Dermatitis, Atopic
Conditions
Keywords
Vehicle-Controlled, GSK2894512, Double blind, Dose-finding, Atopic Dermatitis
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 adolescent and adult subjects with atopic dermatitis. Results from this study will be considered when selecting the most appropriate concentration of GSK2894512 cream and application frequency in future clinical studies. This is a multicenter (United States, Canada, and Japan), randomized, double-blind (sponsor-unblind), vehicle-controlled, 6-arm, parallel-group, dose-finding study in adolescent and adult subjects with atopic dermatitis. Two concentrations of GSK2894512 cream (0.5% and 1%) and a vehicle control cream will be equally randomized and evaluated following application to all atopic dermatitis 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 adolescent and adult males and females subjects with atopic dermatitis 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
12 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female between 12 and 65 years of age inclusive, at the time of signing the informed consent * Diagnosis of atopic dermatitis according to Hanifin and Rajka criteria and having active inflammation. * Body surface area involvement \>=5% and \<=35%, excluding scalp, at Screening and Baseline. * An IGA of atopic dermatitis score of \>=3 at Baseline. * At least one target lesion that measure at least 3 centimetre (cm) х 3 cm in size at Screening and Baseline and must be representative of the subject's disease state, but not located on the hands, feet, or genitalia. * 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 after the last dose of study medication and completion of the follow-up visit.
Exclusion criteria
* Unstable course of atopic dermatitis (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks prior to Baseline. * Concurrent conditions and history of other diseases: 1) Immunocompromized (eg, lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich Syndrome) or have a history of malignant disease within 5 years before the baseline visit; 2) Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks before the baseline visit; 3) Active acute bacterial, fungal, or viral (eg, herpes simplex, herpes zoster, chicken pox) skin infection within 1 week before the baseline visit; 4) Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton's Syndrome, or psoriasis); pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of AD lesions or compromise subject safety; 5) Presence of AD lesions only on the hands or feet without prior history of involvement of other classical areas of involvement such as the face or the folds; 6) Other types of eczema. * 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 study treatment excipients. * 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 (HBsAg), or positive hepatitis C antibody test result within 3 months of screening. * Liver function tests: alanine aminotransferase (ALT) \>=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 atopic dermatitis. * Used any of the following treatments within the indicated washout period before the baseline visit: 12 weeks or 5 half-lives (whichever is longer) - biologic agents (eg, 18 weeks for omalizumab); 8 weeks - cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (eg, mycophenolate or tacrolimus); 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs; 2 weeks - topical treatments: corticosteroids, calcineurin inhibitors, or coal tar (on the body); 2 weeks - immunizations; sedating antihistamines (non sedating antihistamines are permitted); 1 week - topical antibiotics, antibacterial cleansing body wash/soap or diluted sodium hypochlorite bleach baths. * 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 an Investigator Global Assessment (IGA) Score of Clear or Almost Clear (0 or 1) at Week 12 and a Minimum 2 Grade Improvement in IGA Score From Baseline to Week 12 for Intent to Treat (ITT) Population | Baseline and up to Week 12 | The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. The percentage of participants who have an IGA score of clear or almost clear at Week 12 and a minimum 2 grade improvement from Baseline to Week 12 in IGA score was presented. . The analysis was performed on ITT Population which comprised of all randomized participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Weekly Average of Daily Itch/Pruritus (Numeric Rating Scale [NRS]) Score | Baseline and up to Week 12 | NRS is a 11-point tool ranging from 0 (absent) to 10 (worst imaginable) to assess the severity of 11 disease-related signs and symptoms including itching, discoloration, bleeding, oozing, cracking, scaling, flaking, dry/rough, painful, burning, and stinging. Participants were asked to complete the self-administered sign and symptom severity diary containing NRS using a recall period of the past 24 hours. Question 1 of the diary was used to assess itch. Mean change from Baseline to Week 12 in weekly average of daily itch/pruritus based on the NRS was presented using mean and standard deviation (SD). Baseline was defined as the latest assessment prior to first dose and Change from Baseline was defined as post-dose weekly average value minus Baseline value. |
| Mean Percent Change From Baseline in Weekly Average of Daily Itch/Pruritus NRS Score | Baseline and up to Week 12 | NRS is a 11-point tool ranging from 0 (absent) to 10 (worst imaginable) to assess the severity of 11 disease-related signs and symptoms including itching, discoloration, bleeding, oozing, cracking, scaling, flaking, dry/rough, painful, burning, and stinging. Participants were asked to complete the self-administered sign and symptom severity diary containing NRS using a recall period of the past 24 hours. Question 1 of the diary was used to assess itch. Mean percent change in weekly average of daily itch/pruritus based on the NRS was presented using mean and SD from Baseline to Week 12. Baseline was defined as the latest assessment prior to first dose and Change from Baseline was defined as post-dose weekly average value minus Baseline value. |
| Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 1, 2, 4, 8, 12, 14, 16, early withdrawal (EW) (up to Week 16) | NRS is a 11-point tool ranging from 0 (absent) to 10 (worst imaginable) to assess the severity of 11 disease-related signs and symptoms including itching, discoloration, bleeding, oozing, cracking, scaling, flaking, dry/rough, painful, burning, and stinging. Participants were asked to complete the self-administered sign and symptom severity diary containing NRS using a recall period of the past 24 hours. Question 1 of the diary was used to assess itch. Percentage of participants who achieved a minimum 3-point improvement in itch/pruritus (NRS) from Baseline to each study visit were measured. Baseline was defined as the latest assessment prior to first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). |
| Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) | The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale (0 \[absent\] to 3 \[severe\]) for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Body area involvement ranged from 0 (0%) to 6 (90-100%). Total EASI score was calculated as a sum of scores of all 4 specified body region. Range for EASI total score is 0 (absent) to 72 (severe). Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean change from Baseline was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Mean Percent Change From Baseline in EASI Score | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) | The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale (0 \[absent\] to 3 \[severe\]) for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Body area involvement ranged from 0 (0%) to 6 (90-100%). Total EASI score was calculated as a sum of scores of all 4 specified body region. Range for EASI total score is 0 (absent) to 72 (severe). Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean percent change from Baseline was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) | The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. The percentage of participants with a minimum 2-grade improvement in IGA score from Baseline at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and early withdrawal (EW) visit was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) | The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. The percentage of participants with an IGA score of 0 or 1 at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) | The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Percentage of participants with \>=50 percent improvement in EASI score from Baseline to Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW were presented and statistical analysis was performed using a repeated measures factorial logistic regression model. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) | The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Percentage of participants with \>=75 percent improvement in EASI score from Baseline to Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW were presented and statistical analysis was performed using a repeated measures factorial logistic regression model. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Mean Change From Baseline in Total Severity Score (TSS) | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) | A target lesion of at least 3 centimeter square (cm\^2) was selected at Baseline. The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe), with higher values indicating greater severity of symptoms. TSS (maximum score 15) was calculated based on these signs. Mean change from Baseline in TSS at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Mean Percent Change From Baseline in TSS | Week 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) | A target lesion of at least 3 cm\^2 was selected at Baseline. The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe) , with higher values indicating greater severity of symptoms. TSS (maximum score 15) was calculated based on these signs. Mean percent change from Baseline in TSS at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Mean Change From Baseline in Individual Signs of TSS | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) | The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe) and TSS (maximum score 15) was calculated based on these signs. Mean change from Baseline in individual signs of TSS was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. If the participant had more than 3 missing days during the week, then the weekly average was not calculated and treated as missing data and excluded from the analysis. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Mean Percent Change From Baseline in Individual Signs of TSS | Week 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) | The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe) and TSS (maximum score 15) was calculated based on these signs. Mean percent change from Baseline in individual signs of TSS was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. NA indicates that data were not available. If the participant had more than 3 missing days during the week, then the weekly average was not calculated and treated as missing data and excluded from the analysis. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Mean Change From Baseline in Body Surface Area (Percent BSA) | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) | The extent of BSA affected by AD is a general indicator of disease severity and the assessment of BSA with AD was performed separately for four body surface regions: the head (h), the upper extremities (u), the trunk (t) and the lower extremities (l), corresponding to 10, 20, 30, and 40 percent of the total body area, respectively. Mean change from Baseline in percent BSA was presented using mean and SD at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit. Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Mean Change From Baseline in IGA Score | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16) | The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. Score ranges from 0 (clear) to 4 (severe). Higher values represent a severe disease. Mean change from Baseline in IGA score was presented using mean and SD at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit. Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to week 16) | The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. The percentage of participants who have an IGA score of clear or almost clear and a minimum 2 grade improvement from Baseline to each study visit in IGA score was presented. The statistical analysis was performed using a repeated measures factorial logistic regression model with covariates for dose, frequency of administration, and study day as well as a dose by frequency interaction term. The analysis was performed on ITT Population which comprised of all randomized participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category title). |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | Weeks 1, 2, 4, 8, 12, 14, EW (up to week 14) | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function. Treatment emergent AEs (TEAE) is defined as AE occurred on or after study treatment start date and on or before last visit. Number of participants with AEs and serious TEAEs were presented. The analysis was performed on Safety population which comprised of all participants who receive at least one dose of study treatment. |
| Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1, 2, 4, 8, 12, 14, EW (up to Week 14) | Participants were asked to use a 5-point tolerability scale from 0 (none) to 4 (severe) to assess the presence and degree of burning/stinging and itching at the application sites that has generally been experienced following application of the study treatment. The score represented an 'average' across all application sites. A score of 3 or 4 was reported as an AE. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Change From Baseline in Albumin and Total Protein | Week 1, 2, 4, 8, 12, 14, EW (up to week 14) | Blood samples were collected to evaluate change from Baseline in albumin and total protein values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. |
| Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Week 2, 4, 8, 12, 14, EW (up to week 14) | Blood samples were collected to evaluate change from Baseline in Alk.phosph., ALT, AST and GGT values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. |
| Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Week 2, 4, 8, 12, 14, EW (up to week 14) | Blood samples were collected to evaluate change from Baseline in direct and total bilirubin, creatinine and urate values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. |
| Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Week 2, 4, 8, 12, 14, EW (up to week 14) | Blood samples were collected to evaluate change from Baseline in calcium, chloride, CO2, glucose, potassium, sodium and BUN values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. |
| Number of Participants With Chemistry Data of Potential Clinical Importance | Week 2, 4, 8, 12, 14, EW (up to week 14) | Blood samples were collected from participants for evaluation of clinical chemistry parameters by Potential Clinical Importance Criteria from Baseline to Week 14, EW and any visit post-screen. The vital signs included alk.phosph., ALT, AST, bilirubin, calcium, CO2, creatinine, glucose and potassium. 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 the category titles). |
| Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Week 2, 4, 8, 12, 14, EW (up to week 14) | Blood samples were collected to evaluate change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet and leukocytes and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. |
| Change From Baseline in Hematocrit Levels | Week 2, 4, 8, 12, 14, EW (up to week 14) | Blood samples were collected to evaluate change from Baseline in hematocrit and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. |
| Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Week 2, 4, 8, 12, 14, EW (up to week 14) | Blood samples were collected to evaluate change from Baseline in hemoglobin and MCHC and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. |
| Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 2, 4, 8, 12, 14, EW (up to week 14) | Blood samples were collected to evaluate change from Baseline in MCH and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. |
| Change From Baseline in Mean Corpuscle Volume (MCV) | Week 2, 4, 8, 12, 14, EW (up to week 14) | Blood samples were collected to evaluate change from Baseline in MCV and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. |
| Change From Baseline in Erythrocyte Count | Weeks 2, 4, 8, 12, 14, EW (week up to 14) | Blood samples were collected to evaluate change from Baseline in erythrocytes and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. |
| Number of Participants With Hematology Data of Potential Clinical Importance | Baseline, Week 2, 4, 8, 12, 14, early withdrawal, and post screen (up to Week 16) | Blood samples were collected from participants for evaluation of hematology parameters by Potential Clinical Importance Criteria from Baseline to Week 14, EW and any visit post-screen. The vital signs included hematocrit, hemoglobin, lymphocytes, neutrophils, platelet and leukocytes. 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 the category titles). |
| Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | Week, 4, 8 and 12 | Blood samples were collected to evaluate change from Baseline in total T lympho, B lympho, T and B NK cells and (Foxp3) values at Baseline throughout the 12 weeks of study treatment. The immunophenotyping parameters included cluster of differentiation (CD)19, CD3, CD3+CD8+, CD3+CD4+, CD16+CD56+, CD3+CD4+CD25+CD127, CD3+CD4+foxP3+CD25+CD127 and T and NK lympho. CD3, CD3+CD8+ and CD3+CD4+ were also evaluated by using treg flow cytometry (cyto). 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 the category titles). Mean and SD were measured. |
| Number of Participants With Immunopheotyping Data Outside the Reference Range | Baseline, Week, 4, 8, 12 and post-screen (up to Week 16) | Blood samples were collected from participants for evaluation of immunophenotyping parameters by Potential Clinical Importance Criteria at Baseline, Week 4, Week 8, Week 12 nd any visit post-screen. The immunophenotyping parameters included CD 19, CD3, CD3+CD8+, CD3+CD4+, CD16+CD56+, CD3+CD4+CD25+CD127, CD3+CD4+foxP3+CD25+CD127 and T and NK lympho. CD3, CD3+CD8+ and CD3+CD4+ were also evaluated by using treg flow cyto. 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 the category titles). |
| Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | Week, 4, 8 and 12 | Blood samples were collected to evaluate change from Baseline in IgA, IgG, IM values at Baseline throughout the 12 weeks of study treatment. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. |
| Number of Participants With Immunoglobulin Data Outside the Reference Range | Baseline, Week, 4, 8, 12, post-screen (up to Week 16) | Blood samples were collected from participants for evaluation of immunoglobulin data outside the reference range at Baseline, Week 4, Week 8, Week 12 and any visit post-screen. The immunoglobulin parameters included IgA, IgG and Ig M. 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 the category titles). |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Week 1, 2, 4, 8, 12, 14, EW (up to week 14) | SBP and DBP were measured from Baseline up to follow up Visit 1 at Week 14 in semi-supine position after at least 5 minutes of rest. The Baseline value was taken at Day 1 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. |
| Change From Baseline in Pulse Rate | Week 1, 2, 4, 8, 12, 14, EW (up to week 14) | Pulse rate were measured from Baseline up to follow up Visit 1 at Week 14 in semi-supine position after at least 5 minutes of rest. The Baseline value was taken at Day 1 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. |
| Change From Baseline in Temperature | Week 1, 2, 4, 8, 12, 14, EW (up to week 14) | Temperature were measured from Baseline up to follow up Visit 1 at Week 14 in semi-supine position after at least 5 minutes of rest. The Baseline value was taken at Day 1 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured. |
| Number of Participants With Vital Signs of Potential Clinical Importance | Baseline, Week 2, 4, 8, 12, 14, EW (up to week 14) | Blood samples were collected from participants for evaluation of vital signs by Potential Clinical Importance Criteria from Baseline to Week 14, EW and any visit post-screen. The vital signs included SBP, DBP and pulse rate. 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 the category titles). |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Baseline, Week 1, 12, 14, EW ( up to Week 14), post-screen | Single measurements of 12-lead ECGs were obtained at Baseline , Week 1, Week 12, Week 14 (follow up 1), EW and at any time post-screen using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc). Baseline was defined as the latest assessment prior to the first dose. For multiple ECGs at one visit, or Any visit post-screen, a participant was categorized as Abnormal if \>=1 assessment was abnormal. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
Countries
Canada, Japan, United States
Participant flow
Recruitment details
Eligible participants entered a 4 weeks screening phase and participants who met the eligibility criteria entered into the 12 weeks double-blind treatment phase and 4 weeks post-treatment follow-up phase. The total duration of participation in the study was 16 to 20 weeks.
Pre-assignment details
A total of 363 adolescent and adult participants with atopic dermatitis (AD) were screened, of which 116 were screen failures and 247 entered the treatment phase. Participants in the treatment phase were randomized to receive GSK2894512 cream (0.5 or 1%) or vehicle control once daily (QD) or twice daily (BID).
Participants by arm
| Arm | Count |
|---|---|
| GSK2894512 1% BID Participants received 1% of GSK2894512 cream BID applied to all AD lesions via topical route for 12 weeks. | 40 |
| GSK2894512 1% QD Participants received 1% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. | 41 |
| GSK2894512 0.5% BID Participants received 0.5% of GSK 2894512 cream BID applied to all AD lesions via topical route for 12 weeks. | 43 |
| GSK2894512 0.5% QD Participants received 0.5% of GSK2894512 cream QD applied to all AD lesions via topical route for 12 weeks. | 41 |
| Vehicle BID Participants received vehicle control cream BID applied to all AD lesions via topical route for 12 weeks | 42 |
| Vehicle QD Participants received vehicle control cream QD applied to all AD lesions via topical route for 12 weeks | 40 |
| Total | 247 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 4 | 1 | 4 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 | 4 | 2 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Reached stopping criteria | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 4 | 3 | 3 | 10 | 10 |
Baseline characteristics
| Characteristic | GSK2894512 1% BID | GSK2894512 1% QD | GSK2894512 0.5% BID | GSK2894512 0.5% QD | Vehicle BID | Vehicle QD | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 28.5 Years STANDARD_DEVIATION 13.9 | 31.6 Years STANDARD_DEVIATION 15.72 | 29.0 Years STANDARD_DEVIATION 15.91 | 29.3 Years STANDARD_DEVIATION 14.02 | 27.9 Years STANDARD_DEVIATION 14.72 | 29.4 Years STANDARD_DEVIATION 15.15 | 29.3 Years STANDARD_DEVIATION 14.83 |
| Race/Ethnicity, Customized Race/Ethnicity, Customized American Indian/Alaska Native | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, Customized American Indian/Alaska Native and African American | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, Customized Asian/S.E. Asian Descent/Japanese | 15 Participants | 13 Participants | 13 Participants | 10 Participants | 15 Participants | 14 Participants | 80 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, Customized Asian/S.E. Asian/Japanese and African American | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, Customized Asian/S.E. Asian/Japanese and Black and White | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, Customized Asian/S.E. Asian/Japanese and White/Caucasian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, Customized Black/African American | 7 Participants | 10 Participants | 11 Participants | 12 Participants | 6 Participants | 12 Participants | 58 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, Customized Black/African American and White/Caucasian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity, Customized White/Caucasian | 16 Participants | 18 Participants | 17 Participants | 17 Participants | 20 Participants | 12 Participants | 100 Participants |
| Sex: Female, Male Female | 18 Participants | 24 Participants | 17 Participants | 22 Participants | 23 Participants | 17 Participants | 121 Participants |
| Sex: Female, Male Male | 22 Participants | 17 Participants | 26 Participants | 19 Participants | 19 Participants | 23 Participants | 126 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 / 40 | 0 / 41 | 0 / 43 | 0 / 41 | 0 / 42 | 0 / 40 |
| other Total, other adverse events | 28 / 40 | 22 / 41 | 20 / 43 | 23 / 41 | 19 / 42 | 15 / 40 |
| serious Total, serious adverse events | 1 / 40 | 0 / 41 | 0 / 43 | 0 / 41 | 0 / 42 | 0 / 40 |
Outcome results
Primary
Percentage of Participants Who Have an Investigator Global Assessment (IGA) Score of Clear or Almost Clear (0 or 1) at Week 12 and a Minimum 2 Grade Improvement in IGA Score From Baseline to Week 12 for Intent to Treat (ITT) Population
The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. The percentage of participants who have an IGA score of clear or almost clear at Week 12 and a minimum 2 grade improvement from Baseline to Week 12 in IGA score was presented. . The analysis was performed on ITT Population which comprised of all randomized participants.
Time frame: Baseline and up to Week 12
Population: ITT Population. Only those participants with data available at specified data points were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK2894512 1% BID | Percentage of Participants Who Have an Investigator Global Assessment (IGA) Score of Clear or Almost Clear (0 or 1) at Week 12 and a Minimum 2 Grade Improvement in IGA Score From Baseline to Week 12 for Intent to Treat (ITT) Population | 58 Percentage of participant |
| GSK2894512 1% QD | Percentage of Participants Who Have an Investigator Global Assessment (IGA) Score of Clear or Almost Clear (0 or 1) at Week 12 and a Minimum 2 Grade Improvement in IGA Score From Baseline to Week 12 for Intent to Treat (ITT) Population | 51 Percentage of participant |
| GSK2894512 0.5% BID | Percentage of Participants Who Have an Investigator Global Assessment (IGA) Score of Clear or Almost Clear (0 or 1) at Week 12 and a Minimum 2 Grade Improvement in IGA Score From Baseline to Week 12 for Intent to Treat (ITT) Population | 50 Percentage of participant |
| GSK2894512 0.5% QD | Percentage of Participants Who Have an Investigator Global Assessment (IGA) Score of Clear or Almost Clear (0 or 1) at Week 12 and a Minimum 2 Grade Improvement in IGA Score From Baseline to Week 12 for Intent to Treat (ITT) Population | 40 Percentage of participant |
| Vehicle BID | Percentage of Participants Who Have an Investigator Global Assessment (IGA) Score of Clear or Almost Clear (0 or 1) at Week 12 and a Minimum 2 Grade Improvement in IGA Score From Baseline to Week 12 for Intent to Treat (ITT) Population | 36 Percentage of participant |
| Vehicle QD | Percentage of Participants Who Have an Investigator Global Assessment (IGA) Score of Clear or Almost Clear (0 or 1) at Week 12 and a Minimum 2 Grade Improvement in IGA Score From Baseline to Week 12 for Intent to Treat (ITT) Population | 44 Percentage of participant |
95% CI: [-2.4, 45.5]
95% CI: [-18.3, 32]
95% CI: [-11.2, 38.7]
95% CI: [-29.3, 21.6]
Secondary
Change From Baseline in Albumin and Total Protein
Blood samples were collected to evaluate change from Baseline in albumin and total protein values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.
