 38, 35, 37 | -0.00 degree Celsius | Standard Deviation 0.336 |
| GSK2894512 1% QD | Change From Baseline in Temperature | EW, n=10, 7, 4, 2, 10, 9 | -0.09 degree Celsius | Standard Deviation 0.339 |
| GSK2894512 1% QD | Change From Baseline in Temperature | Week 14, n=29, 31, 33, 34, 27, 26 | 0.10 degree Celsius | Standard Deviation 0.364 |
| GSK2894512 0.5% BID | Change From Baseline in Temperature | Week 4, n=31, 34, 35, 38, 29, 31 | 0.06 degree Celsius | Standard Deviation 0.333 |
| GSK2894512 0.5% BID | Change From Baseline in Temperature | Week 2, n=36, 36, 36, 38, 31, 35 | -0.01 degree Celsius | Standard Deviation 0.314 |
| GSK2894512 0.5% BID | Change From Baseline in Temperature | Week 1, n=36, 38, 37, 38, 35, 37 | -0.03 degree Celsius | Standard Deviation 0.271 |
| GSK2894512 0.5% BID | Change From Baseline in Temperature | Week 12, n=26, 30, 32, 36, 26, 25 | 0.12 degree Celsius | Standard Deviation 0.429 |
| GSK2894512 0.5% BID | Change From Baseline in Temperature | Week 14, n=29, 31, 33, 34, 27, 26 | 0.01 degree Celsius | Standard Deviation 0.456 |
| GSK2894512 0.5% BID | Change From Baseline in Temperature | Week 8, n=29, 31, 32, 38, 27, 26 | 0.12 degree Celsius | Standard Deviation 0.345 |
| GSK2894512 0.5% BID | Change From Baseline in Temperature | EW, n=10, 7, 4, 2, 10, 9 | 0.22 degree Celsius | Standard Deviation 0.33 |
| GSK2894512 0.5% QD | Change From Baseline in Temperature | Week 8, n=29, 31, 32, 38, 27, 26 | 0.17 degree Celsius | Standard Deviation 0.453 |
| GSK2894512 0.5% QD | Change From Baseline in Temperature | Week 1, n=36, 38, 37, 38, 35, 37 | 0.07 degree Celsius | Standard Deviation 0.401 |
| GSK2894512 0.5% QD | Change From Baseline in Temperature | Week 2, n=36, 36, 36, 38, 31, 35 | 0.19 degree Celsius | Standard Deviation 0.442 |
| GSK2894512 0.5% QD | Change From Baseline in Temperature | Week 4, n=31, 34, 35, 38, 29, 31 | 0.07 degree Celsius | Standard Deviation 0.318 |
| GSK2894512 0.5% QD | Change From Baseline in Temperature | Week 12, n=26, 30, 32, 36, 26, 25 | 0.18 degree Celsius | Standard Deviation 0.52 |
| GSK2894512 0.5% QD | Change From Baseline in Temperature | Week 14, n=29, 31, 33, 34, 27, 26 | 0.11 degree Celsius | Standard Deviation 0.406 |
| GSK2894512 0.5% QD | Change From Baseline in Temperature | EW, n=10, 7, 4, 2, 10, 9 | 0.25 degree Celsius | Standard Deviation 0.778 |
| Vehicle BID | Change From Baseline in Temperature | Week 4, n=31, 34, 35, 38, 29, 31 | -0.04 degree Celsius | Standard Deviation 0.405 |
| Vehicle BID | Change From Baseline in Temperature | Week 2, n=36, 36, 36, 38, 31, 35 | -0.17 degree Celsius | Standard Deviation 0.473 |
| Vehicle BID | Change From Baseline in Temperature | EW, n=10, 7, 4, 2, 10, 9 | 0.30 degree Celsius | Standard Deviation 0.533 |
| Vehicle BID | Change From Baseline in Temperature | Week 1, n=36, 38, 37, 38, 35, 37 | -0.03 degree Celsius | Standard Deviation 0.548 |
| Vehicle BID | Change From Baseline in Temperature | Week 14, n=29, 31, 33, 34, 27, 26 | -0.03 degree Celsius | Standard Deviation 0.522 |
| Vehicle BID | Change From Baseline in Temperature | Week 8, n=29, 31, 32, 38, 27, 26 | 0.14 degree Celsius | Standard Deviation 0.473 |
| Vehicle BID | Change From Baseline in Temperature | Week 12, n=26, 30, 32, 36, 26, 25 | 0.02 degree Celsius | Standard Deviation 0.492 |
| Vehicle QD | Change From Baseline in Temperature | EW, n=10, 7, 4, 2, 10, 9 | -0.27 degree Celsius | Standard Deviation 0.255 |
| Vehicle QD | Change From Baseline in Temperature | Week 12, n=26, 30, 32, 36, 26, 25 | 0.12 degree Celsius | Standard Deviation 0.561 |
| Vehicle QD | Change From Baseline in Temperature | Week 4, n=31, 34, 35, 38, 29, 31 | 0.03 degree Celsius | Standard Deviation 0.439 |
| Vehicle QD | Change From Baseline in Temperature | Week 2, n=36, 36, 36, 38, 31, 35 | 0.03 degree Celsius | Standard Deviation 0.384 |
| Vehicle QD | Change From Baseline in Temperature | Week 14, n=29, 31, 33, 34, 27, 26 | 0.00 degree Celsius | Standard Deviation 0.591 |
| Vehicle QD | Change From Baseline in Temperature | Week 1, n=36, 38, 37, 38, 35, 37 | -0.03 degree Celsius | Standard Deviation 0.468 |
| Vehicle QD | Change From Baseline in Temperature | Week 8, n=29, 31, 32, 38, 27, 26 | 0.11 degree Celsius | Standard Deviation 0.473 |
Secondary
Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit
A single target lesion of at least 3 centimeter (cm) x 3 cm was selected at Baseline. For the selected lesion, the severity of erythema, scaling and plaque thickness (induration) was assessed by the investigator on a 5-point scale ranging from 0=none to 4=severe. The mean change in individual grading scores from Baseline was summarized for each study visit. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Baseline and up to Week 16
Population: mITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 16, n=24, 26, 26, 28, 19, 19 | -2.1 Scores on a scale | Standard Deviation 1.19 |
| GSK2894512 1% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 2, n=32, 33, 30, 32, 24, 30 | -0.9 Scores on a scale | Standard Deviation 0.78 |
| GSK2894512 1% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 4, n=28, 31, 29, 32, 22, 26 | -1.5 Scores on a scale | Standard Deviation 0.88 |
| GSK2894512 1% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 8, n=26, 27, 27, 32, 20, 20 | -2.0 Scores on a scale | Standard Deviation 1.11 |
| GSK2894512 1% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 12, n=23, 25, 26, 29, 19, 20 | -2.3 Scores on a scale | Standard Deviation 0.96 |
| GSK2894512 1% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 14, n=23, 26, 24, 27, 19, 19 | -2.1 Scores on a scale | Standard Deviation 1.2 |
| GSK2894512 1% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 1, n=32, 35, 31, 32, 28, 32 | -0.7 Scores on a scale | Standard Deviation 0.7 |
| GSK2894512 1% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; EW, n=10, 7, 4, 2, 10, 9 | -1.5 Scores on a scale | Standard Deviation 1.27 |
| GSK2894512 1% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 1, n=32, 35, 31, 32, 28, 32 | -0.4 Scores on a scale | Standard Deviation 0.66 |
| GSK2894512 1% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 2, n=32, 33, 30, 32, 24, 30 | -0.8 Scores on a scale | Standard Deviation 0.83 |
| GSK2894512 1% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 4, n=28, 31, 29, 32, 22, 26 | -1.3 Scores on a scale | Standard Deviation 0.9 |
| GSK2894512 1% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 8, n=26, 27, 27, 32, 20, 20 | -1.8 Scores on a scale | Standard Deviation 1.1 |
| GSK2894512 1% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 12, n=23, 25, 26, 29, 19, 20 | -2.3 Scores on a scale | Standard Deviation 1.1 |
| GSK2894512 1% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 14, n=23, 26, 24, 27, 19, 19 | -2.1 Scores on a scale | Standard Deviation 1.28 |
| GSK2894512 1% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 16, n=24, 26, 26, 28, 19, 19 | -2.1 Scores on a scale | Standard Deviation 1.23 |
| GSK2894512 1% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; EW, n=10, 7, 4, 2, 10, 9 | -1.3 Scores on a scale | Standard Deviation 1.06 |
| GSK2894512 1% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 1, n=32,35,31,32,28,32 | -0.5 Scores on a scale | Standard Deviation 0.67 |
| GSK2894512 1% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 2, n=32,33,30,32,24,30 | -0.9 Scores on a scale | Standard Deviation 0.84 |
| GSK2894512 1% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 4, n=28,31,29,32,22,26 | -1.4 Scores on a scale | Standard Deviation 1.03 |
| GSK2894512 1% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 8, n=26,27,27,32,20,20 | -1.8 Scores on a scale | Standard Deviation 1.17 |
| GSK2894512 1% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 12, n=23,25,26,29,19,20 | -2.3 Scores on a scale | Standard Deviation 0.93 |
| GSK2894512 1% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 14, n=23,26,24,27,19,19 | -2.1 Scores on a scale | Standard Deviation 1.16 |
| GSK2894512 1% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 16, n=24,26 26,28,19,19 | -2.1 Scores on a scale | Standard Deviation 1.19 |
| GSK2894512 1% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; EW, n=10,7,4,2,10,9 | -1.3 Scores on a scale | Standard Deviation 1.06 |
| GSK2894512 1% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 12, n=23, 25, 26, 29, 19, 20 | -2.4 Scores on a scale | Standard Deviation 1.15 |
| GSK2894512 1% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 12, n=23, 25, 26, 29, 19, 20 | -2.5 Scores on a scale | Standard Deviation 1.08 |
| GSK2894512 1% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 4, n=28, 31, 29, 32, 22, 26 | -1.5 Scores on a scale | Standard Deviation 1.21 |
| GSK2894512 1% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; EW, n=10, 7, 4, 2, 10, 9 | -1.4 Scores on a scale | Standard Deviation 1.4 |
| GSK2894512 1% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 16, n=24,26 26,28,19,19 | -2.1 Scores on a scale | Standard Deviation 1.32 |
| GSK2894512 1% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 14, n=23, 26, 24, 27, 19, 19 | -2.2 Scores on a scale | Standard Deviation 1.21 |
| GSK2894512 1% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 16, n=24, 26, 26, 28, 19, 19 | -2.3 Scores on a scale | Standard Deviation 1.09 |
| GSK2894512 1% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 16, n=24, 26, 26, 28, 19, 19 | -2.2 Scores on a scale | Standard Deviation 1.24 |
| GSK2894512 1% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 2, n=32, 33, 30, 32, 24, 30 | -1.0 Scores on a scale | Standard Deviation 1.07 |
| GSK2894512 1% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 14, n=23,26,24,27,19,19 | -2.1 Scores on a scale | Standard Deviation 1.2 |
| GSK2894512 1% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; EW, n=10, 7, 4, 2, 10, 9 | -1.6 Scores on a scale | Standard Deviation 1.27 |
| GSK2894512 1% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 8, n=26, 27, 27, 32, 20, 20 | -2.0 Scores on a scale | Standard Deviation 1.19 |
| GSK2894512 1% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 12, n=23,25,26,29,19,20 | -2.1 Scores on a scale | Standard Deviation 1.19 |
| GSK2894512 1% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 1, n=32, 35, 31, 32, 28, 32 | -0.5 Scores on a scale | Standard Deviation 0.78 |
| GSK2894512 1% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 1, n=32, 35, 31, 32, 28, 32 | -0.7 Scores on a scale | Standard Deviation 0.9 |
| GSK2894512 1% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 2, n=32, 33, 30, 32, 24, 30 | -1.1 Scores on a scale | Standard Deviation 0.97 |
| GSK2894512 1% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 14, n=23, 26, 24, 27, 19, 19 | -2.2 Scores on a scale | Standard Deviation 1.43 |
| GSK2894512 1% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 8, n=26,27,27,32,20,20 | -1.8 Scores on a scale | Standard Deviation 1.15 |
| GSK2894512 1% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; EW, n=10,7,4,2,10,9 | -1.9 Scores on a scale | Standard Deviation 1.21 |
| GSK2894512 1% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 4, n=28, 31, 29, 32, 22, 26 | -1.5 Scores on a scale | Standard Deviation 0.89 |
| GSK2894512 1% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 4, n=28,31,29,32,22,26 | -1.5 Scores on a scale | Standard Deviation 1.26 |
| GSK2894512 1% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 2, n=32,33,30,32,24,30 | -0.9 Scores on a scale | Standard Deviation 1.01 |
| GSK2894512 1% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 8, n=26, 27, 27, 32, 20, 20 | -2.0 Scores on a scale | Standard Deviation 1.04 |
| GSK2894512 1% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 1, n=32,35,31,32,28,32 | -0.5 Scores on a scale | Standard Deviation 0.82 |
| GSK2894512 0.5% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 14, n=23,26,24,27,19,19 | -1.8 Scores on a scale | Standard Deviation 1.19 |
| GSK2894512 0.5% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 1, n=32,35,31,32,28,32 | -0.4 Scores on a scale | Standard Deviation 0.56 |
| GSK2894512 0.5% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 12, n=23, 25, 26, 29, 19, 20 | -2.2 Scores on a scale | Standard Deviation 1.01 |
| GSK2894512 0.5% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 1, n=32, 35, 31, 32, 28, 32 | -0.3 Scores on a scale | Standard Deviation 0.64 |
| GSK2894512 0.5% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 4, n=28, 31, 29, 32, 22, 26 | -1.4 Scores on a scale | Standard Deviation 0.95 |
| GSK2894512 0.5% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 16, n=24, 26, 26, 28, 19, 19 | -1.8 Scores on a scale | Standard Deviation 1.1 |
| GSK2894512 0.5% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 4, n=28, 31, 29, 32, 22, 26 | -1.3 Scores on a scale | Standard Deviation 0.85 |
| GSK2894512 0.5% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; EW, n=10,7,4,2,10,9 | -1.0 Scores on a scale | Standard Deviation 1.41 |
| GSK2894512 0.5% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 14, n=23, 26, 24, 27, 19, 19 | -1.9 Scores on a scale | Standard Deviation 0.95 |
| GSK2894512 0.5% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 12, n=23,25,26,29,19,20 | -1.9 Scores on a scale | Standard Deviation 1.2 |
| GSK2894512 0.5% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 8, n=26,27,27,32,20,20 | -1.8 Scores on a scale | Standard Deviation 1.09 |
| GSK2894512 0.5% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 16, n=24,26 26,28,19,19 | -1.6 Scores on a scale | Standard Deviation 1.39 |
| GSK2894512 0.5% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; EW, n=10, 7, 4, 2, 10, 9 | -0.8 Scores on a scale | Standard Deviation 1.5 |
| GSK2894512 0.5% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 14, n=23, 26, 24, 27, 19, 19 | -1.7 Scores on a scale | Standard Deviation 1.17 |
| GSK2894512 0.5% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 16, n=24, 26, 26, 28, 19, 19 | -1.6 Scores on a scale | Standard Deviation 1.45 |
| GSK2894512 0.5% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 8, n=26, 27, 27, 32, 20, 20 | -1.7 Scores on a scale | Standard Deviation 1.07 |
| GSK2894512 0.5% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 2, n=32, 33, 30, 32, 24, 30 | -0.9 Scores on a scale | Standard Deviation 0.87 |
| GSK2894512 0.5% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 2, n=32, 33, 30, 32, 24, 30 | -0.7 Scores on a scale | Standard Deviation 0.94 |
| GSK2894512 0.5% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 8, n=26, 27, 27, 32, 20, 20 | -1.9 Scores on a scale | Standard Deviation 0.95 |
| GSK2894512 0.5% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 2, n=32,33,30,32,24,30 | -0.9 Scores on a scale | Standard Deviation 0.94 |
| GSK2894512 0.5% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; EW, n=10, 7, 4, 2, 10, 9 | -1.3 Scores on a scale | Standard Deviation 1.5 |
| GSK2894512 0.5% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 12, n=23, 25, 26, 29, 19, 20 | -2.1 Scores on a scale | Standard Deviation 1.07 |
| GSK2894512 0.5% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 4, n=28,31,29,32,22,26 | -1.3 Scores on a scale | Standard Deviation 1 |
| GSK2894512 0.5% BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 1, n=32, 35, 31, 32, 28, 32 | -0.4 Scores on a scale | Standard Deviation 0.76 |
| GSK2894512 0.5% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 14, n=23,26,24,27,19,19 | -1.7 Scores on a scale | Standard Deviation 1.32 |
| GSK2894512 0.5% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 12, n=23, 25, 26, 29, 19, 20 | -2.0 Scores on a scale | Standard Deviation 1.05 |
| GSK2894512 0.5% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 14, n=23, 26, 24, 27, 19, 19 | -1.8 Scores on a scale | Standard Deviation 1.37 |
| GSK2894512 0.5% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; EW, n=10,7,4,2,10,9 | 0.0 Scores on a scale | Standard Deviation 0 |
| GSK2894512 0.5% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 16, n=24, 26, 26, 28, 19, 19 | -1.8 Scores on a scale | Standard Deviation 1.29 |
| GSK2894512 0.5% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; EW, n=10, 7, 4, 2, 10, 9 | -0.5 Scores on a scale | Standard Deviation 0.71 |
| GSK2894512 0.5% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 1, n=32, 35, 31, 32, 28, 32 | -0.4 Scores on a scale | Standard Deviation 0.5 |
| GSK2894512 0.5% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 2, n=32, 33, 30, 32, 24, 30 | -0.8 Scores on a scale | Standard Deviation 0.74 |
| GSK2894512 0.5% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 4, n=28, 31, 29, 32, 22, 26 | -1.1 Scores on a scale | Standard Deviation 0.8 |
| GSK2894512 0.5% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 8, n=26, 27, 27, 32, 20, 20 | -1.5 Scores on a scale | Standard Deviation 0.92 |
| GSK2894512 0.5% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 12, n=23, 25, 26, 29, 19, 20 | -1.9 Scores on a scale | Standard Deviation 1.13 |
| GSK2894512 0.5% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 14, n=23, 26, 24, 27, 19, 19 | -1.7 Scores on a scale | Standard Deviation 1.27 |
| GSK2894512 0.5% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 16, n=24, 26, 26, 28, 19, 19 | -2.0 Scores on a scale | Standard Deviation 1.26 |
| GSK2894512 0.5% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 16, n=24,26 26,28,19,19 | -1.8 Scores on a scale | Standard Deviation 1.31 |
| GSK2894512 0.5% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; EW, n=10, 7, 4, 2, 10, 9 | 0.0 Scores on a scale | Standard Deviation 1.41 |
| GSK2894512 0.5% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 1, n=32,35,31,32,28,32 | -0.3 Scores on a scale | Standard Deviation 0.6 |
| GSK2894512 0.5% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 2, n=32,33,30,32,24,30 | -0.8 Scores on a scale | Standard Deviation 0.8 |
| GSK2894512 0.5% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 4, n=28,31,29,32,22,26 | -1.2 Scores on a scale | Standard Deviation 0.93 |
| GSK2894512 0.5% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 8, n=26,27,27,32,20,20 | -1.7 Scores on a scale | Standard Deviation 1.12 |
| GSK2894512 0.5% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 1, n=32, 35, 31, 32, 28, 32 | -0.6 Scores on a scale | Standard Deviation 0.56 |
| GSK2894512 0.5% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 2, n=32, 33, 30, 32, 24, 30 | -1.0 Scores on a scale | Standard Deviation 0.84 |
| GSK2894512 0.5% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 4, n=28, 31, 29, 32, 22, 26 | -1.4 Scores on a scale | Standard Deviation 0.98 |
| GSK2894512 0.5% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 12, n=23,25,26,29,19,20 | -1.9 Scores on a scale | Standard Deviation 1.13 |
| GSK2894512 0.5% QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 8, n=26, 27, 27, 32, 20, 20 | -1.9 Scores on a scale | Standard Deviation 1.03 |
| Vehicle BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 4, n=28, 31, 29, 32, 22, 26 | -0.6 Scores on a scale | Standard Deviation 0.85 |
| Vehicle BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 1, n=32, 35, 31, 32, 28, 32 | -0.2 Scores on a scale | Standard Deviation 0.48 |
| Vehicle BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 14, n=23,26,24,27,19,19 | -0.9 Scores on a scale | Standard Deviation 1.13 |
| Vehicle BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 4, n=28, 31, 29, 32, 22, 26 | -1.0 Scores on a scale | Standard Deviation 0.84 |
| Vehicle BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 1, n=32, 35, 31, 32, 28, 32 | -0.5 Scores on a scale | Standard Deviation 0.69 |
| Vehicle BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 4, n=28,31,29,32,22,26 | -1.0 Scores on a scale | Standard Deviation 0.65 |
| Vehicle BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; EW, n=10, 7, 4, 2, 10, 9 | -0.5 Scores on a scale | Standard Deviation 0.97 |
| Vehicle BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 2, n=32,33,30,32,24,30 | -0.7 Scores on a scale | Standard Deviation 0.76 |
| Vehicle BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 16, n=24, 26, 26, 28, 19, 19 | -0.6 Scores on a scale | Standard Deviation 1.07 |
| Vehicle BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 12, n=23, 25, 26, 29, 19, 20 | -1.0 Scores on a scale | Standard Deviation 1.11 |
| Vehicle BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 2, n=32, 33, 30, 32, 24, 30 | -1.0 Scores on a scale | Standard Deviation 0.75 |
| Vehicle BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 8, n=26, 27, 27, 32, 20, 20 | -0.8 Scores on a scale | Standard Deviation 0.85 |
| Vehicle BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 2, n=32, 33, 30, 32, 24, 30 | -0.3 Scores on a scale | Standard Deviation 0.75 |
| Vehicle BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 14, n=23, 26, 24, 27, 19, 19 | -0.6 Scores on a scale | Standard Deviation 1.12 |
| Vehicle BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 12, n=23,25,26,29,19,20 | -1.0 Scores on a scale | Standard Deviation 0.94 |
| Vehicle BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 8, n=26, 27, 27, 32, 20, 20 | -1.2 Scores on a scale | Standard Deviation 0.93 |
| Vehicle BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 16, n=24, 26, 26, 28, 19, 19 | -0.6 Scores on a scale | Standard Deviation 0.96 |
| Vehicle BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 8, n=26,27,27,32,20,20 | -0.9 Scores on a scale | Standard Deviation 0.88 |
| Vehicle BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 14, n=23, 26, 24, 27, 19, 19 | -0.7 Scores on a scale | Standard Deviation 1.05 |
| Vehicle BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 12, n=23, 25, 26, 29, 19, 20 | -0.5 Scores on a scale | Standard Deviation 1.07 |
| Vehicle BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; EW, n=10,7,4,2,10,9 | -0.6 Scores on a scale | Standard Deviation 1.07 |
| Vehicle BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 1, n=32,35,31,32,28,32 | -0.4 Scores on a scale | Standard Deviation 0.5 |
| Vehicle BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; EW, n=10, 7, 4, 2, 10, 9 | -0.5 Scores on a scale | Standard Deviation 0.97 |
| Vehicle BID | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 16, n=24,26 26,28,19,19 | -0.7 Scores on a scale | Standard Deviation 1.1 |
| Vehicle QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; EW, n=10, 7, 4, 2, 10, 9 | -0.1 Scores on a scale | Standard Deviation 0.6 |
| Vehicle QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 8, n=26, 27, 27, 32, 20, 20 | -0.5 Scores on a scale | Standard Deviation 0.76 |
| Vehicle QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 8, n=26, 27, 27, 32, 20, 20 | -0.4 Scores on a scale | Standard Deviation 0.81 |
| Vehicle QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 1, n=32,35,31,32,28,32 | -0.2 Scores on a scale | Standard Deviation 0.45 |
| Vehicle QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 16, n=24,26 26,28,19,19 | -0.4 Scores on a scale | Standard Deviation 0.69 |
| Vehicle QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 14, n=23,26,24,27,19,19 | -0.7 Scores on a scale | Standard Deviation 0.87 |
| Vehicle QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 4, n=28, 31, 29, 32, 22, 26 | -0.4 Scores on a scale | Standard Deviation 0.64 |
| Vehicle QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 2, n=32,33,30,32,24,30 | -0.3 Scores on a scale | Standard Deviation 0.66 |