Time frame: Week 1, 2, 4, 8, 12, 14, EW (up to week 14)
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Albumin and Total Protein | Total protein; EW; n= 3,3,7,3,11,11 | -2.3 Gram per Liter (G/L) | Standard Deviation 6.43 |
| GSK2894512 1% BID | Change From Baseline in Albumin and Total Protein | Total protein; Week 2; n= 38,39,38,39,33,32 | -1.5 Gram per Liter (G/L) | Standard Deviation 4.49 |
| GSK2894512 1% BID | Change From Baseline in Albumin and Total Protein | Total protein; Week 8; n= 35,37,34,38,29,28 | -2.8 Gram per Liter (G/L) | Standard Deviation 3.91 |
| GSK2894512 1% BID | Change From Baseline in Albumin and Total Protein | Albumin; Week 4; n=38,39,38,38,30,32 | -1.1 Gram per Liter (G/L) | Standard Deviation 2.87 |
| GSK2894512 1% BID | Change From Baseline in Albumin and Total Protein | Albumin; EW;n = 3,3,7,3,11,11 | -1.3 Gram per Liter (G/L) | Standard Deviation 4.04 |
| GSK2894512 1% BID | Change From Baseline in Albumin and Total Protein | Albumin; Week 8; n= 35,37,34,38,29,28 | -1.7 Gram per Liter (G/L) | Standard Deviation 2.47 |
| GSK2894512 1% BID | Change From Baseline in Albumin and Total Protein | Albumin; Week 2; n=38,39,38,39,33,32 | -1.2 Gram per Liter (G/L) | Standard Deviation 2.96 |
| GSK2894512 1% BID | Change From Baseline in Albumin and Total Protein | Albumin; Week 12; n= 36,37,32,35,28,28 | -1.1 Gram per Liter (G/L) | Standard Deviation 2.48 |
| GSK2894512 1% BID | Change From Baseline in Albumin and Total Protein | Total protein; Week 14; n= 33,35,32,34,31,29 | -3.0 Gram per Liter (G/L) | Standard Deviation 3.8 |
| GSK2894512 1% BID | Change From Baseline in Albumin and Total Protein | Total protein; Week 12; n= 36,37,32,35,28,28 | -2.0 Gram per Liter (G/L) | Standard Deviation 4.16 |
| GSK2894512 1% BID | Change From Baseline in Albumin and Total Protein | Albumin; Week 14; n= 33,35,32,34,31,29 | -1.6 Gram per Liter (G/L) | Standard Deviation 2.36 |
| GSK2894512 1% BID | Change From Baseline in Albumin and Total Protein | Total protein; Week 4; n= 38,39,38,38,30,32 | -1.9 Gram per Liter (G/L) | Standard Deviation 4.32 |
| GSK2894512 1% QD | Change From Baseline in Albumin and Total Protein | Albumin; Week 2; n=38,39,38,39,33,32 | -1.3 Gram per Liter (G/L) | Standard Deviation 1.89 |
| GSK2894512 1% QD | Change From Baseline in Albumin and Total Protein | Albumin; EW;n = 3,3,7,3,11,11 | -3.3 Gram per Liter (G/L) | Standard Deviation 2.52 |
| GSK2894512 1% QD | Change From Baseline in Albumin and Total Protein | Total protein; Week 4; n= 38,39,38,38,30,32 | -1.1 Gram per Liter (G/L) | Standard Deviation 3.49 |
| GSK2894512 1% QD | Change From Baseline in Albumin and Total Protein | Total protein; Week 12; n= 36,37,32,35,28,28 | -2.5 Gram per Liter (G/L) | Standard Deviation 4.43 |
| GSK2894512 1% QD | Change From Baseline in Albumin and Total Protein | Total protein; Week 14; n= 33,35,32,34,31,29 | -2.4 Gram per Liter (G/L) | Standard Deviation 3.23 |
| GSK2894512 1% QD | Change From Baseline in Albumin and Total Protein | Total protein; EW; n= 3,3,7,3,11,11 | -4.0 Gram per Liter (G/L) | Standard Deviation 2 |
| GSK2894512 1% QD | Change From Baseline in Albumin and Total Protein | Albumin; Week 4; n=38,39,38,38,30,32 | -0.6 Gram per Liter (G/L) | Standard Deviation 2.17 |
| GSK2894512 1% QD | Change From Baseline in Albumin and Total Protein | Albumin; Week 8; n= 35,37,34,38,29,28 | -1.0 Gram per Liter (G/L) | Standard Deviation 1.86 |
| GSK2894512 1% QD | Change From Baseline in Albumin and Total Protein | Albumin; Week 12; n= 36,37,32,35,28,28 | -1.2 Gram per Liter (G/L) | Standard Deviation 2.65 |
| GSK2894512 1% QD | Change From Baseline in Albumin and Total Protein | Albumin; Week 14; n= 33,35,32,34,31,29 | -1.5 Gram per Liter (G/L) | Standard Deviation 2.41 |
| GSK2894512 1% QD | Change From Baseline in Albumin and Total Protein | Total protein; Week 2; n= 38,39,38,39,33,32 | -2.2 Gram per Liter (G/L) | Standard Deviation 2.84 |
| GSK2894512 1% QD | Change From Baseline in Albumin and Total Protein | Total protein; Week 8; n= 35,37,34,38,29,28 | -2.1 Gram per Liter (G/L) | Standard Deviation 3.02 |
| GSK2894512 0.5% BID | Change From Baseline in Albumin and Total Protein | Albumin; Week 8; n= 35,37,34,38,29,28 | -1.9 Gram per Liter (G/L) | Standard Deviation 2.38 |
| GSK2894512 0.5% BID | Change From Baseline in Albumin and Total Protein | Albumin; Week 12; n= 36,37,32,35,28,28 | -2.2 Gram per Liter (G/L) | Standard Deviation 2.35 |
| GSK2894512 0.5% BID | Change From Baseline in Albumin and Total Protein | Total protein; Week 4; n= 38,39,38,38,30,32 | -2.4 Gram per Liter (G/L) | Standard Deviation 4.43 |
| GSK2894512 0.5% BID | Change From Baseline in Albumin and Total Protein | Albumin; EW;n = 3,3,7,3,11,11 | -3.0 Gram per Liter (G/L) | Standard Deviation 1.29 |
| GSK2894512 0.5% BID | Change From Baseline in Albumin and Total Protein | Albumin; Week 14; n= 33,35,32,34,31,29 | -2.0 Gram per Liter (G/L) | Standard Deviation 2.48 |
| GSK2894512 0.5% BID | Change From Baseline in Albumin and Total Protein | Total protein; Week 14; n= 33,35,32,34,31,29 | -3.3 Gram per Liter (G/L) | Standard Deviation 4.07 |
| GSK2894512 0.5% BID | Change From Baseline in Albumin and Total Protein | Albumin; Week 2; n=38,39,38,39,33,32 | -2.2 Gram per Liter (G/L) | Standard Deviation 2.96 |
| GSK2894512 0.5% BID | Change From Baseline in Albumin and Total Protein | Total protein; Week 12; n= 36,37,32,35,28,28 | -3.8 Gram per Liter (G/L) | Standard Deviation 4.4 |
| GSK2894512 0.5% BID | Change From Baseline in Albumin and Total Protein | Total protein; Week 8; n= 35,37,34,38,29,28 | -2.8 Gram per Liter (G/L) | Standard Deviation 4.46 |
| GSK2894512 0.5% BID | Change From Baseline in Albumin and Total Protein | Albumin; Week 4; n=38,39,38,38,30,32 | -1.9 Gram per Liter (G/L) | Standard Deviation 2.49 |
| GSK2894512 0.5% BID | Change From Baseline in Albumin and Total Protein | Total protein; EW; n= 3,3,7,3,11,11 | -2.0 Gram per Liter (G/L) | Standard Deviation 2.16 |
| GSK2894512 0.5% BID | Change From Baseline in Albumin and Total Protein | Total protein; Week 2; n= 38,39,38,39,33,32 | -2.3 Gram per Liter (G/L) | Standard Deviation 4.48 |
| GSK2894512 0.5% QD | Change From Baseline in Albumin and Total Protein | Total protein; EW; n= 3,3,7,3,11,11 | -1.0 Gram per Liter (G/L) | Standard Deviation 2 |
| GSK2894512 0.5% QD | Change From Baseline in Albumin and Total Protein | Albumin; Week 8; n= 35,37,34,38,29,28 | -1.1 Gram per Liter (G/L) | Standard Deviation 2.29 |
| GSK2894512 0.5% QD | Change From Baseline in Albumin and Total Protein | Total protein; Week 14; n= 33,35,32,34,31,29 | -2.0 Gram per Liter (G/L) | Standard Deviation 4.75 |
| GSK2894512 0.5% QD | Change From Baseline in Albumin and Total Protein | Total protein; Week 8; n= 35,37,34,38,29,28 | -1.7 Gram per Liter (G/L) | Standard Deviation 3.89 |
| GSK2894512 0.5% QD | Change From Baseline in Albumin and Total Protein | Albumin; Week 12; n= 36,37,32,35,28,28 | -1.7 Gram per Liter (G/L) | Standard Deviation 2.47 |
| GSK2894512 0.5% QD | Change From Baseline in Albumin and Total Protein | Albumin; EW;n = 3,3,7,3,11,11 | -0.7 Gram per Liter (G/L) | Standard Deviation 0.58 |
| GSK2894512 0.5% QD | Change From Baseline in Albumin and Total Protein | Albumin; Week 14; n= 33,35,32,34,31,29 | -1.6 Gram per Liter (G/L) | Standard Deviation 3.04 |
| GSK2894512 0.5% QD | Change From Baseline in Albumin and Total Protein | Total protein; Week 4; n= 38,39,38,38,30,32 | -1.7 Gram per Liter (G/L) | Standard Deviation 5.12 |
| GSK2894512 0.5% QD | Change From Baseline in Albumin and Total Protein | Total protein; Week 2; n= 38,39,38,39,33,32 | -2.0 Gram per Liter (G/L) | Standard Deviation 3.34 |
| GSK2894512 0.5% QD | Change From Baseline in Albumin and Total Protein | Albumin; Week 2; n=38,39,38,39,33,32 | -1.4 Gram per Liter (G/L) | Standard Deviation 2.02 |
| GSK2894512 0.5% QD | Change From Baseline in Albumin and Total Protein | Total protein; Week 12; n= 36,37,32,35,28,28 | -2.4 Gram per Liter (G/L) | Standard Deviation 4.07 |
| GSK2894512 0.5% QD | Change From Baseline in Albumin and Total Protein | Albumin; Week 4; n=38,39,38,38,30,32 | -1.3 Gram per Liter (G/L) | Standard Deviation 2.74 |
| Vehicle BID | Change From Baseline in Albumin and Total Protein | Total protein; Week 12; n= 36,37,32,35,28,28 | -2.2 Gram per Liter (G/L) | Standard Deviation 5.38 |
| Vehicle BID | Change From Baseline in Albumin and Total Protein | Total protein; Week 8; n= 35,37,34,38,29,28 | -1.7 Gram per Liter (G/L) | Standard Deviation 4.09 |
| Vehicle BID | Change From Baseline in Albumin and Total Protein | Albumin; Week 12; n= 36,37,32,35,28,28 | -1.6 Gram per Liter (G/L) | Standard Deviation 2.79 |
| Vehicle BID | Change From Baseline in Albumin and Total Protein | Total protein; EW; n= 3,3,7,3,11,11 | -1.4 Gram per Liter (G/L) | Standard Deviation 3.64 |
| Vehicle BID | Change From Baseline in Albumin and Total Protein | Albumin; Week 2; n=38,39,38,39,33,32 | -1.2 Gram per Liter (G/L) | Standard Deviation 3.91 |
| Vehicle BID | Change From Baseline in Albumin and Total Protein | Albumin; Week 4; n=38,39,38,38,30,32 | -1.2 Gram per Liter (G/L) | Standard Deviation 2.46 |
| Vehicle BID | Change From Baseline in Albumin and Total Protein | Albumin; Week 8; n= 35,37,34,38,29,28 | -1.4 Gram per Liter (G/L) | Standard Deviation 2.54 |
| Vehicle BID | Change From Baseline in Albumin and Total Protein | Total protein; Week 14; n= 33,35,32,34,31,29 | -2.3 Gram per Liter (G/L) | Standard Deviation 4.26 |
| Vehicle BID | Change From Baseline in Albumin and Total Protein | Albumin; Week 14; n= 33,35,32,34,31,29 | -2.0 Gram per Liter (G/L) | Standard Deviation 2.7 |
| Vehicle BID | Change From Baseline in Albumin and Total Protein | Albumin; EW;n = 3,3,7,3,11,11 | -0.7 Gram per Liter (G/L) | Standard Deviation 2.87 |
| Vehicle BID | Change From Baseline in Albumin and Total Protein | Total protein; Week 2; n= 38,39,38,39,33,32 | -1.9 Gram per Liter (G/L) | Standard Deviation 6.66 |
| Vehicle BID | Change From Baseline in Albumin and Total Protein | Total protein; Week 4; n= 38,39,38,38,30,32 | -2.3 Gram per Liter (G/L) | Standard Deviation 3.86 |
| Vehicle QD | Change From Baseline in Albumin and Total Protein | Total protein; Week 8; n= 35,37,34,38,29,28 | -1.8 Gram per Liter (G/L) | Standard Deviation 4.82 |
| Vehicle QD | Change From Baseline in Albumin and Total Protein | Albumin; Week 8; n= 35,37,34,38,29,28 | -1.4 Gram per Liter (G/L) | Standard Deviation 3.14 |
| Vehicle QD | Change From Baseline in Albumin and Total Protein | Albumin; Week 12; n= 36,37,32,35,28,28 | -0.9 Gram per Liter (G/L) | Standard Deviation 2.09 |
| Vehicle QD | Change From Baseline in Albumin and Total Protein | Albumin; EW;n = 3,3,7,3,11,11 | -2.5 Gram per Liter (G/L) | Standard Deviation 2.84 |
| Vehicle QD | Change From Baseline in Albumin and Total Protein | Total protein; EW; n= 3,3,7,3,11,11 | -3.0 Gram per Liter (G/L) | Standard Deviation 5.08 |
| Vehicle QD | Change From Baseline in Albumin and Total Protein | Total protein; Week 2; n= 38,39,38,39,33,32 | -1.6 Gram per Liter (G/L) | Standard Deviation 3.31 |
| Vehicle QD | Change From Baseline in Albumin and Total Protein | Albumin; Week 2; n=38,39,38,39,33,32 | -1.2 Gram per Liter (G/L) | Standard Deviation 2.17 |
| Vehicle QD | Change From Baseline in Albumin and Total Protein | Total protein; Week 4; n= 38,39,38,38,30,32 | -1.1 Gram per Liter (G/L) | Standard Deviation 4.62 |
| Vehicle QD | Change From Baseline in Albumin and Total Protein | Total protein; Week 12; n= 36,37,32,35,28,28 | -1.0 Gram per Liter (G/L) | Standard Deviation 3.18 |
| Vehicle QD | Change From Baseline in Albumin and Total Protein | Albumin; Week 4; n=38,39,38,38,30,32 | -0.7 Gram per Liter (G/L) | Standard Deviation 2.74 |
| Vehicle QD | Change From Baseline in Albumin and Total Protein | Albumin; Week 14; n= 33,35,32,34,31,29 | -0.9 Gram per Liter (G/L) | Standard Deviation 2.21 |
| Vehicle QD | Change From Baseline in Albumin and Total Protein | Total protein; Week 14; n= 33,35,32,34,31,29 | -1.3 Gram per Liter (G/L) | Standard Deviation 3.84 |
Secondary
Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT)
Blood samples were collected to evaluate change from Baseline in Alk.phosph., ALT, AST and GGT values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.
Time frame: Week 2, 4, 8, 12, 14, EW (up to week 14)
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 12; n= 36,37,32,35,28,28 | -1.8 International unit per liter (IU/L) | Standard Deviation 14.77 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 12; n= 36,37,32,35,28,28 | -0.3 International unit per liter (IU/L) | Standard Deviation 12.51 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 8; n= 35,37,34,38,29,28 | -2.0 International unit per liter (IU/L) | Standard Deviation 14.19 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 12; n=36,37,32,35,28,28 | 0.1 International unit per liter (IU/L) | Standard Deviation 8.54 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 2; n= 38,39,38,39,33,32 | 3.6 International unit per liter (IU/L) | Standard Deviation 21.02 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; Week 4; n= 38,39,38,38,30,32 | 2.1 International unit per liter (IU/L) | Standard Deviation 15.59 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; Week 12; n= 36,37,32,35,28,28 | 3.1 International unit per liter (IU/L) | Standard Deviation 15.36 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 4; n=38,39,38,38,30,32 | -0.4 International unit per liter (IU/L) | Standard Deviation 5.24 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk. Phosph.; Week 14; n= 33,35,32,34,31,29 | -1.4 International unit per liter (IU/L) | Standard Deviation 13.46 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; EW; n= 3,3,7,3,11,11 | 13.0 International unit per liter (IU/L) | Standard Deviation 37.64 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 2; n= 38,39,38,39,33,32 | 1.6 International unit per liter (IU/L) | Standard Deviation 9.36 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; EW; n= 3,3,7,3,11,11 | 5.7 International unit per liter (IU/L) | Standard Deviation 31.01 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; Week 2; n= 38,39,38,39,33,32 | 3.7 International unit per liter (IU/L) | Standard Deviation 14.58 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 8; n= 35,37,34,38,29,28 | 18.4 International unit per liter (IU/L) | Standard Deviation 97.92 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; Week 8; n= 35,37,34,38,29,28 | 2.0 International unit per liter (IU/L) | Standard Deviation 12.4 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 2; n= 38,39,38,39,33,32 | -0.3 International unit per liter (IU/L) | Standard Deviation 6.36 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 14; n= 33,35,32,34,31,29 | 3.3 International unit per liter (IU/L) | Standard Deviation 24.1 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 14; n= 33,35,32,34,31,29 | -2.2 International unit per liter (IU/L) | Standard Deviation 15.76 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 8; n= 35,37,34,38,29,28 | 4.9 International unit per liter (IU/L) | Standard Deviation 30.93 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; EW; n= 3,3,7,3,11,11 | 4.7 International unit per liter (IU/L) | Standard Deviation 8.62 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 4; n= 38,39,38,38,30,32 | -0.8 International unit per liter (IU/L) | Standard Deviation 9.2 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 4; n= 38,39,38,38,30,32 | -2.1 International unit per liter (IU/L) | Standard Deviation 9.47 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 14; n= 33,35,32,34,31,29 | 4.4 International unit per liter (IU/L) | Standard Deviation 28.19 |
| GSK2894512 1% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; EW; n= 3,3,7,3,11,11 | -2.3 International unit per liter (IU/L) | Standard Deviation 27.74 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; EW; n= 3,3,7,3,11,11 | 5.3 International unit per liter (IU/L) | Standard Deviation 12.5 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk. Phosph.; Week 14; n= 33,35,32,34,31,29 | -3.0 International unit per liter (IU/L) | Standard Deviation 17.56 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 14; n= 33,35,32,34,31,29 | -1.0 International unit per liter (IU/L) | Standard Deviation 3.43 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 4; n= 38,39,38,38,30,32 | -0.8 International unit per liter (IU/L) | Standard Deviation 4.01 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; EW; n= 3,3,7,3,11,11 | -8.0 International unit per liter (IU/L) | Standard Deviation 16.52 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; Week 12; n= 36,37,32,35,28,28 | -0.4 International unit per liter (IU/L) | Standard Deviation 10.14 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 12; n= 36,37,32,35,28,28 | -1.6 International unit per liter (IU/L) | Standard Deviation 4.05 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 8; n= 35,37,34,38,29,28 | -1.2 International unit per liter (IU/L) | Standard Deviation 4.8 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 2; n= 38,39,38,39,33,32 | -1.8 International unit per liter (IU/L) | Standard Deviation 3.92 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 2; n= 38,39,38,39,33,32 | -1.3 International unit per liter (IU/L) | Standard Deviation 4.61 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; Week 4; n= 38,39,38,38,30,32 | -0.4 International unit per liter (IU/L) | Standard Deviation 12.17 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; EW; n= 3,3,7,3,11,11 | 1.7 International unit per liter (IU/L) | Standard Deviation 14.57 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; Week 2; n= 38,39,38,39,33,32 | -1.7 International unit per liter (IU/L) | Standard Deviation 12.24 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 12; n=36,37,32,35,28,28 | -1.2 International unit per liter (IU/L) | Standard Deviation 4.67 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 12; n= 36,37,32,35,28,28 | -3.1 International unit per liter (IU/L) | Standard Deviation 4.78 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 8; n= 35,37,34,38,29,28 | -0.9 International unit per liter (IU/L) | Standard Deviation 5.06 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 4; n=38,39,38,38,30,32 | -1.1 International unit per liter (IU/L) | Standard Deviation 4.18 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 2; n= 38,39,38,39,33,32 | -1.3 International unit per liter (IU/L) | Standard Deviation 2.98 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; EW; n= 3,3,7,3,11,11 | -3.7 International unit per liter (IU/L) | Standard Deviation 16.62 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 14; n= 33,35,32,34,31,29 | -3.2 International unit per liter (IU/L) | Standard Deviation 5.47 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 8; n= 35,37,34,38,29,28 | -1.4 International unit per liter (IU/L) | Standard Deviation 7 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 4; n= 38,39,38,38,30,32 | -1.1 International unit per liter (IU/L) | Standard Deviation 5.23 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 14; n= 33,35,32,34,31,29 | -2.2 International unit per liter (IU/L) | Standard Deviation 4.89 |
| GSK2894512 1% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; Week 8; n= 35,37,34,38,29,28 | -0.7 International unit per liter (IU/L) | Standard Deviation 9.39 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 4; n=38,39,38,38,30,32 | 1.0 International unit per liter (IU/L) | Standard Deviation 6.37 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; Week 4; n= 38,39,38,38,30,32 | 1.7 International unit per liter (IU/L) | Standard Deviation 15.22 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 4; n= 38,39,38,38,30,32 | 2.7 International unit per liter (IU/L) | Standard Deviation 8.07 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 8; n= 35,37,34,38,29,28 | 1.2 International unit per liter (IU/L) | Standard Deviation 6.77 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 14; n= 33,35,32,34,31,29 | -0.9 International unit per liter (IU/L) | Standard Deviation 4.51 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 8; n= 35,37,34,38,29,28 | 0.2 International unit per liter (IU/L) | Standard Deviation 4.8 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; EW; n= 3,3,7,3,11,11 | 4.0 International unit per liter (IU/L) | Standard Deviation 12.83 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 4; n= 38,39,38,38,30,32 | 1.3 International unit per liter (IU/L) | Standard Deviation 6.38 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 14; n= 33,35,32,34,31,29 | 0.7 International unit per liter (IU/L) | Standard Deviation 4.93 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; Week 12; n= 36,37,32,35,28,28 | -5.1 International unit per liter (IU/L) | Standard Deviation 18.47 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk. Phosph.; Week 14; n= 33,35,32,34,31,29 | -7.2 International unit per liter (IU/L) | Standard Deviation 19.31 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; EW; n= 3,3,7,3,11,11 | 8.0 International unit per liter (IU/L) | Standard Deviation 18.13 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 2; n= 38,39,38,39,33,32 | 7.7 International unit per liter (IU/L) | Standard Deviation 28.01 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 12; n= 36,37,32,35,28,28 | -1.4 International unit per liter (IU/L) | Standard Deviation 4.13 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; EW; n= 3,3,7,3,11,11 | 11.3 International unit per liter (IU/L) | Standard Deviation 36.6 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 2; n= 38,39,38,39,33,32 | 3.1 International unit per liter (IU/L) | Standard Deviation 13.84 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 12; n=36,37,32,35,28,28 | -1.3 International unit per liter (IU/L) | Standard Deviation 5.12 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 14; n= 33,35,32,34,31,29 | -1.3 International unit per liter (IU/L) | Standard Deviation 3.92 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 2; n= 38,39,38,39,33,32 | 4.0 International unit per liter (IU/L) | Standard Deviation 13.82 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 8; n= 35,37,34,38,29,28 | 1.6 International unit per liter (IU/L) | Standard Deviation 10.32 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 12; n= 36,37,32,35,28,28 | 0.8 International unit per liter (IU/L) | Standard Deviation 8.38 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; EW; n= 3,3,7,3,11,11 | 3.7 International unit per liter (IU/L) | Standard Deviation 9.48 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; Week 2; n= 38,39,38,39,33,32 | 3.7 International unit per liter (IU/L) | Standard Deviation 21.04 |
| GSK2894512 0.5% BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; Week 8; n= 35,37,34,38,29,28 | -1.2 International unit per liter (IU/L) | Standard Deviation 12.85 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; Week 4; n= 38,39,38,38,30,32 | -2.7 International unit per liter (IU/L) | Standard Deviation 12.36 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; Week 2; n= 38,39,38,39,33,32 | -2.3 International unit per liter (IU/L) | Standard Deviation 13.49 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 2; n= 38,39,38,39,33,32 | 0.2 International unit per liter (IU/L) | Standard Deviation 4.99 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; EW; n= 3,3,7,3,11,11 | 3.0 International unit per liter (IU/L) | Standard Deviation 1.73 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 14; n= 33,35,32,34,31,29 | -1.0 International unit per liter (IU/L) | Standard Deviation 3.93 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 4; n=38,39,38,38,30,32 | 1.1 International unit per liter (IU/L) | Standard Deviation 6.81 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 12; n=36,37,32,35,28,28 | -0.7 International unit per liter (IU/L) | Standard Deviation 4.9 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 2; n= 38,39,38,39,33,32 | 0.7 International unit per liter (IU/L) | Standard Deviation 3.49 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 4; n= 38,39,38,38,30,32 | 1.7 International unit per liter (IU/L) | Standard Deviation 9.28 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 12; n= 36,37,32,35,28,28 | -0.6 International unit per liter (IU/L) | Standard Deviation 4.64 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 14; n= 33,35,32,34,31,29 | -1.1 International unit per liter (IU/L) | Standard Deviation 3.48 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 12; n= 36,37,32,35,28,28 | 1.1 International unit per liter (IU/L) | Standard Deviation 4.52 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 8; n= 35,37,34,38,29,28 | -1.5 International unit per liter (IU/L) | Standard Deviation 3.98 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; Week 8; n= 35,37,34,38,29,28 | -4.8 International unit per liter (IU/L) | Standard Deviation 18.15 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; EW; n= 3,3,7,3,11,11 | -0.7 International unit per liter (IU/L) | Standard Deviation 7.23 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; EW; n= 3,3,7,3,11,11 | 0.3 International unit per liter (IU/L) | Standard Deviation 9.87 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; Week 12; n= 36,37,32,35,28,28 | -6.3 International unit per liter (IU/L) | Standard Deviation 17.29 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 8; n= 35,37,34,38,29,28 | -1.1 International unit per liter (IU/L) | Standard Deviation 4.56 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 4; n= 38,39,38,38,30,32 | 0.9 International unit per liter (IU/L) | Standard Deviation 4.87 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 2; n= 38,39,38,39,33,32 | 1.5 International unit per liter (IU/L) | Standard Deviation 12.52 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; EW; n= 3,3,7,3,11,11 | 2.0 International unit per liter (IU/L) | Standard Deviation 6.56 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk. Phosph.; Week 14; n= 33,35,32,34,31,29 | -7.2 International unit per liter (IU/L) | Standard Deviation 20.07 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 8; n= 35,37,34,38,29,28 | -0.5 International unit per liter (IU/L) | Standard Deviation 6.96 |