| Vehicle QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; EW, n=10,7,4,2,10,9 | 0.4 Scores on a scale | Standard Deviation 0.73 |
| Vehicle QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 4, n=28, 31, 29, 32, 22, 26 | -0.4 Scores on a scale | Standard Deviation 0.8 |
| Vehicle QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 4, n=28,31,29,32,22,26 | -0.4 Scores on a scale | Standard Deviation 0.64 |
| Vehicle QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 2, n=32, 33, 30, 32, 24, 30 | -0.2 Scores on a scale | Standard Deviation 0.48 |
| Vehicle QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 8, n=26,27,27,32,20,20 | -0.5 Scores on a scale | Standard Deviation 0.6 |
| Vehicle QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 1, n=32, 35, 31, 32, 28, 32 | -0.1 Scores on a scale | Standard Deviation 0.39 |
| Vehicle QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; EW, n=10, 7, 4, 2, 10, 9 | 0.0 Scores on a scale | Standard Deviation 0.71 |
| Vehicle QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 12, n=23, 25, 26, 29, 19, 20 | -0.7 Scores on a scale | Standard Deviation 0.81 |
| Vehicle QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 1, n=32, 35, 31, 32, 28, 32 | -0.3 Scores on a scale | Standard Deviation 0.44 |
| Vehicle QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 16, n=24, 26, 26, 28, 19, 19 | -0.3 Scores on a scale | Standard Deviation 0.67 |
| Vehicle QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 2, n=32, 33, 30, 32, 24, 30 | -0.3 Scores on a scale | Standard Deviation 0.8 |
| Vehicle QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 14, n=23, 26, 24, 27, 19, 19 | -0.9 Scores on a scale | Standard Deviation 0.91 |
| Vehicle QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 12, n=23, 25, 26, 29, 19, 20 | -0.8 Scores on a scale | Standard Deviation 0.97 |
| Vehicle QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Scaling; Week 14, n=23, 26, 24, 27, 19, 19 | -0.5 Scores on a scale | Standard Deviation 0.77 |
| Vehicle QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Erythema; Week 16, n=24, 26, 26, 28, 19, 19 | -0.5 Scores on a scale | Standard Deviation 0.9 |
| Vehicle QD | Mean Change in Individual Target Lesion Grading Scores From Baseline to Each Study Visit | Plaque thickness; Week 12, n=23,25,26,29,19,20 | -0.7 Scores on a scale | Standard Deviation 0.8 |
Secondary
Mean Change in PASI Score From Baseline to Each Study Visit
The PASI is a standard clinical tool for assessing the severity of psoriasis based on severity of erythema, thickness and scale, as well as the extent of BSA affected with psoriasis. The 3 clinical signs were graded on a 5 point scale (0=None to 4=Severe) and the percent of BSA affected is scored on a 7-point scale (0=0% involvement to 6=90-100%) for each of 4 specified body regions (head, upper extremities, trunk and lower extremities). The individual scores were multiplied by a weighted factor for each body region. The sum of these scores gave the overall PASI score. PASI score ranged from 0=no psoriasis to 72=worse psoriasis. The mean change in PASI score from Baseline was summarized for each study visit. Baseline was the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Baseline and up to Week 16
Population: mITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Mean Change in PASI Score From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | -6.07 Scores on a scale | Standard Deviation 5.051 |
| GSK2894512 1% BID | Mean Change in PASI Score From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | -4.10 Scores on a scale | Standard Deviation 3.756 |
| GSK2894512 1% BID | Mean Change in PASI Score From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | -2.22 Scores on a scale | Standard Deviation 2.795 |
| GSK2894512 1% BID | Mean Change in PASI Score From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | -7.52 Scores on a scale | Standard Deviation 5.612 |
| GSK2894512 1% BID | Mean Change in PASI Score From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | -8.70 Scores on a scale | Standard Deviation 5.617 |
| GSK2894512 1% BID | Mean Change in PASI Score From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | -8.61 Scores on a scale | Standard Deviation 5.328 |
| GSK2894512 1% BID | Mean Change in PASI Score From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | -8.46 Scores on a scale | Standard Deviation 5.432 |
| GSK2894512 1% BID | Mean Change in PASI Score From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | -3.70 Scores on a scale | Standard Deviation 3.391 |
| GSK2894512 1% QD | Mean Change in PASI Score From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | -5.77 Scores on a scale | Standard Deviation 3.556 |
| GSK2894512 1% QD | Mean Change in PASI Score From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | -4.00 Scores on a scale | Standard Deviation 3.636 |
| GSK2894512 1% QD | Mean Change in PASI Score From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | -1.73 Scores on a scale | Standard Deviation 2.374 |
| GSK2894512 1% QD | Mean Change in PASI Score From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | -6.63 Scores on a scale | Standard Deviation 4.067 |
| GSK2894512 1% QD | Mean Change in PASI Score From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | -6.65 Scores on a scale | Standard Deviation 3.973 |
| GSK2894512 1% QD | Mean Change in PASI Score From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | -4.45 Scores on a scale | Standard Deviation 3.072 |
| GSK2894512 1% QD | Mean Change in PASI Score From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | -3.07 Scores on a scale | Standard Deviation 3.016 |
| GSK2894512 1% QD | Mean Change in PASI Score From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | -6.62 Scores on a scale | Standard Deviation 3.709 |
| GSK2894512 0.5% BID | Mean Change in PASI Score From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | -2.39 Scores on a scale | Standard Deviation 3.118 |
| GSK2894512 0.5% BID | Mean Change in PASI Score From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | -3.83 Scores on a scale | Standard Deviation 3.827 |
| GSK2894512 0.5% BID | Mean Change in PASI Score From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | -5.79 Scores on a scale | Standard Deviation 5.055 |
| GSK2894512 0.5% BID | Mean Change in PASI Score From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | -1.18 Scores on a scale | Standard Deviation 1.167 |
| GSK2894512 0.5% BID | Mean Change in PASI Score From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | -6.30 Scores on a scale | Standard Deviation 5.138 |
| GSK2894512 0.5% BID | Mean Change in PASI Score From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | -5.67 Scores on a scale | Standard Deviation 5.1 |
| GSK2894512 0.5% BID | Mean Change in PASI Score From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | -5.65 Scores on a scale | Standard Deviation 5.646 |
| GSK2894512 0.5% BID | Mean Change in PASI Score From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | -1.11 Scores on a scale | Standard Deviation 2.083 |
| GSK2894512 0.5% QD | Mean Change in PASI Score From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | -5.13 Scores on a scale | Standard Deviation 4.712 |
| GSK2894512 0.5% QD | Mean Change in PASI Score From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | -5.28 Scores on a scale | Standard Deviation 4.422 |
| GSK2894512 0.5% QD | Mean Change in PASI Score From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | -5.41 Scores on a scale | Standard Deviation 4.424 |
| GSK2894512 0.5% QD | Mean Change in PASI Score From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | -1.33 Scores on a scale | Standard Deviation 1.807 |
| GSK2894512 0.5% QD | Mean Change in PASI Score From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | -3.31 Scores on a scale | Standard Deviation 2.796 |
| GSK2894512 0.5% QD | Mean Change in PASI Score From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | -4.58 Scores on a scale | Standard Deviation 3.902 |
| GSK2894512 0.5% QD | Mean Change in PASI Score From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 1.50 Scores on a scale | Standard Deviation 8.627 |
| GSK2894512 0.5% QD | Mean Change in PASI Score From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | -2.49 Scores on a scale | Standard Deviation 2.316 |
| Vehicle BID | Mean Change in PASI Score From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | -0.06 Scores on a scale | Standard Deviation 2.784 |
| Vehicle BID | Mean Change in PASI Score From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | -0.85 Scores on a scale | Standard Deviation 1.203 |
| Vehicle BID | Mean Change in PASI Score From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | -2.77 Scores on a scale | Standard Deviation 4.291 |
| Vehicle BID | Mean Change in PASI Score From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | -2.60 Scores on a scale | Standard Deviation 4.491 |
| Vehicle BID | Mean Change in PASI Score From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | -2.41 Scores on a scale | Standard Deviation 4.285 |
| Vehicle BID | Mean Change in PASI Score From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | -1.78 Scores on a scale | Standard Deviation 2.826 |
| Vehicle BID | Mean Change in PASI Score From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | -2.88 Scores on a scale | Standard Deviation 3.308 |
| Vehicle BID | Mean Change in PASI Score From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | -2.82 Scores on a scale | Standard Deviation 4.081 |
| Vehicle QD | Mean Change in PASI Score From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 0.12 Scores on a scale | Standard Deviation 2.742 |
| Vehicle QD | Mean Change in PASI Score From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | -1.54 Scores on a scale | Standard Deviation 2.97 |
| Vehicle QD | Mean Change in PASI Score From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | -1.08 Scores on a scale | Standard Deviation 2.026 |
| Vehicle QD | Mean Change in PASI Score From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | -1.34 Scores on a scale | Standard Deviation 2.288 |
| Vehicle QD | Mean Change in PASI Score From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | -1.29 Scores on a scale | Standard Deviation 3.28 |
| Vehicle QD | Mean Change in PASI Score From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | -0.61 Scores on a scale | Standard Deviation 1.644 |
| Vehicle QD | Mean Change in PASI Score From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | -1.09 Scores on a scale | Standard Deviation 3.914 |
| Vehicle QD | Mean Change in PASI Score From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | -0.28 Scores on a scale | Standard Deviation 1.165 |
Secondary
Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit
The extent of BSA affected by psoriasis is a general indicator of disease severity and was measured throughout the study. The extent of BSA to which study treatment was applied was also recorded. For the purpose of approximate clinical estimation, the total palmar surface of the palm plus 5 digits was assumed to be approximately equivalent to 1 percent BSA. Assessment of BSA affected with psoriasis was performed separately for four body surface regions: the head, the upper extremities, the trunk and the lower extremities, corresponding to 10, 20, 30 and 40 percent of the total body area, respectively. The mean change in percent BSA affected from Baseline was summarized for each study visit. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Baseline and up to Week 16
Population: mITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | -2.14 Percentage of BSA | Standard Deviation 3.275 |
| GSK2894512 1% BID | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | -1.06 Percentage of BSA | Standard Deviation 1.496 |
| GSK2894512 1% BID | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | -0.53 Percentage of BSA | Standard Deviation 1.136 |
| GSK2894512 1% BID | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | -3.37 Percentage of BSA | Standard Deviation 3.59 |
| GSK2894512 1% BID | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | -4.88 Percentage of BSA | Standard Deviation 4.211 |
| GSK2894512 1% BID | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | -5.01 Percentage of BSA | Standard Deviation 4.108 |
| GSK2894512 1% BID | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | -5.30 Percentage of BSA | Standard Deviation 4.468 |
| GSK2894512 1% BID | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | -1.92 Percentage of BSA | Standard Deviation 2.218 |
| GSK2894512 1% QD | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | -3.60 Percentage of BSA | Standard Deviation 3.22 |
| GSK2894512 1% QD | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | -2.31 Percentage of BSA | Standard Deviation 3.465 |
| GSK2894512 1% QD | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | -0.30 Percentage of BSA | Standard Deviation 0.99 |
| GSK2894512 1% QD | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | -4.47 Percentage of BSA | Standard Deviation 3.833 |
| GSK2894512 1% QD | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | -4.63 Percentage of BSA | Standard Deviation 3.548 |
| GSK2894512 1% QD | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | -2.13 Percentage of BSA | Standard Deviation 2.529 |
| GSK2894512 1% QD | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | -0.75 Percentage of BSA | Standard Deviation 1.789 |
| GSK2894512 1% QD | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | -4.28 Percentage of BSA | Standard Deviation 3.508 |
| GSK2894512 0.5% BID | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | -0.79 Percentage of BSA | Standard Deviation 1.35 |
| GSK2894512 0.5% BID | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | -1.93 Percentage of BSA | Standard Deviation 2.951 |
| GSK2894512 0.5% BID | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | -3.51 Percentage of BSA | Standard Deviation 3.756 |
| GSK2894512 0.5% BID | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 0.25 Percentage of BSA | Standard Deviation 1.893 |
| GSK2894512 0.5% BID | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | -4.29 Percentage of BSA | Standard Deviation 3.882 |
| GSK2894512 0.5% BID | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | -4.26 Percentage of BSA | Standard Deviation 4.172 |
| GSK2894512 0.5% BID | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | -4.34 Percentage of BSA | Standard Deviation 4.299 |
| GSK2894512 0.5% BID | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | -0.35 Percentage of BSA | Standard Deviation 0.774 |
| GSK2894512 0.5% QD | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | -3.56 Percentage of BSA | Standard Deviation 4.716 |
| GSK2894512 0.5% QD | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | -3.59 Percentage of BSA | Standard Deviation 4.201 |
| GSK2894512 0.5% QD | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | -3.59 Percentage of BSA | Standard Deviation 3.931 |
| GSK2894512 0.5% QD | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 0.02 Percentage of BSA | Standard Deviation 0.773 |
| GSK2894512 0.5% QD | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | -0.80 Percentage of BSA | Standard Deviation 1.468 |
| GSK2894512 0.5% QD | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | -1.77 Percentage of BSA | Standard Deviation 2.8 |
| GSK2894512 0.5% QD | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 1.25 Percentage of BSA | Standard Deviation 9.546 |
| GSK2894512 0.5% QD | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | -0.51 Percentage of BSA | Standard Deviation 1.157 |
| Vehicle BID | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 0.74 Percentage of BSA | Standard Deviation 1.536 |
| Vehicle BID | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | -0.05 Percentage of BSA | Standard Deviation 0.51 |
| Vehicle BID | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | -1.57 Percentage of BSA | Standard Deviation 2.38 |
| Vehicle BID | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | -1.33 Percentage of BSA | Standard Deviation 2.475 |
| Vehicle BID | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | -1.18 Percentage of BSA | Standard Deviation 2.49 |
| Vehicle BID | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | -0.18 Percentage of BSA | Standard Deviation 0.657 |
| Vehicle BID | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | -0.60 Percentage of BSA | Standard Deviation 1.332 |
| Vehicle BID | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | -1.05 Percentage of BSA | Standard Deviation 1.823 |
| Vehicle QD | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 1.17 Percentage of BSA | Standard Deviation 2.094 |
| Vehicle QD | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | -0.98 Percentage of BSA | Standard Deviation 3.335 |
| Vehicle QD | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | -0.17 Percentage of BSA | Standard Deviation 1.432 |
| Vehicle QD | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | -0.65 Percentage of BSA | Standard Deviation 1.435 |
| Vehicle QD | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | -0.58 Percentage of BSA | Standard Deviation 3.634 |
| Vehicle QD | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | -0.13 Percentage of BSA | Standard Deviation 1.159 |
| Vehicle QD | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | -1.10 Percentage of BSA | Standard Deviation 3.627 |
| Vehicle QD | Mean Change in Percent of BSA Affected With Psoriasis From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 0.01 Percentage of BSA | Standard Deviation 0.277 |
Secondary
Mean Change in PGA Score From Baseline to Each Study Visit
The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The mean change in PGA scores from Baseline was summarized for each study visit. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Baseline and up to Week 16
Population: mITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Mean Change in PGA Score From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | -1.0 Scores on a scale | Standard Deviation 0.69 |
| GSK2894512 1% BID | Mean Change in PGA Score From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | -0.7 Scores on a scale | Standard Deviation 0.75 |
| GSK2894512 1% BID | Mean Change in PGA Score From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | -0.3 Scores on a scale | Standard Deviation 0.44 |
| GSK2894512 1% BID | Mean Change in PGA Score From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | -1.4 Scores on a scale | Standard Deviation 0.9 |
| GSK2894512 1% BID | Mean Change in PGA Score From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | -1.8 Scores on a scale | Standard Deviation 0.9 |
| GSK2894512 1% BID | Mean Change in PGA Score From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | -1.7 Scores on a scale | Standard Deviation 0.93 |
| GSK2894512 1% BID | Mean Change in PGA Score From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | -1.6 Scores on a scale | Standard Deviation 1.01 |
| GSK2894512 1% BID | Mean Change in PGA Score From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | -0.5 Scores on a scale | Standard Deviation 1.18 |
| GSK2894512 1% QD | Mean Change in PGA Score From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | -1.3 Scores on a scale | Standard Deviation 0.88 |
| GSK2894512 1% QD | Mean Change in PGA Score From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | -1.3 Scores on a scale | Standard Deviation 1.38 |
| GSK2894512 1% QD | Mean Change in PGA Score From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | -0.3 Scores on a scale | Standard Deviation 0.48 |
| GSK2894512 1% QD | Mean Change in PGA Score From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | -1.6 Scores on a scale | Standard Deviation 1.24 |
| GSK2894512 1% QD | Mean Change in PGA Score From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | -1.6 Scores on a scale | Standard Deviation 1.2 |
| GSK2894512 1% QD | Mean Change in PGA Score From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | -1.1 Scores on a scale | Standard Deviation 0.7 |
| GSK2894512 1% QD | Mean Change in PGA Score From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | -0.6 Scores on a scale | Standard Deviation 0.7 |
| GSK2894512 1% QD | Mean Change in PGA Score From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | -1.7 Scores on a scale | Standard Deviation 1.03 |
| GSK2894512 0.5% BID | Mean Change in PGA Score From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | -0.6 Scores on a scale | Standard Deviation 0.77 |
| GSK2894512 0.5% BID | Mean Change in PGA Score From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | -0.9 Scores on a scale | Standard Deviation 0.83 |
| GSK2894512 0.5% BID | Mean Change in PGA Score From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | -1.4 Scores on a scale | Standard Deviation 0.84 |
| GSK2894512 0.5% BID | Mean Change in PGA Score From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | -1.0 Scores on a scale | Standard Deviation 1.41 |
| GSK2894512 0.5% BID | Mean Change in PGA Score From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | -1.7 Scores on a scale | Standard Deviation 1.06 |
| GSK2894512 0.5% BID | Mean Change in PGA Score From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | -1.4 Scores on a scale | Standard Deviation 0.88 |
| GSK2894512 0.5% BID | Mean Change in PGA Score From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | -1.4 Scores on a scale | Standard Deviation 0.9 |
| GSK2894512 0.5% BID | Mean Change in PGA Score From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | -0.3 Scores on a scale | Standard Deviation 0.69 |
| GSK2894512 0.5% QD | Mean Change in PGA Score From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | -1.3 Scores on a scale | Standard Deviation 1 |
| GSK2894512 0.5% QD | Mean Change in PGA Score From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | -1.2 Scores on a scale | Standard Deviation 0.92 |
| GSK2894512 0.5% QD | Mean Change in PGA Score From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | -1.3 Scores on a scale | Standard Deviation 0.81 |
| GSK2894512 0.5% QD | Mean Change in PGA Score From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | -0.3 Scores on a scale | Standard Deviation 0.47 |
| GSK2894512 0.5% QD | Mean Change in PGA Score From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | -0.8 Scores on a scale | Standard Deviation 0.78 |
| GSK2894512 0.5% QD | Mean Change in PGA Score From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | -1.2 Scores on a scale | Standard Deviation 0.97 |
| GSK2894512 0.5% QD | Mean Change in PGA Score From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 0.0 Scores on a scale | Standard Deviation 1.41 |
| GSK2894512 0.5% QD | Mean Change in PGA Score From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | -0.4 Scores on a scale | Standard Deviation 0.62 |
| Vehicle BID | Mean Change in PGA Score From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 0.0 Scores on a scale | Standard Deviation 0.47 |
| Vehicle BID | Mean Change in PGA Score From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | -0.1 Scores on a scale | Standard Deviation 0.52 |
| Vehicle BID | Mean Change in PGA Score From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | -0.5 Scores on a scale | Standard Deviation 0.77 |
| Vehicle BID | Mean Change in PGA Score From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | -0.5 Scores on a scale | Standard Deviation 0.7 |
| Vehicle BID | Mean Change in PGA Score From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | -0.4 Scores on a scale | Standard Deviation 0.49 |
| Vehicle BID | Mean Change in PGA Score From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | -0.4 Scores on a scale | Standard Deviation 0.69 |
| Vehicle BID | Mean Change in PGA Score From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | -0.5 Scores on a scale | Standard Deviation 0.6 |
| Vehicle BID | Mean Change in PGA Score From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | -0.5 Scores on a scale | Standard Deviation 0.6 |
| Vehicle QD | Mean Change in PGA Score From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | -0.4 Scores on a scale | Standard Deviation 0.67 |
| Vehicle QD | Mean Change in PGA Score From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | -0.2 Scores on a scale | Standard Deviation 0.5 |
| Vehicle QD | Mean Change in PGA Score From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | -0.2 Scores on a scale | Standard Deviation 0.51 |
| Vehicle QD | Mean Change in PGA Score From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | -0.4 Scores on a scale | Standard Deviation 0.49 |
| Vehicle QD | Mean Change in PGA Score From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | -0.4 Scores on a scale | Standard Deviation 0.5 |
| Vehicle QD | Mean Change in PGA Score From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 0.1 Scores on a scale | Standard Deviation 0.6 |
| Vehicle QD | Mean Change in PGA Score From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | -0.3 Scores on a scale | Standard Deviation 0.56 |
| Vehicle QD | Mean Change in PGA Score From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | -0.1 Scores on a scale | Standard Deviation 0.3 |
Secondary
Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit
The participant reported itch severity was obtained from the response of the participants to the itch NRS item in the psoriasis symptom diary (PSD). PSD was developed to assess daily self-reports of psoriasis symptoms and the functional impact related to the underlying pathophysiology of the disease. The participants answered questions related to the severity and impact of the signs and symptoms daily using a 11 point NRS with scores ranging from 0 (absent) to 10 (worst imaginable). Mean change in itch/pruritis NRS from Baseline to each study visit was presented. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the post dose weekly average value minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Baseline and up to Week 16
Population: mITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 12, n=14, 20, 21, 24, 15, 18 | -3.53 Scores on a scale | Standard Deviation 2.933 |
| GSK2894512 1% BID | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | EW, n=6, 3, 2, 0, 5, 5 | -1.77 Scores on a scale | Standard Deviation 1.647 |
| GSK2894512 1% BID | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 4, n=20, 25, 21, 30, 17, 24 | -2.35 Scores on a scale | Standard Deviation 3.057 |
| GSK2894512 1% BID | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 1, n=28, 33, 21, 31, 21, 29 | -0.66 Scores on a scale | Standard Deviation 1.8 |
| GSK2894512 1% BID | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 14, n=13, 14, 15, 24, 15, 13 | -3.56 Scores on a scale | Standard Deviation 2.698 |
| GSK2894512 1% BID | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 16, n=10, 9, 12, 19, 13, 10 | -3.67 Scores on a scale | Standard Deviation 3.766 |
| GSK2894512 1% BID | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 8, n=18, 22, 20, 29, 16, 20 | -3.66 Scores on a scale | Standard Deviation 3.248 |
| GSK2894512 1% BID | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 2, n=27, 30, 22, 32, 20, 25 | -1.62 Scores on a scale | Standard Deviation 2.334 |
| GSK2894512 1% QD | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 14, n=13, 14, 15, 24, 15, 13 | -3.52 Scores on a scale | Standard Deviation 2.489 |
| GSK2894512 1% QD | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 16, n=10, 9, 12, 19, 13, 10 | -2.19 Scores on a scale | Standard Deviation 2.695 |
| GSK2894512 1% QD | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 2, n=27, 30, 22, 32, 20, 25 | -0.85 Scores on a scale | Standard Deviation 1.87 |
| GSK2894512 1% QD | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | EW, n=6, 3, 2, 0, 5, 5 | -0.07 Scores on a scale | Standard Deviation 1.501 |
| GSK2894512 1% QD | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 4, n=20, 25, 21, 30, 17, 24 | -1.78 Scores on a scale | Standard Deviation 2.402 |
| GSK2894512 1% QD | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 1, n=28, 33, 21, 31, 21, 29 | -0.17 Scores on a scale | Standard Deviation 2.007 |
| GSK2894512 1% QD | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 8, n=18, 22, 20, 29, 16, 20 | -1.93 Scores on a scale | Standard Deviation 2.543 |
| GSK2894512 1% QD | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 12, n=14, 20, 21, 24, 15, 18 | -2.59 Scores on a scale | Standard Deviation 2.923 |
| GSK2894512 0.5% BID | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 8, n=18, 22, 20, 29, 16, 20 | -3.29 Scores on a scale | Standard Deviation 2.605 |
| GSK2894512 0.5% BID | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 14, n=13, 14, 15, 24, 15, 13 | -3.58 Scores on a scale | Standard Deviation 2.296 |
| GSK2894512 0.5% BID | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 12, n=14, 20, 21, 24, 15, 18 | -3.65 Scores on a scale | Standard Deviation 2.605 |
| GSK2894512 0.5% BID | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 2, n=27, 30, 22, 32, 20, 25 | -1.97 Scores on a scale | Standard Deviation 2.366 |
| GSK2894512 0.5% BID | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | EW, n=6, 3, 2, 0, 5, 5 | -5.67 Scores on a scale | Standard Deviation 6.128 |
| GSK2894512 0.5% BID | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 4, n=20, 25, 21, 30, 17, 24 | -3.13 Scores on a scale | Standard Deviation 2.075 |
| GSK2894512 0.5% BID | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 1, n=28, 33, 21, 31, 21, 29 | -1.00 Scores on a scale | Standard Deviation 2.038 |
| GSK2894512 0.5% BID | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 16, n=10, 9, 12, 19, 13, 10 | -3.66 Scores on a scale | Standard Deviation 2.059 |
| GSK2894512 0.5% QD | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 4, n=20, 25, 21, 30, 17, 24 | -1.91 Scores on a scale | Standard Deviation 2.723 |
| GSK2894512 0.5% QD | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 2, n=27, 30, 22, 32, 20, 25 | -1.24 Scores on a scale | Standard Deviation 1.949 |
| GSK2894512 0.5% QD | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 8, n=18, 22, 20, 29, 16, 20 | -2.06 Scores on a scale | Standard Deviation 2.842 |
| GSK2894512 0.5% QD | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 16, n=10, 9, 12, 19, 13, 10 | -2.25 Scores on a scale | Standard Deviation 2.992 |
| GSK2894512 0.5% QD | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 14, n=13, 14, 15, 24, 15, 13 | -2.24 Scores on a scale | Standard Deviation 3.067 |
| GSK2894512 0.5% QD | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 12, n=14, 20, 21, 24, 15, 18 | -2.73 Scores on a scale | Standard Deviation 2.922 |
| GSK2894512 0.5% QD | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 1, n=28, 33, 21, 31, 21, 29 | -0.32 Scores on a scale | Standard Deviation 1.71 |
| Vehicle BID | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 2, n=27, 30, 22, 32, 20, 25 | -1.66 Scores on a scale | Standard Deviation 2.444 |
| Vehicle BID | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 1, n=28, 33, 21, 31, 21, 29 | -1.31 Scores on a scale | Standard Deviation 1.689 |
| Vehicle BID | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 4, n=20, 25, 21, 30, 17, 24 | -1.67 Scores on a scale | Standard Deviation 2.727 |
| Vehicle BID | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 8, n=18, 22, 20, 29, 16, 20 | -1.98 Scores on a scale | Standard Deviation 3.239 |
| Vehicle BID | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 12, n=14, 20, 21, 24, 15, 18 | -2.46 Scores on a scale | Standard Deviation 3.389 |
| Vehicle BID | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 14, n=13, 14, 15, 24, 15, 13 | -1.90 Scores on a scale | Standard Deviation 2.643 |
| Vehicle BID | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 16, n=10, 9, 12, 19, 13, 10 | -2.36 Scores on a scale | Standard Deviation 2.837 |
| Vehicle BID | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | EW, n=6, 3, 2, 0, 5, 5 | -1.79 Scores on a scale | Standard Deviation 1.654 |
| Vehicle QD | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 8, n=18, 22, 20, 29, 16, 20 | -1.43 Scores on a scale | Standard Deviation 2.664 |
| Vehicle QD | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | EW, n=6, 3, 2, 0, 5, 5 | -0.51 Scores on a scale | Standard Deviation 1.391 |
| Vehicle QD | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 16, n=10, 9, 12, 19, 13, 10 | -2.06 Scores on a scale | Standard Deviation 3.225 |
| Vehicle QD | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 4, n=20, 25, 21, 30, 17, 24 | -1.31 Scores on a scale | Standard Deviation 2.338 |
| Vehicle QD | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 2, n=27, 30, 22, 32, 20, 25 | -1.12 Scores on a scale | Standard Deviation 2.147 |
| Vehicle QD | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 1, n=28, 33, 21, 31, 21, 29 | -0.63 Scores on a scale | Standard Deviation 1.612 |
| Vehicle QD | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 14, n=13, 14, 15, 24, 15, 13 | -2.19 Scores on a scale | Standard Deviation 2.898 |
| Vehicle QD | Mean Change in Weekly Average Itch/Pruritus Numeric Rating Scale (NRS) From Baseline to Each Study Visit | Week 12, n=14, 20, 21, 24, 15, 18 | -1.43 Scores on a scale | Standard Deviation 2.765 |
Secondary
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Single 12-lead ECGs were obtained over a brief recording period at each specified time point during the study using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. For multiple ECGs at one visit, or Any time post-screen, a participant is categorized as Abnormal if \>=1 assessment is abnormal. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Up to Week 14
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2894512 1% BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Baseline, n=38, 38, 38, 38, 37, 38 | 5 Participants |
| GSK2894512 1% BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 1, n=36, 38, 37, 37, 34, 37 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 12, n=26, 30, 32, 36, 26, 25 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 14, n=29, 31, 33, 34, 27, 25 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | EW, n=10, 6, 4, 2, 10, 9 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | PS, n=38, 38, 38, 38, 36, 37 | 7 Participants |
| GSK2894512 1% QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 1, n=36, 38, 37, 37, 34, 37 | 8 Participants |
| GSK2894512 1% QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 14, n=29, 31, 33, 34, 27, 25 | 5 Participants |
| GSK2894512 1% QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | PS, n=38, 38, 38, 38, 36, 37 | 11 Participants |
| GSK2894512 1% QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Baseline, n=38, 38, 38, 38, 37, 38 | 8 Participants |
| GSK2894512 1% QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 12, n=26, 30, 32, 36, 26, 25 | 6 Participants |
| GSK2894512 1% QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | EW, n=10, 6, 4, 2, 10, 9 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | PS, n=38, 38, 38, 38, 36, 37 | 10 Participants |
| GSK2894512 0.5% BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | EW, n=10, 6, 4, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 14, n=29, 31, 33, 34, 27, 25 | 10 Participants |
| GSK2894512 0.5% BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 12, n=26, 30, 32, 36, 26, 25 | 7 Participants |
| GSK2894512 0.5% BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Baseline, n=38, 38, 38, 38, 37, 38 | 6 Participants |
| GSK2894512 0.5% BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 1, n=36, 38, 37, 37, 34, 37 | 7 Participants |
| GSK2894512 0.5% QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 14, n=29, 31, 33, 34, 27, 25 | 5 Participants |
| GSK2894512 0.5% QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 1, n=36, 38, 37, 37, 34, 37 | 4 Participants |
| GSK2894512 0.5% QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 12, n=26, 30, 32, 36, 26, 25 | 4 Participants |
| GSK2894512 0.5% QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | PS, n=38, 38, 38, 38, 36, 37 | 7 Participants |
| GSK2894512 0.5% QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | EW, n=10, 6, 4, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Baseline, n=38, 38, 38, 38, 37, 38 | 4 Participants |
| Vehicle BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Baseline, n=38, 38, 38, 38, 37, 38 | 6 Participants |
| Vehicle BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | EW, n=10, 6, 4, 2, 10, 9 | 0 Participants |
| Vehicle BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 1, n=36, 38, 37, 37, 34, 37 | 5 Participants |
| Vehicle BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 12, n=26, 30, 32, 36, 26, 25 | 4 Participants |
| Vehicle BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 14, n=29, 31, 33, 34, 27, 25 | 2 Participants |
| Vehicle BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | PS, n=38, 38, 38, 38, 36, 37 | 7 Participants |
| Vehicle QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 14, n=29, 31, 33, 34, 27, 25 | 3 Participants |
| Vehicle QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 12, n=26, 30, 32, 36, 26, 25 | 4 Participants |
| Vehicle QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | EW, n=10, 6, 4, 2, 10, 9 | 1 Participants |
| Vehicle QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | PS, n=38, 38, 38, 38, 36, 37 | 7 Participants |
| Vehicle QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 1, n=36, 38, 37, 37, 34, 37 | 4 Participants |
| Vehicle QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Baseline, n=38, 38, 38, 38, 37, 38 | 5 Participants |
Secondary
Number of Participants With Chemistry Data of Potential Clinical Importance
Blood samples were collected for the evaluation of clinical chemistry parameters including alk phos, ALT, AST, bil, calcium, CO2, creatinine, glucose and potassium. The number of participants with chemistry data of potential clinical importance for the mentioned parameters was presented. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Up to Week 14
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 8, n=30, 31, 32, 37, 27, 26 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 4, n=32, 34, 33, 37, 29, 30 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 12, n=27, 30, 32, 36, 26, 24 | 3 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 2, n=35, 36, 35, 37, 29, 34 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 8, n=30, 31, 32, 37, 27, 26 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos,post-screen(PS),n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 2, n=35, 36, 35, 37, 29, 34 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 14, n=29, 31, 33, 34, 27, 24 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, PS, n=38, 37, 37, 38, 36, 36 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, PS, n=38, 37, 37, 38, 36, 36 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, PS, n=38, 37, 37, 38, 36, 36 | 7 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, EW, n=10, 6, 3, 2, 10, 9 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 4, n=32, 34, 33, 37, 29, 30 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, PS, n=38, 37, 37, 38, 36, 36 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 4, n=32, 34, 33, 37, 29, 30 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 8, n=30, 31, 32, 37, 27, 26 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 2, n=35, 36, 35, 37, 29, 34 | 5 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 4, n=32, 34, 33, 37, 29, 30 | 4 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 8, n=30, 31, 32, 37, 27, 26 | 3 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 12, n=27, 30, 32, 36, 26, 24 | 3 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, PS, n=38, 37, 37, 38, 36, 36 | 7 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 14, n=29, 31, 33, 34, 27, 24 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos,post-screen(PS),n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, PS, n=38, 37, 37, 38, 36, 36 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 8, n=30, 31, 32, 37, 27, 26 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 4, n=32, 34, 33, 37, 29, 30 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Baseline, n=38, 38, 38, 38, 37, 38 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Baseline, n=38, 38, 38, 38, 37, 38 | 4 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 2, n=35, 36, 35, 37, 29, 34 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 8, n=30, 31, 32, 37, 27, 26 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, PS, n=38, 37, 37, 38, 36, 36 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, PS, n=38, 37, 37, 38, 36, 36 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 8, n=30, 31, 32, 37, 27, 26 | 6 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Baseline, n=38, 38, 38, 38, 37, 38 | 5 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 14, n=29, 31, 33, 34, 27, 24 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 8, n=30, 31, 32, 37, 27, 26 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, PS, n=38, 37, 37, 38, 36, 36 | 8 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 4, n=32, 34, 33, 37, 29, 30 | 4 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, PS, n=38, 37, 37, 38, 36, 36 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos,post-screen(PS),n=38, 37, 37, 38, 36, 36 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 2, n=35, 36, 35, 37, 29, 34 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 2, n=35, 36, 35, 37, 29, 34 | 4 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 2, n=35, 36, 35, 37, 29, 34 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Baseline, n=38, 38, 38, 38, 37, 38 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 4, n=32, 34, 33, 37, 29, 30 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 14, n=29, 31, 33, 34, 27, 24 | 7 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, PS, n=38, 37, 37, 38, 36, 36 | 7 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 12, n=27, 30, 32, 36, 26, 24 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, PS, n=38, 37, 37, 38, 36, 36 | 2 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 8, n=30, 31, 32, 37, 27, 26 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 12, n=27, 30, 32, 36, 26, 24 | 7 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, EW, n=10, 6, 3, 2, 10, 9 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 2, n=35, 36, 35, 37, 29, 34 | 5 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 12, n=27, 30, 32, 36, 26, 24 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, PS, n=38, 37, 37, 38, 36, 36 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 4, n=32, 34, 33, 37, 29, 30 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 12, n=27, 30, 32, 36, 26, 24 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos,post-screen(PS),n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, PS, n=38, 37, 37, 38, 36, 36 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Baseline, n=38, 38, 38, 38, 37, 38 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 2, n=35, 36, 35, 37, 29, 34 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 4, n=32, 34, 33, 37, 29, 30 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 8, n=30, 31, 32, 37, 27, 26 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 12, n=27, 30, 32, 36, 26, 24 | 4 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 14, n=29, 31, 33, 34, 27, 24 | 4 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, PS, n=38, 37, 37, 38, 36, 36 | 8 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 12, n=27, 30, 32, 36, 26, 24 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, PS, n=38, 37, 37, 38, 36, 36 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 2, n=35, 36, 35, 37, 29, 34 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 14, n=29, 31, 33, 34, 27, 24 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, PS, n=38, 37, 37, 38, 36, 36 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 8, n=30, 31, 32, 37, 27, 26 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 4, n=32, 34, 33, 37, 29, 30 | 2 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 2, n=35, 36, 35, 37, 29, 34 | 1 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, PS, n=38, 37, 37, 38, 36, 36 | 2 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Baseline, n=38, 38, 38, 38, 37, 38 | 5 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, PS, n=38, 37, 37, 38, 36, 36 | 1 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos,post-screen(PS),n=38, 37, 37, 38, 36, 36 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 14, n=29, 31, 33, 34, 27, 24 | 5 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 12, n=27, 30, 32, 36, 26, 24 | 2 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, PS, n=38, 37, 37, 38, 36, 36 | 6 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 8, n=30, 31, 32, 37, 27, 26 | 4 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 4, n=32, 34, 33, 37, 29, 30 | 5 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 2, n=35, 36, 35, 37, 29, 34 | 2 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 2, n=35, 36, 35, 37, 29, 34 | 1 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 8, n=30, 31, 32, 37, 27, 26 | 3 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 12, n=27, 30, 32, 36, 26, 24 | 1 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 8, n=30, 31, 32, 37, 27, 26 | 1 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 8, n=30, 31, 32, 37, 27, 26 | 2 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 4, n=32, 34, 33, 37, 29, 30 | 1 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos,post-screen(PS),n=38, 37, 37, 38, 36, 36 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 2, n=35, 36, 35, 37, 29, 34 | 1 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Baseline, n=38, 38, 38, 38, 37, 38 | 1 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 4, n=32, 34, 33, 37, 29, 30 | 3 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 12, n=27, 30, 32, 36, 26, 24 | 1 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 4, n=32, 34, 33, 37, 29, 30 | 1 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, PS, n=38, 37, 37, 38, 36, 36 | 2 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 14, n=29, 31, 33, 34, 27, 24 | 3 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 4, n=32, 34, 33, 37, 29, 30 | 1 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Week 2, n=35, 36, 35, 37, 29, 34 | 1 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Baseline, n=38, 38, 38, 38, 37, 38 | 1 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 12, n=27, 30, 32, 36, 26, 24 | 2 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, PS, n=38, 37, 37, 38, 36, 36 | 1 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, Week 2, n=35, 36, 35, 37, 29, 34 | 2 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, PS, n=38, 37, 37, 38, 36, 36 | 2 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 14, n=29, 31, 33, 34, 27, 24 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine, Week 8, n=30, 31, 32, 37, 27, 26 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium, Week 2, n=35, 36, 35, 37, 29, 34 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phos, Week 4, n=32, 34, 33, 37, 29, 30 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bil, Week 14, n=29, 31, 33, 34, 27, 24 | 1 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose, PS, n=38, 37, 37, 38, 36, 36 | 9 Participants |