| GSK2894512 0.5% QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 14; n= 33,35,32,34,31,29 | 1.0 International unit per liter (IU/L) | Standard Deviation 3.63 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 8; n= 35,37,34,38,29,28 | -0.2 International unit per liter (IU/L) | Standard Deviation 11.68 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; EW; n= 3,3,7,3,11,11 | -0.8 International unit per liter (IU/L) | Standard Deviation 2.14 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 2; n= 38,39,38,39,33,32 | 0.2 International unit per liter (IU/L) | Standard Deviation 7.21 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 12; n=36,37,32,35,28,28 | 0.9 International unit per liter (IU/L) | Standard Deviation 6.88 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 8; n= 35,37,34,38,29,28 | -2.0 International unit per liter (IU/L) | Standard Deviation 6.06 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 12; n= 36,37,32,35,28,28 | 0.8 International unit per liter (IU/L) | Standard Deviation 7.97 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 8; n= 35,37,34,38,29,28 | -1.9 International unit per liter (IU/L) | Standard Deviation 6.05 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; Week 8; n= 35,37,34,38,29,28 | -1.6 International unit per liter (IU/L) | Standard Deviation 19.08 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; EW; n= 3,3,7,3,11,11 | -1.7 International unit per liter (IU/L) | Standard Deviation 4.73 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 2; n= 38,39,38,39,33,32 | -0.8 International unit per liter (IU/L) | Standard Deviation 4.99 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 14; n= 33,35,32,34,31,29 | -0.5 International unit per liter (IU/L) | Standard Deviation 5.58 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 4; n=38,39,38,38,30,32 | 0.0 International unit per liter (IU/L) | Standard Deviation 5.68 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; Week 2; n= 38,39,38,39,33,32 | -2.3 International unit per liter (IU/L) | Standard Deviation 15.32 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 14; n= 33,35,32,34,31,29 | 0.5 International unit per liter (IU/L) | Standard Deviation 8.12 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 4; n= 38,39,38,38,30,32 | 0.3 International unit per liter (IU/L) | Standard Deviation 7.63 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 4; n= 38,39,38,38,30,32 | 0.1 International unit per liter (IU/L) | Standard Deviation 10.95 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; EW; n= 3,3,7,3,11,11 | 0.9 International unit per liter (IU/L) | Standard Deviation 6.74 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; Week 12; n= 36,37,32,35,28,28 | -8.1 International unit per liter (IU/L) | Standard Deviation 21.6 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; Week 4; n= 38,39,38,38,30,32 | -3.8 International unit per liter (IU/L) | Standard Deviation 16.24 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 12; n= 36,37,32,35,28,28 | 1.7 International unit per liter (IU/L) | Standard Deviation 11.65 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 14; n= 33,35,32,34,31,29 | 0.1 International unit per liter (IU/L) | Standard Deviation 8.19 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; EW; n= 3,3,7,3,11,11 | -1.9 International unit per liter (IU/L) | Standard Deviation 8.19 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk. Phosph.; Week 14; n= 33,35,32,34,31,29 | -6.5 International unit per liter (IU/L) | Standard Deviation 24.86 |
| Vehicle BID | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 2; n= 38,39,38,39,33,32 | -0.9 International unit per liter (IU/L) | Standard Deviation 8.04 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 4; n= 38,39,38,38,30,32 | -1.0 International unit per liter (IU/L) | Standard Deviation 4.79 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; EW; n= 3,3,7,3,11,11 | -0.5 International unit per liter (IU/L) | Standard Deviation 7.39 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 14; n= 33,35,32,34,31,29 | -0.3 International unit per liter (IU/L) | Standard Deviation 3.07 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 14; n= 33,35,32,34,31,29 | -0.8 International unit per liter (IU/L) | Standard Deviation 3.15 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; EW; n= 3,3,7,3,11,11 | 3.3 International unit per liter (IU/L) | Standard Deviation 7.7 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; Week 12; n= 36,37,32,35,28,28 | -7.8 International unit per liter (IU/L) | Standard Deviation 15.34 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk. Phosph.; Week 14; n= 33,35,32,34,31,29 | -8.3 International unit per liter (IU/L) | Standard Deviation 14.83 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; EW; n= 3,3,7,3,11,11 | -4.8 International unit per liter (IU/L) | Standard Deviation 17.11 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 8; n= 35,37,34,38,29,28 | 0.4 International unit per liter (IU/L) | Standard Deviation 5.73 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 2; n= 38,39,38,39,33,32 | 0.5 International unit per liter (IU/L) | Standard Deviation 3.54 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; EW; n= 3,3,7,3,11,11 | 3.1 International unit per liter (IU/L) | Standard Deviation 6.3 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 12; n= 36,37,32,35,28,28 | 1.9 International unit per liter (IU/L) | Standard Deviation 7.12 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | GGT; Week 2; n= 38,39,38,39,33,32 | -2.9 International unit per liter (IU/L) | Standard Deviation 9.86 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; Week 4; n= 38,39,38,38,30,32 | -3.9 International unit per liter (IU/L) | Standard Deviation 9.79 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 8; n= 35,37,34,38,29,28 | 0.3 International unit per liter (IU/L) | Standard Deviation 5.16 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 8; n= 35,37,34,38,29,28 | -0.1 International unit per liter (IU/L) | Standard Deviation 5.8 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 14; n= 33,35,32,34,31,29 | 0.0 International unit per liter (IU/L) | Standard Deviation 4.49 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 4; n= 38,39,38,38,30,32 | 0.6 International unit per liter (IU/L) | Standard Deviation 4.55 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 12; n=36,37,32,35,28,28 | 0.2 International unit per liter (IU/L) | Standard Deviation 5.2 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 12; n= 36,37,32,35,28,28 | -0.2 International unit per liter (IU/L) | Standard Deviation 5.58 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | ALT; Week 2; n= 38,39,38,39,33,32 | 0.2 International unit per liter (IU/L) | Standard Deviation 6.06 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; Week 2; n= 38,39,38,39,33,32 | -2.0 International unit per liter (IU/L) | Standard Deviation 8.7 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | AST; Week 4; n=38,39,38,38,30,32 | 0.5 International unit per liter (IU/L) | Standard Deviation 4.17 |
| Vehicle QD | Change From Baseline in Alkaline Phosphatase (Alk.Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) | Alk.Phosph.; Week 8; n= 35,37,34,38,29,28 | -5.7 International unit per liter (IU/L) | Standard Deviation 12.03 |
Secondary
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count
Blood samples were collected to evaluate change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet and leukocytes and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.
Time frame: Week 2, 4, 8, 12, 14, EW (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, Platelet, Leukocytes Count | Leukocytes; EW; n= 3,3,7,3,10,10 | -0.73 Giga cells per liter (GI/L) | Standard Deviation 0.666 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 4; n= 38,38,38,37,30,31 | 0.46 Giga cells per liter (GI/L) | Standard Deviation 1.913 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 4; n=38,38,38,37,30,31 | -12.4 Giga cells per liter (GI/L) | Standard Deviation 36.57 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 8; n= 34,36,34,37,29,27 | 0.100 Giga cells per liter (GI/L) | Standard Deviation 0.3953 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 4; n= 38,38,38,37,30,31 | -0.004 Giga cells per liter (GI/L) | Standard Deviation 0.1769 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 2; n=37,38,38,37,33,31 | 0.45 Giga cells per liter (GI/L) | Standard Deviation 1.749 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 14; n= 33,33,32,32,31,27 | -0.078 Giga cells per liter (GI/L) | Standard Deviation 0.3178 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 2; n=37,38,38,37,33,31 | -15.4 Giga cells per liter (GI/L) | Standard Deviation 44.06 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; EW; n= 3,3,7,3,10,10 | -0.317 Giga cells per liter (GI/L) | Standard Deviation 0.5315 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 12; n= 36,36,32,34,28,27 | 0.045 Giga cells per liter (GI/L) | Standard Deviation 0.4806 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 4; n=38,38,38,37,30,31 | -0.075 Giga cells per liter (GI/L) | Standard Deviation 0.3146 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 14; n=33,33,32,32,31,27 | 0.02 Giga cells per liter (GI/L) | Standard Deviation 1.234 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; EW; n=3,3,7,3,10,10 | -0.420 Giga cells per liter (GI/L) | Standard Deviation 0.9924 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 14; n= 33,33,32,32,31,27 | 0.030 Giga cells per liter (GI/L) | Standard Deviation 0.4869 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; EW; n=3,3,7,3,10,10 | -85.0 Giga cells per liter (GI/L) | Standard Deviation 11 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 14; n=33,33,32,32,31,27 | 0.090 Giga cells per liter (GI/L) | Standard Deviation 1.2037 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 8; n= 34,36,34,37,29,27 | -0.004 Giga cells per liter (GI/L) | Standard Deviation 0.0224 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; EW; n=3,3,7,3,10,10 | 0.113 Giga cells per liter (GI/L) | Standard Deviation 0.1501 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 12; n= 36,36,32,34,28,27 | 0.127 Giga cells per liter (GI/L) | Standard Deviation 1.3363 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 2; n= 37,38,38,37,33,31 | -0.006 Giga cells per liter (GI/L) | Standard Deviation 0.0177 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 8; n= 34,36,34,37,29,27 | 0.009 Giga cells per liter (GI/L) | Standard Deviation 1.4215 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 14; n=33,33,32,32,31,27 | 3.5 Giga cells per liter (GI/L) | Standard Deviation 40.84 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 12; n= 36,36,32,34,28,27 | 0.001 Giga cells per liter (GI/L) | Standard Deviation 0.0166 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 12; n=36,36,32,34,28,27 | -0.061 Giga cells per liter (GI/L) | Standard Deviation 0.1653 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 12; n=36,36,32,34,28,27 | 0.03 Giga cells per liter (GI/L) | Standard Deviation 1.488 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 4; n=38,38,38,37,30,31 | 0.487 Giga cells per liter (GI/L) | Standard Deviation 2.0425 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 14; n= 33,33,32,32,31,27 | -0.001 Giga cells per liter (GI/L) | Standard Deviation 0.016 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 2; n= 37,38,38,37,33,31 | 0.035 Giga cells per liter (GI/L) | Standard Deviation 0.4672 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 8; n=34,36,34,37,29,27 | -0.052 Giga cells per liter (GI/L) | Standard Deviation 0.3486 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 8; n=34,36,34,37,29,27 | 0.03 Giga cells per liter (GI/L) | Standard Deviation 1.466 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 2; n=37,38,38,37,33,31 | 0.480 Giga cells per liter (GI/L) | Standard Deviation 1.7953 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 8; n= 34,36,34,37,29,27 | -0.071 Giga cells per liter (GI/L) | Standard Deviation 0.1443 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; EW; n= 3,3,7,3,10,10 | -0.000 Giga cells per liter (GI/L) | Standard Deviation 0.0173 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 12; n=36,36,32,34,28,27 | -7.5 Giga cells per liter (GI/L) | Standard Deviation 37.94 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 12; n= 36,36,32,34,28,27 | -0.083 Giga cells per liter (GI/L) | Standard Deviation 0.3212 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; EW; n=3,3,7,3,10,10 | -0.127 Giga cells per liter (GI/L) | Standard Deviation 0.0924 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 8; n= 34,36,34,37,29,27 | -6.2 Giga cells per liter (GI/L) | Standard Deviation 34.81 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 14; n=33,33,32,32,31,27 | -0.026 Giga cells per liter (GI/L) | Standard Deviation 0.1532 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 4; n= 38,38,38,37,30,31 | 0.054 Giga cells per liter (GI/L) | Standard Deviation 0.5264 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 4; n= 38,38,38,37,30,31 | -0.002 Giga cells per liter (GI/L) | Standard Deviation 0.0195 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 2; n=37,38,38,37,33,31 | -0.028 Giga cells per liter (GI/L) | Standard Deviation 0.1465 |
| GSK2894512 1% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 2; n=37,38,38,37,33,31 | -0.035 Giga cells per liter (GI/L) | Standard Deviation 0.2153 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; EW; n=3,3,7,3,10,10 | 0.007 Giga cells per liter (GI/L) | Standard Deviation 0.085 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 8; n=34,36,34,37,29,27 | -0.12 Giga cells per liter (GI/L) | Standard Deviation 1.257 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 4; n=38,38,38,37,30,31 | -0.049 Giga cells per liter (GI/L) | Standard Deviation 0.2401 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 2; n=37,38,38,37,33,31 | -0.025 Giga cells per liter (GI/L) | Standard Deviation 0.1271 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; EW; n= 3,3,7,3,10,10 | 0.040 Giga cells per liter (GI/L) | Standard Deviation 0.0954 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 14; n= 33,33,32,32,31,27 | 0.146 Giga cells per liter (GI/L) | Standard Deviation 0.5891 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 8; n= 34,36,34,37,29,27 | -0.041 Giga cells per liter (GI/L) | Standard Deviation 0.1224 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; EW; n=3,3,7,3,10,10 | 0.117 Giga cells per liter (GI/L) | Standard Deviation 0.168 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 4; n= 38,38,38,37,30,31 | 0.40 Giga cells per liter (GI/L) | Standard Deviation 1.232 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 12; n= 36,36,32,34,28,27 | -0.026 Giga cells per liter (GI/L) | Standard Deviation 0.1811 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 2; n=37,38,38,37,33,31 | 0.21 Giga cells per liter (GI/L) | Standard Deviation 1.085 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 14; n= 33,33,32,32,31,27 | -0.043 Giga cells per liter (GI/L) | Standard Deviation 0.2237 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 4; n= 38,38,38,37,30,31 | 0.000 Giga cells per liter (GI/L) | Standard Deviation 0.0201 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; EW; n=3,3,7,3,10,10 | 12.7 Giga cells per liter (GI/L) | Standard Deviation 56.01 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 14; n=33,33,32,32,31,27 | -9.0 Giga cells per liter (GI/L) | Standard Deviation 38.2 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 12; n=36,36,32,34,28,27 | -5.4 Giga cells per liter (GI/L) | Standard Deviation 30.15 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 2; n= 37,38,38,37,33,31 | 0.076 Giga cells per liter (GI/L) | Standard Deviation 0.5239 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 14; n=33,33,32,32,31,27 | 0.30 Giga cells per liter (GI/L) | Standard Deviation 1.2 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 8; n= 34,36,34,37,29,27 | -9.1 Giga cells per liter (GI/L) | Standard Deviation 51.69 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 4; n= 38,38,38,37,30,31 | 0.217 Giga cells per liter (GI/L) | Standard Deviation 0.5292 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 8; n= 34,36,34,37,29,27 | -0.001 Giga cells per liter (GI/L) | Standard Deviation 0.0214 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 4; n=38,38,38,37,30,31 | -19.7 Giga cells per liter (GI/L) | Standard Deviation 36.44 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 8; n= 34,36,34,37,29,27 | 0.165 Giga cells per liter (GI/L) | Standard Deviation 0.6213 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 2; n= 37,38,38,37,33,31 | -0.001 Giga cells per liter (GI/L) | Standard Deviation 0.0205 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 2; n=37,38,38,37,33,31 | -18.7 Giga cells per liter (GI/L) | Standard Deviation 36.48 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; EW; n=3,3,7,3,10,10 | 0.047 Giga cells per liter (GI/L) | Standard Deviation 0.7478 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 12; n= 36,36,32,34,28,27 | 0.232 Giga cells per liter (GI/L) | Standard Deviation 0.6258 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 14; n=33,33,32,32,31,27 | 0.164 Giga cells per liter (GI/L) | Standard Deviation 1.2465 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 12; n=36,36,32,34,28,27 | 0.18 Giga cells per liter (GI/L) | Standard Deviation 1.249 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 12; n= 36,36,32,34,28,27 | -0.009 Giga cells per liter (GI/L) | Standard Deviation 1.1315 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 4; n= 38,38,38,37,30,31 | -0.023 Giga cells per liter (GI/L) | Standard Deviation 0.123 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 8; n= 34,36,34,37,29,27 | -0.203 Giga cells per liter (GI/L) | Standard Deviation 1.0365 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 4; n=38,38,38,37,30,31 | 0.253 Giga cells per liter (GI/L) | Standard Deviation 1.1437 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 12; n= 36,36,32,34,28,27 | 0.002 Giga cells per liter (GI/L) | Standard Deviation 0.0191 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 14; n= 33,33,32,32,31,27 | -0.000 Giga cells per liter (GI/L) | Standard Deviation 0.019 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 2; n=37,38,38,37,33,31 | 0.152 Giga cells per liter (GI/L) | Standard Deviation 1.0058 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 2; n=37,38,38,37,33,31 | 0.012 Giga cells per liter (GI/L) | Standard Deviation 0.1629 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; EW; n= 3,3,7,3,10,10 | 0.020 Giga cells per liter (GI/L) | Standard Deviation 0.01 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 8; n=34,36,34,37,29,27 | -0.040 Giga cells per liter (GI/L) | Standard Deviation 0.1398 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 14; n=33,33,32,32,31,27 | 0.027 Giga cells per liter (GI/L) | Standard Deviation 0.1427 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 12; n=36,36,32,34,28,27 | -0.022 Giga cells per liter (GI/L) | Standard Deviation 0.1219 |
| GSK2894512 1% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; EW; n= 3,3,7,3,10,10 | 0.23 Giga cells per liter (GI/L) | Standard Deviation 1.115 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; EW; n=3,3,7,3,10,10 | -0.220 Giga cells per liter (GI/L) | Standard Deviation 0.3114 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 2; n= 37,38,38,37,33,31 | -0.000 Giga cells per liter (GI/L) | Standard Deviation 0.0201 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 8; n= 34,36,34,37,29,27 | 0.000 Giga cells per liter (GI/L) | Standard Deviation 0.0165 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 8; n=34,36,34,37,29,27 | -0.107 Giga cells per liter (GI/L) | Standard Deviation 0.3276 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 12; n= 36,36,32,34,28,27 | -0.120 Giga cells per liter (GI/L) | Standard Deviation 0.3025 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 14; n= 33,33,32,32,31,27 | -0.104 Giga cells per liter (GI/L) | Standard Deviation 0.2377 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 2; n= 37,38,38,37,33,31 | 0.123 Giga cells per liter (GI/L) | Standard Deviation 0.5263 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 4; n= 38,38,38,37,30,31 | 0.083 Giga cells per liter (GI/L) | Standard Deviation 0.5894 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 8; n= 34,36,34,37,29,27 | 0.012 Giga cells per liter (GI/L) | Standard Deviation 0.4463 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 12; n= 36,36,32,34,28,27 | 0.061 Giga cells per liter (GI/L) | Standard Deviation 0.5758 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 14; n= 33,33,32,32,31,27 | -0.093 Giga cells per liter (GI/L) | Standard Deviation 0.6048 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 12; n= 36,36,32,34,28,27 | 0.005 Giga cells per liter (GI/L) | Standard Deviation 0.0244 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 14; n= 33,33,32,32,31,27 | 0.003 Giga cells per liter (GI/L) | Standard Deviation 0.0202 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; EW; n= 3,3,7,3,10,10 | 0.007 Giga cells per liter (GI/L) | Standard Deviation 0.018 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 4; n= 38,38,38,37,30,31 | 0.005 Giga cells per liter (GI/L) | Standard Deviation 0.0241 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 2; n=37,38,38,37,33,31 | -0.092 Giga cells per liter (GI/L) | Standard Deviation 0.2733 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 4; n=38,38,38,37,30,31 | -0.119 Giga cells per liter (GI/L) | Standard Deviation 0.3926 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 8; n= 34,36,34,37,29,27 | -0.032 Giga cells per liter (GI/L) | Standard Deviation 0.1355 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; EW; n= 3,3,7,3,10,10 | -0.136 Giga cells per liter (GI/L) | Standard Deviation 0.4644 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 2; n=37,38,38,37,33,31 | 0.013 Giga cells per liter (GI/L) | Standard Deviation 0.1659 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 4; n= 38,38,38,37,30,31 | -0.059 Giga cells per liter (GI/L) | Standard Deviation 0.1648 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 12; n=36,36,32,34,28,27 | -0.042 Giga cells per liter (GI/L) | Standard Deviation 0.1539 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 14; n=33,33,32,32,31,27 | -0.016 Giga cells per liter (GI/L) | Standard Deviation 0.1446 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; EW; n=3,3,7,3,10,10 | 0.030 Giga cells per liter (GI/L) | Standard Deviation 0.1133 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 2; n=37,38,38,37,33,31 | 0.067 Giga cells per liter (GI/L) | Standard Deviation 1.7035 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 4; n=38,38,38,37,30,31 | -0.058 Giga cells per liter (GI/L) | Standard Deviation 1.7028 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 8; n= 34,36,34,37,29,27 | -0.083 Giga cells per liter (GI/L) | Standard Deviation 1.4454 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 12; n= 36,36,32,34,28,27 | 0.049 Giga cells per liter (GI/L) | Standard Deviation 1.4294 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 14; n=33,33,32,32,31,27 | -0.368 Giga cells per liter (GI/L) | Standard Deviation 1.0224 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; EW; n=3,3,7,3,10,10 | 0.797 Giga cells per liter (GI/L) | Standard Deviation 2.1506 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 2; n=37,38,38,37,33,31 | -25.9 Giga cells per liter (GI/L) | Standard Deviation 43.03 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 4; n=38,38,38,37,30,31 | -25.2 Giga cells per liter (GI/L) | Standard Deviation 35.75 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 8; n= 34,36,34,37,29,27 | -22.1 Giga cells per liter (GI/L) | Standard Deviation 37.57 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 12; n=36,36,32,34,28,27 | -23.6 Giga cells per liter (GI/L) | Standard Deviation 38.11 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 14; n=33,33,32,32,31,27 | -19.9 Giga cells per liter (GI/L) | Standard Deviation 44.95 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; EW; n=3,3,7,3,10,10 | -19.7 Giga cells per liter (GI/L) | Standard Deviation 25.77 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 2; n=37,38,38,37,33,31 | 0.10 Giga cells per liter (GI/L) | Standard Deviation 1.668 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 4; n= 38,38,38,37,30,31 | -0.15 Giga cells per liter (GI/L) | Standard Deviation 1.807 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 8; n=34,36,34,37,29,27 | -0.21 Giga cells per liter (GI/L) | Standard Deviation 1.567 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 12; n=36,36,32,34,28,27 | -0.05 Giga cells per liter (GI/L) | Standard Deviation 1.371 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 14; n=33,33,32,32,31,27 | -0.57 Giga cells per liter (GI/L) | Standard Deviation 1.142 |