Secondary
Number of Participants With Hematology Data of Clinical Importance
Blood samples were collected for the evaluation of hematology parameters including hematocrit, Hgb, lymphocytes, neutrophils and platelets. The number of participants with clinically significant abnormal values of the mentioned hematology parameters was presented. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Up to Week 14
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 14, n=29, 30, 33, 34, 27, 23 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 2, n=35, 35, 36, 37, 29, 35 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 14, n=29, 30, 33, 34, 27, 23 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Platelets, PS, n=38, 37, 37, 38, 35, 36 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Platelets,Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 8, n=30, 31, 32, 38, 27, 26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 8, n=30, 31, 32, 38, 27, 26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 4, n=32, 34, 35, 37, 29, 31 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 14, n=29, 30, 33, 34, 27, 23 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 8, n=30, 31, 32, 38, 27, 26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 2, n=35, 35, 36, 37, 29, 35 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Platelets, EW, n=10, 5, 3, 2, 9, 9 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 4, n=32, 34, 35, 37, 29, 31 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Hgb, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Hgb, PS, n=38, 37, 37, 38, 36, 36 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 14, n=29, 30, 33, 34, 27, 23 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Neutrophils,Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 2, n=35, 35, 36, 37, 29, 35 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 8, n=30, 30, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 2, n=35, 35, 36, 37, 29, 35 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Hematocrit,Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, PS, n=38, 37, 37, 38, 36, 36 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 14, n=29, 30, 33, 34, 27, 23 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 4, n=31, 34, 35, 37, 29, 31 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 4, n=31, 34, 35, 37, 29, 31 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 2, n=35, 35, 36, 37, 29, 35 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 4, n=32, 34, 35, 37, 29, 31 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 8, n=30, 30, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Clinical Importance | Hgb,Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 2, n=35, 35, 36, 37, 29, 35 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 14, n=29, 30, 33, 34, 27, 23 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 4, n=32, 34, 35, 37, 29, 31 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 4, n=32, 34, 35, 37, 29, 31 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 14, n=29, 30, 33, 34, 27, 23 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Hematocrit,Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Hgb, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 4, n=31, 34, 35, 37, 29, 31 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 14, n=29, 30, 33, 34, 27, 23 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Hgb, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, PS, n=38, 37, 37, 38, 36, 36 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 8, n=30, 30, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 14, n=29, 30, 33, 34, 27, 23 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 8, n=30, 31, 32, 38, 27, 26 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 2, n=35, 35, 36, 37, 29, 35 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Platelets, EW, n=10, 5, 3, 2, 9, 9 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Hgb,Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 8, n=30, 31, 32, 38, 27, 26 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 4, n=31, 34, 35, 37, 29, 31 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Neutrophils,Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 8, n=30, 31, 32, 38, 27, 26 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 8, n=30, 30, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 2, n=35, 35, 36, 37, 29, 35 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Platelets, PS, n=38, 37, 37, 38, 35, 36 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 2, n=35, 35, 36, 37, 29, 35 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 2, n=35, 35, 36, 37, 29, 35 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 14, n=29, 30, 33, 34, 27, 23 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Platelets,Baseline, n=38, 38, 38, 38, 37, 38 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 4, n=32, 34, 35, 37, 29, 31 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 4, n=32, 34, 35, 37, 29, 31 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 14, n=29, 30, 33, 34, 27, 23 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Hgb,Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Hematocrit,Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Platelets, EW, n=10, 5, 3, 2, 9, 9 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Platelets, PS, n=38, 37, 37, 38, 35, 36 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Platelets,Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 2, n=35, 35, 36, 37, 29, 35 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 4, n=32, 34, 35, 37, 29, 31 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 8, n=30, 31, 32, 38, 27, 26 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 2, n=35, 35, 36, 37, 29, 35 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Hgb, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 4, n=32, 34, 35, 37, 29, 31 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 14, n=29, 30, 33, 34, 27, 23 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Neutrophils,Baseline, n=38, 38, 38, 38, 37, 38 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 2, n=35, 35, 36, 37, 29, 35 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 4, n=31, 34, 35, 37, 29, 31 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 8, n=30, 30, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 2, n=35, 35, 36, 37, 29, 35 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 14, n=29, 30, 33, 34, 27, 23 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 8, n=30, 31, 32, 38, 27, 26 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 8, n=30, 31, 32, 38, 27, 26 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 14, n=29, 30, 33, 34, 27, 23 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Hgb, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, PS, n=38, 37, 37, 38, 36, 36 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 4, n=31, 34, 35, 37, 29, 31 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 8, n=30, 30, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 2, n=35, 35, 36, 37, 29, 35 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 14, n=29, 30, 33, 34, 27, 23 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 2, n=35, 35, 36, 37, 29, 35 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Hgb, PS, n=38, 37, 37, 38, 36, 36 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 14, n=29, 30, 33, 34, 27, 23 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 8, n=30, 30, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 2, n=35, 35, 36, 37, 29, 35 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Platelets,Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 12, n=27, 30, 31, 36, 26, 25 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 4, n=31, 34, 35, 37, 29, 31 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 2, n=35, 35, 36, 37, 29, 35 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 4, n=31, 34, 35, 37, 29, 31 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, PS, n=38, 37, 37, 38, 36, 36 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 2, n=35, 35, 36, 37, 29, 35 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Neutrophils,Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Hgb,Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 8, n=30, 30, 32, 37, 27, 26 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 14, n=29, 30, 33, 34, 27, 23 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 4, n=32, 34, 35, 37, 29, 31 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Platelets, EW, n=10, 5, 3, 2, 9, 9 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Hematocrit,Baseline, n=38, 38, 38, 38, 37, 38 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 2, n=35, 35, 36, 37, 29, 35 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 4, n=32, 34, 35, 37, 29, 31 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 8, n=30, 31, 32, 38, 27, 26 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 14, n=29, 30, 33, 34, 27, 23 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 14, n=29, 30, 33, 34, 27, 23 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 14, n=29, 30, 33, 34, 27, 23 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 8, n=30, 31, 32, 38, 27, 26 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 4, n=32, 34, 35, 37, 29, 31 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Hgb, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Platelets, PS, n=38, 37, 37, 38, 35, 36 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 8, n=30, 31, 32, 38, 27, 26 | 2 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Platelets,Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 2, n=35, 35, 36, 37, 29, 35 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, PS, n=38, 37, 37, 38, 36, 36 | 1 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Hgb,Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 2, n=35, 35, 36, 37, 29, 35 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 4, n=32, 34, 35, 37, 29, 31 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, PS, n=38, 37, 37, 38, 36, 36 | 1 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Neutrophils,Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 2, n=35, 35, 36, 37, 29, 35 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 4, n=31, 34, 35, 37, 29, 31 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 8, n=30, 30, 32, 37, 27, 26 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 14, n=29, 30, 33, 34, 27, 23 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 8, n=30, 31, 32, 38, 27, 26 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 14, n=29, 30, 33, 34, 27, 23 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Hgb, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Hgb, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 2, n=35, 35, 36, 37, 29, 35 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 4, n=31, 34, 35, 37, 29, 31 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 8, n=30, 30, 32, 37, 27, 26 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 12, n=27, 30, 31, 36, 26, 25 | 1 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 14, n=29, 30, 33, 34, 27, 23 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 12, n=27, 30, 31, 36, 26, 25 | 1 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 14, n=29, 30, 33, 34, 27, 23 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Platelets, EW, n=10, 5, 3, 2, 9, 9 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Platelets, PS, n=38, 37, 37, 38, 35, 36 | 1 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 4, n=32, 34, 35, 37, 29, 31 | 1 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 8, n=30, 31, 32, 38, 27, 26 | 1 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Hematocrit,Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 2, n=35, 35, 36, 37, 29, 35 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 4, n=32, 34, 35, 37, 29, 31 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 8, n=30, 31, 32, 38, 27, 26 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 14, n=29, 30, 33, 34, 27, 23 | 1 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 14, n=29, 30, 33, 34, 27, 23 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Hgb,Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Hematocrit,Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 14, n=29, 30, 33, 34, 27, 23 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 8, n=30, 30, 32, 37, 27, 26 | 1 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 4, n=31, 34, 35, 37, 29, 31 | 1 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, PS, n=38, 37, 37, 38, 36, 36 | 1 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 2, n=35, 35, 36, 37, 29, 35 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Week 2, n=35, 35, 36, 37, 29, 35 | 1 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Hgb, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Hgb, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 14, n=29, 30, 33, 34, 27, 23 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Platelets, PS, n=38, 37, 37, 38, 35, 36 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 4, n=32, 34, 35, 37, 29, 31 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 8, n=30, 31, 32, 38, 27, 26 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, PS, n=38, 37, 37, 38, 36, 36 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 8, n=30, 31, 32, 38, 27, 26 | 1 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 14, n=29, 30, 33, 34, 27, 23 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 8, n=30, 30, 32, 37, 27, 26 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 4, n=31, 34, 35, 37, 29, 31 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 12, n=27, 30, 31, 36, 26, 25 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Neutrophils, Week 2, n=35, 35, 36, 37, 29, 35 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Neutrophils,Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, PS, n=38, 37, 37, 38, 36, 36 | 1 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Lymphocytes, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, EW, n=10, 6, 3, 2, 10, 9 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 4, n=32, 34, 35, 37, 29, 31 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 2, n=35, 35, 36, 37, 29, 35 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Hematocrit, Week 14, n=29, 30, 33, 34, 27, 23 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Platelets, Week 8, n=30, 31, 32, 38, 27, 26 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Platelets,Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 2, n=35, 35, 36, 37, 29, 35 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Hgb, Week 4, n=32, 34, 35, 37, 29, 31 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Clinical Importance | Platelets, EW, n=10, 5, 3, 2, 9, 9 | 0 Participants |
Secondary
Number of Participants With Ig Data Outside the Reference Range
Blood samples were collected for the evaluation of change in Ig levels from Baseline throughout the study. Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Up to Week 12
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2894512 1% BID | Number of Participants With Ig Data Outside the Reference Range | IgM, Week 4, n=32, 34, 35, 38, 29, 31 | 9 Participants |
| GSK2894512 1% BID | Number of Participants With Ig Data Outside the Reference Range | IgA, Week 8, n=30, 31, 33, 38, 27, 26 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Ig Data Outside the Reference Range | IgG, Baseline, n=38, 38, 38, 38, 37, 38 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Ig Data Outside the Reference Range | IgM, Week 8, n=30, 31, 33, 38, 27, 26 | 9 Participants |
| GSK2894512 1% BID | Number of Participants With Ig Data Outside the Reference Range | IgM, Week 12, n=27, 30, 32, 36, 26, 24 | 8 Participants |
| GSK2894512 1% BID | Number of Participants With Ig Data Outside the Reference Range | IgA, Baseline, n=38, 38, 38, 38, 37, 38 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Ig Data Outside the Reference Range | IgA, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Ig Data Outside the Reference Range | IgM, PS, n=33, 34, 36, 38, 29, 31 | 11 Participants |
| GSK2894512 1% BID | Number of Participants With Ig Data Outside the Reference Range | IgA, PS, n=33, 34, 36, 38, 29, 31 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Ig Data Outside the Reference Range | IgM, Baseline, n=38, 38, 38, 38, 37, 38 | 11 Participants |
| GSK2894512 1% BID | Number of Participants With Ig Data Outside the Reference Range | IgG, PS, n=33, 34, 36, 38, 29, 31 | 3 Participants |
| GSK2894512 1% BID | Number of Participants With Ig Data Outside the Reference Range | IgA, Week 4, n=32, 34, 35, 38, 29, 31 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Ig Data Outside the Reference Range | IgG, Week 8, n=30, 31, 33, 38, 27, 26 | 3 Participants |
| GSK2894512 1% BID | Number of Participants With Ig Data Outside the Reference Range | IgG, Week 12, n=27, 30, 32, 36, 26, 24 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Ig Data Outside the Reference Range | IgG, Week 4, n=32, 34, 35, 38, 29, 31 | 3 Participants |
| GSK2894512 1% QD | Number of Participants With Ig Data Outside the Reference Range | IgA, Week 8, n=30, 31, 33, 38, 27, 26 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Ig Data Outside the Reference Range | IgM, Baseline, n=38, 38, 38, 38, 37, 38 | 5 Participants |
| GSK2894512 1% QD | Number of Participants With Ig Data Outside the Reference Range | IgG, Week 12, n=27, 30, 32, 36, 26, 24 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Ig Data Outside the Reference Range | IgM, PS, n=33, 34, 36, 38, 29, 31 | 6 Participants |
| GSK2894512 1% QD | Number of Participants With Ig Data Outside the Reference Range | IgG, PS, n=33, 34, 36, 38, 29, 31 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Ig Data Outside the Reference Range | IgA, Week 4, n=32, 34, 35, 38, 29, 31 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Ig Data Outside the Reference Range | IgA, Baseline, n=38, 38, 38, 38, 37, 38 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Ig Data Outside the Reference Range | IgM, Week 12, n=27, 30, 32, 36, 26, 24 | 5 Participants |
| GSK2894512 1% QD | Number of Participants With Ig Data Outside the Reference Range | IgA, Week 12, n=27, 30, 32, 36, 26, 24 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Ig Data Outside the Reference Range | IgM, Week 8, n=30, 31, 33, 38, 27, 26 | 6 Participants |
| GSK2894512 1% QD | Number of Participants With Ig Data Outside the Reference Range | IgA, PS, n=33, 34, 36, 38, 29, 31 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Ig Data Outside the Reference Range | IgG, Baseline, n=38, 38, 38, 38, 37, 38 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Ig Data Outside the Reference Range | IgM, Week 4, n=32, 34, 35, 38, 29, 31 | 5 Participants |
| GSK2894512 1% QD | Number of Participants With Ig Data Outside the Reference Range | IgG, Week 4, n=32, 34, 35, 38, 29, 31 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Ig Data Outside the Reference Range | IgG, Week 8, n=30, 31, 33, 38, 27, 26 | 2 Participants |
| GSK2894512 0.5% BID | Number of Participants With Ig Data Outside the Reference Range | IgA, Week 4, n=32, 34, 35, 38, 29, 31 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Ig Data Outside the Reference Range | IgM, Week 4, n=32, 34, 35, 38, 29, 31 | 9 Participants |
| GSK2894512 0.5% BID | Number of Participants With Ig Data Outside the Reference Range | IgA, Week 8, n=30, 31, 33, 38, 27, 26 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Ig Data Outside the Reference Range | IgM, Baseline, n=38, 38, 38, 38, 37, 38 | 9 Participants |
| GSK2894512 0.5% BID | Number of Participants With Ig Data Outside the Reference Range | IgG, Baseline, n=38, 38, 38, 38, 37, 38 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Ig Data Outside the Reference Range | IgG, Week 12, n=27, 30, 32, 36, 26, 24 | 4 Participants |
| GSK2894512 0.5% BID | Number of Participants With Ig Data Outside the Reference Range | IgM, Week 12, n=27, 30, 32, 36, 26, 24 | 8 Participants |
| GSK2894512 0.5% BID | Number of Participants With Ig Data Outside the Reference Range | IgG, Week 8, n=30, 31, 33, 38, 27, 26 | 4 Participants |
| GSK2894512 0.5% BID | Number of Participants With Ig Data Outside the Reference Range | IgG, Week 4, n=32, 34, 35, 38, 29, 31 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Ig Data Outside the Reference Range | IgM, PS, n=33, 34, 36, 38, 29, 31 | 10 Participants |
| GSK2894512 0.5% BID | Number of Participants With Ig Data Outside the Reference Range | IgM, Week 8, n=30, 31, 33, 38, 27, 26 | 8 Participants |
| GSK2894512 0.5% BID | Number of Participants With Ig Data Outside the Reference Range | IgA, Baseline, n=38, 38, 38, 38, 37, 38 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Ig Data Outside the Reference Range | IgA, Week 12, n=27, 30, 32, 36, 26, 24 | 2 Participants |
| GSK2894512 0.5% BID | Number of Participants With Ig Data Outside the Reference Range | IgG, PS, n=33, 34, 36, 38, 29, 31 | 5 Participants |
| GSK2894512 0.5% BID | Number of Participants With Ig Data Outside the Reference Range | IgA, PS, n=33, 34, 36, 38, 29, 31 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Ig Data Outside the Reference Range | IgM, Week 8, n=30, 31, 33, 38, 27, 26 | 4 Participants |
| GSK2894512 0.5% QD | Number of Participants With Ig Data Outside the Reference Range | IgA, PS, n=33, 34, 36, 38, 29, 31 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Ig Data Outside the Reference Range | IgG, Baseline, n=38, 38, 38, 38, 37, 38 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Ig Data Outside the Reference Range | IgA, Baseline, n=38, 38, 38, 38, 37, 38 | 4 Participants |
| GSK2894512 0.5% QD | Number of Participants With Ig Data Outside the Reference Range | IgA, Week 4, n=32, 34, 35, 38, 29, 31 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Ig Data Outside the Reference Range | IgA, Week 8, n=30, 31, 33, 38, 27, 26 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Ig Data Outside the Reference Range | IgA, Week 12, n=27, 30, 32, 36, 26, 24 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Ig Data Outside the Reference Range | IgG, Week 4, n=32, 34, 35, 38, 29, 31 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Ig Data Outside the Reference Range | IgG, Week 8, n=30, 31, 33, 38, 27, 26 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Ig Data Outside the Reference Range | IgG, Week 12, n=27, 30, 32, 36, 26, 24 | 4 Participants |
| GSK2894512 0.5% QD | Number of Participants With Ig Data Outside the Reference Range | IgM, PS, n=33, 34, 36, 38, 29, 31 | 5 Participants |
| GSK2894512 0.5% QD | Number of Participants With Ig Data Outside the Reference Range | IgG, PS, n=33, 34, 36, 38, 29, 31 | 4 Participants |