| GSK2894512 0.5% BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; EW; n= 3,3,7,3,10,10 | 0.47 Giga cells per liter (GI/L) | Standard Deviation 2.394 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 2; n=37,38,38,37,33,31 | -0.018 Giga cells per liter (GI/L) | Standard Deviation 0.2325 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 8; n=34,36,34,37,29,27 | 0.47 Giga cells per liter (GI/L) | Standard Deviation 1.469 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 12; n=36,36,32,34,28,27 | -0.019 Giga cells per liter (GI/L) | Standard Deviation 0.1434 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 14; n=33,33,32,32,31,27 | 0.015 Giga cells per liter (GI/L) | Standard Deviation 0.1666 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; EW; n= 3,3,7,3,10,10 | 0.017 Giga cells per liter (GI/L) | Standard Deviation 0.0115 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; EW; n=3,3,7,3,10,10 | 0.040 Giga cells per liter (GI/L) | Standard Deviation 0.0608 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 14; n= 33,33,32,32,31,27 | -0.003 Giga cells per liter (GI/L) | Standard Deviation 0.0226 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 2; n=37,38,38,37,33,31 | -0.088 Giga cells per liter (GI/L) | Standard Deviation 1.468 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 12; n= 36,36,32,34,28,27 | 0.003 Giga cells per liter (GI/L) | Standard Deviation 0.0343 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 4; n=38,38,38,37,30,31 | 0.035 Giga cells per liter (GI/L) | Standard Deviation 1.3063 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; EW; n= 3,3,7,3,10,10 | 1.20 Giga cells per liter (GI/L) | Standard Deviation 1.127 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 8; n= 34,36,34,37,29,27 | 0.550 Giga cells per liter (GI/L) | Standard Deviation 1.5918 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 4; n= 38,38,38,37,30,31 | 0.006 Giga cells per liter (GI/L) | Standard Deviation 0.1151 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 12; n=36,36,32,34,28,27 | 0.23 Giga cells per liter (GI/L) | Standard Deviation 1.248 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 12; n= 36,36,32,34,28,27 | 0.237 Giga cells per liter (GI/L) | Standard Deviation 1.1459 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 14; n=33,33,32,32,31,27 | -0.058 Giga cells per liter (GI/L) | Standard Deviation 1.5202 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 12; n= 36,36,32,34,28,27 | 0.072 Giga cells per liter (GI/L) | Standard Deviation 0.4836 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; EW; n=3,3,7,3,10,10 | 0.630 Giga cells per liter (GI/L) | Standard Deviation 1.0741 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 8; n= 34,36,34,37,29,27 | -0.031 Giga cells per liter (GI/L) | Standard Deviation 0.3914 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 8; n= 34,36,34,37,29,27 | -0.007 Giga cells per liter (GI/L) | Standard Deviation 0.0161 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 2; n=37,38,38,37,33,31 | -20.2 Giga cells per liter (GI/L) | Standard Deviation 30.63 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 4; n= 38,38,38,37,30,31 | -0.000 Giga cells per liter (GI/L) | Standard Deviation 0.0191 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 4; n=38,38,38,37,30,31 | -7.7 Giga cells per liter (GI/L) | Standard Deviation 38.4 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 8; n= 34,36,34,37,29,27 | -11.5 Giga cells per liter (GI/L) | Standard Deviation 44.8 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 2; n= 37,38,38,37,33,31 | 0.064 Giga cells per liter (GI/L) | Standard Deviation 0.351 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 14; n=33,33,32,32,31,27 | 0.10 Giga cells per liter (GI/L) | Standard Deviation 1.705 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 12; n=36,36,32,34,28,27 | -18.9 Giga cells per liter (GI/L) | Standard Deviation 38.67 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; EW; n=3,3,7,3,10,10 | 0.047 Giga cells per liter (GI/L) | Standard Deviation 0.0643 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 14; n=33,33,32,32,31,27 | -8.2 Giga cells per liter (GI/L) | Standard Deviation 47.6 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 14; n= 33,33,32,32,31,27 | -0.056 Giga cells per liter (GI/L) | Standard Deviation 0.1493 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; EW; n=3,3,7,3,10,10 | 11.7 Giga cells per liter (GI/L) | Standard Deviation 18.56 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 2; n=37,38,38,37,33,31 | -0.02 Giga cells per liter (GI/L) | Standard Deviation 1.585 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 12; n= 36,36,32,34,28,27 | -0.063 Giga cells per liter (GI/L) | Standard Deviation 0.1751 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 2; n= 37,38,38,37,33,31 | -0.002 Giga cells per liter (GI/L) | Standard Deviation 0.0175 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 4; n= 38,38,38,37,30,31 | 0.03 Giga cells per liter (GI/L) | Standard Deviation 1.517 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 4; n= 38,38,38,37,30,31 | 0.021 Giga cells per liter (GI/L) | Standard Deviation 0.4099 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 8; n= 34,36,34,37,29,27 | -0.012 Giga cells per liter (GI/L) | Standard Deviation 0.1359 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 14; n= 33,33,32,32,31,27 | 0.195 Giga cells per liter (GI/L) | Standard Deviation 0.5632 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; EW; n= 3,3,7,3,10,10 | 0.450 Giga cells per liter (GI/L) | Standard Deviation 0.0755 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 4; n=38,38,38,37,30,31 | -0.034 Giga cells per liter (GI/L) | Standard Deviation 0.2143 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 8; n=34,36,34,37,29,27 | -0.034 Giga cells per liter (GI/L) | Standard Deviation 0.2271 |
| GSK2894512 0.5% QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 2; n=37,38,38,37,33,31 | 0.008 Giga cells per liter (GI/L) | Standard Deviation 0.0965 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 12; n= 36,36,32,34,28,27 | -0.028 Giga cells per liter (GI/L) | Standard Deviation 0.2176 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 12; n= 36,36,32,34,28,27 | -0.034 Giga cells per liter (GI/L) | Standard Deviation 0.5779 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 12; n=36,36,32,34,28,27 | -0.49 Giga cells per liter (GI/L) | Standard Deviation 1.456 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 8; n= 34,36,34,37,29,27 | -0.066 Giga cells per liter (GI/L) | Standard Deviation 0.1465 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 14; n=33,33,32,32,31,27 | -0.155 Giga cells per liter (GI/L) | Standard Deviation 1.984 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 4; n= 38,38,38,37,30,31 | -0.21 Giga cells per liter (GI/L) | Standard Deviation 2.221 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; EW; n=3,3,7,3,10,10 | -0.331 Giga cells per liter (GI/L) | Standard Deviation 1.2306 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 8; n= 34,36,34,37,29,27 | -0.018 Giga cells per liter (GI/L) | Standard Deviation 0.5285 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 2; n=37,38,38,37,33,31 | -0.5 Giga cells per liter (GI/L) | Standard Deviation 31.18 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 4; n= 38,38,38,37,30,31 | -0.078 Giga cells per liter (GI/L) | Standard Deviation 0.4874 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 4; n=38,38,38,37,30,31 | -2.4 Giga cells per liter (GI/L) | Standard Deviation 30.48 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 2; n= 37,38,38,37,33,31 | 0.030 Giga cells per liter (GI/L) | Standard Deviation 0.4724 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; EW; n= 3,3,7,3,10,10 | -0.29 Giga cells per liter (GI/L) | Standard Deviation 1.454 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 8; n= 34,36,34,37,29,27 | 1.4 Giga cells per liter (GI/L) | Standard Deviation 37.7 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 14; n= 33,33,32,32,31,27 | -0.035 Giga cells per liter (GI/L) | Standard Deviation 0.5757 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; EW; n=3,3,7,3,10,10 | 0.065 Giga cells per liter (GI/L) | Standard Deviation 0.1905 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 4; n= 38,38,38,37,30,31 | -0.006 Giga cells per liter (GI/L) | Standard Deviation 0.0192 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 12; n=36,36,32,34,28,27 | -4.6 Giga cells per liter (GI/L) | Standard Deviation 35.71 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 14; n=33,33,32,32,31,27 | -0.32 Giga cells per liter (GI/L) | Standard Deviation 2.121 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 8; n=34,36,34,37,29,27 | 0.009 Giga cells per liter (GI/L) | Standard Deviation 0.1923 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 14; n=33,33,32,32,31,27 | 5.1 Giga cells per liter (GI/L) | Standard Deviation 31.34 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 14; n= 33,33,32,32,31,27 | -0.041 Giga cells per liter (GI/L) | Standard Deviation 0.2107 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 12; n=36,36,32,34,28,27 | -0.078 Giga cells per liter (GI/L) | Standard Deviation 0.1736 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; EW; n= 3,3,7,3,10,10 | 0.011 Giga cells per liter (GI/L) | Standard Deviation 0.011 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 8; n=34,36,34,37,29,27 | -0.52 Giga cells per liter (GI/L) | Standard Deviation 1.721 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; EW; n= 3,3,7,3,10,10 | -0.021 Giga cells per liter (GI/L) | Standard Deviation 0.4694 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 14; n=33,33,32,32,31,27 | -0.093 Giga cells per liter (GI/L) | Standard Deviation 0.1497 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; EW; n=3,3,7,3,10,10 | 8.4 Giga cells per liter (GI/L) | Standard Deviation 24.56 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; EW; n=3,3,7,3,10,10 | -0.018 Giga cells per liter (GI/L) | Standard Deviation 0.0966 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 14; n= 33,33,32,32,31,27 | 0.008 Giga cells per liter (GI/L) | Standard Deviation 0.0312 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 2; n=37,38,38,37,33,31 | -0.028 Giga cells per liter (GI/L) | Standard Deviation 0.1415 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 2; n=37,38,38,37,33,31 | -0.097 Giga cells per liter (GI/L) | Standard Deviation 1.8249 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 12; n= 36,36,32,34,28,27 | 0.003 Giga cells per liter (GI/L) | Standard Deviation 0.0348 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 2; n= 37,38,38,37,33,31 | -0.004 Giga cells per liter (GI/L) | Standard Deviation 0.0166 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 4; n=38,38,38,37,30,31 | -0.141 Giga cells per liter (GI/L) | Standard Deviation 2.1024 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 8; n= 34,36,34,37,29,27 | -0.005 Giga cells per liter (GI/L) | Standard Deviation 0.0218 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 4; n= 38,38,38,37,30,31 | -0.047 Giga cells per liter (GI/L) | Standard Deviation 0.1611 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 2; n=37,38,38,37,33,31 | -0.05 Giga cells per liter (GI/L) | Standard Deviation 1.972 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 8; n= 34,36,34,37,29,27 | -0.432 Giga cells per liter (GI/L) | Standard Deviation 1.5971 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 4; n=38,38,38,37,30,31 | 0.063 Giga cells per liter (GI/L) | Standard Deviation 0.4729 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 2; n=37,38,38,37,33,31 | 0.064 Giga cells per liter (GI/L) | Standard Deviation 0.4397 |
| Vehicle BID | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 12; n= 36,36,32,34,28,27 | -0.348 Giga cells per liter (GI/L) | Standard Deviation 1.5514 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 8; n= 34,36,34,37,29,27 | 0.214 Giga cells per liter (GI/L) | Standard Deviation 1.1894 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 2; n= 37,38,38,37,33,31 | 0.000 Giga cells per liter (GI/L) | Standard Deviation 0.0176 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 4; n= 38,38,38,37,30,31 | 0.010 Giga cells per liter (GI/L) | Standard Deviation 0.1419 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 14; n=33,33,32,32,31,27 | 0.23 Giga cells per liter (GI/L) | Standard Deviation 1.498 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 12; n= 36,36,32,34,28,27 | 0.328 Giga cells per liter (GI/L) | Standard Deviation 1.6786 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 14; n=33,33,32,32,31,27 | -0.013 Giga cells per liter (GI/L) | Standard Deviation 1.4826 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 12; n=36,36,32,34,28,27 | 0.007 Giga cells per liter (GI/L) | Standard Deviation 0.1801 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 8; n= 34,36,34,37,29,27 | 0.166 Giga cells per liter (GI/L) | Standard Deviation 0.4024 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 12; n=36,36,32,34,28,27 | 0.49 Giga cells per liter (GI/L) | Standard Deviation 1.776 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 8; n= 34,36,34,37,29,27 | -0.001 Giga cells per liter (GI/L) | Standard Deviation 0.1171 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; EW; n= 3,3,7,3,10,10 | -0.005 Giga cells per liter (GI/L) | Standard Deviation 0.0264 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; EW; n=3,3,7,3,10,10 | 0.158 Giga cells per liter (GI/L) | Standard Deviation 1.816 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 2; n=37,38,38,37,33,31 | -0.258 Giga cells per liter (GI/L) | Standard Deviation 1.2803 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 4; n= 38,38,38,37,30,31 | 0.34 Giga cells per liter (GI/L) | Standard Deviation 1.694 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 2; n=37,38,38,37,33,31 | 0.052 Giga cells per liter (GI/L) | Standard Deviation 0.1474 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 12; n= 36,36,32,34,28,27 | 0.116 Giga cells per liter (GI/L) | Standard Deviation 0.3819 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 2; n=37,38,38,37,33,31 | 0.019 Giga cells per liter (GI/L) | Standard Deviation 0.1948 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 2; n=37,38,38,37,33,31 | 6.9 Giga cells per liter (GI/L) | Standard Deviation 31.6 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 4; n= 38,38,38,37,30,31 | 0.151 Giga cells per liter (GI/L) | Standard Deviation 0.5349 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 8; n= 34,36,34,37,29,27 | 0.004 Giga cells per liter (GI/L) | Standard Deviation 0.0162 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; EW; n=3,3,7,3,10,10 | 0.062 Giga cells per liter (GI/L) | Standard Deviation 0.3301 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 4; n= 38,38,38,37,30,31 | 0.006 Giga cells per liter (GI/L) | Standard Deviation 0.0218 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 2; n=37,38,38,37,33,31 | -0.16 Giga cells per liter (GI/L) | Standard Deviation 1.624 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 4; n=38,38,38,37,30,31 | 12.7 Giga cells per liter (GI/L) | Standard Deviation 29.38 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 2; n= 37,38,38,37,33,31 | 0.018 Giga cells per liter (GI/L) | Standard Deviation 0.4654 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; Week 14; n=33,33,32,32,31,27 | 0.035 Giga cells per liter (GI/L) | Standard Deviation 0.1821 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; EW; n= 3,3,7,3,10,10 | -0.225 Giga cells per liter (GI/L) | Standard Deviation 0.4165 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; EW; n= 3,3,7,3,10,10 | -0.16 Giga cells per liter (GI/L) | Standard Deviation 2.151 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 14; n= 33,33,32,32,31,27 | -0.001 Giga cells per liter (GI/L) | Standard Deviation 0.0188 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 8; n= 34,36,34,37,29,27 | 8.8 Giga cells per liter (GI/L) | Standard Deviation 39.83 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Leukocytes; Week 8; n=34,36,34,37,29,27 | 0.49 Giga cells per liter (GI/L) | Standard Deviation 1.113 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; EW; n=3,3,7,3,10,10 | 11.3 Giga cells per liter (GI/L) | Standard Deviation 59.83 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Lymphocytes; Week 14; n= 33,33,32,32,31,27 | 0.184 Giga cells per liter (GI/L) | Standard Deviation 0.3451 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 8; n=34,36,34,37,29,27 | 0.106 Giga cells per liter (GI/L) | Standard Deviation 0.2805 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Monocytes; EW; n=3,3,7,3,10,10 | -0.159 Giga cells per liter (GI/L) | Standard Deviation 0.1672 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 12; n=36,36,32,34,28,27 | -6.8 Giga cells per liter (GI/L) | Standard Deviation 24.06 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 4; n=38,38,38,37,30,31 | 0.057 Giga cells per liter (GI/L) | Standard Deviation 0.1644 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 14; n= 33,33,32,32,31,27 | 0.038 Giga cells per liter (GI/L) | Standard Deviation 0.1779 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Neutrophils; Week 4; n=38,38,38,37,30,31 | 0.100 Giga cells per liter (GI/L) | Standard Deviation 1.4283 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Eosinophils; Week 12; n= 36,36,32,34,28,27 | 0.033 Giga cells per liter (GI/L) | Standard Deviation 0.1606 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Basophils; Week 12; n= 36,36,32,34,28,27 | 0.010 Giga cells per liter (GI/L) | Standard Deviation 0.0236 |
| Vehicle QD | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Platelet, Leukocytes Count | Platelet; Week 14; n=33,33,32,32,31,27 | 6.5 Giga cells per liter (GI/L) | Standard Deviation 51.77 |
Secondary
Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN)
Blood samples were collected to evaluate change from Baseline in calcium, chloride, CO2, glucose, potassium, sodium and BUN values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.
Time frame: Week 2, 4, 8, 12, 14, EW (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, Blood Urea Nitrogen (BUN) | CO2; Week 2; n= 38,39,38,39,33,32 | -1.8 Millimoles per liter (mmol/L) | Standard Deviation 2.04 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 12; n= 36,37,32,35,28,28 | -0.38 Millimoles per liter (mmol/L) | Standard Deviation 1.25 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 2; n= 38,39,38,39,33,32 | -0.042 Millimoles per liter (mmol/L) | Standard Deviation 0.0941 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; EW; n= 3,3,7,3,11,11 | -1.0 Millimoles per liter (mmol/L) | Standard Deviation 1 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 12; n= 36,37,32,35,28,28 | 0.04 Millimoles per liter (mmol/L) | Standard Deviation 0.371 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 14; n=33,35,32,34,31,29 | 0.29 Millimoles per liter (mmol/L) | Standard Deviation 1.091 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 8; n= 35,37,34,38,29,28 | -0.27 Millimoles per liter (mmol/L) | Standard Deviation 1.251 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 14; n=33,35,32,34,31,29 | 0.9 Millimoles per liter (mmol/L) | Standard Deviation 2.34 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 14; n=33,35,32,34,31,29 | -1.1 Millimoles per liter (mmol/L) | Standard Deviation 2.23 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 14; n=33,35,32,34,31,29 | 0.09 Millimoles per liter (mmol/L) | Standard Deviation 0.309 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 4; n=38,39,38,38,30,32 | -0.38 Millimoles per liter (mmol/L) | Standard Deviation 1.142 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 12; n= 36,37,32,35,28,28 | 0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.57 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; EW; n= 3,3,7,3,11,11 | -0.30 Millimoles per liter (mmol/L) | Standard Deviation 0.557 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 8; n= 35,37,34,38,29,28 | 1.0 Millimoles per liter (mmol/L) | Standard Deviation 2.32 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; EW; n= 3,3,7,3,11,11 | -0.20 Millimoles per liter (mmol/L) | Standard Deviation 0.1 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 14; n=33,35,32,34,31,29 | 0.02 Millimoles per liter (mmol/L) | Standard Deviation 1.361 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 4; n= 38,39,38,38,30,32 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.16 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 8; n= 35,37,34,38,29,28 | 0.05 Millimoles per liter (mmol/L) | Standard Deviation 0.389 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 4; n=38,39,38,38,30,32 | 0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.54 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 12; n=36,37,32,35,28,28 | -1.1 Millimoles per liter (mmol/L) | Standard Deviation 2.12 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 2; n= 38,39,38,39,33,32 | -0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.19 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 2; n= 38,39,38,39,33,32 | -0.38 Millimoles per liter (mmol/L) | Standard Deviation 1.205 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 12; n= 36,37,32,35,28,28 | 0.22 Millimoles per liter (mmol/L) | Standard Deviation 1.664 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 2; n= 38,39,38,39,33,32 | 0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.68 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 8; n= 35,37,34,38,29,28 | -1.9 Millimoles per liter (mmol/L) | Standard Deviation 2.34 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; EW; n= 3,3,7,3,11,11 | -0.073 Millimoles per liter (mmol/L) | Standard Deviation 0.1102 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 2; n= 38,39,38,39,33,32 | -0.06 Millimoles per liter (mmol/L) | Standard Deviation 0.318 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 4; n= 38,39,38,38,30,32 | 0.53 Millimoles per liter (mmol/L) | Standard Deviation 1.334 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 14; n=33,35,32,34,31,29 | -0.022 Millimoles per liter (mmol/L) | Standard Deviation 0.0793 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; EW; n=3,3,7,3,11,11 | -1.3 Millimoles per liter (mmol/L) | Standard Deviation 1.15 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 8; n=35,37,34,38,29,28 | -0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.19 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 4; n= 38,39,38,38,30,32 | -1.4 Millimoles per liter (mmol/L) | Standard Deviation 1.98 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 12; n=36,37,32,35,28,28 | -0.022 Millimoles per liter (mmol/L) | Standard Deviation 0.0928 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 2; n=38,39,38,39,33,32 | 0.55 Millimoles per liter (mmol/L) | Standard Deviation 1.71 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 12; n=36,37,32,35,28,28 | -0.4 Millimoles per liter (mmol/L) | Standard Deviation 2.11 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; EW; n=3,3,7,3,11,11 | 0.0 Millimoles per liter (mmol/L) | Standard Deviation 1 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 8; n=35,37,34,38,29,28 | -0.053 Millimoles per liter (mmol/L) | Standard Deviation 0.0939 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 8; n=35,37,34,38,29,28 | 0.40 Millimoles per liter (mmol/L) | Standard Deviation 1.45 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 4; n= 38,39,38,38,30,32 | -0.037 Millimoles per liter (mmol/L) | Standard Deviation 0.1076 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 14; n=33,35,32,34,31,29 | 0.2 Millimoles per liter (mmol/L) | Standard Deviation 1.97 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; EW; n= 3,3,7,3,11,11 | -0.33 Millimoles per liter (mmol/L) | Standard Deviation 0.577 |
| GSK2894512 1% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 4; n= 38,39,38,38,30,32 | -0.02 Millimoles per liter (mmol/L) | Standard Deviation 0.359 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 8; n=35,37,34,38,29,28 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.75 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; EW; n= 3,3,7,3,11,11 | -0.50 Millimoles per liter (mmol/L) | Standard Deviation 1 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; EW; n=3,3,7,3,11,11 | -1.3 Millimoles per liter (mmol/L) | Standard Deviation 2.08 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 12; n=36,37,32,35,28,28 | -0.4 Millimoles per liter (mmol/L) | Standard Deviation 2.3 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 14; n=33,35,32,34,31,29 | 0.21 Millimoles per liter (mmol/L) | Standard Deviation 1.54 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 2; n= 38,39,38,39,33,32 | -0.33 Millimoles per liter (mmol/L) | Standard Deviation 1.078 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 12; n= 36,37,32,35,28,28 | -0.09 Millimoles per liter (mmol/L) | Standard Deviation 1.767 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 8; n= 35,37,34,38,29,28 | 0.08 Millimoles per liter (mmol/L) | Standard Deviation 1.199 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 4; n=38,39,38,38,30,32 | -0.21 Millimoles per liter (mmol/L) | Standard Deviation 1.276 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 4; n= 38,39,38,38,30,32 | 0.25 Millimoles per liter (mmol/L) | Standard Deviation 1.101 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 2; n=38,39,38,39,33,32 | 0.65 Millimoles per liter (mmol/L) | Standard Deviation 1.384 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 8; n=35,37,34,38,29,28 | 0.42 Millimoles per liter (mmol/L) | Standard Deviation 1.253 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; EW; n=3,3,7,3,11,11 | -0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.08 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 12; n= 36,37,32,35,28,28 | 0.16 Millimoles per liter (mmol/L) | Standard Deviation 0.99 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 14; n=33,35,32,34,31,29 | -0.8 Millimoles per liter (mmol/L) | Standard Deviation 3.09 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 12; n=36,37,32,35,28,28 | -1.0 Millimoles per liter (mmol/L) | Standard Deviation 3.2 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; EW; n= 3,3,7,3,11,11 | -0.70 Millimoles per liter (mmol/L) | Standard Deviation 0.889 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 8; n= 35,37,34,38,29,28 | -1.1 Millimoles per liter (mmol/L) | Standard Deviation 3.35 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 2; n= 38,39,38,39,33,32 | 0.04 Millimoles per liter (mmol/L) | Standard Deviation 0.36 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 4; n= 38,39,38,38,30,32 | -0.8 Millimoles per liter (mmol/L) | Standard Deviation 3.07 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 2; n= 38,39,38,39,33,32 | -0.8 Millimoles per liter (mmol/L) | Standard Deviation 2.52 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 4; n= 38,39,38,38,30,32 | 0.09 Millimoles per liter (mmol/L) | Standard Deviation 0.446 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 14; n=33,35,32,34,31,29 | 0.47 Millimoles per liter (mmol/L) | Standard Deviation 1.275 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; EW; n= 3,3,7,3,11,11 | 1.3 Millimoles per liter (mmol/L) | Standard Deviation 1.53 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 8; n= 35,37,34,38,29,28 | 0.09 Millimoles per liter (mmol/L) | Standard Deviation 0.303 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 12; n= 36,37,32,35,28,28 | 0.13 Millimoles per liter (mmol/L) | Standard Deviation 0.335 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 14; n=33,35,32,34,31,29 | 0.4 Millimoles per liter (mmol/L) | Standard Deviation 1.82 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 12; n= 36,37,32,35,28,28 | 0.7 Millimoles per liter (mmol/L) | Standard Deviation 2.31 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 4; n= 38,39,38,38,30,32 | -0.5 Millimoles per liter (mmol/L) | Standard Deviation 1.94 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 8; n= 35,37,34,38,29,28 | 0.5 Millimoles per liter (mmol/L) | Standard Deviation 1.99 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; EW; n= 3,3,7,3,11,11 | -0.13 Millimoles per liter (mmol/L) | Standard Deviation 0.208 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 4; n=38,39,38,38,30,32 | 0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.31 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 2; n= 38,39,38,39,33,32 | 0.9 Millimoles per liter (mmol/L) | Standard Deviation 2.32 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 2; n= 38,39,38,39,33,32 | 0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.17 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; EW; n= 3,3,7,3,11,11 | -0.053 Millimoles per liter (mmol/L) | Standard Deviation 0.1405 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 14; n=33,35,32,34,31,29 | 0.13 Millimoles per liter (mmol/L) | Standard Deviation 0.422 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 14; n=33,35,32,34,31,29 | -0.019 Millimoles per liter (mmol/L) | Standard Deviation 0.0787 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 12; n=36,37,32,35,28,28 | -0.028 Millimoles per liter (mmol/L) | Standard Deviation 0.0861 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 2; n= 38,39,38,39,33,32 | -0.037 Millimoles per liter (mmol/L) | Standard Deviation 0.0918 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 8; n=35,37,34,38,29,28 | -0.024 Millimoles per liter (mmol/L) | Standard Deviation 0.0973 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 4; n= 38,39,38,38,30,32 | -0.014 Millimoles per liter (mmol/L) | Standard Deviation 0.0899 |
| GSK2894512 1% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 14; n=33,35,32,34,31,29 | -0.6 Millimoles per liter (mmol/L) | Standard Deviation 1.75 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 2; n= 38,39,38,39,33,32 | 0.03 Millimoles per liter (mmol/L) | Standard Deviation 1.026 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 14; n=33,35,32,34,31,29 | 0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.87 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 4; n= 38,39,38,38,30,32 | -1.3 Millimoles per liter (mmol/L) | Standard Deviation 2.14 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 8; n= 35,37,34,38,29,28 | -1.1 Millimoles per liter (mmol/L) | Standard Deviation 2.21 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 12; n=36,37,32,35,28,28 | -1.1 Millimoles per liter (mmol/L) | Standard Deviation 2.45 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 2; n=38,39,38,39,33,32 | 0.13 Millimoles per liter (mmol/L) | Standard Deviation 1.084 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 12; n= 36,37,32,35,28,28 | 0.01 Millimoles per liter (mmol/L) | Standard Deviation 1.097 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; EW; n= 3,3,7,3,11,11 | 0.67 Millimoles per liter (mmol/L) | Standard Deviation 1.154 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 4; n= 38,39,38,38,30,32 | 0.19 Millimoles per liter (mmol/L) | Standard Deviation 0.74 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 12; n= 36,37,32,35,28,28 | -0.01 Millimoles per liter (mmol/L) | Standard Deviation 0.449 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 14; n=33,35,32,34,31,29 | 0.09 Millimoles per liter (mmol/L) | Standard Deviation 0.57 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; EW; n= 3,3,7,3,11,11 | 0.10 Millimoles per liter (mmol/L) | Standard Deviation 0.252 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 2; n= 38,39,38,39,33,32 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.33 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 4; n= 38,39,38,38,30,32 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 1.78 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 12; n=36,37,32,35,28,28 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.06 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 14; n=33,35,32,34,31,29 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.34 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; EW; n=3,3,7,3,11,11 | -2.0 Millimoles per liter (mmol/L) | Standard Deviation 1 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 4; n=38,39,38,38,30,32 | 0.00 Millimoles per liter (mmol/L) | Standard Deviation 1.202 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 8; n= 35,37,34,38,29,28 | -0.03 Millimoles per liter (mmol/L) | Standard Deviation 0.807 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 12; n= 36,37,32,35,28,28 | -0.05 Millimoles per liter (mmol/L) | Standard Deviation 1.08 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 14; n=33,35,32,34,31,29 | 0.19 Millimoles per liter (mmol/L) | Standard Deviation 1.148 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; EW; n= 3,3,7,3,11,11 | -0.36 Millimoles per liter (mmol/L) | Standard Deviation 1.144 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 2; n= 38,39,38,39,33,32 | -0.067 Millimoles per liter (mmol/L) | Standard Deviation 0.097 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 4; n= 38,39,38,38,30,32 | -0.050 Millimoles per liter (mmol/L) | Standard Deviation 0.0873 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 8; n=35,37,34,38,29,28 | -0.063 Millimoles per liter (mmol/L) | Standard Deviation 0.08 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 12; n=36,37,32,35,28,28 | -0.061 Millimoles per liter (mmol/L) | Standard Deviation 0.0934 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 14; n=33,35,32,34,31,29 | -0.037 Millimoles per liter (mmol/L) | Standard Deviation 0.0964 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; EW; n= 3,3,7,3,11,11 | -0.003 Millimoles per liter (mmol/L) | Standard Deviation 0.1122 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 2; n= 38,39,38,39,33,32 | 0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.68 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 4; n=38,39,38,38,30,32 | 0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.05 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 8; n= 35,37,34,38,29,28 | 0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.27 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 12; n= 36,37,32,35,28,28 | 0.3 Millimoles per liter (mmol/L) | Standard Deviation 1.85 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; EW; n= 3,3,7,3,11,11 | 0.3 Millimoles per liter (mmol/L) | Standard Deviation 1.98 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 2; n= 38,39,38,39,33,32 | -1.2 Millimoles per liter (mmol/L) | Standard Deviation 2.3 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 2; n= 38,39,38,39,33,32 | 0.04 Millimoles per liter (mmol/L) | Standard Deviation 0.359 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 14; n=33,35,32,34,31,29 | -1.3 Millimoles per liter (mmol/L) | Standard Deviation 2.59 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; EW; n=3,3,7,3,11,11 | -1.9 Millimoles per liter (mmol/L) | Standard Deviation 3.18 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 4; n= 38,39,38,38,30,32 | 0.02 Millimoles per liter (mmol/L) | Standard Deviation 1.089 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 8; n=35,37,34,38,29,28 | 0.01 Millimoles per liter (mmol/L) | Standard Deviation 0.942 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 14; n=33,35,32,34,31,29 | -0.14 Millimoles per liter (mmol/L) | Standard Deviation 1.465 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 8; n= 35,37,34,38,29,28 | 0.19 Millimoles per liter (mmol/L) | Standard Deviation 0.765 |
| GSK2894512 0.5% BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 8; n=35,37,34,38,29,28 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.21 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 12; n=36,37,32,35,28,28 | -0.7 Millimoles per liter (mmol/L) | Standard Deviation 2.1 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 14; n=33,35,32,34,31,29 | 0.14 Millimoles per liter (mmol/L) | Standard Deviation 1.482 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 14; n=33,35,32,34,31,29 | -0.6 Millimoles per liter (mmol/L) | Standard Deviation 3.13 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 2; n= 38,39,38,39,33,32 | -0.022 Millimoles per liter (mmol/L) | Standard Deviation 0.0822 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; EW; n= 3,3,7,3,11,11 | -0.047 Millimoles per liter (mmol/L) | Standard Deviation 0.0503 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 12; n=36,37,32,35,28,28 | -0.8 Millimoles per liter (mmol/L) | Standard Deviation 2.02 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 2; n=38,39,38,39,33,32 | 0.37 Millimoles per liter (mmol/L) | Standard Deviation 1.431 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 4; n= 38,39,38,38,30,32 | 0.64 Millimoles per liter (mmol/L) | Standard Deviation 1.209 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 4; n=38,39,38,38,30,32 | -0.08 Millimoles per liter (mmol/L) | Standard Deviation 1.094 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 2; n= 38,39,38,39,33,32 | -0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.19 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 8; n= 35,37,34,38,29,28 | -0.18 Millimoles per liter (mmol/L) | Standard Deviation 1.099 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; EW; n= 3,3,7,3,11,11 | -1.00 Millimoles per liter (mmol/L) | Standard Deviation 0.866 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 2; n= 38,39,38,39,33,32 | 0.10 Millimoles per liter (mmol/L) | Standard Deviation 1.001 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 4; n= 38,39,38,38,30,32 | -0.028 Millimoles per liter (mmol/L) | Standard Deviation 0.084 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; EW; n=3,3,7,3,11,11 | 0.3 Millimoles per liter (mmol/L) | Standard Deviation 1.53 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 12; n= 36,37,32,35,28,28 | 0.07 Millimoles per liter (mmol/L) | Standard Deviation 1.03 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 2; n= 38,39,38,39,33,32 | -0.4 Millimoles per liter (mmol/L) | Standard Deviation 2.47 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 2; n= 38,39,38,39,33,32 | 0.6 Millimoles per liter (mmol/L) | Standard Deviation 2.22 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 14; n=33,35,32,34,31,29 | 0.15 Millimoles per liter (mmol/L) | Standard Deviation 1.209 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; EW; n=3,3,7,3,11,11 | -0.3 Millimoles per liter (mmol/L) | Standard Deviation 0.58 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 12; n= 36,37,32,35,28,28 | 0.36 Millimoles per liter (mmol/L) | Standard Deviation 1.077 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 8; n=35,37,34,38,29,28 | 0.51 Millimoles per liter (mmol/L) | Standard Deviation 1.106 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; EW; n= 3,3,7,3,11,11 | -0.37 Millimoles per liter (mmol/L) | Standard Deviation 0.058 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 4; n=38,39,38,38,30,32 | 0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.26 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 8; n=35,37,34,38,29,28 | -0.025 Millimoles per liter (mmol/L) | Standard Deviation 0.0754 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 8; n= 35,37,34,38,29,28 | -0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.45 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 14; n=33,35,32,34,31,29 | 0.03 Millimoles per liter (mmol/L) | Standard Deviation 0.349 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; EW; n= 3,3,7,3,11,11 | 1.0 Millimoles per liter (mmol/L) | Standard Deviation 2 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 12; n= 36,37,32,35,28,28 | 0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.44 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 12; n= 36,37,32,35,28,28 | -0.01 Millimoles per liter (mmol/L) | Standard Deviation 0.339 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 14; n=33,35,32,34,31,29 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.4 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 8; n=35,37,34,38,29,28 | -0.7 Millimoles per liter (mmol/L) | Standard Deviation 1.94 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 12; n=36,37,32,35,28,28 | -0.029 Millimoles per liter (mmol/L) | Standard Deviation 0.0911 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 4; n= 38,39,38,38,30,32 | 0.01 Millimoles per liter (mmol/L) | Standard Deviation 0.337 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 8; n= 35,37,34,38,29,28 | 0.03 Millimoles per liter (mmol/L) | Standard Deviation 0.316 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 14; n=33,35,32,34,31,29 | -1.0 Millimoles per liter (mmol/L) | Standard Deviation 2 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 2; n= 38,39,38,39,33,32 | 0.03 Millimoles per liter (mmol/L) | Standard Deviation 0.381 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 4; n= 38,39,38,38,30,32 | -0.7 Millimoles per liter (mmol/L) | Standard Deviation 2.22 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 4; n= 38,39,38,38,30,32 | -0.9 Millimoles per liter (mmol/L) | Standard Deviation 1.83 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 8; n= 35,37,34,38,29,28 | -0.7 Millimoles per liter (mmol/L) | Standard Deviation 2.6 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; EW; n= 3,3,7,3,11,11 | -0.10 Millimoles per liter (mmol/L) | Standard Deviation 2.007 |
| GSK2894512 0.5% QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 14; n=33,35,32,34,31,29 | -0.019 Millimoles per liter (mmol/L) | Standard Deviation 0.0868 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; EW; n= 3,3,7,3,11,11 | -0.02 Millimoles per liter (mmol/L) | Standard Deviation 0.236 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 14; n=33,35,32,34,31,29 | -0.028 Millimoles per liter (mmol/L) | Standard Deviation 0.0897 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 14; n=33,35,32,34,31,29 | 0.12 Millimoles per liter (mmol/L) | Standard Deviation 0.868 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 8; n= 35,37,34,38,29,28 | -0.8 Millimoles per liter (mmol/L) | Standard Deviation 2.43 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; EW; n= 3,3,7,3,11,11 | 0.50 Millimoles per liter (mmol/L) | Standard Deviation 0.775 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; EW; n= 3,3,7,3,11,11 | 0.1 Millimoles per liter (mmol/L) | Standard Deviation 1.7 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 14; n=33,35,32,34,31,29 | -0.9 Millimoles per liter (mmol/L) | Standard Deviation 2.29 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 4; n= 38,39,38,38,30,32 | -0.031 Millimoles per liter (mmol/L) | Standard Deviation 0.0952 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 8; n=35,37,34,38,29,28 | 0.44 Millimoles per liter (mmol/L) | Standard Deviation 1.048 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 2; n= 38,39,38,39,33,32 | -0.4 Millimoles per liter (mmol/L) | Standard Deviation 1.9 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; EW; n=3,3,7,3,11,11 | 0.0 Millimoles per liter (mmol/L) | Standard Deviation 2.19 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 4; n= 38,39,38,38,30,32 | -0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.71 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 4; n= 38,39,38,38,30,32 | -0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.14 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 8; n=35,37,34,38,29,28 | -0.035 Millimoles per liter (mmol/L) | Standard Deviation 0.0989 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 2; n=38,39,38,39,33,32 | 0.46 Millimoles per liter (mmol/L) | Standard Deviation 0.687 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 14; n=33,35,32,34,31,29 | 0.14 Millimoles per liter (mmol/L) | Standard Deviation 0.503 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 4; n=38,39,38,38,30,32 | -0.4 Millimoles per liter (mmol/L) | Standard Deviation 2.01 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 8; n=35,37,34,38,29,28 | -0.6 Millimoles per liter (mmol/L) | Standard Deviation 1.84 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 12; n=36,37,32,35,28,28 | -0.026 Millimoles per liter (mmol/L) | Standard Deviation 0.1112 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 4; n=38,39,38,38,30,32 | 0.10 Millimoles per liter (mmol/L) | Standard Deviation 1.367 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 8; n= 35,37,34,38,29,28 | -0.4 Millimoles per liter (mmol/L) | Standard Deviation 2.21 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 2; n= 38,39,38,39,33,32 | -0.024 Millimoles per liter (mmol/L) | Standard Deviation 0.1346 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 2; n= 38,39,38,39,33,32 | 0.29 Millimoles per liter (mmol/L) | Standard Deviation 1.256 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 4; n= 38,39,38,38,30,32 | 0.38 Millimoles per liter (mmol/L) | Standard Deviation 1.154 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 12; n=36,37,32,35,28,28 | -0.8 Millimoles per liter (mmol/L) | Standard Deviation 2.14 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 8; n= 35,37,34,38,29,28 | 0.17 Millimoles per liter (mmol/L) | Standard Deviation 1.159 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 14; n=33,35,32,34,31,29 | -0.7 Millimoles per liter (mmol/L) | Standard Deviation 2.22 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 2; n= 38,39,38,39,33,32 | -0.9 Millimoles per liter (mmol/L) | Standard Deviation 2.39 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; EW; n= 3,3,7,3,11,11 | 0.32 Millimoles per liter (mmol/L) | Standard Deviation 0.873 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 12; n= 36,37,32,35,28,28 | -0.4 Millimoles per liter (mmol/L) | Standard Deviation 1.83 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 12; n= 36,37,32,35,28,28 | 0.50 Millimoles per liter (mmol/L) | Standard Deviation 1.028 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 12; n= 36,37,32,35,28,28 | 0.23 Millimoles per liter (mmol/L) | Standard Deviation 1.384 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 12; n= 36,37,32,35,28,28 | 0.06 Millimoles per liter (mmol/L) | Standard Deviation 0.398 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 2; n= 38,39,38,39,33,32 | 0.08 Millimoles per liter (mmol/L) | Standard Deviation 0.371 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; EW; n=3,3,7,3,11,11 | 0.1 Millimoles per liter (mmol/L) | Standard Deviation 1.58 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; EW; n= 3,3,7,3,11,11 | -0.025 Millimoles per liter (mmol/L) | Standard Deviation 0.1092 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 12; n=36,37,32,35,28,28 | -0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.49 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 14; n=33,35,32,34,31,29 | 0.02 Millimoles per liter (mmol/L) | Standard Deviation 1.268 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 2; n= 38,39,38,39,33,32 | -0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.49 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 14; n=33,35,32,34,31,29 | -0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.32 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 8; n= 35,37,34,38,29,28 | 0.04 Millimoles per liter (mmol/L) | Standard Deviation 0.344 |
| Vehicle BID | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 4; n= 38,39,38,38,30,32 | 0.04 Millimoles per liter (mmol/L) | Standard Deviation 0.254 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 8; n= 35,37,34,38,29,28 | 0.02 Millimoles per liter (mmol/L) | Standard Deviation 1.572 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; EW; n= 3,3,7,3,11,11 | -0.23 Millimoles per liter (mmol/L) | Standard Deviation 1.915 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 8; n=35,37,34,38,29,28 | -0.34 Millimoles per liter (mmol/L) | Standard Deviation 3.256 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 2; n= 38,39,38,39,33,32 | -0.027 Millimoles per liter (mmol/L) | Standard Deviation 0.0758 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 12; n=36,37,32,35,28,28 | -0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.14 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 8; n= 35,37,34,38,29,28 | -1.8 Millimoles per liter (mmol/L) | Standard Deviation 2.65 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 4; n= 38,39,38,38,30,32 | -0.031 Millimoles per liter (mmol/L) | Standard Deviation 0.09 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 8; n=35,37,34,38,29,28 | -0.0 Millimoles per liter (mmol/L) | Standard Deviation 2.5 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 4; n= 38,39,38,38,30,32 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 1.65 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 12; n=36,37,32,35,28,28 | -0.004 Millimoles per liter (mmol/L) | Standard Deviation 0.0596 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 12; n= 36,37,32,35,28,28 | -0.49 Millimoles per liter (mmol/L) | Standard Deviation 3.24 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 14; n=33,35,32,34,31,29 | -0.024 Millimoles per liter (mmol/L) | Standard Deviation 0.0668 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 2; n= 38,39,38,39,33,32 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 1.6 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 4; n= 38,39,38,38,30,32 | 0.01 Millimoles per liter (mmol/L) | Standard Deviation 0.428 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; EW; n= 3,3,7,3,11,11 | -0.038 Millimoles per liter (mmol/L) | Standard Deviation 0.0914 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; EW; n= 3,3,7,3,11,11 | -0.00 Millimoles per liter (mmol/L) | Standard Deviation 0.366 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 2; n= 38,39,38,39,33,32 | 0.4 Millimoles per liter (mmol/L) | Standard Deviation 2.27 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 4; n=38,39,38,38,30,32 | 0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.38 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 14; n=33,35,32,34,31,29 | -0.00 Millimoles per liter (mmol/L) | Standard Deviation 0.348 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Calcium; Week 8; n=35,37,34,38,29,28 | -0.038 Millimoles per liter (mmol/L) | Standard Deviation 0.0788 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 12; n= 36,37,32,35,28,28 | 0.01 Millimoles per liter (mmol/L) | Standard Deviation 0.403 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 12; n= 36,37,32,35,28,28 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.76 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; EW; n= 3,3,7,3,11,11 | 0.6 Millimoles per liter (mmol/L) | Standard Deviation 2.66 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 2; n= 38,39,38,39,33,32 | 0.03 Millimoles per liter (mmol/L) | Standard Deviation 0.339 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 2; n= 38,39,38,39,33,32 | -1.0 Millimoles per liter (mmol/L) | Standard Deviation 2.15 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 4; n= 38,39,38,38,30,32 | -1.0 Millimoles per liter (mmol/L) | Standard Deviation 2.06 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; EW; n= 3,3,7,3,11,11 | 0.11 Millimoles per liter (mmol/L) | Standard Deviation 0.997 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Potassium; Week 8; n= 35,37,34,38,29,28 | -0.06 Millimoles per liter (mmol/L) | Standard Deviation 0.37 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 14; n=33,35,32,34,31,29 | -0.52 Millimoles per liter (mmol/L) | Standard Deviation 3.871 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 12; n=36,37,32,35,28,28 | -1.1 Millimoles per liter (mmol/L) | Standard Deviation 2.07 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 14; n=33,35,32,34,31,29 | 0.6 Millimoles per liter (mmol/L) | Standard Deviation 2.64 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; Week 14; n=33,35,32,34,31,29 | -1.3 Millimoles per liter (mmol/L) | Standard Deviation 1.86 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Chloride; Week 8; n= 35,37,34,38,29,28 | 0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.86 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | CO2; EW; n=3,3,7,3,11,11 | -0.4 Millimoles per liter (mmol/L) | Standard Deviation 1.8 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 4; n= 38,39,38,38,30,32 | -0.00 Millimoles per liter (mmol/L) | Standard Deviation 3.164 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Glucose; Week 2; n=38,39,38,39,33,32 | -0.10 Millimoles per liter (mmol/L) | Standard Deviation 3.059 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 4; n=38,39,38,38,30,32 | -0.11 Millimoles per liter (mmol/L) | Standard Deviation 1.091 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 2; n= 38,39,38,39,33,32 | -0.19 Millimoles per liter (mmol/L) | Standard Deviation 1.098 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 12; n= 36,37,32,35,28,28 | 0.07 Millimoles per liter (mmol/L) | Standard Deviation 1.614 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; EW; n=3,3,7,3,11,11 | 0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.34 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | BUN; Week 14; n=33,35,32,34,31,29 | 0.19 Millimoles per liter (mmol/L) | Standard Deviation 1.429 |
| Vehicle QD | Change From Baseline in Calcium, Chloride, Carbon Dioxide (CO2), Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) | Sodium; Week 14; n=33,35,32,34,31,29 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 1.93 |
Secondary
Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate
Blood samples were collected to evaluate change from Baseline in direct and total bilirubin, creatinine and urate values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.