| GSK2894512 0.5% QD | Number of Participants With Ig Data Outside the Reference Range | IgM, Baseline, n=38, 38, 38, 38, 37, 38 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Ig Data Outside the Reference Range | IgM, Week 4, n=32, 34, 35, 38, 29, 31 | 4 Participants |
| GSK2894512 0.5% QD | Number of Participants With Ig Data Outside the Reference Range | IgM, Week 12, n=27, 30, 32, 36, 26, 24 | 3 Participants |
| Vehicle BID | Number of Participants With Ig Data Outside the Reference Range | IgG, Week 12, n=27, 30, 32, 36, 26, 24 | 1 Participants |
| Vehicle BID | Number of Participants With Ig Data Outside the Reference Range | IgG, PS, n=33, 34, 36, 38, 29, 31 | 1 Participants |
| Vehicle BID | Number of Participants With Ig Data Outside the Reference Range | IgG, Week 8, n=30, 31, 33, 38, 27, 26 | 1 Participants |
| Vehicle BID | Number of Participants With Ig Data Outside the Reference Range | IgM, Baseline, n=38, 38, 38, 38, 37, 38 | 2 Participants |
| Vehicle BID | Number of Participants With Ig Data Outside the Reference Range | IgG, Week 4, n=32, 34, 35, 38, 29, 31 | 0 Participants |
| Vehicle BID | Number of Participants With Ig Data Outside the Reference Range | IgA, Baseline, n=38, 38, 38, 38, 37, 38 | 2 Participants |
| Vehicle BID | Number of Participants With Ig Data Outside the Reference Range | IgM, Week 4, n=32, 34, 35, 38, 29, 31 | 2 Participants |
| Vehicle BID | Number of Participants With Ig Data Outside the Reference Range | IgA, PS, n=33, 34, 36, 38, 29, 31 | 2 Participants |
| Vehicle BID | Number of Participants With Ig Data Outside the Reference Range | IgA, Week 12, n=27, 30, 32, 36, 26, 24 | 0 Participants |
| Vehicle BID | Number of Participants With Ig Data Outside the Reference Range | IgM, Week 8, n=30, 31, 33, 38, 27, 26 | 2 Participants |
| Vehicle BID | Number of Participants With Ig Data Outside the Reference Range | IgA, Week 8, n=30, 31, 33, 38, 27, 26 | 1 Participants |
| Vehicle BID | Number of Participants With Ig Data Outside the Reference Range | IgA, Week 4, n=32, 34, 35, 38, 29, 31 | 2 Participants |
| Vehicle BID | Number of Participants With Ig Data Outside the Reference Range | IgG, Baseline, n=38, 38, 38, 38, 37, 38 | 1 Participants |
| Vehicle BID | Number of Participants With Ig Data Outside the Reference Range | IgM, Week 12, n=27, 30, 32, 36, 26, 24 | 2 Participants |
| Vehicle BID | Number of Participants With Ig Data Outside the Reference Range | IgM, PS, n=33, 34, 36, 38, 29, 31 | 3 Participants |
| Vehicle QD | Number of Participants With Ig Data Outside the Reference Range | IgA, Week 4, n=32, 34, 35, 38, 29, 31 | 1 Participants |
| Vehicle QD | Number of Participants With Ig Data Outside the Reference Range | IgA, Week 12, n=27, 30, 32, 36, 26, 24 | 1 Participants |
| Vehicle QD | Number of Participants With Ig Data Outside the Reference Range | IgG, PS, n=33, 34, 36, 38, 29, 31 | 4 Participants |
| Vehicle QD | Number of Participants With Ig Data Outside the Reference Range | IgG, Week 8, n=30, 31, 33, 38, 27, 26 | 4 Participants |
| Vehicle QD | Number of Participants With Ig Data Outside the Reference Range | IgG, Week 12, n=27, 30, 32, 36, 26, 24 | 2 Participants |
| Vehicle QD | Number of Participants With Ig Data Outside the Reference Range | IgG, Week 4, n=32, 34, 35, 38, 29, 31 | 4 Participants |
| Vehicle QD | Number of Participants With Ig Data Outside the Reference Range | IgA, Baseline, n=38, 38, 38, 38, 37, 38 | 2 Participants |
| Vehicle QD | Number of Participants With Ig Data Outside the Reference Range | IgA, Week 8, n=30, 31, 33, 38, 27, 26 | 1 Participants |
| Vehicle QD | Number of Participants With Ig Data Outside the Reference Range | IgM, Baseline, n=38, 38, 38, 38, 37, 38 | 5 Participants |
| Vehicle QD | Number of Participants With Ig Data Outside the Reference Range | IgM, PS, n=33, 34, 36, 38, 29, 31 | 4 Participants |
| Vehicle QD | Number of Participants With Ig Data Outside the Reference Range | IgG, Baseline, n=38, 38, 38, 38, 37, 38 | 4 Participants |
| Vehicle QD | Number of Participants With Ig Data Outside the Reference Range | IgA, PS, n=33, 34, 36, 38, 29, 31 | 1 Participants |
| Vehicle QD | Number of Participants With Ig Data Outside the Reference Range | IgM, Week 8, n=30, 31, 33, 38, 27, 26 | 4 Participants |
| Vehicle QD | Number of Participants With Ig Data Outside the Reference Range | IgM, Week 12, n=27, 30, 32, 36, 26, 24 | 2 Participants |
| Vehicle QD | Number of Participants With Ig Data Outside the Reference Range | IgM, Week 4, n=32, 34, 35, 38, 29, 31 | 3 Participants |
Secondary
Number of Participants With Immunophenotyping Data Outside the Reference Range
Blood samples were collected for the evaluation of change in levels of cluster of differentiation (CD)19, CD3, CD3 Treg flow cytometry (CD3TFLC), CD3+CD8+, CD3+CD8+ TFLC, CD3+CD4+, CD3+CD4+ TFLC, CD16+CD56+, CD3+CD4+CD25+CD127 flow cytometry (CD3+CD4+CD25+CD127), CD3+CD4+foxP3+CD25+CD127 flow cytometry (CD3+CD4+fP3+CD25+CD127) and T Cell B Cell Natural Killer Lymphocytes flow cytometry (T-B cell NKL). Baseline was defined as the latest assessment (including unscheduled visits) prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Up to Week 12
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, Week 12, n=27, 29, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, Week 8, n=30, 31, 33, 38, 27, 26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, Week 4, n=30, 32, 35, 38, 29, 30 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, Week 12, n=27, 29, 32, 36, 26, 24 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, Baseline, n=38, 38, 38, 38, 37, 38 | 5 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, PS, n=33, 33, 36, 38, 29, 31 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, Week 12, n=26,26,30, 34, 24, 24 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, Week 4, n=28, 30, 32, 36, 28, 26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, Week 8, n=30,31,33,38,27,26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, Baseline, n=37,36,38, 38, 36, 38 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, PS, n=33, 34, 36, 38, 29, 31 | 3 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, Week 4, n=30,32,35,38,29,30 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, Week 8, n=30,29,31,34,25,22 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, Baseline, n=38,38,38,38,37,38 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127, PS,n=33,33,36,38,29,31 | 11 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127 Week 12,n=26,26,30,34,24,24 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127, Week 8,n=30,29,31,34,25,22 | 6 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, Week 4, n=30, 32, 35, 38, 29, 30 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, Week 8, n=30, 31, 33, 38, 27, 26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127, Week 4,n=28,30,32,36,28,36 | 5 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127Baseline,n=37,36,38,38,36,38 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, PS, n=33,33,36,38,29,31 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, Week 12, n=26,26,30,34,24,24 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, Week 8, n=30, 31, 33, 38, 27, 26 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TF, PS, n=33, 33, 36, 38, 29, 31 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, Week 4, n=28,30,32,36,28,36 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, Baseline, n=37,36,38,38,36,38 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, PS, n=33, 34, 36, 38, 29, 31 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, Week 12, n=27, 29, 32, 36, 26, 24 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, Week 8, n=30, 29, 31, 34, 25, 22 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, Week 12, n=27, 29, 32, 36, 26, 24 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, Week 4, n=30, 32, 35, 38, 29, 30 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TFLC, Week 12, n=26, 26, 30, 34, 24, 24 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, PS, n=33, 34, 36, 38, 29, 31 | 5 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, PS, n=33,34,36,38,29,31 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TFLC, Week 8, n=30, 29, 31, 34, 25, 22 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TFLC, Baseline, n=37, 36, 38, 38, 36, 38 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, PS, n=33, 34, 36, 38, 29, 31 | 5 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, Week 12, n=27, 29, 32, 36, 26, 24 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, Baseline, n=38, 38, 38, 38, 37, 38 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TFLC, Week 4, n=28, 30, 32, 36, 28, 36 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, Week 4, n=30, 32, 35, 38, 29, 30 | 3 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, Baseline, n=38, 38, 38, 38, 37, 38 | 6 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+TFLC, PS, n=33, 33,36, 38, 29, 31 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+ TFLC, Week 12, n=26, 26, 30, 34, 24, 24 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, Week 4, n=30, 32, 35, 38, 29, 30 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, Week 8, n=30, 31, 33, 38, 27, 26 | 3 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+ TFLC, Week 8, n=30, 29, 31, 34, 25, 22 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+ TFLC, Week 4, n=28, 30, 32, 36, 28, 36 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+ TFLC, Baseline, n=37, 36, 38, 38, 36, 38 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, PS, n=33, 34, 36, 38, 29, 31 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, Week 8, n=30, 31, 33, 38, 27, 26 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, Week 12, n=27,29,32,36,26,24 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, Week 4, n=28, 30, 32, 36, 28, 26 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, Week 8, n=30, 29, 31, 34, 25, 22 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, Baseline, n=38, 38, 38, 38, 37, 38 | 5 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, Week 4, n=30, 32, 35, 38, 29, 30 | 6 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, Week 8, n=30, 31, 33, 38, 27, 26 | 5 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, Week 12, n=27, 29, 32, 36, 26, 24 | 4 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, PS, n=33, 34, 36, 38, 29, 31 | 7 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, Baseline, n=38, 38, 38, 38, 37, 38 | 3 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, Week 4, n=30, 32, 35, 38, 29, 30 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, Week 8, n=30, 31, 33, 38, 27, 26 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, Week 12, n=27, 29, 32, 36, 26, 24 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, Baseline, n=37,36,38, 38, 36, 38 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, PS, n=33, 34, 36, 38, 29, 31 | 4 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, Week 12, n=26,26,30, 34, 24, 24 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, PS, n=33, 33, 36, 38, 29, 31 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, Baseline, n=38, 38, 38, 38, 37, 38 | 4 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, Week 4, n=30, 32, 35, 38, 29, 30 | 3 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, Week 8, n=30, 31, 33, 38, 27, 26 | 3 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, Week 12, n=27, 29, 32, 36, 26, 24 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+ TFLC, Baseline, n=37, 36, 38, 38, 36, 38 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+ TFLC, Week 4, n=28, 30, 32, 36, 28, 36 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+ TFLC, Week 8, n=30, 29, 31, 34, 25, 22 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+ TFLC, Week 12, n=26, 26, 30, 34, 24, 24 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+TFLC, PS, n=33, 33,36, 38, 29, 31 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, Baseline, n=38, 38, 38, 38, 37, 38 | 5 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, Week 4, n=30, 32, 35, 38, 29, 30 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, Week 8, n=30, 31, 33, 38, 27, 26 | 3 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, Week 12, n=27, 29, 32, 36, 26, 24 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, PS, n=33, 34, 36, 38, 29, 31 | 6 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TFLC, Baseline, n=37, 36, 38, 38, 36, 38 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TFLC, Week 4, n=28, 30, 32, 36, 28, 36 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TFLC, Week 8, n=30, 29, 31, 34, 25, 22 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TF, PS, n=33, 33, 36, 38, 29, 31 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, Week 4, n=30, 32, 35, 38, 29, 30 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, Week 8, n=30, 31, 33, 38, 27, 26 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, Week 12, n=27, 29, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, PS, n=33, 34, 36, 38, 29, 31 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, Baseline, n=37,36,38,38,36,38 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, Week 4, n=28,30,32,36,28,36 | 3 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, Week 12, n=26,26,30,34,24,24 | 6 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, PS, n=33,33,36,38,29,31 | 7 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127Baseline,n=37,36,38,38,36,38 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127, Week 4,n=28,30,32,36,28,36 | 8 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127, Week 8,n=30,29,31,34,25,22 | 7 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127 Week 12,n=26,26,30,34,24,24 | 6 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127, PS,n=33,33,36,38,29,31 | 14 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, Baseline, n=38,38,38,38,37,38 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, Week 4, n=30,32,35,38,29,30 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, Week 8, n=30,31,33,38,27,26 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, PS, n=33,34,36,38,29,31 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, PS, n=33, 34, 36, 38, 29, 31 | 4 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TFLC, Week 12, n=26, 26, 30, 34, 24, 24 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, Week 8, n=30,29,31,34,25,22 | 4 Participants |
| GSK2894512 1% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, Week 12, n=27,29,32,36,26,24 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127, Week 8,n=30,29,31,34,25,22 | 6 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, PS, n=33,33,36,38,29,31 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, Week 12, n=26,26,30, 34, 24, 24 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, Week 12, n=27, 29, 32, 36, 26, 24 | 4 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, Week 4, n=28,30,32,36,28,36 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+TFLC, PS, n=33, 33,36, 38, 29, 31 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, Week 4, n=30,32,35,38,29,30 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127, Week 4,n=28,30,32,36,28,36 | 4 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, Baseline, n=37,36,38,38,36,38 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, PS, n=33, 34, 36, 38, 29, 31 | 8 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, Week 8, n=30, 31, 33, 38, 27, 26 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+ TFLC, Week 4, n=28, 30, 32, 36, 28, 36 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127Baseline,n=37,36,38,38,36,38 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, PS, n=33,34,36,38,29,31 | 2 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TFLC, Baseline, n=37, 36, 38, 38, 36, 38 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127 Week 12,n=26,26,30,34,24,24 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+ TFLC, Baseline, n=37, 36, 38, 38, 36, 38 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, Week 4, n=30, 32, 35, 38, 29, 30 | 4 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TFLC, Week 4, n=28, 30, 32, 36, 28, 36 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, Week 8, n=30,29,31,34,25,22 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, PS, n=33, 34, 36, 38, 29, 31 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, PS, n=33, 34, 36, 38, 29, 31 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, PS, n=33, 34, 36, 38, 29, 31 | 8 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, Baseline, n=37,36,38, 38, 36, 38 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TFLC, Week 8, n=30, 29, 31, 34, 25, 22 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, Week 12, n=27,29,32,36,26,24 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, Baseline, n=38, 38, 38, 38, 37, 38 | 4 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, PS, n=33, 34, 36, 38, 29, 31 | 8 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, Week 12, n=27, 29, 32, 36, 26, 24 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+ TFLC, Week 12, n=26, 26, 30, 34, 24, 24 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, Week 4, n=30, 32, 35, 38, 29, 30 | 4 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, PS, n=33, 33, 36, 38, 29, 31 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, Week 4, n=30, 32, 35, 38, 29, 30 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TF, PS, n=33, 33, 36, 38, 29, 31 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, Baseline, n=38, 38, 38, 38, 37, 38 | 5 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, Baseline, n=38,38,38,38,37,38 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+ TFLC, Week 8, n=30, 29, 31, 34, 25, 22 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, Baseline, n=38, 38, 38, 38, 37, 38 | 2 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, Week 4, n=30, 32, 35, 38, 29, 30 | 5 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, Week 12, n=26,26,30,34,24,24 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, Week 8, n=30, 31, 33, 38, 27, 26 | 4 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, Week 4, n=28, 30, 32, 36, 28, 26 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, Week 4, n=30, 32, 35, 38, 29, 30 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TFLC, Week 12, n=26, 26, 30, 34, 24, 24 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, Week 8, n=30, 31, 33, 38, 27, 26 | 6 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, Week 8, n=30, 31, 33, 38, 27, 26 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, Week 8, n=30, 31, 33, 38, 27, 26 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, Baseline, n=38, 38, 38, 38, 37, 38 | 5 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, Week 12, n=27, 29, 32, 36, 26, 24 | 4 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, Week 8, n=30, 29, 31, 34, 25, 22 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, Week 12, n=27, 29, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, Week 8, n=30,31,33,38,27,26 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, Week 12, n=27, 29, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127, PS,n=33,33,36,38,29,31 | 12 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127, PS,n=33,33,36,38,29,31 | 15 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, PS, n=33, 34, 36, 38, 29, 31 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, Week 12, n=27, 29, 32, 36, 26, 24 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, Week 4, n=28, 30, 32, 36, 28, 26 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, Baseline, n=37,36,38,38,36,38 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, Baseline, n=38, 38, 38, 38, 37, 38 | 7 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+ TFLC, Week 12, n=26, 26, 30, 34, 24, 24 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127 Week 12,n=26,26,30,34,24,24 | 8 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, Week 4, n=28,30,32,36,28,36 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, Week 8, n=30,29,31,34,25,22 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, Week 8, n=30, 31, 33, 38, 27, 26 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, Week 8, n=30, 31, 33, 38, 27, 26 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, Week 12, n=26,26,30,34,24,24 | 7 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127, Week 8,n=30,29,31,34,25,22 | 6 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, PS, n=33,33,36,38,29,31 | 9 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, Week 4, n=30, 32, 35, 38, 29, 30 | 6 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+TFLC, PS, n=33, 33,36, 38, 29, 31 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127Baseline,n=37,36,38,38,36,38 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, PS, n=33, 33, 36, 38, 29, 31 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, Baseline, n=38, 38, 38, 38, 37, 38 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, Baseline, n=38, 38, 38, 38, 37, 38 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+ TFLC, Baseline, n=37, 36, 38, 38, 36, 38 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, Week 12, n=27,29,32,36,26,24 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, Week 4, n=30, 32, 35, 38, 29, 30 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, Week 8, n=30, 31, 33, 38, 27, 26 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, Week 4, n=30,32,35,38,29,30 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, Week 8, n=30, 31, 33, 38, 27, 26 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, Week 12, n=27, 29, 32, 36, 26, 24 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, Week 12, n=26,26,30, 34, 24, 24 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, Week 12, n=27, 29, 32, 36, 26, 24 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, Week 4, n=30, 32, 35, 38, 29, 30 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, Week 8, n=30,31,33,38,27,26 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127, Week 4,n=28,30,32,36,28,36 | 5 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, PS, n=33, 34, 36, 38, 29, 31 | 5 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, PS, n=33, 34, 36, 38, 29, 31 | 7 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+ TFLC, Week 4, n=28, 30, 32, 36, 28, 36 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, PS, n=33, 34, 36, 38, 29, 31 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, PS, n=33,34,36,38,29,31 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TFLC, Week 4, n=28, 30, 32, 36, 28, 36 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, Baseline, n=37,36,38, 38, 36, 38 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TFLC, Week 8, n=30, 29, 31, 34, 25, 22 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, Week 4, n=30, 32, 35, 38, 29, 30 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, Week 8, n=30, 31, 33, 38, 27, 26 | 6 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TFLC, Week 12, n=26, 26, 30, 34, 24, 24 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, Baseline, n=38,38,38,38,37,38 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TF, PS, n=33, 33, 36, 38, 29, 31 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, Week 8, n=30, 29, 31, 34, 25, 22 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, Baseline, n=38, 38, 38, 38, 37, 38 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+ TFLC, Week 8, n=30, 29, 31, 34, 25, 22 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, Week 12, n=27, 29, 32, 36, 26, 24 | 4 