Time frame: Week 2, 4, 8, 12, 14, EW (up to week 14)
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 12; n= 36,37,32,35,28,28 | -1.84 Micromoles per liter (µmol/L) | Standard Deviation 11.918 |
| GSK2894512 1% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; EW; n = 3,3,7,3,11,11 | -1.3 Micromoles per liter (µmol/L) | Standard Deviation 5.77 |
| GSK2894512 1% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 14; n= 33,35,32,34,31,29 | 2.04 Micromoles per liter (µmol/L) | Standard Deviation 10.306 |
| GSK2894512 1% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 8; n=35,37,34, 38,29,28 | -20.0 Micromoles per liter (µmol/L) | Standard Deviation 60.44 |
| GSK2894512 1% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 2; n= 38,39,38,39,33,32 | -26.1 Micromoles per liter (µmol/L) | Standard Deviation 74.09 |
| GSK2894512 1% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 4; n=38,39,38,38,30,32 | -18.7 Micromoles per liter (µmol/L) | Standard Deviation 58.92 |
| GSK2894512 1% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 2; n= 38,39,38,39,33,32 | -3.00 Micromoles per liter (µmol/L) | Standard Deviation 10.771 |
| GSK2894512 1% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 4; n= 38,39,38,38,30,32 | -0.1 Micromoles per liter (µmol/L) | Standard Deviation 1.18 |
| GSK2894512 1% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 4; n= 38,39,38,38,30,32 | -0.04 Micromoles per liter (µmol/L) | Standard Deviation 11.471 |
| GSK2894512 1% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 8; n= 35,37,34, 38,29,28 | -2.03 Micromoles per liter (µmol/L) | Standard Deviation 12.571 |
| GSK2894512 1% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; EW; n=3,3,7,3,11,11 | 1.20 Micromoles per liter (µmol/L) | Standard Deviation 2.651 |
| GSK2894512 1% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 8; n= 35,37,34, 38,29,28 | 0.1 Micromoles per liter (µmol/L) | Standard Deviation 1.41 |
| GSK2894512 1% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Week 14; n= 33,35,32,34,31,29 | -0.1 Micromoles per liter (µmol/L) | Standard Deviation 2.81 |
| GSK2894512 1% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 2; n= 38,39,38,39,33,32 | -0.1 Micromoles per liter (µmol/L) | Standard Deviation 0.98 |
| GSK2894512 1% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; EW; n= 3,3,7,3,11,11 | 0.0 Micromoles per liter (µmol/L) | Standard Deviation 2 |
| GSK2894512 1% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 12; n= 36,37,32,35,28,28 | 0.3 Micromoles per liter (µmol/L) | Standard Deviation 1.19 |
| GSK2894512 1% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; EW; n=3,3,7,3,11,11 | -6.7 Micromoles per liter (µmol/L) | Standard Deviation 20.82 |
| GSK2894512 1% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 14; n= 33,35,32,34,31,29 | -0.1 Micromoles per liter (µmol/L) | Standard Deviation 1.17 |
| GSK2894512 1% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Week 8; n= 35,37,34, 38,29,28 | 0.0 Micromoles per liter (µmol/L) | Standard Deviation 4.97 |
| GSK2894512 1% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Week 2; n=38,39,38,39,33,32 | -1.1 Micromoles per liter (µmol/L) | Standard Deviation 3.21 |
| GSK2894512 1% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Week 4; n= 38,39,38,38,30,32 | -1.2 Micromoles per liter (µmol/L) | Standard Deviation 3.18 |
| GSK2894512 1% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 14; n=33,35,32,34,31,29 | -10.9 Micromoles per liter (µmol/L) | Standard Deviation 58.44 |
| GSK2894512 1% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Weel 12; n= 36,37,32,35,28,28 | 0.5 Micromoles per liter (µmol/L) | Standard Deviation 4.15 |
| GSK2894512 1% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 12; n=36,37,32,35,28,28 | -20.8 Micromoles per liter (µmol/L) | Standard Deviation 70.48 |
| GSK2894512 1% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 2; n= 38,39,38,39,33,32 | -3.65 Micromoles per liter (µmol/L) | Standard Deviation 6.186 |
| GSK2894512 1% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 4; n= 38,39,38,38,30,32 | -0.3 Micromoles per liter (µmol/L) | Standard Deviation 0.82 |
| GSK2894512 1% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 12; n= 36,37,32,35,28,28 | -1.41 Micromoles per liter (µmol/L) | Standard Deviation 9.573 |
| GSK2894512 1% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 2; n= 38,39,38,39,33,32 | -7.9 Micromoles per liter (µmol/L) | Standard Deviation 41.56 |
| GSK2894512 1% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; EW; n=3,3,7,3,11,11 | -16.7 Micromoles per liter (µmol/L) | Standard Deviation 15.28 |
| GSK2894512 1% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 14; n=33,35,32,34,31,29 | -5.4 Micromoles per liter (µmol/L) | Standard Deviation 46.86 |
| GSK2894512 1% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Week 2; n=38,39,38,39,33,32 | -0.8 Micromoles per liter (µmol/L) | Standard Deviation 3.23 |
| GSK2894512 1% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 12; n=36,37,32,35,28,28 | -5.1 Micromoles per liter (µmol/L) | Standard Deviation 93.2 |
| GSK2894512 1% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 12; n= 36,37,32,35,28,28 | 0.0 Micromoles per liter (µmol/L) | Standard Deviation 1.15 |
| GSK2894512 1% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 8; n= 35,37,34, 38,29,28 | -0.2 Micromoles per liter (µmol/L) | Standard Deviation 0.99 |
| GSK2894512 1% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 14; n= 33,35,32,34,31,29 | -0.2 Micromoles per liter (µmol/L) | Standard Deviation 1.32 |
| GSK2894512 1% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; EW; n= 3,3,7,3,11,11 | -0.7 Micromoles per liter (µmol/L) | Standard Deviation 1.15 |
| GSK2894512 1% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 8; n= 35,37,34, 38,29,28 | -1.70 Micromoles per liter (µmol/L) | Standard Deviation 8.249 |
| GSK2894512 1% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 4; n= 38,39,38,38,30,32 | -3.30 Micromoles per liter (µmol/L) | Standard Deviation 6.974 |
| GSK2894512 1% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Weel 12; n= 36,37,32,35,28,28 | 0.1 Micromoles per liter (µmol/L) | Standard Deviation 2.26 |
| GSK2894512 1% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Week 14; n= 33,35,32,34,31,29 | -0.4 Micromoles per liter (µmol/L) | Standard Deviation 3.9 |
| GSK2894512 1% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Week 8; n= 35,37,34, 38,29,28 | -0.3 Micromoles per liter (µmol/L) | Standard Deviation 2.93 |
| GSK2894512 1% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 2; n= 38,39,38,39,33,32 | -0.3 Micromoles per liter (µmol/L) | Standard Deviation 1.08 |
| GSK2894512 1% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 8; n=35,37,34, 38,29,28 | -0.5 Micromoles per liter (µmol/L) | Standard Deviation 52.54 |
| GSK2894512 1% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; EW; n = 3,3,7,3,11,11 | -2.0 Micromoles per liter (µmol/L) | Standard Deviation 2 |
| GSK2894512 1% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; EW; n=3,3,7,3,11,11 | -5.33 Micromoles per liter (µmol/L) | Standard Deviation 2.65 |
| GSK2894512 1% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 14; n= 33,35,32,34,31,29 | -1.48 Micromoles per liter (µmol/L) | Standard Deviation 9.986 |
| GSK2894512 1% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Week 4; n= 38,39,38,38,30,32 | -0.8 Micromoles per liter (µmol/L) | Standard Deviation 2.54 |
| GSK2894512 1% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 4; n=38,39,38,38,30,32 | -8.7 Micromoles per liter (µmol/L) | Standard Deviation 39.21 |
| GSK2894512 0.5% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 2; n= 38,39,38,39,33,32 | -3.46 Micromoles per liter (µmol/L) | Standard Deviation 7.165 |
| GSK2894512 0.5% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Week 8; n= 35,37,34, 38,29,28 | -1.8 Micromoles per liter (µmol/L) | Standard Deviation 3.24 |
| GSK2894512 0.5% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 2; n= 38,39,38,39,33,32 | -14.5 Micromoles per liter (µmol/L) | Standard Deviation 43.91 |
| GSK2894512 0.5% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 8; n=35,37,34, 38,29,28 | -7.9 Micromoles per liter (µmol/L) | Standard Deviation 51.63 |
| GSK2894512 0.5% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 4; n= 38,39,38,38,30,32 | -1.14 Micromoles per liter (µmol/L) | Standard Deviation 7.897 |
| GSK2894512 0.5% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; EW; n = 3,3,7,3,11,11 | -0.9 Micromoles per liter (µmol/L) | Standard Deviation 3.44 |
| GSK2894512 0.5% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 2; n= 38,39,38,39,33,32 | -0.5 Micromoles per liter (µmol/L) | Standard Deviation 1.18 |
| GSK2894512 0.5% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 12; n=36,37,32,35,28,28 | -14.7 Micromoles per liter (µmol/L) | Standard Deviation 46.97 |
| GSK2894512 0.5% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; EW; n=3,3,7,3,11,11 | -22.9 Micromoles per liter (µmol/L) | Standard Deviation 39.46 |
| GSK2894512 0.5% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 4; n= 38,39,38,38,30,32 | -0.5 Micromoles per liter (µmol/L) | Standard Deviation 1.18 |
| GSK2894512 0.5% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Week 14; n= 33,35,32,34,31,29 | 0.0 Micromoles per liter (µmol/L) | Standard Deviation 4.1 |
| GSK2894512 0.5% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 8; n= 35,37,34, 38,29,28 | -0.4 Micromoles per liter (µmol/L) | Standard Deviation 1.08 |
| GSK2894512 0.5% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 12; n= 36,37,32,35,28,28 | -0.4 Micromoles per liter (µmol/L) | Standard Deviation 0.94 |
| GSK2894512 0.5% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 8; n= 35,37,34, 38,29,28 | -0.29 Micromoles per liter (µmol/L) | Standard Deviation 8.357 |
| GSK2894512 0.5% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 14; n= 33,35,32,34,31,29 | 0.1 Micromoles per liter (µmol/L) | Standard Deviation 1.19 |
| GSK2894512 0.5% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Week 4; n= 38,39,38,38,30,32 | -1.5 Micromoles per liter (µmol/L) | Standard Deviation 3.11 |
| GSK2894512 0.5% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; EW; n= 3,3,7,3,11,11 | -0.6 Micromoles per liter (µmol/L) | Standard Deviation 0.98 |
| GSK2894512 0.5% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 14; n=33,35,32,34,31,29 | 3.8 Micromoles per liter (µmol/L) | Standard Deviation 48.64 |
| GSK2894512 0.5% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 12; n= 36,37,32,35,28,28 | 0.16 Micromoles per liter (µmol/L) | Standard Deviation 5.886 |
| GSK2894512 0.5% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Week 2; n=38,39,38,39,33,32 | -2.2 Micromoles per liter (µmol/L) | Standard Deviation 3.37 |
| GSK2894512 0.5% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 14; n= 33,35,32,34,31,29 | 2.77 Micromoles per liter (µmol/L) | Standard Deviation 7.351 |
| GSK2894512 0.5% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; EW; n=3,3,7,3,11,11 | -8.19 Micromoles per liter (µmol/L) | Standard Deviation 9.071 |
| GSK2894512 0.5% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 4; n=38,39,38,38,30,32 | -2.9 Micromoles per liter (µmol/L) | Standard Deviation 52.96 |
| GSK2894512 0.5% BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Weel 12; n= 36,37,32,35,28,28 | -1.9 Micromoles per liter (µmol/L) | Standard Deviation 2.56 |
| GSK2894512 0.5% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 8; n= 35,37,34, 38,29,28 | -0.2 Micromoles per liter (µmol/L) | Standard Deviation 1.26 |
| GSK2894512 0.5% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 4; n= 38,39,38,38,30,32 | -0.2 Micromoles per liter (µmol/L) | Standard Deviation 1.02 |
| GSK2894512 0.5% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Week 8; n= 35,37,34, 38,29,28 | -0.8 Micromoles per liter (µmol/L) | Standard Deviation 4.5 |
| GSK2894512 0.5% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 12; n= 36,37,32,35,28,28 | 1.03 Micromoles per liter (µmol/L) | Standard Deviation 7.618 |
| GSK2894512 0.5% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 2; n= 38,39,38,39,33,32 | 7.9 Micromoles per liter (µmol/L) | Standard Deviation 49.96 |
| GSK2894512 0.5% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 8; n=35,37,34, 38,29,28 | -5.5 Micromoles per liter (µmol/L) | Standard Deviation 59.76 |
| GSK2894512 0.5% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Week 2; n=38,39,38,39,33,32 | -0.6 Micromoles per liter (µmol/L) | Standard Deviation 2.64 |
| GSK2894512 0.5% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; EW; n = 3,3,7,3,11,11 | -0.7 Micromoles per liter (µmol/L) | Standard Deviation 1.15 |
| GSK2894512 0.5% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 2; n= 38,39,38,39,33,32 | -0.84 Micromoles per liter (µmol/L) | Standard Deviation 7.294 |
| GSK2894512 0.5% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 14; n= 33,35,32,34,31,29 | 3.17 Micromoles per liter (µmol/L) | Standard Deviation 7.99 |
| GSK2894512 0.5% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 2; n= 38,39,38,39,33,32 | -0.1 Micromoles per liter (µmol/L) | Standard Deviation 1.07 |
| GSK2894512 0.5% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; EW; n=3,3,7,3,11,11 | -16.7 Micromoles per liter (µmol/L) | Standard Deviation 85.05 |
| GSK2894512 0.5% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Week 4; n= 38,39,38,38,30,32 | -1.4 Micromoles per liter (µmol/L) | Standard Deviation 3.15 |
| GSK2894512 0.5% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; EW; n=3,3,7,3,11,11 | -4.13 Micromoles per liter (µmol/L) | Standard Deviation 8.251 |
| GSK2894512 0.5% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 12; n= 36,37,32,35,28,28 | -0.2 Micromoles per liter (µmol/L) | Standard Deviation 1.17 |
| GSK2894512 0.5% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Week 14; n= 33,35,32,34,31,29 | -0.6 Micromoles per liter (µmol/L) | Standard Deviation 3.43 |
| GSK2894512 0.5% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 14; n= 33,35,32,34,31,29 | -0.2 Micromoles per liter (µmol/L) | Standard Deviation 1.07 |
| GSK2894512 0.5% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 12; n=36,37,32,35,28,28 | 2.6 Micromoles per liter (µmol/L) | Standard Deviation 60.89 |
| GSK2894512 0.5% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 14; n=33,35,32,34,31,29 | 15.9 Micromoles per liter (µmol/L) | Standard Deviation 61.5 |
| GSK2894512 0.5% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 4; n= 38,39,38,38,30,32 | 0.51 Micromoles per liter (µmol/L) | Standard Deviation 8.99 |
| GSK2894512 0.5% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; EW; n= 3,3,7,3,11,11 | -0.7 Micromoles per liter (µmol/L) | Standard Deviation 1.15 |
| GSK2894512 0.5% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 8; n= 35,37,34, 38,29,28 | -0.04 Micromoles per liter (µmol/L) | Standard Deviation 8.114 |
| GSK2894512 0.5% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 4; n=38,39,38,38,30,32 | 3.9 Micromoles per liter (µmol/L) | Standard Deviation 59.84 |
| GSK2894512 0.5% QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Weel 12; n= 36,37,32,35,28,28 | -0.9 Micromoles per liter (µmol/L) | Standard Deviation 3.3 |
| Vehicle BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 4; n= 38,39,38,38,30,32 | -1.19 Micromoles per liter (µmol/L) | Standard Deviation 10.945 |
| Vehicle BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 8; n= 35,37,34, 38,29,28 | 0.1 Micromoles per liter (µmol/L) | Standard Deviation 1.36 |
| Vehicle BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; EW; n = 3,3,7,3,11,11 | 0.5 Micromoles per liter (µmol/L) | Standard Deviation 4.82 |
| Vehicle BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 2; n= 38,39,38,39,33,32 | -1.56 Micromoles per liter (µmol/L) | Standard Deviation 10.461 |
| Vehicle BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; EW; n=3,3,7,3,11,11 | -1.35 Micromoles per liter (µmol/L) | Standard Deviation 8.386 |
| Vehicle BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 2; n= 38,39,38,39,33,32 | 0.0 Micromoles per liter (µmol/L) | Standard Deviation 50.19 |
| Vehicle BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 14; n=33,35,32,34,31,29 | 5.2 Micromoles per liter (µmol/L) | Standard Deviation 56.32 |
| Vehicle BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Week 14; n= 33,35,32,34,31,29 | 0.1 Micromoles per liter (µmol/L) | Standard Deviation 3.92 |
| Vehicle BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 2; n= 38,39,38,39,33,32 | 0.0 Micromoles per liter (µmol/L) | Standard Deviation 1.66 |
| Vehicle BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 4; n= 38,39,38,38,30,32 | 0.1 Micromoles per liter (µmol/L) | Standard Deviation 1.23 |
| Vehicle BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 12; n= 36,37,32,35,28,28 | 0.0 Micromoles per liter (µmol/L) | Standard Deviation 1.33 |
| Vehicle BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 14; n= 33,35,32,34,31,29 | 0.0 Micromoles per liter (µmol/L) | Standard Deviation 1.26 |
| Vehicle BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; EW; n= 3,3,7,3,11,11 | -0.5 Micromoles per liter (µmol/L) | Standard Deviation 1.81 |
| Vehicle BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Week 2; n=38,39,38,39,33,32 | -0.4 Micromoles per liter (µmol/L) | Standard Deviation 5.49 |
| Vehicle BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Week 4; n= 38,39,38,38,30,32 | 0.3 Micromoles per liter (µmol/L) | Standard Deviation 4.27 |
| Vehicle BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Week 8; n= 35,37,34, 38,29,28 | -0.1 Micromoles per liter (µmol/L) | Standard Deviation 5.06 |
| Vehicle BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 8; n= 35,37,34, 38,29,28 | -0.58 Micromoles per liter (µmol/L) | Standard Deviation 11.799 |
| Vehicle BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 12; n= 36,37,32,35,28,28 | -0.70 Micromoles per liter (µmol/L) | Standard Deviation 10.789 |
| Vehicle BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 14; n= 33,35,32,34,31,29 | -0.05 Micromoles per liter (µmol/L) | Standard Deviation 7.859 |
| Vehicle BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 4; n=38,39,38,38,30,32 | -2.7 Micromoles per liter (µmol/L) | Standard Deviation 62.69 |
| Vehicle BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 8; n=35,37,34, 38,29,28 | 12.8 Micromoles per liter (µmol/L) | Standard Deviation 44.07 |
| Vehicle BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 12; n=36,37,32,35,28,28 | 6.8 Micromoles per liter (µmol/L) | Standard Deviation 51.43 |
| Vehicle BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; EW; n=3,3,7,3,11,11 | 0.9 Micromoles per liter (µmol/L) | Standard Deviation 42.3 |
| Vehicle BID | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Weel 12; n= 36,37,32,35,28,28 | 0.6 Micromoles per liter (µmol/L) | Standard Deviation 4.42 |
| Vehicle QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 12; n= 36,37,32,35,28,28 | 1.58 Micromoles per liter (µmol/L) | Standard Deviation 6.241 |
| Vehicle QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 14; n=33,35,32,34,31,29 | 17.2 Micromoles per liter (µmol/L) | Standard Deviation 43.33 |
| Vehicle QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 8; n= 35,37,34, 38,29,28 | -0.51 Micromoles per liter (µmol/L) | Standard Deviation 7.53 |
| Vehicle QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; EW; n = 3,3,7,3,11,11 | -0.4 Micromoles per liter (µmol/L) | Standard Deviation 4.27 |
| Vehicle QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Week 8; n= 35,37,34, 38,29,28 | -1.1 Micromoles per liter (µmol/L) | Standard Deviation 2.14 |
| Vehicle QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 8; n=35,37,34, 38,29,28 | 12.9 Micromoles per liter (µmol/L) | Standard Deviation 59.25 |
| Vehicle QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 12; n=36,37,32,35,28,28 | 5.0 Micromoles per liter (µmol/L) | Standard Deviation 46.79 |
| Vehicle QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Week 4; n= 38,39,38,38,30,32 | 0.0 Micromoles per liter (µmol/L) | Standard Deviation 2.16 |
| Vehicle QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Week 2; n=38,39,38,39,33,32 | -0.1 Micromoles per liter (µmol/L) | Standard Deviation 2.8 |
| Vehicle QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; EW; n= 3,3,7,3,11,11 | 0.0 Micromoles per liter (µmol/L) | Standard Deviation 1.26 |
| Vehicle QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 14; n= 33,35,32,34,31,29 | -0.3 Micromoles per liter (µmol/L) | Standard Deviation 1.58 |
| Vehicle QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 12; n= 36,37,32,35,28,28 | -0.1 Micromoles per liter (µmol/L) | Standard Deviation 1.21 |
| Vehicle QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 4; n= 38,39,38,38,30,32 | -0.4 Micromoles per liter (µmol/L) | Standard Deviation 0.94 |
| Vehicle QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 2; n= 38,39,38,39,33,32 | -0.3 Micromoles per liter (µmol/L) | Standard Deviation 1.15 |
| Vehicle QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Week 14; n= 33,35,32,34,31,29 | -0.4 Micromoles per liter (µmol/L) | Standard Deviation 4.19 |
| Vehicle QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 4; n= 38,39,38,38,30,32 | 3.70 Micromoles per liter (µmol/L) | Standard Deviation 14.019 |
| Vehicle QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; EW; n=3,3,7,3,11,11 | 8.2 Micromoles per liter (µmol/L) | Standard Deviation 43.55 |
| Vehicle QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Direct bilirubin; Week 8; n= 35,37,34, 38,29,28 | -0.5 Micromoles per liter (µmol/L) | Standard Deviation 1.17 |
| Vehicle QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Total bilirubin; Weel 12; n= 36,37,32,35,28,28 | -0.1 Micromoles per liter (µmol/L) | Standard Deviation 3.17 |
| Vehicle QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 2; n= 38,39,38,39,33,32 | 2.5 Micromoles per liter (µmol/L) | Standard Deviation 38.44 |
| Vehicle QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 2; n= 38,39,38,39,33,32 | 0.11 Micromoles per liter (µmol/L) | Standard Deviation 8.059 |
| Vehicle QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Urate; Week 4; n=38,39,38,38,30,32 | 24.1 Micromoles per liter (µmol/L) | Standard Deviation 62.21 |
| Vehicle QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; EW; n=3,3,7,3,11,11 | 0.09 Micromoles per liter (µmol/L) | Standard Deviation 11.172 |
| Vehicle QD | Change From Baseline in Direct and Total Bilirubin, Creatinine and Urate | Creatinine; Week 14; n= 33,35,32,34,31,29 | 1.52 Micromoles per liter (µmol/L) | Standard Deviation 5.86 |
Secondary
Change From Baseline in Erythrocyte Count
Blood samples were collected to evaluate change from Baseline in erythrocytes and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.