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, Week 4, n=30, 32, 35, 38, 29, 30 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TFLC, Baseline, n=37, 36, 38, 38, 36, 38 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, PS, n=33, 34, 36, 38, 29, 31 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, Week 12, n=27, 29, 32, 36, 26, 24 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, Baseline, n=38, 38, 38, 38, 37, 38 | 3 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, Week 8, n=30, 31, 33, 38, 27, 26 | 2 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, Week 12, n=27, 29, 32, 36, 26, 24 | 2 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, PS, n=33, 34, 36, 38, 29, 31 | 3 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, Week 4, n=30, 32, 35, 38, 29, 30 | 0 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+ TFLC, Baseline, n=37, 36, 38, 38, 36, 38 | 0 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+ TFLC, Week 4, n=28, 30, 32, 36, 28, 36 | 1 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+ TFLC, Week 8, n=30, 29, 31, 34, 25, 22 | 1 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, Week 8, n=30, 29, 31, 34, 25, 22 | 0 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+ TFLC, Week 12, n=26, 26, 30, 34, 24, 24 | 0 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, Baseline, n=38, 38, 38, 38, 37, 38 | 1 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, PS, n=33,34,36,38,29,31 | 1 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+TFLC, PS, n=33, 33,36, 38, 29, 31 | 2 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, Baseline, n=38, 38, 38, 38, 37, 38 | 2 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, Week 4, n=30, 32, 35, 38, 29, 30 | 1 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, Week 12, n=27,29,32,36,26,24 | 1 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, Week 12, n=27, 29, 32, 36, 26, 24 | 1 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, PS, n=33, 34, 36, 38, 29, 31 | 9 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, PS, n=33, 34, 36, 38, 29, 31 | 5 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TFLC, Baseline, n=37, 36, 38, 38, 36, 38 | 0 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TFLC, Week 4, n=28, 30, 32, 36, 28, 36 | 0 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TFLC, Week 8, n=30, 29, 31, 34, 25, 22 | 0 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TFLC, Week 12, n=26, 26, 30, 34, 24, 24 | 0 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127, Week 4,n=28,30,32,36,28,36 | 7 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, Week 12, n=27, 29, 32, 36, 26, 24 | 6 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, Week 8, n=30, 31, 33, 38, 27, 26 | 1 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, Week 12, n=27, 29, 32, 36, 26, 24 | 0 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, Week 8, n=30,31,33,38,27,26 | 0 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, PS, n=33, 34, 36, 38, 29, 31 | 1 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, Baseline, n=37,36,38,38,36,38 | 0 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, Week 8, n=30, 31, 33, 38, 27, 26 | 5 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, Week 4, n=28,30,32,36,28,36 | 5 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, Week 8, n=30,29,31,34,25,22 | 5 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TF, PS, n=33, 33, 36, 38, 29, 31 | 0 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, Week 4, n=30, 32, 35, 38, 29, 30 | 6 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, PS, n=33,33,36,38,29,31 | 7 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, Week 4, n=30, 32, 35, 38, 29, 30 | 0 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127Baseline,n=37,36,38,38,36,38 | 0 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, Week 4, n=28, 30, 32, 36, 28, 26 | 0 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127, Week 8,n=30,29,31,34,25,22 | 5 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, Baseline, n=38, 38, 38, 38, 37, 38 | 11 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127 Week 12,n=26,26,30,34,24,24 | 2 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127, PS,n=33,33,36,38,29,31 | 11 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, Baseline, n=38,38,38,38,37,38 | 1 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, PS, n=33, 34, 36, 38, 29, 31 | 2 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, Baseline, n=37,36,38, 38, 36, 38 | 0 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, Week 12, n=27, 29, 32, 36, 26, 24 | 2 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, Week 12, n=26,26,30, 34, 24, 24 | 0 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, PS, n=33, 33, 36, 38, 29, 31 | 0 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, Week 4, n=30,32,35,38,29,30 | 0 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, Baseline, n=38, 38, 38, 38, 37, 38 | 3 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, Week 4, n=30, 32, 35, 38, 29, 30 | 0 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, Week 8, n=30, 31, 33, 38, 27, 26 | 1 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, Week 8, n=30, 31, 33, 38, 27, 26 | 3 Participants |
| Vehicle BID | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, Week 12, n=26,26,30,34,24,24 | 5 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, PS, n=33, 34, 36, 38, 29, 31 | 1 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, Week 8, n=30, 31, 33, 38, 27, 26 | 2 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, Week 12, n=27, 29, 32, 36, 26, 24 | 1 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, Week 4, n=30,32,35,38,29,30 | 1 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127, PS,n=33,33,36,38,29,31 | 7 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, Week 8, n=30, 31, 33, 38, 27, 26 | 1 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, PS, n=33, 34, 36, 38, 29, 31 | 3 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TF, PS, n=33, 33, 36, 38, 29, 31 | 0 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TFLC, Week 12, n=26, 26, 30, 34, 24, 24 | 0 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, Week 8, n=30,31,33,38,27,26 | 1 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, Baseline, n=38,38,38,38,37,38 | 0 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, Week 12, n=27, 29, 32, 36, 26, 24 | 1 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, Week 8, n=30,29,31,34,25,22 | 0 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TFLC, Week 8, n=30, 29, 31, 34, 25, 22 | 0 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+ TFLC, Week 4, n=28, 30, 32, 36, 28, 36 | 0 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, PS, n=33, 34, 36, 38, 29, 31 | 3 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, Week 12, n=27, 29, 32, 36, 26, 24 | 0 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, PS, n=33,34,36,38,29,31 | 1 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TFLC, Week 4, n=28, 30, 32, 36, 28, 36 | 0 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, Week 12, n=27, 29, 32, 36, 26, 24 | 2 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, Baseline, n=37,36,38, 38, 36, 38 | 0 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+ TFLC, Baseline, n=37, 36, 38, 38, 36, 38 | 0 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, Week 8, n=30, 29, 31, 34, 25, 22 | 0 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, Week 4, n=30, 32, 35, 38, 29, 30 | 3 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, Week 12, n=27, 29, 32, 36, 26, 24 | 0 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | T-B cell NKL, Week 12, n=27,29,32,36,26,24 | 0 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, PS, n=33, 34, 36, 38, 29, 31 | 4 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, Week 8, n=30, 31, 33, 38, 27, 26 | 3 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, Week 12, n=26,26,30, 34, 24, 24 | 0 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, Week 8, n=30, 31, 33, 38, 27, 26 | 1 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, Week 4, n=30, 32, 35, 38, 29, 30 | 3 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+, Baseline, n=38, 38, 38, 38, 37, 38 | 1 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+TFLC, PS, n=33, 33,36, 38, 29, 31 | 0 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+ TFLC, Baseline, n=37, 36, 38, 38, 36, 38 | 0 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, PS, n=33, 33, 36, 38, 29, 31 | 0 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+ TFLC, Week 12, n=26, 26, 30, 34, 24, 24 | 0 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, PS, n=33, 34, 36, 38, 29, 31 | 5 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, Baseline, n=38, 38, 38, 38, 37, 38 | 2 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127Baseline,n=37,36,38,38,36,38 | 0 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, Week 4, n=30, 32, 35, 38, 29, 30 | 1 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, PS, n=33,33,36,38,29,31 | 2 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127, Week 4,n=28,30,32,36,28,36 | 3 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, Baseline, n=38, 38, 38, 38, 37, 38 | 1 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+ TFLC, Week 8, n=30, 29, 31, 34, 25, 22 | 0 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD16+CD56+, Baseline, n=38, 38, 38, 38, 37, 38 | 1 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, Week 12, n=26,26,30,34,24,24 | 0 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, Week 4, n=30, 32, 35, 38, 29, 30 | 2 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127, Week 8,n=30,29,31,34,25,22 | 4 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD8+, Baseline, n=38, 38, 38, 38, 37, 38 | 5 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD19, Week 4, n=30, 32, 35, 38, 29, 30 | 3 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, Week 4, n=28,30,32,36,28,36 | 0 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3 TFLC, Week 4, n=28, 30, 32, 36, 28, 26 | 0 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3, Week 8, n=30, 31, 33, 38, 27, 26 | 2 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+fP3+CD25+CD127 Week 12,n=26,26,30,34,24,24 | 2 Participants |
| Vehicle QD | Number of Participants With Immunophenotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127, Baseline, n=37,36,38,38,36,38 | 0 Participants |
Secondary
Number of Participants With Reported Local Tolerability Scores
The assessment of the presence and degree of burning/stinging and itching at the application site following application of the study treatment was done at each specified study visit using a 5 point tolerability scale. The scores ranged from 0 to 4 where 0=None and 4=Strong/Severe. The score represented an average across all application sites. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Up to Week 14
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | EW, slight, n=9, 7, 4, 2, 10, 9 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 2, slight, n=36, 36, 36,38, 31, 35 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 12, strong/severe, n=27, 29, 32,35, 26, 25 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 1, mild, n=36, 38, 37,38, 35, 37 | 8 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 12, mild, n=27, 29, 32,35, 26, 25 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 1, none, n=36, 38, 37,38, 35, 37 | 19 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 4, slight, n=32, 34, 35,38, 29, 31 | 7 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 2, mild, n=36, 36, 36,38, 31, 35 | 7 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 12, none, n=27, 29, 32,35, 26, 25 | 20 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 14, moderate, n=27, 30, 33, 33, 27, 24 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 4, none, n=32, 34, 35,38, 29, 31 | 19 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 8, moderate, n=30, 31, 33,38, 27, 26 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | EW, none, n=9, 7, 4, 2, 10, 9 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 2, moderate, n=36, 36, 36,38, 31, 35 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 1, moderate, n=36, 38, 37,38, 35, 37 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 14, strong/severe, n=27, 30, 33, 33, 27, 24 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | EW, strong/severe, n=9,7,4, 2, 10, 9 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 2, strong/severe, n=36, 36, 36,38, 31, 35 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 8, none, n=30, 31, 33,38, 27, 26 | 24 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 4, strong/severe, n=32, 34, 35,38, 29, 31 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 12, moderate, n=27, 29, 32,35, 26, 25 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 12, slight, n=27, 29, 32,35, 26, 25 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 14, slight, n=27, 30, 33, 33, 27, 24 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | EW, moderate, n=9, 7, 4, 2, 10, 9 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 1, strong/severe, n=36, 38, 37,38, 35, 37 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 8, strong/severe, n=30, 31, 33,38, 27, 26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 4, moderate, n=32, 34, 35,38, 29, 31 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 8, mild, n=30, 31, 33,38, 27, 26 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | EW, mild, n=9, 7, 4, 2, 10, 9 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 14, mild, n=27, 30, 33, 33, 27, 24 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 2, none, n=36, 36, 36,38, 31, 35 | 24 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 8, slight, n=30, 31, 33,38, 27, 26 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 4, mild, n=32, 34, 35,38, 29, 31 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 1, slight, n=36, 38, 37,38, 35, 37 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Local Tolerability Scores | Week 14, none, n=27, 30, 33, 33, 27, 24 | 24 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 8, none, n=30, 31, 33,38, 27, 26 | 24 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 12, moderate, n=27, 29, 32,35, 26, 25 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 8, moderate, n=30, 31, 33,38, 27, 26 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 1, moderate, n=36, 38, 37,38, 35, 37 | 4 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 8, strong/severe, n=30, 31, 33,38, 27, 26 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 12, mild, n=27, 29, 32,35, 26, 25 | 3 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 12, none, n=27, 29, 32,35, 26, 25 | 24 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 12, slight, n=27, 29, 32,35, 26, 25 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | EW, mild, n=9, 7, 4, 2, 10, 9 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 1, strong/severe, n=36, 38, 37,38, 35, 37 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | EW, strong/severe, n=9,7,4, 2, 10, 9 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 2, none, n=36, 36, 36,38, 31, 35 | 28 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | EW, slight, n=9, 7, 4, 2, 10, 9 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 2, slight, n=36, 36, 36,38, 31, 35 | 4 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 1, slight, n=36, 38, 37,38, 35, 37 | 8 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 2, mild, n=36, 36, 36,38, 31, 35 | 4 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | EW, none, n=9, 7, 4, 2, 10, 9 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 2, moderate, n=36, 36, 36,38, 31, 35 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 14, strong/severe, n=27, 30, 33, 33, 27, 24 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 2, strong/severe, n=36, 36, 36,38, 31, 35 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 4, none, n=32, 34, 35,38, 29, 31 | 24 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 14, moderate, n=27, 30, 33, 33, 27, 24 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 4, slight, n=32, 34, 35,38, 29, 31 | 5 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 14, mild, n=27, 30, 33, 33, 27, 24 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 4, mild, n=32, 34, 35,38, 29, 31 | 4 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 1, mild, n=36, 38, 37,38, 35, 37 | 9 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 4, moderate, n=32, 34, 35,38, 29, 31 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 14, slight, n=27, 30, 33, 33, 27, 24 | 3 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 4, strong/severe, n=32, 34, 35,38, 29, 31 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 1, none, n=36, 38, 37,38, 35, 37 | 17 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 14, none, n=27, 30, 33, 33, 27, 24 | 25 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | EW, moderate, n=9, 7, 4, 2, 10, 9 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 8, slight, n=30, 31, 33,38, 27, 26 | 7 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 12, strong/severe, n=27, 29, 32,35, 26, 25 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Local Tolerability Scores | Week 8, mild, n=30, 31, 33,38, 27, 26 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 14, mild, n=27, 30, 33, 33, 27, 24 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 8, moderate, n=30, 31, 33,38, 27, 26 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 2, none, n=36, 36, 36,38, 31, 35 | 20 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 1, moderate, n=36, 38, 37,38, 35, 37 | 6 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 4, mild, n=32, 34, 35,38, 29, 31 | 5 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 12, strong/severe, n=27, 29, 32,35, 26, 25 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | EW, slight, n=9, 7, 4, 2, 10, 9 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 14, slight, n=27, 30, 33, 33, 27, 24 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 1, strong/severe, n=36, 38, 37,38, 35, 37 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 8, strong/severe, n=30, 31, 33,38, 27, 26 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 4, moderate, n=32, 34, 35,38, 29, 31 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 1, mild, n=36, 38, 37,38, 35, 37 | 5 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 12, moderate, n=27, 29, 32,35, 26, 25 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | EW, mild, n=9, 7, 4, 2, 10, 9 | 2 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 12, slight, n=27, 29, 32,35, 26, 25 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 8, slight, n=30, 31, 33,38, 27, 26 | 5 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 4, strong/severe, n=32, 34, 35,38, 29, 31 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 12, mild, n=27, 29, 32,35, 26, 25 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 14, none, n=27, 30, 33, 33, 27, 24 | 25 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 14, strong/severe, n=27, 30, 33, 33, 27, 24 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 8, mild, n=30, 31, 33,38, 27, 26 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 2, strong/severe, n=36, 36, 36,38, 31, 35 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 1, none, n=36, 38, 37,38, 35, 37 | 18 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 2, moderate, n=36, 36, 36,38, 31, 35 | 6 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 14, moderate, n=27, 30, 33, 33, 27, 24 | 2 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 1, slight, n=36, 38, 37,38, 35, 37 | 7 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | EW, strong/severe, n=9,7,4, 2, 10, 9 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 4, none, n=32, 34, 35,38, 29, 31 | 23 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | EW, moderate, n=9, 7, 4, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 12, none, n=27, 29, 32,35, 26, 25 | 25 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 2, mild, n=36, 36, 36,38, 31, 35 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | EW, none, n=9, 7, 4, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 8, none, n=30, 31, 33,38, 27, 26 | 24 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 4, slight, n=32, 34, 35,38, 29, 31 | 4 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Local Tolerability Scores | Week 2, slight, n=36, 36, 36,38, 31, 35 | 7 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | EW, none, n=9, 7, 4, 2, 10, 9 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 1, none, n=36, 38, 37,38, 35, 37 | 26 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 1, slight, n=36, 38, 37,38, 35, 37 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 1, mild, n=36, 38, 37,38, 35, 37 | 8 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 1, moderate, n=36, 38, 37,38, 35, 37 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 1, strong/severe, n=36, 38, 37,38, 35, 37 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 2, none, n=36, 36, 36,38, 31, 35 | 31 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 2, slight, n=36, 36, 36,38, 31, 35 | 4 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 2, mild, n=36, 36, 36,38, 31, 35 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 2, moderate, n=36, 36, 36,38, 31, 35 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 2, strong/severe, n=36, 36, 36,38, 31, 35 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 4, none, n=32, 34, 35,38, 29, 31 | 32 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 4, slight, n=32, 34, 35,38, 29, 31 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 4, mild, n=32, 34, 35,38, 29, 31 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 4, moderate, n=32, 34, 35,38, 29, 31 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 4, strong/severe, n=32, 34, 35,38, 29, 31 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 8, none, n=30, 31, 33,38, 27, 26 | 33 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 8, slight, n=30, 31, 33,38, 27, 26 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 8, mild, n=30, 31, 33,38, 27, 26 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 8, moderate, n=30, 31, 33,38, 27, 26 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 8, strong/severe, n=30, 31, 33,38, 27, 26 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 12, none, n=27, 29, 32,35, 26, 25 | 31 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 12, slight, n=27, 29, 32,35, 26, 25 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 12, mild, n=27, 29, 32,35, 26, 25 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 12, moderate, n=27, 29, 32,35, 26, 25 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 12, strong/severe, n=27, 29, 32,35, 26, 25 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 14, none, n=27, 30, 33, 33, 27, 24 | 31 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 14, slight, n=27, 30, 33, 33, 27, 24 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 14, mild, n=27, 30, 33, 33, 27, 24 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 14, moderate, n=27, 30, 33, 33, 27, 24 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | Week 14, strong/severe, n=27, 30, 33, 33, 27, 24 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | EW, slight, n=9, 7, 4, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | EW, mild, n=9, 7, 4, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | EW, moderate, n=9, 7, 4, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Local Tolerability Scores | EW, strong/severe, n=9,7,4, 2, 10, 9 | 0 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 4, moderate, n=32, 34, 35,38, 29, 31 | 1 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 2, moderate, n=36, 36, 36,38, 31, 35 | 1 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 8, slight, n=30, 31, 33,38, 27, 26 | 3 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 14, strong/severe, n=27, 30, 33, 33, 27, 24 | 0 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | EW, moderate, n=9, 7, 4, 2, 10, 9 | 1 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 14, slight, n=27, 30, 33, 33, 27, 24 | 1 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 2, mild, n=36, 36, 36,38, 31, 35 | 1 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 8, none, n=30, 31, 33,38, 27, 26 | 24 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 2, slight, n=36, 36, 36,38, 31, 35 | 4 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | EW, none, n=9, 7, 4, 2, 10, 9 | 4 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 4, mild, n=32, 34, 35,38, 29, 31 | 3 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 1, mild, n=36, 38, 37,38, 35, 37 | 6 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 2, none, n=36, 36, 36,38, 31, 35 | 23 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 4, slight, n=32, 34, 35,38, 29, 31 | 3 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 1, none, n=36, 38, 37,38, 35, 37 | 19 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | EW, slight, n=9, 7, 4, 2, 10, 9 | 2 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 4, strong/severe, n=32, 34, 35,38, 29, 31 | 1 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 1, strong/severe, n=36, 38, 37,38, 35, 37 | 2 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 14, mild, n=27, 30, 33, 33, 27, 24 | 1 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 1, moderate, n=36, 38, 37,38, 35, 37 | 2 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | EW, strong/severe, n=9,7,4, 2, 10, 9 | 1 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | EW, mild, n=9, 7, 4, 2, 10, 9 | 2 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 14, none, n=27, 30, 33, 33, 27, 24 | 25 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 12, none, n=27, 29, 32,35, 26, 25 | 24 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 4, none, n=32, 34, 35,38, 29, 31 | 21 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 12, slight, n=27, 29, 32,35, 26, 25 | 2 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 12, moderate, n=27, 29, 32,35, 26, 25 | 0 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 1, slight, n=36, 38, 37,38, 35, 37 | 6 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 8, strong/severe, n=30, 31, 33,38, 27, 26 | 0 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 14, moderate, n=27, 30, 33, 33, 27, 24 | 0 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 12, strong/severe, n=27, 29, 32,35, 26, 25 | 0 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 12, mild, n=27, 29, 32,35, 26, 25 | 0 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 2, strong/severe, n=36, 36, 36,38, 31, 35 | 2 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 8, moderate, n=30, 31, 33,38, 27, 26 | 0 Participants |
| Vehicle BID | Number of Participants With Reported Local Tolerability Scores | Week 8, mild, n=30, 31, 33,38, 27, 26 | 0 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 8, mild, n=30, 31, 33,38, 27, 26 | 0 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 12, moderate, n=27, 29, 32,35, 26, 25 | 1 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 8, slight, n=30, 31, 33,38, 27, 26 | 2 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 8, none, n=30, 31, 33,38, 27, 26 | 22 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 1, slight, n=36, 38, 37,38, 35, 37 | 8 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 12, strong/severe, n=27, 29, 32,35, 26, 25 | 0 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 4, strong/severe, n=32, 34, 35,38, 29, 31 | 0 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 14, none, n=27, 30, 33, 33, 27, 24 | 23 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 4, moderate, n=32, 34, 35,38, 29, 31 | 1 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 4, mild, n=32, 34, 35,38, 29, 31 | 1 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 14, slight, n=27, 30, 33, 33, 27, 24 | 0 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 4, slight, n=32, 34, 35,38, 29, 31 | 3 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | EW, moderate, n=9, 7, 4, 2, 10, 9 | 1 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 14, mild, n=27, 30, 33, 33, 27, 24 | 0 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 4, none, n=32, 34, 35,38, 29, 31 | 26 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 2, strong/severe, n=36, 36, 36,38, 31, 35 | 0 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 14, moderate, n=27, 30, 33, 33, 27, 24 | 1 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 2, moderate, n=36, 36, 36,38, 31, 35 | 0 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 1, none, n=36, 38, 37,38, 35, 37 | 26 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 14, strong/severe, n=27, 30, 33, 33, 27, 24 | 0 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 2, mild, n=36, 36, 36,38, 31, 35 | 4 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 2, slight, n=36, 36, 36,38, 31, 35 | 5 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | EW, none, n=9, 7, 4, 2, 10, 9 | 8 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 2, none, n=36, 36, 36,38, 31, 35 | 26 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 1, strong/severe, n=36, 38, 37,38, 35, 37 | 0 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | EW, slight, n=9, 7, 4, 2, 10, 9 | 0 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 1, moderate, n=36, 38, 37,38, 35, 37 | 1 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | EW, strong/severe, n=9,7,4, 2, 10, 9 | 0 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 12, none, n=27, 29, 32,35, 26, 25 | 23 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | EW, mild, n=9, 7, 4, 2, 10, 9 | 0 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 12, slight, n=27, 29, 32,35, 26, 25 | 1 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 8, strong/severe, n=30, 31, 33,38, 27, 26 | 0 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 8, moderate, n=30, 31, 33,38, 27, 26 | 2 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 1, mild, n=36, 38, 37,38, 35, 37 | 2 Participants |
| Vehicle QD | Number of Participants With Reported Local Tolerability Scores | Week 12, mild, n=27, 29, 32,35, 26, 25 | 0 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
An AE is defined as any untoward medical occurrence in a participant under clinical investigation, temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. A TEAE is defined as an AE which occurred on or after study treatment start date and on or before the last visit. Number of participants with AEs and SAEs were presented. The analysis was performed on safety Population which comprised of all participants who received at least one dose of study treatment.
Time frame: Up to Week 16
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2894512 1% BID | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | TEAEs | 26 Participants |
| GSK2894512 1% BID | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | serious TEAEs | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | TEAEs | 20 Participants |
| GSK2894512 1% QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | serious TEAEs | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | TEAEs | 22 Participants |
| GSK2894512 0.5% BID | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | serious TEAEs | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | TEAEs | 17 Participants |
| GSK2894512 0.5% QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | serious TEAEs | 0 Participants |
| Vehicle BID | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | TEAEs | 9 Participants |
| Vehicle BID | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | serious TEAEs | 0 Participants |
| Vehicle QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | TEAEs | 10 Participants |
| Vehicle QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | serious TEAEs | 0 Participants |
Secondary
Number of Participants With Vital Signs of Clinical Importance
The vital signs including SBP, DBP and pulse rate were measured from Baseline throughout the study. The number of participants with clinically significant abnormal vital signs were presented. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Up to Week 14
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 4, n=32, 34, 35, 38, 29, 31 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | SBP, EW, n=10, 7, 4, 2, 10, 9 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 12, n=26, 30, 32, 36, 26, 25 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 8, n=30, 31, 33, 38, 27, 26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 2, n=36, 36, 36, 38, 31, 35 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, PS, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 14, n=29, 31, 33, 34, 27, 26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | SBP, PS, n=n=38, 38, 38, 38, 37, 38 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 2, n=36, 36, 36, 38, 31, 35 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 1, n=36, 38, 37, 38, 35, 37 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 1, n=36, 38, 37, 38, 35, 37 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, EW, n=10, 7, 4, 2, 10, 9 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | DBP, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 8, n=30, 31, 33, 38, 27, 26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 12, n=26, 30, 32, 36, 26, 25 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 1, n=36, 38, 37, 38, 35, 37 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 2, n=36, 36, 36, 38, 31, 35 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 8, n=30, 31, 33, 38, 27, 26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 4, n=32, 34, 35, 38, 29, 31 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 14, n=29, 31, 33, 34, 27, 26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | SBP, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 14, n=29, 31, 33, 34, 27, 26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | DBP, PS, n=38, 38, 38, 38, 37, 38 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 4, n=32, 34, 35, 38, 29, 31 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | DBP, EW, n=10, 7, 4, 2, 10, 9 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 12, n=26, 30, 32, 36, 26, 25 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 2, n=36, 36, 36, 38, 31, 35 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | DBP, EW, n=10, 7, 4, 2, 10, 9 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | DBP, PS, n=38, 38, 38, 38, 37, 38 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 1, n=36, 38, 37, 38, 35, 37 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 12, n=26, 30, 32, 36, 26, 25 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | SBP, Baseline, n=38, 38, 38, 38, 37, 38 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 14, n=29, 31, 33, 34, 27, 26 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 4, n=32, 34, 35, 38, 29, 31 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, PS, n=38, 38, 38, 38, 37, 38 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | SBP, EW, n=10, 7, 4, 2, 10, 9 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | SBP, PS, n=n=38, 38, 38, 38, 37, 38 | 3 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 2, n=36, 36, 36, 38, 31, 35 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, EW, n=10, 7, 4, 2, 10, 9 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | DBP, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 14, n=29, 31, 33, 34, 27, 26 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 1, n=36, 38, 37, 38, 35, 37 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 1, n=36, 38, 37, 38, 35, 37 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 2, n=36, 36, 36, 38, 31, 35 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 12, n=26, 30, 32, 36, 26, 25 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 4, n=32, 34, 35, 38, 29, 31 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 8, n=30, 31, 33, 38, 27, 26 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 8, n=30, 31, 33, 38, 27, 26 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 8, n=30, 31, 33, 38, 27, 26 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 12, n=26, 30, 32, 36, 26, 25 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 4, n=32, 34, 35, 38, 29, 31 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 14, n=29, 31, 33, 34, 27, 26 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 2, n=36, 36, 36, 38, 31, 35 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | SBP, EW, n=10, 7, 4, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 8, n=30, 31, 33, 38, 27, 26 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, PS, n=38, 38, 38, 38, 37, 38 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 14, n=29, 31, 33, 34, 27, 26 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | DBP, EW, n=10, 7, 4, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 4, n=32, 34, 35, 38, 29, 31 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 2, n=36, 36, 36, 38, 31, 35 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 8, n=30, 31, 33, 38, 27, 26 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | DBP, PS, n=38, 38, 38, 38, 37, 38 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 12, n=26, 30, 32, 36, 26, 25 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 1, n=36, 38, 37, 38, 35, 37 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 8, n=30, 31, 33, 38, 27, 26 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 2, n=36, 36, 36, 38, 31, 35 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | DBP, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 1, n=36, 38, 37, 38, 35, 37 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 14, n=29, 31, 33, 34, 27, 26 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 4, n=32, 34, 35, 38, 29, 31 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | SBP, PS, n=n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | SBP, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 1, n=36, 38, 37, 38, 35, 37 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 14, n=29, 31, 33, 34, 27, 26 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, EW, n=10, 7, 4, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 12, n=26, 30, 32, 36, 26, 25 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 4, n=32, 34, 35, 38, 29, 31 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 12, n=26, 30, 32, 36, 26, 25 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 4, n=32, 34, 35, 38, 29, 31 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 2, n=36, 36, 36, 38, 31, 35 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 4, n=32, 34, 35, 38, 29, 31 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 8, n=30, 31, 33, 38, 27, 26 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 12, n=26, 30, 32, 36, 26, 25 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 14, n=29, 31, 33, 34, 27, 26 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | SBP, EW, n=10, 7, 4, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | SBP, PS, n=n=38, 38, 38, 38, 37, 38 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | DBP, Baseline, n=38, 38, 38, 38, 37, 38 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 1, n=36, 38, 37, 38, 35, 37 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 2, n=36, 36, 36, 38, 31, 35 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 8, n=30, 31, 33, 38, 27, 26 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 12, n=26, 30, 32, 36, 26, 25 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 14, n=29, 31, 33, 34, 27, 26 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | DBP, EW, n=10, 7, 4, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | DBP, PS, n=38, 38, 38, 38, 37, 38 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 1, n=36, 38, 37, 38, 35, 37 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 2, n=36, 36, 36, 38, 31, 35 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 4, n=32, 34, 35, 38, 29, 31 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 8, n=30, 31, 33, 38, 27, 26 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 12, n=26, 30, 32, 36, 26, 25 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 14, n=29, 31, 33, 34, 27, 26 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, EW, n=10, 7, 4, 2, 10, 9 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, PS, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | SBP, Baseline, n=38, 38, 38, 38, 37, 38 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 1, n=36, 38, 37, 38, 35, 37 | 1 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 8, n=30, 31, 33, 38, 27, 26 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 2, n=36, 36, 36, 38, 31, 35 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 12, n=26, 30, 32, 36, 26, 25 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 4, n=32, 34, 35, 38, 29, 31 | 1 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 8, n=30, 31, 33, 38, 27, 26 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 4, n=32, 34, 35, 38, 29, 31 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 4, n=32, 34, 35, 38, 29, 31 | 1 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 8, n=30, 31, 33, 38, 27, 26 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 2, n=36, 36, 36, 38, 31, 35 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | DBP, PS, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 12, n=26, 30, 32, 36, 26, 25 | 1 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 1, n=36, 38, 37, 38, 35, 37 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | DBP, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 1, n=36, 38, 37, 38, 35, 37 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 14, n=29, 31, 33, 34, 27, 26 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | SBP, PS, n=n=38, 38, 38, 38, 37, 38 | 1 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, EW, n=10, 7, 4, 2, 10, 9 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | SBP, EW, n=10, 7, 4, 2, 10, 9 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 14, n=29, 31, 33, 34, 27, 26 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, PS, n=38, 38, 38, 38, 37, 38 | 1 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 12, n=26, 30, 32, 36, 26, 25 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 2, n=36, 36, 36, 38, 31, 35 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | SBP, Baseline, n=38, 38, 38, 38, 37, 38 | 1 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 1, n=36, 38, 37, 38, 35, 37 | 1 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | DBP, EW, n=10, 7, 4, 2, 10, 9 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 14, n=29, 31, 33, 34, 27, 26 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | SBP, PS, n=n=38, 38, 38, 38, 37, 38 | 1 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | SBP, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 2, n=36, 36, 36, 38, 31, 35 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 12, n=26, 30, 32, 36, 26, 25 | 1 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | SBP, EW, n=10, 7, 4, 2, 10, 9 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 8, n=30, 31, 33, 38, 27, 26 | 1 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 4, n=32, 34, 35, 38, 29, 31 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 1, n=36, 38, 37, 38, 35, 37 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 4, n=32, 34, 35, 38, 29, 31 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 14, n=29, 31, 33, 34, 27, 26 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 4, n=32, 34, 35, 38, 29, 31 | 1 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, EW, n=10, 7, 4, 2, 10, 9 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 14, n=29, 31, 33, 34, 27, 26 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 8, n=30, 31, 33, 38, 27, 26 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 2, n=36, 36, 36, 38, 31, 35 | 1 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 1, n=36, 38, 37, 38, 35, 37 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | DBP, Week 1, n=36, 38, 37, 38, 35, 37 | 1 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 2, n=36, 36, 36, 38, 31, 35 | 1 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | DBP, PS, n=38, 38, 38, 38, 37, 38 | 1 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 12, n=26, 30, 32, 36, 26, 25 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, PS, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | DBP, Baseline, n=38, 38, 38, 38, 37, 38 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 12, n=26, 30, 32, 36, 26, 25 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | DBP, EW, n=10, 7, 4, 2, 10, 9 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | SBP, Week 8, n=30, 31, 33, 38, 27, 26 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Clinical Importance | Pulse rate, Week 14, n=29, 31, 33, 34, 27, 26 | 0 Participants |
Secondary
Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit
The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of responders that is, participants who achieved a PGA score of 0 or 1 and a minimum 2-grade improvement from baseline were summarized. Baseline was defined as the latest assessment prior to the first dose and change from Baseline was defined as the value at post dose visit minus the Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Baseline and up to Week 16
Population: mITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2894512 1% BID | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 14 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 9 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 0 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 42 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 65 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 57 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 58 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 10 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 37 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 43 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 0 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 54 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 62 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 19 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 9 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 56 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 10 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 17 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 33 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 25 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 46 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 29 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 35 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 3 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 36 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 37 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 36 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 0 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 13 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 41 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 0 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 6 Percentage of participants |