Time frame: Weeks 2, 4, 8, 12, 14, EW (week up to 14)
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Erythrocyte Count | Week 2; n= 37,38,38,37,33,31 | -0.06 Tetra cells per liter (TI/L) | Standard Deviation 0.325 |
| GSK2894512 1% BID | Change From Baseline in Erythrocyte Count | Week 4; n= 38,38,38,37,30,31 | -0.12 Tetra cells per liter (TI/L) | Standard Deviation 0.347 |
| GSK2894512 1% BID | Change From Baseline in Erythrocyte Count | Week 8; n=34,36,34,37,29,27 | -0.10 Tetra cells per liter (TI/L) | Standard Deviation 0.371 |
| GSK2894512 1% BID | Change From Baseline in Erythrocyte Count | Week 12; n= 36,36,32,34,28,27 | -0.09 Tetra cells per liter (TI/L) | Standard Deviation 0.345 |
| GSK2894512 1% BID | Change From Baseline in Erythrocyte Count | Week 14; n= 33,33,32,32,31,28 | -0.20 Tetra cells per liter (TI/L) | Standard Deviation 0.342 |
| GSK2894512 1% BID | Change From Baseline in Erythrocyte Count | EW; n= 3,3,7,3,10,10 | -0.03 Tetra cells per liter (TI/L) | Standard Deviation 0.252 |
| GSK2894512 1% QD | Change From Baseline in Erythrocyte Count | Week 4; n= 38,38,38,37,30,31 | -0.10 Tetra cells per liter (TI/L) | Standard Deviation 0.256 |
| GSK2894512 1% QD | Change From Baseline in Erythrocyte Count | Week 12; n= 36,36,32,34,28,27 | -0.18 Tetra cells per liter (TI/L) | Standard Deviation 0.244 |
| GSK2894512 1% QD | Change From Baseline in Erythrocyte Count | EW; n= 3,3,7,3,10,10 | -0.07 Tetra cells per liter (TI/L) | Standard Deviation 0.321 |
| GSK2894512 1% QD | Change From Baseline in Erythrocyte Count | Week 2; n= 37,38,38,37,33,31 | -0.16 Tetra cells per liter (TI/L) | Standard Deviation 0.218 |
| GSK2894512 1% QD | Change From Baseline in Erythrocyte Count | Week 8; n=34,36,34,37,29,27 | -0.21 Tetra cells per liter (TI/L) | Standard Deviation 0.227 |
| GSK2894512 1% QD | Change From Baseline in Erythrocyte Count | Week 14; n= 33,33,32,32,31,28 | -0.22 Tetra cells per liter (TI/L) | Standard Deviation 0.262 |
| GSK2894512 0.5% BID | Change From Baseline in Erythrocyte Count | EW; n= 3,3,7,3,10,10 | -0.19 Tetra cells per liter (TI/L) | Standard Deviation 0.297 |
| GSK2894512 0.5% BID | Change From Baseline in Erythrocyte Count | Week 14; n= 33,33,32,32,31,28 | -0.21 Tetra cells per liter (TI/L) | Standard Deviation 0.229 |
| GSK2894512 0.5% BID | Change From Baseline in Erythrocyte Count | Week 12; n= 36,36,32,34,28,27 | -0.21 Tetra cells per liter (TI/L) | Standard Deviation 0.25 |
| GSK2894512 0.5% BID | Change From Baseline in Erythrocyte Count | Week 8; n=34,36,34,37,29,27 | -0.12 Tetra cells per liter (TI/L) | Standard Deviation 0.265 |
| GSK2894512 0.5% BID | Change From Baseline in Erythrocyte Count | Week 2; n= 37,38,38,37,33,31 | -0.15 Tetra cells per liter (TI/L) | Standard Deviation 0.287 |
| GSK2894512 0.5% BID | Change From Baseline in Erythrocyte Count | Week 4; n= 38,38,38,37,30,31 | -0.13 Tetra cells per liter (TI/L) | Standard Deviation 0.273 |
| GSK2894512 0.5% QD | Change From Baseline in Erythrocyte Count | Week 12; n= 36,36,32,34,28,27 | -0.15 Tetra cells per liter (TI/L) | Standard Deviation 0.191 |
| GSK2894512 0.5% QD | Change From Baseline in Erythrocyte Count | Week 4; n= 38,38,38,37,30,31 | -0.10 Tetra cells per liter (TI/L) | Standard Deviation 0.215 |
| GSK2894512 0.5% QD | Change From Baseline in Erythrocyte Count | Week 8; n=34,36,34,37,29,27 | -0.08 Tetra cells per liter (TI/L) | Standard Deviation 0.205 |
| GSK2894512 0.5% QD | Change From Baseline in Erythrocyte Count | EW; n= 3,3,7,3,10,10 | -0.13 Tetra cells per liter (TI/L) | Standard Deviation 0.153 |
| GSK2894512 0.5% QD | Change From Baseline in Erythrocyte Count | Week 14; n= 33,33,32,32,31,28 | -0.10 Tetra cells per liter (TI/L) | Standard Deviation 0.261 |
| GSK2894512 0.5% QD | Change From Baseline in Erythrocyte Count | Week 2; n= 37,38,38,37,33,31 | -0.12 Tetra cells per liter (TI/L) | Standard Deviation 0.26 |
| Vehicle BID | Change From Baseline in Erythrocyte Count | Week 2; n= 37,38,38,37,33,31 | -0.03 Tetra cells per liter (TI/L) | Standard Deviation 0.293 |
| Vehicle BID | Change From Baseline in Erythrocyte Count | Week 14; n= 33,33,32,32,31,28 | -0.03 Tetra cells per liter (TI/L) | Standard Deviation 0.33 |
| Vehicle BID | Change From Baseline in Erythrocyte Count | Week 4; n= 38,38,38,37,30,31 | -0.11 Tetra cells per liter (TI/L) | Standard Deviation 0.317 |
| Vehicle BID | Change From Baseline in Erythrocyte Count | Week 8; n=34,36,34,37,29,27 | -0.03 Tetra cells per liter (TI/L) | Standard Deviation 0.268 |
| Vehicle BID | Change From Baseline in Erythrocyte Count | Week 12; n= 36,36,32,34,28,27 | -0.09 Tetra cells per liter (TI/L) | Standard Deviation 0.314 |
| Vehicle BID | Change From Baseline in Erythrocyte Count | EW; n= 3,3,7,3,10,10 | 0.04 Tetra cells per liter (TI/L) | Standard Deviation 0.246 |
| Vehicle QD | Change From Baseline in Erythrocyte Count | Week 12; n= 36,36,32,34,28,27 | -0.15 Tetra cells per liter (TI/L) | Standard Deviation 0.262 |
| Vehicle QD | Change From Baseline in Erythrocyte Count | Week 8; n=34,36,34,37,29,27 | -0.14 Tetra cells per liter (TI/L) | Standard Deviation 0.318 |
| Vehicle QD | Change From Baseline in Erythrocyte Count | Week 14; n= 33,33,32,32,31,28 | -0.14 Tetra cells per liter (TI/L) | Standard Deviation 0.312 |
| Vehicle QD | Change From Baseline in Erythrocyte Count | EW; n= 3,3,7,3,10,10 | -0.03 Tetra cells per liter (TI/L) | Standard Deviation 0.267 |
| Vehicle QD | Change From Baseline in Erythrocyte Count | Week 4; n= 38,38,38,37,30,31 | -0.13 Tetra cells per liter (TI/L) | Standard Deviation 0.312 |
| Vehicle QD | Change From Baseline in Erythrocyte Count | Week 2; n= 37,38,38,37,33,31 | -0.12 Tetra cells per liter (TI/L) | Standard Deviation 0.241 |
Secondary
Change From Baseline in Hematocrit Levels
Blood samples were collected to evaluate change from Baseline in hematocrit and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.
Time frame: Week 2, 4, 8, 12, 14, EW (up to week 14)
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Hematocrit Levels | Week 8; n=34,36,34,37,29,27 | -0.0066 Proportion of red blood cells in blood | Standard Deviation 0.0316 |
| GSK2894512 1% BID | Change From Baseline in Hematocrit Levels | Week 2; n= 37,38,38,37,33,31 | -0.0054 Proportion of red blood cells in blood | Standard Deviation 0.0276 |
| GSK2894512 1% BID | Change From Baseline in Hematocrit Levels | EW; n= 3,3,7,3,10,10 | 0.0037 Proportion of red blood cells in blood | Standard Deviation 0.0123 |
| GSK2894512 1% BID | Change From Baseline in Hematocrit Levels | Week 4; n= 38,38,38,37,30,31 | -0.0107 Proportion of red blood cells in blood | Standard Deviation 0.0315 |
| GSK2894512 1% BID | Change From Baseline in Hematocrit Levels | Week 14; n= 33,33,32,32,31,28 | -0.0151 Proportion of red blood cells in blood | Standard Deviation 0.0292 |
| GSK2894512 1% BID | Change From Baseline in Hematocrit Levels | Week 12; n= 36,36,32,34,28,27 | -0.0054 Proportion of red blood cells in blood | Standard Deviation 0.0302 |
| GSK2894512 1% QD | Change From Baseline in Hematocrit Levels | Week 14; n= 33,33,32,32,31,28 | -0.0170 Proportion of red blood cells in blood | Standard Deviation 0.0236 |
| GSK2894512 1% QD | Change From Baseline in Hematocrit Levels | Week 8; n=34,36,34,37,29,27 | -0.0148 Proportion of red blood cells in blood | Standard Deviation 0.0225 |
| GSK2894512 1% QD | Change From Baseline in Hematocrit Levels | Week 2; n= 37,38,38,37,33,31 | -0.0132 Proportion of red blood cells in blood | Standard Deviation 0.0195 |
| GSK2894512 1% QD | Change From Baseline in Hematocrit Levels | Week 12; n= 36,36,32,34,28,27 | -0.0129 Proportion of red blood cells in blood | Standard Deviation 0.0222 |
| GSK2894512 1% QD | Change From Baseline in Hematocrit Levels | EW; n= 3,3,7,3,10,10 | -0.0063 Proportion of red blood cells in blood | Standard Deviation 0.0352 |
| GSK2894512 1% QD | Change From Baseline in Hematocrit Levels | Week 4; n= 38,38,38,37,30,31 | -0.0075 Proportion of red blood cells in blood | Standard Deviation 0.0241 |
| GSK2894512 0.5% BID | Change From Baseline in Hematocrit Levels | Week 4; n= 38,38,38,37,30,31 | -0.0081 Proportion of red blood cells in blood | Standard Deviation 0.0253 |
| GSK2894512 0.5% BID | Change From Baseline in Hematocrit Levels | Week 2; n= 37,38,38,37,33,31 | -0.0138 Proportion of red blood cells in blood | Standard Deviation 0.026 |
| GSK2894512 0.5% BID | Change From Baseline in Hematocrit Levels | Week 8; n=34,36,34,37,29,27 | -0.0091 Proportion of red blood cells in blood | Standard Deviation 0.0225 |
| GSK2894512 0.5% BID | Change From Baseline in Hematocrit Levels | Week 12; n= 36,36,32,34,28,27 | -0.0131 Proportion of red blood cells in blood | Standard Deviation 0.0205 |
| GSK2894512 0.5% BID | Change From Baseline in Hematocrit Levels | Week 14; n= 33,33,32,32,31,28 | -0.0132 Proportion of red blood cells in blood | Standard Deviation 0.0193 |
| GSK2894512 0.5% BID | Change From Baseline in Hematocrit Levels | EW; n= 3,3,7,3,10,10 | -0.0174 Proportion of red blood cells in blood | Standard Deviation 0.0292 |
| GSK2894512 0.5% QD | Change From Baseline in Hematocrit Levels | Week 12; n= 36,36,32,34,28,27 | -0.0106 Proportion of red blood cells in blood | Standard Deviation 0.0227 |
| GSK2894512 0.5% QD | Change From Baseline in Hematocrit Levels | Week 2; n= 37,38,38,37,33,31 | -0.0116 Proportion of red blood cells in blood | Standard Deviation 0.0246 |
| GSK2894512 0.5% QD | Change From Baseline in Hematocrit Levels | Week 8; n=34,36,34,37,29,27 | -0.0042 Proportion of red blood cells in blood | Standard Deviation 0.0235 |
| GSK2894512 0.5% QD | Change From Baseline in Hematocrit Levels | Week 4; n= 38,38,38,37,30,31 | -0.0075 Proportion of red blood cells in blood | Standard Deviation 0.0233 |
| GSK2894512 0.5% QD | Change From Baseline in Hematocrit Levels | EW; n= 3,3,7,3,10,10 | -0.0117 Proportion of red blood cells in blood | Standard Deviation 0.0133 |
| GSK2894512 0.5% QD | Change From Baseline in Hematocrit Levels | Week 14; n= 33,33,32,32,31,28 | -0.0063 Proportion of red blood cells in blood | Standard Deviation 0.0286 |
| Vehicle BID | Change From Baseline in Hematocrit Levels | Week 2; n= 37,38,38,37,33,31 | -0.0014 Proportion of red blood cells in blood | Standard Deviation 0.0267 |
| Vehicle BID | Change From Baseline in Hematocrit Levels | Week 14; n= 33,33,32,32,31,28 | -0.0007 Proportion of red blood cells in blood | Standard Deviation 0.0277 |
| Vehicle BID | Change From Baseline in Hematocrit Levels | Week 12; n= 36,36,32,34,28,27 | -0.0052 Proportion of red blood cells in blood | Standard Deviation 0.0312 |
| Vehicle BID | Change From Baseline in Hematocrit Levels | EW; n= 3,3,7,3,10,10 | 0.0027 Proportion of red blood cells in blood | Standard Deviation 0.0152 |
| Vehicle BID | Change From Baseline in Hematocrit Levels | Week 8; n=34,36,34,37,29,27 | -0.0011 Proportion of red blood cells in blood | Standard Deviation 0.0264 |
| Vehicle BID | Change From Baseline in Hematocrit Levels | Week 4; n= 38,38,38,37,30,31 | -0.0090 Proportion of red blood cells in blood | Standard Deviation 0.0283 |
| Vehicle QD | Change From Baseline in Hematocrit Levels | Week 8; n=34,36,34,37,29,27 | -0.0124 Proportion of red blood cells in blood | Standard Deviation 0.0314 |
| Vehicle QD | Change From Baseline in Hematocrit Levels | Week 12; n= 36,36,32,34,28,27 | -0.0111 Proportion of red blood cells in blood | Standard Deviation 0.024 |
| Vehicle QD | Change From Baseline in Hematocrit Levels | Week 2; n= 37,38,38,37,33,31 | -0.0095 Proportion of red blood cells in blood | Standard Deviation 0.0239 |
| Vehicle QD | Change From Baseline in Hematocrit Levels | Week 14; n= 33,33,32,32,31,28 | -0.0117 Proportion of red blood cells in blood | Standard Deviation 0.0292 |
| Vehicle QD | Change From Baseline in Hematocrit Levels | EW; n= 3,3,7,3,10,10 | 0.0048 Proportion of red blood cells in blood | Standard Deviation 0.0248 |
| Vehicle QD | Change From Baseline in Hematocrit Levels | Week 4; n= 38,38,38,37,30,31 | -0.0123 Proportion of red blood cells in blood | Standard Deviation 0.0295 |
Secondary
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)
Blood samples were collected to evaluate change from Baseline in hemoglobin and MCHC and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.
Time frame: Week 2, 4, 8, 12, 14, EW (up to week 14)
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 14; n= 33,33,32,32,31,28 | -5.5 G/L | Standard Deviation 9.25 |
| GSK2894512 1% BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 2; n= 37,38,38,37,33,31 | 0.1 G/L | Standard Deviation 7.47 |
| GSK2894512 1% BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; EW; n= 3,3,7,3,10,10 | 0.7 G/L | Standard Deviation 11.59 |
| GSK2894512 1% BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 4; n= 38,38,38,37,30,31 | -3.2 G/L | Standard Deviation 8.88 |
| GSK2894512 1% BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 14; n= 33,33,32,32,31,28 | -1.2 G/L | Standard Deviation 11.15 |
| GSK2894512 1% BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 12; n= 36,36,32,34,28,27 | -1.0 G/L | Standard Deviation 10.23 |
| GSK2894512 1% BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 8; n=34,36,34,37,29,27 | -2.7 G/L | Standard Deviation 9.64 |
| GSK2894512 1% BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 8; n=34,36,34,37,29,27 | -1.1 G/L | Standard Deviation 9.28 |
| GSK2894512 1% BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 2; n= 37,38,38,37,33,31 | -1.8 G/L | Standard Deviation 9.02 |
| GSK2894512 1% BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 12; n= 36,36,32,34,28,27 | -2.3 G/L | Standard Deviation 9.33 |
| GSK2894512 1% BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; EW; n= 3,3,7,3,10,10 | -1.7 G/L | Standard Deviation 20.26 |
| GSK2894512 1% BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 4; n= 38,38,38,37,30,31 | 0.9 G/L | Standard Deviation 8.89 |
| GSK2894512 1% QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 4; n= 38,38,38,37,30,31 | -0.3 G/L | Standard Deviation 9.51 |
| GSK2894512 1% QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 14; n= 33,33,32,32,31,28 | -3.9 G/L | Standard Deviation 6.76 |
| GSK2894512 1% QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 14; n= 33,33,32,32,31,28 | 3.9 G/L | Standard Deviation 10.96 |
| GSK2894512 1% QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 8; n=34,36,34,37,29,27 | -4.6 G/L | Standard Deviation 6.43 |
| GSK2894512 1% QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; EW; n= 3,3,7,3,10,10 | -1.3 G/L | Standard Deviation 11.59 |
| GSK2894512 1% QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; EW; n= 3,3,7,3,10,10 | 1.7 G/L | Standard Deviation 2.52 |
| GSK2894512 1% QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 8; n=34,36,34,37,29,27 | 0.4 G/L | Standard Deviation 11.61 |
| GSK2894512 1% QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 4; n= 38,38,38,37,30,31 | -2.7 G/L | Standard Deviation 6.42 |
| GSK2894512 1% QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 2; n= 37,38,38,37,33,31 | -3.8 G/L | Standard Deviation 5.54 |
| GSK2894512 1% QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 12; n= 36,36,32,34,28,27 | -4.2 G/L | Standard Deviation 6.61 |
| GSK2894512 1% QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 12; n= 36,36,32,34,28,27 | 0.1 G/L | Standard Deviation 11.12 |
| GSK2894512 1% QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 2; n= 37,38,38,37,33,31 | 0.9 G/L | Standard Deviation 7.83 |
| GSK2894512 0.5% BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 4; n= 38,38,38,37,30,31 | -1.9 G/L | Standard Deviation 9.53 |
| GSK2894512 0.5% BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 2; n= 37,38,38,37,33,31 | -4.3 G/L | Standard Deviation 8.08 |
| GSK2894512 0.5% BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 4; n= 38,38,38,37,30,31 | -3.5 G/L | Standard Deviation 7.72 |
| GSK2894512 0.5% BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 8; n=34,36,34,37,29,27 | -3.7 G/L | Standard Deviation 6.9 |
| GSK2894512 0.5% BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 12; n= 36,36,32,34,28,27 | -5.2 G/L | Standard Deviation 6.77 |
| GSK2894512 0.5% BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 14; n= 33,33,32,32,31,28 | -5.2 G/L | Standard Deviation 6.73 |
| GSK2894512 0.5% BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; EW; n= 3,3,7,3,10,10 | -6.0 G/L | Standard Deviation 8.47 |
| GSK2894512 0.5% BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 2; n= 37,38,38,37,33,31 | 0.8 G/L | Standard Deviation 6.65 |
| GSK2894512 0.5% BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 8; n=34,36,34,37,29,27 | -1.9 G/L | Standard Deviation 8.69 |
| GSK2894512 0.5% BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 12; n= 36,36,32,34,28,27 | -2.5 G/L | Standard Deviation 10.95 |
| GSK2894512 0.5% BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 14; n= 33,33,32,32,31,28 | -2.2 G/L | Standard Deviation 10.24 |
| GSK2894512 0.5% BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; EW; n= 3,3,7,3,10,10 | -1.1 G/L | Standard Deviation 10.64 |
| GSK2894512 0.5% QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 4; n= 38,38,38,37,30,31 | -2.4 G/L | Standard Deviation 6.27 |
| GSK2894512 0.5% QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 14; n= 33,33,32,32,31,28 | 0.7 G/L | Standard Deviation 10.42 |
| GSK2894512 0.5% QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 4; n= 38,38,38,37,30,31 | 0.2 G/L | Standard Deviation 9.62 |
| GSK2894512 0.5% QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; EW; n= 3,3,7,3,10,10 | -2.0 G/L | Standard Deviation 9 |
| GSK2894512 0.5% QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 14; n= 33,33,32,32,31,28 | -1.8 G/L | Standard Deviation 8.17 |
| GSK2894512 0.5% QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 2; n= 37,38,38,37,33,31 | -2.8 G/L | Standard Deviation 6.78 |
| GSK2894512 0.5% QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 8; n=34,36,34,37,29,27 | -1.6 G/L | Standard Deviation 6.7 |
| GSK2894512 0.5% QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 2; n= 37,38,38,37,33,31 | 2.0 G/L | Standard Deviation 10.23 |
| GSK2894512 0.5% QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 8; n=34,36,34,37,29,27 | -0.5 G/L | Standard Deviation 11.02 |
| GSK2894512 0.5% QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 12; n= 36,36,32,34,28,27 | -3.1 G/L | Standard Deviation 5.58 |
| GSK2894512 0.5% QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; EW; n= 3,3,7,3,10,10 | 3.3 G/L | Standard Deviation 12.86 |
| GSK2894512 0.5% QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 12; n= 36,36,32,34,28,27 | 0.9 G/L | Standard Deviation 10.85 |
| Vehicle BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 8; n=34,36,34,37,29,27 | -0.5 G/L | Standard Deviation 10.28 |
| Vehicle BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 2; n= 37,38,38,37,33,31 | -1.4 G/L | Standard Deviation 8.37 |
| Vehicle BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; EW; n= 3,3,7,3,10,10 | -2.2 G/L | Standard Deviation 5.25 |
| Vehicle BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 8; n=34,36,34,37,29,27 | -0.8 G/L | Standard Deviation 7.59 |
| Vehicle BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 14; n= 33,33,32,32,31,28 | -1.0 G/L | Standard Deviation 11.18 |
| Vehicle BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 12; n= 36,36,32,34,28,27 | -2.5 G/L | Standard Deviation 9.52 |
| Vehicle BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 4; n= 38,38,38,37,30,31 | 0.0 G/L | Standard Deviation 9.14 |
| Vehicle BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 14; n= 33,33,32,32,31,28 | -0.8 G/L | Standard Deviation 8.51 |
| Vehicle BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 2; n= 37,38,38,37,33,31 | -0.9 G/L | Standard Deviation 8.76 |
| Vehicle BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 12; n= 36,36,32,34,28,27 | -1.4 G/L | Standard Deviation 10.77 |
| Vehicle BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; EW; n= 3,3,7,3,10,10 | 0.0 G/L | Standard Deviation 3.77 |
| Vehicle BID | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 4; n= 38,38,38,37,30,31 | -3.0 G/L | Standard Deviation 9.17 |
| Vehicle QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; EW; n= 3,3,7,3,10,10 | -1.1 G/L | Standard Deviation 5.69 |
| Vehicle QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 12; n= 36,36,32,34,28,27 | -4.4 G/L | Standard Deviation 6.63 |
| Vehicle QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 12; n= 36,36,32,34,28,27 | -1.8 G/L | Standard Deviation 9.95 |
| Vehicle QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 2; n= 37,38,38,37,33,31 | 8.37 G/L | Standard Deviation 8.92 |
| Vehicle QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 8; n=34,36,34,37,29,27 | -4.6 G/L | Standard Deviation 9.72 |
| Vehicle QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 4; n= 38,38,38,37,30,31 | 0.1 G/L | Standard Deviation 8.17 |
| Vehicle QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; EW; n= 3,3,7,3,10,10 | -6.6 G/L | Standard Deviation 9.09 |
| Vehicle QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 8; n=34,36,34,37,29,27 | -1.3 G/L | Standard Deviation 8.96 |
| Vehicle QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 4; n= 38,38,38,37,30,31 | -4.1 G/L | Standard Deviation 9.05 |
| Vehicle QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 2; n= 37,38,38,37,33,31 | -3.0 G/L | Standard Deviation 6.55 |
| Vehicle QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Week 14; n= 33,33,32,32,31,28 | -0.1 G/L | Standard Deviation 8.59 |
| Vehicle QD | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Week 14; n= 33,33,32,32,31,28 | -4.0 G/L | Standard Deviation 7.93 |
Secondary
Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels
Blood samples were collected to evaluate change from Baseline in IgA, IgG, IM values at Baseline throughout the 12 weeks of study treatment. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.