| Vehicle BID | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 0 Percentage of participants |
| Vehicle BID | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 4 Percentage of participants |
| Vehicle BID | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 11 Percentage of participants |
| Vehicle BID | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 5 Percentage of participants |
| Vehicle BID | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 5 Percentage of participants |
| Vehicle BID | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 0 Percentage of participants |
| Vehicle BID | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 5 Percentage of participants |
| Vehicle BID | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 0 Percentage of participants |
| Vehicle QD | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 0 Percentage of participants |
| Vehicle QD | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 5 Percentage of participants |
| Vehicle QD | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 0 Percentage of participants |
| Vehicle QD | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 0 Percentage of participants |
| Vehicle QD | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 0 Percentage of participants |
| Vehicle QD | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 0 Percentage of participants |
| Vehicle QD | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 0 Percentage of participants |
| Vehicle QD | Percentage of Participants Who Achieved a PGA Score of 0 or 1 and a Minimum 2 Grade Improvement From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 0 Percentage of participants |
95% CI: [-28.8, 21.9]
95% CI: [-25.4, 25.1]
95% CI: [-17.5, 35.3]
95% CI: [-15.4, 33.3]
95% CI: [-17.1, 36.1]
95% CI: [-19.3, 31]
95% CI: [-18.2, 36.7]
95% CI: [-6.9, 43.6]
95% CI: [-15.1, 38.9]
95% CI: [-13.6, 37.4]
95% CI: [13.8, 66]
95% CI: [8.7, 61.3]
95% CI: [4.8, 58.2]
95% CI: [12.8, 63.9]
95% CI: [25.9, 76.6]
95% CI: [22.2, 73.2]
95% CI: [6.3, 60.5]
95% CI: [1.6, 55.9]
95% CI: [22, 74]
95% CI: [34.6, 81]
95% CI: [-6.1, 51]
95% CI: [7.8, 61.6]
95% CI: [24.7, 75.6]
95% CI: [25.8, 75.5]
95% CI: [-0.3, 55]
95% CI: [6.5, 60.2]
95% CI: [-36.9, 53.9]
95% CI: [-6.3, 81.6]
95% CI: [-35.7, 80.6]
Secondary
Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit
The PASI is a standard clinical tool for assessing the severity of psoriasis based on severity of erythema, thickness and scale, as well as the extent of body surface area (BSA) affected with psoriasis. The 3 clinical signs were graded on a 5 point scale (0 to 4) and the % BSA affected was scored on a 7-point scale (0 to 6) for each of the 4 specified body regions (head, upper extremities, trunk and lower extremities). The individual scores were multiplied by a weighted factor for each body region. The sum of these scores gave the overall PASI score. Higher scores indicated more severe disease. The percentage of participants with \>=75% improvement in PASI from Baseline were summarized. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Baseline and up to Week 16
Population: mITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2894512 1% BID | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 6 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 0 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Early withdrawal (EW), n=10, 7, 4, 2, 10, 9 | 10 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 32 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 50 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 65 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 65 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 63 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 26 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 58 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Early withdrawal (EW), n=10, 7, 4, 2, 10, 9 | 43 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 65 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 56 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 15 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 3 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 37 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 0 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 3 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 14 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 46 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 37 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 46 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 46 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Early withdrawal (EW), n=10, 7, 4, 2, 10, 9 | 0 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 48 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 46 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 34 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Early withdrawal (EW), n=10, 7, 4, 2, 10, 9 | 0 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 3 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 6 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 54 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 0 Percentage of participants |
| Vehicle BID | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 11 Percentage of participants |
| Vehicle BID | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Early withdrawal (EW), n=10, 7, 4, 2, 10, 9 | 0 Percentage of participants |
| Vehicle BID | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 5 Percentage of participants |
| Vehicle BID | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 16 Percentage of participants |
| Vehicle BID | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 16 Percentage of participants |
| Vehicle BID | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 0 Percentage of participants |
| Vehicle BID | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 0 Percentage of participants |
| Vehicle BID | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 5 Percentage of participants |
| Vehicle QD | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 5 Percentage of participants |
| Vehicle QD | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 0 Percentage of participants |
| Vehicle QD | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 0 Percentage of participants |
| Vehicle QD | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 0 Percentage of participants |
| Vehicle QD | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 5 Percentage of participants |
| Vehicle QD | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 0 Percentage of participants |
| Vehicle QD | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 5 Percentage of participants |
| Vehicle QD | Percentage of Participants With >=75 Percent Improvement in Psoriasis Area and Severity Index (PASI) From Baseline to Each Study Visit | Early withdrawal (EW), n=10, 7, 4, 2, 10, 9 | 0 Percentage of participants |
95% CI: [1, 56.1]
95% CI: [-21, 26.6]
95% CI: [-20.5, 32.4]
95% CI: [-9.6, 39.1]
95% CI: [-23.6, 29.9]
95% CI: [-22.2, 28.1]
95% CI: [-0.5, 52.4]
95% CI: [-0.4, 49.3]
95% CI: [-18.4, 35.7]
95% CI: [-19.7, 31.7]
95% CI: [16.6, 68.4]
95% CI: [8.7, 61.3]
95% CI: [3.5, 57.2]
95% CI: [6.3, 58.7]
95% CI: [20.1, 72.4]
95% CI: [22.2, 73.2]
95% CI: [12.7, 65]
95% CI: [20.1, 72.4]
95% CI: [33.2, 80.1]
95% CI: [0.2, 56.5]
95% CI: [14.4, 66.5]
95% CI: [23.2, 74.4]
95% CI: [24.4, 74]
95% CI: [6.3, 60.5]
95% CI: [19.7, 71.1]
95% CI: [-36.9, 53.9]
95% CI: [-6.3, 81.6]
Secondary
Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit
The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of participants who achieved a minimum 2-grade improvement from Baseline for each study visit were summarized. Baseline was defined as the latest assessment prior to the first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Baseline and up to Week 16
Population: mITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2894512 1% BID | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 21 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 13 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 0 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 46 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 65 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 61 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 58 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 20 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 37 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 43 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 0 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 54 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 62 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 23 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 12 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 56 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 13 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 24 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 41 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 25 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 50 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 38 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 38 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 6 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 36 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 37 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 36 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 0 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 13 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 41 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 0 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 6 Percentage of participants |
| Vehicle BID | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 0 Percentage of participants |
| Vehicle BID | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 4 Percentage of participants |
| Vehicle BID | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 11 Percentage of participants |
| Vehicle BID | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 5 Percentage of participants |
| Vehicle BID | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 5 Percentage of participants |
| Vehicle BID | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 0 Percentage of participants |
| Vehicle BID | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 5 Percentage of participants |
| Vehicle BID | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 0 Percentage of participants |
| Vehicle QD | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 0 Percentage of participants |
| Vehicle QD | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 5 Percentage of participants |
| Vehicle QD | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 0 Percentage of participants |
| Vehicle QD | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 0 Percentage of participants |
| Vehicle QD | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 0 Percentage of participants |
| Vehicle QD | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 0 Percentage of participants |
| Vehicle QD | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 0 Percentage of participants |
| Vehicle QD | Percentage of Participants With a Minimum 2 Grade Improvement in PGA Score From Baseline to Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 0 Percentage of participants |
Secondary
Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit
The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The percentage of participants who achieved a PGA score of 0 or 1 from Baseline at each study visit was summarized. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Up to Week 16
Population: mITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2894512 1% BID | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 21 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 16 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 0 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 54 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 70 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 61 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 58 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 10 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 56 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 57 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 9 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 65 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 69 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 42 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 18 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 72 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 10 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 24 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 44 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 25 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 54 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 42 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 50 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 3 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 43 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 41 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 39 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 0 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 16 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 41 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 0 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 6 Percentage of participants |
| Vehicle BID | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 0 Percentage of participants |
| Vehicle BID | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 4 Percentage of participants |
| Vehicle BID | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 11 Percentage of participants |
| Vehicle BID | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 5 Percentage of participants |
| Vehicle BID | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 5 Percentage of participants |
| Vehicle BID | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 0 Percentage of participants |
| Vehicle BID | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 5 Percentage of participants |
| Vehicle BID | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 0 Percentage of participants |
| Vehicle QD | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 0 Percentage of participants |
| Vehicle QD | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 10 Percentage of participants |
| Vehicle QD | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 4 Percentage of participants |
| Vehicle QD | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 5 Percentage of participants |
| Vehicle QD | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 5 Percentage of participants |
| Vehicle QD | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 0 Percentage of participants |
| Vehicle QD | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 5 Percentage of participants |
| Vehicle QD | Percentage of Participants With a PGA Score of 0 or 1 at Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 0 Percentage of participants |
Secondary
PGA Scores at Each Study Visit
The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, plaque thickness, and scaling as guidelines. Each assessment was made as a visual 'average' of the severity of all treated areas at the time of the assessment. The scores ranged from 0 to 4 where 0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate and 4=Severe. The mean of PGA scores at each study visit was summarized. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time frame: Up to Week 16
Population: mITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | PGA Scores at Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 1.3 Scores on a scale | Standard Deviation 1.08 |
| GSK2894512 1% BID | PGA Scores at Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 2.5 Scores on a scale | Standard Deviation 1.08 |
| GSK2894512 1% BID | PGA Scores at Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 2.3 Scores on a scale | Standard Deviation 0.77 |
| GSK2894512 1% BID | PGA Scores at Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 1.1 Scores on a scale | Standard Deviation 0.92 |
| GSK2894512 1% BID | PGA Scores at Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 1.3 Scores on a scale | Standard Deviation 1.01 |
| GSK2894512 1% BID | PGA Scores at Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 1.5 Scores on a scale | Standard Deviation 0.86 |
| GSK2894512 1% BID | PGA Scores at Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 2.7 Scores on a scale | Standard Deviation 0.59 |
| GSK2894512 1% BID | PGA Scores at Each Study Visit | Baseline, n=34, 35, 32, 32, 30, 33 | 2.9 Scores on a scale | Standard Deviation 0.42 |
| GSK2894512 1% BID | PGA Scores at Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 2.0 Scores on a scale | Standard Deviation 0.67 |
| GSK2894512 1% QD | PGA Scores at Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 1.6 Scores on a scale | Standard Deviation 1.4 |
| GSK2894512 1% QD | PGA Scores at Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 1.1 Scores on a scale | Standard Deviation 0.81 |
| GSK2894512 1% QD | PGA Scores at Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 2.4 Scores on a scale | Standard Deviation 0.65 |
| GSK2894512 1% QD | PGA Scores at Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 2.2 Scores on a scale | Standard Deviation 0.71 |
| GSK2894512 1% QD | PGA Scores at Each Study Visit | Baseline, n=34, 35, 32, 32, 30, 33 | 2.7 Scores on a scale | Standard Deviation 0.51 |
| GSK2894512 1% QD | PGA Scores at Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 1.2 Scores on a scale | Standard Deviation 1.01 |
| GSK2894512 1% QD | PGA Scores at Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 1.6 Scores on a scale | Standard Deviation 0.71 |
| GSK2894512 1% QD | PGA Scores at Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 1.1 Scores on a scale | Standard Deviation 0.99 |
| GSK2894512 1% QD | PGA Scores at Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 1.4 Scores on a scale | Standard Deviation 0.8 |
| GSK2894512 0.5% BID | PGA Scores at Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 2.7 Scores on a scale | Standard Deviation 0.65 |
| GSK2894512 0.5% BID | PGA Scores at Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 1.3 Scores on a scale | Standard Deviation 1.01 |
| GSK2894512 0.5% BID | PGA Scores at Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 2.1 Scores on a scale | Standard Deviation 0.77 |
| GSK2894512 0.5% BID | PGA Scores at Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 1.5 Scores on a scale | Standard Deviation 0.9 |
| GSK2894512 0.5% BID | PGA Scores at Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 2.0 Scores on a scale | Standard Deviation 1.41 |
| GSK2894512 0.5% BID | PGA Scores at Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 2.4 Scores on a scale | Standard Deviation 0.67 |
| GSK2894512 0.5% BID | PGA Scores at Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 1.6 Scores on a scale | Standard Deviation 0.88 |
| GSK2894512 0.5% BID | PGA Scores at Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 1.6 Scores on a scale | Standard Deviation 0.75 |
| GSK2894512 0.5% BID | PGA Scores at Each Study Visit | Baseline, n=34, 35, 32, 32, 30, 33 | 3.0 Scores on a scale | Standard Deviation 0.54 |
| GSK2894512 0.5% QD | PGA Scores at Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 1.6 Scores on a scale | Standard Deviation 0.78 |
| GSK2894512 0.5% QD | PGA Scores at Each Study Visit | Baseline, n=34, 35, 32, 32, 30, 33 | 2.9 Scores on a scale | Standard Deviation 0.39 |
| GSK2894512 0.5% QD | PGA Scores at Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 2.6 Scores on a scale | Standard Deviation 0.56 |
| GSK2894512 0.5% QD | PGA Scores at Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 2.5 Scores on a scale | Standard Deviation 0.62 |
| GSK2894512 0.5% QD | PGA Scores at Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 2.1 Scores on a scale | Standard Deviation 0.78 |
| GSK2894512 0.5% QD | PGA Scores at Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 1.7 Scores on a scale | Standard Deviation 0.85 |
| GSK2894512 0.5% QD | PGA Scores at Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 1.7 Scores on a scale | Standard Deviation 0.94 |
| GSK2894512 0.5% QD | PGA Scores at Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 1.7 Scores on a scale | Standard Deviation 1.06 |
| GSK2894512 0.5% QD | PGA Scores at Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 2.5 Scores on a scale | Standard Deviation 0.71 |
| Vehicle BID | PGA Scores at Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 2.5 Scores on a scale | Standard Deviation 0.51 |
| Vehicle BID | PGA Scores at Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 2.4 Scores on a scale | Standard Deviation 0.59 |
| Vehicle BID | PGA Scores at Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 2.5 Scores on a scale | Standard Deviation 0.61 |
| Vehicle BID | PGA Scores at Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 2.6 Scores on a scale | Standard Deviation 0.5 |
| Vehicle BID | PGA Scores at Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 3.1 Scores on a scale | Standard Deviation 0.57 |
| Vehicle BID | PGA Scores at Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 2.5 Scores on a scale | Standard Deviation 0.61 |
| Vehicle BID | PGA Scores at Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 2.9 Scores on a scale | Standard Deviation 0.52 |
| Vehicle BID | PGA Scores at Each Study Visit | Baseline, n=34, 35, 32, 32, 30, 33 | 3.0 Scores on a scale | Standard Deviation 0.26 |
| Vehicle BID | PGA Scores at Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 2.4 Scores on a scale | Standard Deviation 0.69 |
| Vehicle QD | PGA Scores at Each Study Visit | Baseline, n=34, 35, 32, 32, 30, 33 | 2.8 Scores on a scale | Standard Deviation 0.44 |
| Vehicle QD | PGA Scores at Each Study Visit | Week 4, n=28, 31, 29, 32, 22, 26 | 2.6 Scores on a scale | Standard Deviation 0.64 |
| Vehicle QD | PGA Scores at Each Study Visit | Week 12, n=23, 25, 26, 28, 19, 20 | 2.5 Scores on a scale | Standard Deviation 0.69 |
| Vehicle QD | PGA Scores at Each Study Visit | EW, n=10, 7, 4, 2, 10, 9 | 3.1 Scores on a scale | Standard Deviation 0.6 |
| Vehicle QD | PGA Scores at Each Study Visit | Week 16, n=24, 26, 26, 28, 19, 19 | 2.6 Scores on a scale | Standard Deviation 0.69 |
| Vehicle QD | PGA Scores at Each Study Visit | Week 14, n=23, 26, 24, 27, 19, 19 | 2.5 Scores on a scale | Standard Deviation 0.61 |
| Vehicle QD | PGA Scores at Each Study Visit | Week 2, n=32, 33, 30, 32, 24, 30 | 2.6 Scores on a scale | Standard Deviation 0.49 |
| Vehicle QD | PGA Scores at Each Study Visit | Week 8, n=26, 27, 27, 32, 20, 20 | 2.5 Scores on a scale | Standard Deviation 0.61 |
| Vehicle QD | PGA Scores at Each Study Visit | Week 1, n=32, 35, 31, 32, 28, 32 | 2.8 Scores on a scale | Standard Deviation 0.51 |