Time frame: Week, 4, 8 and 12
Population: Safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgM; Week 8; n= 35,37,34,38,29,28 | -0.070 G/L | Standard Deviation 0.1069 |
| GSK2894512 1% BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgM; Week 12; n= 36,37,32,35,28,27 | -0.055 G/L | Standard Deviation 0.1852 |
| GSK2894512 1% BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgA; Week 12; n= 36,37,32,35,28,27 | -0.056 G/L | Standard Deviation 0.282 |
| GSK2894512 1% BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgG; Week 12; n= 36,37,32,35,28,27 | -0.033 G/L | Standard Deviation 1.2978 |
| GSK2894512 1% BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgM; Week 4; n=37,38,38,38,30,32 | -0.049 G/L | Standard Deviation 0.1524 |
| GSK2894512 1% BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgG; Week 8; n= 35,37,34,38,29,28 | -0.007 G/L | Standard Deviation 1.2785 |
| GSK2894512 1% BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgA; Week 8; n= 35,37,34,38,29,28 | -0.064 G/L | Standard Deviation 0.2558 |
| GSK2894512 1% BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgA; Week 4; n= 37,38,38,38,30,32 | -0.016 G/L | Standard Deviation 0.2528 |
| GSK2894512 1% BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgG; Week 4; n= 37,38,38,38,30,32 | -0.130 G/L | Standard Deviation 1.0945 |
| GSK2894512 1% QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgM; Week 12; n= 36,37,32,35,28,27 | -0.098 G/L | Standard Deviation 0.1955 |
| GSK2894512 1% QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgG; Week 12; n= 36,37,32,35,28,27 | -0.436 G/L | Standard Deviation 3.8561 |
| GSK2894512 1% QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgA; Week 8; n= 35,37,34,38,29,28 | -0.116 G/L | Standard Deviation 0.2314 |
| GSK2894512 1% QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgA; Week 12; n= 36,37,32,35,28,27 | -0.099 G/L | Standard Deviation 0.6148 |
| GSK2894512 1% QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgA; Week 4; n= 37,38,38,38,30,32 | -0.103 G/L | Standard Deviation 0.2108 |
| GSK2894512 1% QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgM; Week 8; n= 35,37,34,38,29,28 | -0.095 G/L | Standard Deviation 0.1314 |
| GSK2894512 1% QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgG; Week 4; n= 37,38,38,38,30,32 | -0.446 G/L | Standard Deviation 0.8854 |
| GSK2894512 1% QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgM; Week 4; n=37,38,38,38,30,32 | -0.102 G/L | Standard Deviation 0.1514 |
| GSK2894512 1% QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgG; Week 8; n= 35,37,34,38,29,28 | -0.457 G/L | Standard Deviation 1.0787 |
| GSK2894512 0.5% BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgA; Week 8; n= 35,37,34,38,29,28 | -0.056 G/L | Standard Deviation 0.257 |
| GSK2894512 0.5% BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgG; Week 12; n= 36,37,32,35,28,27 | -0.367 G/L | Standard Deviation 1.0214 |
| GSK2894512 0.5% BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgG; Week 4; n= 37,38,38,38,30,32 | -0.282 G/L | Standard Deviation 1.2618 |
| GSK2894512 0.5% BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgM; Week 8; n= 35,37,34,38,29,28 | -0.111 G/L | Standard Deviation 0.129 |
| GSK2894512 0.5% BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgM; Week 12; n= 36,37,32,35,28,27 | -0.125 G/L | Standard Deviation 0.1233 |
| GSK2894512 0.5% BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgA; Week 12; n= 36,37,32,35,28,27 | -0.140 G/L | Standard Deviation 0.2207 |
| GSK2894512 0.5% BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgM; Week 4; n=37,38,38,38,30,32 | -0.077 G/L | Standard Deviation 0.0968 |
| GSK2894512 0.5% BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgG; Week 8; n= 35,37,34,38,29,28 | -0.121 G/L | Standard Deviation 1.4233 |
| GSK2894512 0.5% BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgA; Week 4; n= 37,38,38,38,30,32 | -0.079 G/L | Standard Deviation 0.2003 |
| GSK2894512 0.5% QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgG; Week 12; n= 36,37,32,35,28,27 | -0.269 G/L | Standard Deviation 0.9239 |
| GSK2894512 0.5% QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgA; Week 4; n= 37,38,38,38,30,32 | -0.026 G/L | Standard Deviation 0.2342 |
| GSK2894512 0.5% QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgA; Week 8; n= 35,37,34,38,29,28 | 0.035 G/L | Standard Deviation 0.2188 |
| GSK2894512 0.5% QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgA; Week 12; n= 36,37,32,35,28,27 | -0.042 G/L | Standard Deviation 0.2657 |
| GSK2894512 0.5% QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgG; Week 4; n= 37,38,38,38,30,32 | -0.347 G/L | Standard Deviation 1.1148 |
| GSK2894512 0.5% QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgG; Week 8; n= 35,37,34,38,29,28 | -0.200 G/L | Standard Deviation 1.1449 |
| GSK2894512 0.5% QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgM; Week 4; n=37,38,38,38,30,32 | -0.043 G/L | Standard Deviation 0.1303 |
| GSK2894512 0.5% QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgM; Week 8; n= 35,37,34,38,29,28 | -0.052 G/L | Standard Deviation 0.1167 |
| GSK2894512 0.5% QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgM; Week 12; n= 36,37,32,35,28,27 | -0.072 G/L | Standard Deviation 0.1112 |
| Vehicle BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgG; Week 8; n= 35,37,34,38,29,28 | 0.428 G/L | Standard Deviation 1.1984 |
| Vehicle BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgG; Week 4; n= 37,38,38,38,30,32 | -0.198 G/L | Standard Deviation 1.2753 |
| Vehicle BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgM; Week 4; n=37,38,38,38,30,32 | -0.052 G/L | Standard Deviation 0.0933 |
| Vehicle BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgA; Week 12; n= 36,37,32,35,28,27 | -0.038 G/L | Standard Deviation 0.1744 |
| Vehicle BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgM; Week 12; n= 36,37,32,35,28,27 | -0.047 G/L | Standard Deviation 0.13 |
| Vehicle BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgM; Week 8; n= 35,37,34,38,29,28 | -0.014 G/L | Standard Deviation 0.1396 |
| Vehicle BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgA; Week 8; n= 35,37,34,38,29,28 | 0.026 G/L | Standard Deviation 0.2695 |
| Vehicle BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgA; Week 4; n= 37,38,38,38,30,32 | -0.046 G/L | Standard Deviation 0.2179 |
| Vehicle BID | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgG; Week 12; n= 36,37,32,35,28,27 | 0.256 G/L | Standard Deviation 1.5915 |
| Vehicle QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgA; Week 4; n= 37,38,38,38,30,32 | -0.045 G/L | Standard Deviation 0.3141 |
| Vehicle QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgG; Week 4; n= 37,38,38,38,30,32 | -0.112 G/L | Standard Deviation 1.1564 |
| Vehicle QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgG; Week 12; n= 36,37,32,35,28,27 | 0.331 G/L | Standard Deviation 0.8796 |
| Vehicle QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgM; Week 12; n= 36,37,32,35,28,27 | -0.034 G/L | Standard Deviation 0.085 |
| Vehicle QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgM; Week 8; n= 35,37,34,38,29,28 | -0.040 G/L | Standard Deviation 0.0956 |
| Vehicle QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgM; Week 4; n=37,38,38,38,30,32 | -0.040 G/L | Standard Deviation 0.0886 |
| Vehicle QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgA; Week 12; n= 36,37,32,35,28,27 | -0.016 G/L | Standard Deviation 0.2462 |
| Vehicle QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgG; Week 8; n= 35,37,34,38,29,28 | 0.203 G/L | Standard Deviation 1.4037 |
| Vehicle QD | Change From Baseline in Immunoglobin (Ig) A, IgG and IgM Levels | IgA; Week 8; n= 35,37,34,38,29,28 | -0.036 G/L | Standard Deviation 0.3106 |
Secondary
Change From Baseline in Mean Corpuscle Hemoglobin (MCH)
Blood samples were collected to evaluate change from Baseline in MCH and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.
Time frame: Week 2, 4, 8, 12, 14, EW (up to week 14)
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 2; n= 37,38,38,37,33,31 | 0.05 Picogram (Pg) | Standard Deviation 0.425 |
| GSK2894512 1% BID | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 4; n= 38,38,38,37,30,31 | 0.09 Picogram (Pg) | Standard Deviation 0.535 |
| GSK2894512 1% BID | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 8; n=34,36,34,37,29,27 | 0.03 Picogram (Pg) | Standard Deviation 0.635 |
| GSK2894512 1% BID | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 12; n= 36,36,32,34,28,27 | 0.14 Picogram (Pg) | Standard Deviation 0.708 |
| GSK2894512 1% BID | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 14; n= 33,33,32,32,31,28 | 0.06 Picogram (Pg) | Standard Deviation 0.9 |
| GSK2894512 1% BID | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | EW; n= 3,3,7,3,10,10 | 0.57 Picogram (Pg) | Standard Deviation 1.361 |
| GSK2894512 1% QD | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 4; n= 38,38,38,37,30,31 | 0.06 Picogram (Pg) | Standard Deviation 0.593 |
| GSK2894512 1% QD | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 12; n= 36,36,32,34,28,27 | 0.14 Picogram (Pg) | Standard Deviation 0.79 |
| GSK2894512 1% QD | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | EW; n= 3,3,7,3,10,10 | 0.03 Picogram (Pg) | Standard Deviation 0.702 |
| GSK2894512 1% QD | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 2; n= 37,38,38,37,33,31 | 0.09 Picogram (Pg) | Standard Deviation 0.595 |
| GSK2894512 1% QD | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 8; n=34,36,34,37,29,27 | 0.21 Picogram (Pg) | Standard Deviation 0.747 |
| GSK2894512 1% QD | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 14; n= 33,33,32,32,31,28 | 0.55 Picogram (Pg) | Standard Deviation 0.806 |
| GSK2894512 0.5% BID | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | EW; n= 3,3,7,3,10,10 | -0.19 Picogram (Pg) | Standard Deviation 0.596 |
| GSK2894512 0.5% BID | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 14; n= 33,33,32,32,31,28 | 0.08 Picogram (Pg) | Standard Deviation 0.449 |
| GSK2894512 0.5% BID | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 12; n= 36,36,32,34,28,27 | 0.10 Picogram (Pg) | Standard Deviation 0.506 |
| GSK2894512 0.5% BID | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 8; n=34,36,34,37,29,27 | -0.06 Picogram (Pg) | Standard Deviation 0.536 |
| GSK2894512 0.5% BID | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 2; n= 37,38,38,37,33,31 | 0.06 Picogram (Pg) | Standard Deviation 0.408 |
| GSK2894512 0.5% BID | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 4; n= 38,38,38,37,30,31 | -0.01 Picogram (Pg) | Standard Deviation 0.519 |
| GSK2894512 0.5% QD | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 12; n= 36,36,32,34,28,27 | 0.30 Picogram (Pg) | Standard Deviation 0.815 |
| GSK2894512 0.5% QD | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 4; n= 38,38,38,37,30,31 | 0.15 Picogram (Pg) | Standard Deviation 0.567 |
| GSK2894512 0.5% QD | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 8; n=34,36,34,37,29,27 | 0.22 Picogram (Pg) | Standard Deviation 0.781 |
| GSK2894512 0.5% QD | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | EW; n= 3,3,7,3,10,10 | 0.63 Picogram (Pg) | Standard Deviation 0.808 |
| GSK2894512 0.5% QD | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 14; n= 33,33,32,32,31,28 | 0.28 Picogram (Pg) | Standard Deviation 0.612 |
| GSK2894512 0.5% QD | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 2; n= 37,38,38,37,33,31 | 0.19 Picogram (Pg) | Standard Deviation 0.667 |
| Vehicle BID | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 2; n= 37,38,38,37,33,31 | 0.04 Picogram (Pg) | Standard Deviation 0.415 |
| Vehicle BID | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 14; n= 33,33,32,32,31,28 | 0.06 Picogram (Pg) | Standard Deviation 0.804 |
| Vehicle BID | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 4; n= 38,38,38,37,30,31 | 0.06 Picogram (Pg) | Standard Deviation 0.518 |
| Vehicle BID | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 8; n=34,36,34,37,29,27 | 0.02 Picogram (Pg) | Standard Deviation 0.599 |
| Vehicle BID | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 12; n= 36,36,32,34,28,27 | 0.04 Picogram (Pg) | Standard Deviation 0.588 |
| Vehicle BID | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | EW; n= 3,3,7,3,10,10 | -0.13 Picogram (Pg) | Standard Deviation 0.933 |
| Vehicle QD | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 12; n= 36,36,32,34,28,27 | 0.06 Picogram (Pg) | Standard Deviation 0.806 |
| Vehicle QD | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 8; n=34,36,34,37,29,27 | -0.07 Picogram (Pg) | Standard Deviation 0.64 |
| Vehicle QD | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 14; n= 33,33,32,32,31,28 | -0.01 Picogram (Pg) | Standard Deviation 0.589 |
| Vehicle QD | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | EW; n= 3,3,7,3,10,10 | -0.15 Picogram (Pg) | Standard Deviation 0.542 |
| Vehicle QD | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 4; n= 38,38,38,37,30,31 | -0.05 Picogram (Pg) | Standard Deviation 0.528 |
| Vehicle QD | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) | Week 2; n= 37,38,38,37,33,31 | 0.05 Picogram (Pg) | Standard Deviation 0.49 |
Secondary
Change From Baseline in Mean Corpuscle Volume (MCV)
Blood samples were collected to evaluate change from Baseline in MCV and values at Baseline throughout the 12 weeks of study treatment and follow up visit 1 at Week 14. Baseline values were taken at Day 1 and change from Baseline was defined as post-dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.
Time frame: Week 2, 4, 8, 12, 14, EW (up to week 14)
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Mean Corpuscle Volume (MCV) | EW; n= 3,3,7,3,10,10 | 1.7 Femtoliter (fL) | Standard Deviation 1.53 |
| GSK2894512 1% BID | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 8; n=34,36,34,37,29,27 | 0.5 Femtoliter (fL) | Standard Deviation 2.42 |
| GSK2894512 1% BID | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 14; n= 33,33,32,32,31,28 | 0.6 Femtoliter (fL) | Standard Deviation 2.92 |
| GSK2894512 1% BID | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 12; n= 36,36,32,34,28,27 | 0.8 Femtoliter (fL) | Standard Deviation 2.8 |
| GSK2894512 1% BID | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 2; n= 37,38,38,37,33,31 | 0.2 Femtoliter (fL) | Standard Deviation 2.02 |
| GSK2894512 1% BID | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 4; n= 38,38,38,37,30,31 | 0.1 Femtoliter (fL) | Standard Deviation 1.75 |
| GSK2894512 1% QD | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 12; n= 36,36,32,34,28,27 | 0.3 Femtoliter (fL) | Standard Deviation 2.68 |
| GSK2894512 1% QD | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 2; n= 37,38,38,37,33,31 | -0.2 Femtoliter (fL) | Standard Deviation 1.45 |
| GSK2894512 1% QD | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 8; n=34,36,34,37,29,27 | 0.5 Femtoliter (fL) | Standard Deviation 2.52 |
| GSK2894512 1% QD | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 14; n= 33,33,32,32,31,28 | 0.4 Femtoliter (fL) | Standard Deviation 2.54 |
| GSK2894512 1% QD | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 4; n= 38,38,38,37,30,31 | 0.2 Femtoliter (fL) | Standard Deviation 2.04 |
| GSK2894512 1% QD | Change From Baseline in Mean Corpuscle Volume (MCV) | EW; n= 3,3,7,3,10,10 | -0.7 Femtoliter (fL) | Standard Deviation 2.08 |
| GSK2894512 0.5% BID | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 8; n=34,36,34,37,29,27 | 0.4 Femtoliter (fL) | Standard Deviation 1.78 |
| GSK2894512 0.5% BID | Change From Baseline in Mean Corpuscle Volume (MCV) | EW; n= 3,3,7,3,10,10 | -0.4 Femtoliter (fL) | Standard Deviation 2.15 |
| GSK2894512 0.5% BID | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 4; n= 38,38,38,37,30,31 | 0.5 Femtoliter (fL) | Standard Deviation 1.94 |
| GSK2894512 0.5% BID | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 2; n= 37,38,38,37,33,31 | -0.1 Femtoliter (fL) | Standard Deviation 1.47 |
| GSK2894512 0.5% BID | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 12; n= 36,36,32,34,28,27 | 1.0 Femtoliter (fL) | Standard Deviation 2.62 |
| GSK2894512 0.5% BID | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 14; n= 33,33,32,32,31,28 | 0.9 Femtoliter (fL) | Standard Deviation 2.54 |
| GSK2894512 0.5% QD | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 12; n= 36,36,32,34,28,27 | 0.6 Femtoliter (fL) | Standard Deviation 3.2 |
| GSK2894512 0.5% QD | Change From Baseline in Mean Corpuscle Volume (MCV) | EW; n= 3,3,7,3,10,10 | 1.0 Femtoliter (fL) | Standard Deviation 1 |
| GSK2894512 0.5% QD | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 4; n= 38,38,38,37,30,31 | 0.4 Femtoliter (fL) | Standard Deviation 2.8 |
| GSK2894512 0.5% QD | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 2; n= 37,38,38,37,33,31 | -0.1 Femtoliter (fL) | Standard Deviation 2.37 |
| GSK2894512 0.5% QD | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 8; n=34,36,34,37,29,27 | 0.7 Femtoliter (fL) | Standard Deviation 2.9 |
| GSK2894512 0.5% QD | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 14; n= 33,33,32,32,31,28 | 0.7 Femtoliter (fL) | Standard Deviation 2.37 |
| Vehicle BID | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 8; n=34,36,34,37,29,27 | 0.2 Femtoliter (fL) | Standard Deviation 2.39 |
| Vehicle BID | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 14; n= 33,33,32,32,31,28 | 0.4 Femtoliter (fL) | Standard Deviation 3.19 |
| Vehicle BID | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 12; n= 36,36,32,34,28,27 | 0.5 Femtoliter (fL) | Standard Deviation 3.06 |
| Vehicle BID | Change From Baseline in Mean Corpuscle Volume (MCV) | EW; n= 3,3,7,3,10,10 | -0.1 Femtoliter (fL) | Standard Deviation 2.81 |
| Vehicle BID | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 2; n= 37,38,38,37,33,31 | 0.5 Femtoliter (fL) | Standard Deviation 1.87 |
| Vehicle BID | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 4; n= 38,38,38,37,30,31 | 0.1 Femtoliter (fL) | Standard Deviation 1.9 |
| Vehicle QD | Change From Baseline in Mean Corpuscle Volume (MCV) | EW; n= 3,3,7,3,10,10 | 1.4 Femtoliter (fL) | Standard Deviation 2.59 |
| Vehicle QD | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 2; n= 37,38,38,37,33,31 | 0.1 Femtoliter (fL) | Standard Deviation 1.83 |
| Vehicle QD | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 4; n= 38,38,38,37,30,31 | -0.3 Femtoliter (fL) | Standard Deviation 1.85 |
| Vehicle QD | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 8; n=34,36,34,37,29,27 | 0.0 Femtoliter (fL) | Standard Deviation 2.01 |
| Vehicle QD | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 12; n= 36,36,32,34,28,27 | 0.5 Femtoliter (fL) | Standard Deviation 1.99 |
| Vehicle QD | Change From Baseline in Mean Corpuscle Volume (MCV) | Week 14; n= 33,33,32,32,31,28 | -0.1 Femtoliter (fL) | Standard Deviation 2.25 |
Secondary
Change From Baseline in Pulse Rate
Pulse rate were measured from Baseline up to follow up Visit 1 at Week 14 in semi-supine position after at least 5 minutes of rest. The Baseline value was taken at Day 1 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.
Time frame: Week 1, 2, 4, 8, 12, 14, EW (up to week 14)
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Pulse Rate | Week 1; n= 38,41,39,37,38,33 | 5.8 Beats per minute (bpm) | Standard Deviation 9.19 |
| GSK2894512 1% BID | Change From Baseline in Pulse Rate | Week 12; n= 36,37,32,35,28,28 | 3.0 Beats per minute (bpm) | Standard Deviation 10.03 |
| GSK2894512 1% BID | Change From Baseline in Pulse Rate | Week 2; n= 39,39,39,39,33,32 | 3.7 Beats per minute (bpm) | Standard Deviation 10.67 |
| GSK2894512 1% BID | Change From Baseline in Pulse Rate | EW; n= 3,4,7,3,11,11 | -13.7 Beats per minute (bpm) | Standard Deviation 1.15 |
| GSK2894512 1% BID | Change From Baseline in Pulse Rate | Week 4; n= 38,39,38,39,30,32 | 6.2 Beats per minute (bpm) | Standard Deviation 10.02 |
| GSK2894512 1% BID | Change From Baseline in Pulse Rate | Week 14; n= 34,35,32,34,31,29 | 3.3 Beats per minute (bpm) | Standard Deviation 9.38 |
| GSK2894512 1% BID | Change From Baseline in Pulse Rate | Week 8; n= 36,37,34,38,29,28 | 4.1 Beats per minute (bpm) | Standard Deviation 9.72 |
| GSK2894512 1% QD | Change From Baseline in Pulse Rate | Week 2; n= 39,39,39,39,33,32 | 2.3 Beats per minute (bpm) | Standard Deviation 10.9 |
| GSK2894512 1% QD | Change From Baseline in Pulse Rate | Week 8; n= 36,37,34,38,29,28 | 0.6 Beats per minute (bpm) | Standard Deviation 10.27 |
| GSK2894512 1% QD | Change From Baseline in Pulse Rate | Week 4; n= 38,39,38,39,30,32 | 0.6 Beats per minute (bpm) | Standard Deviation 10.79 |
| GSK2894512 1% QD | Change From Baseline in Pulse Rate | Week 12; n= 36,37,32,35,28,28 | -0.0 Beats per minute (bpm) | Standard Deviation 11.55 |
| GSK2894512 1% QD | Change From Baseline in Pulse Rate | Week 1; n= 38,41,39,37,38,33 | 2.5 Beats per minute (bpm) | Standard Deviation 8.68 |
| GSK2894512 1% QD | Change From Baseline in Pulse Rate | EW; n= 3,4,7,3,11,11 | 0.3 Beats per minute (bpm) | Standard Deviation 3.5 |
| GSK2894512 1% QD | Change From Baseline in Pulse Rate | Week 14; n= 34,35,32,34,31,29 | 3.5 Beats per minute (bpm) | Standard Deviation 11.65 |
| GSK2894512 0.5% BID | Change From Baseline in Pulse Rate | Week 4; n= 38,39,38,39,30,32 | -0.3 Beats per minute (bpm) | Standard Deviation 12.3 |
| GSK2894512 0.5% BID | Change From Baseline in Pulse Rate | Week 2; n= 39,39,39,39,33,32 | 0.1 Beats per minute (bpm) | Standard Deviation 9.63 |
| GSK2894512 0.5% BID | Change From Baseline in Pulse Rate | Week 1; n= 38,41,39,37,38,33 | 0.8 Beats per minute (bpm) | Standard Deviation 10.19 |
| GSK2894512 0.5% BID | Change From Baseline in Pulse Rate | Week 12; n= 36,37,32,35,28,28 | 0.0 Beats per minute (bpm) | Standard Deviation 10.08 |
| GSK2894512 0.5% BID | Change From Baseline in Pulse Rate | Week 14; n= 34,35,32,34,31,29 | 0.6 Beats per minute (bpm) | Standard Deviation 10 |
| GSK2894512 0.5% BID | Change From Baseline in Pulse Rate | Week 8; n= 36,37,34,38,29,28 | -1.7 Beats per minute (bpm) | Standard Deviation 9.59 |
| GSK2894512 0.5% BID | Change From Baseline in Pulse Rate | EW; n= 3,4,7,3,11,11 | -6.0 Beats per minute (bpm) | Standard Deviation 9.83 |
| GSK2894512 0.5% QD | Change From Baseline in Pulse Rate | Week 8; n= 36,37,34,38,29,28 | 3.2 Beats per minute (bpm) | Standard Deviation 11.23 |
| GSK2894512 0.5% QD | Change From Baseline in Pulse Rate | Week 1; n= 38,41,39,37,38,33 | -0.4 Beats per minute (bpm) | Standard Deviation 9.39 |
| GSK2894512 0.5% QD | Change From Baseline in Pulse Rate | Week 2; n= 39,39,39,39,33,32 | 1.0 Beats per minute (bpm) | Standard Deviation 10.9 |
| GSK2894512 0.5% QD | Change From Baseline in Pulse Rate | Week 4; n= 38,39,38,39,30,32 | 0.4 Beats per minute (bpm) | Standard Deviation 10.88 |
| GSK2894512 0.5% QD | Change From Baseline in Pulse Rate | Week 12; n= 36,37,32,35,28,28 | 0.4 Beats per minute (bpm) | Standard Deviation 9.74 |
| GSK2894512 0.5% QD | Change From Baseline in Pulse Rate | Week 14; n= 34,35,32,34,31,29 | 2.5 Beats per minute (bpm) | Standard Deviation 10.97 |
| GSK2894512 0.5% QD | Change From Baseline in Pulse Rate | EW; n= 3,4,7,3,11,11 | -2.7 Beats per minute (bpm) | Standard Deviation 8.96 |
| Vehicle BID | Change From Baseline in Pulse Rate | Week 4; n= 38,39,38,39,30,32 | -1.7 Beats per minute (bpm) | Standard Deviation 11.67 |
| Vehicle BID | Change From Baseline in Pulse Rate | Week 2; n= 39,39,39,39,33,32 | 1.5 Beats per minute (bpm) | Standard Deviation 11.99 |
| Vehicle BID | Change From Baseline in Pulse Rate | EW; n= 3,4,7,3,11,11 | 4.2 Beats per minute (bpm) | Standard Deviation 12.18 |
| Vehicle BID | Change From Baseline in Pulse Rate | Week 1; n= 38,41,39,37,38,33 | 0.4 Beats per minute (bpm) | Standard Deviation 9.43 |
| Vehicle BID | Change From Baseline in Pulse Rate | Week 14; n= 34,35,32,34,31,29 | 0.8 Beats per minute (bpm) | Standard Deviation 11.06 |
| Vehicle BID | Change From Baseline in Pulse Rate | Week 8; n= 36,37,34,38,29,28 | -0.2 Beats per minute (bpm) | Standard Deviation 11.45 |
| Vehicle BID | Change From Baseline in Pulse Rate | Week 12; n= 36,37,32,35,28,28 | -1.9 Beats per minute (bpm) | Standard Deviation 9.58 |
| Vehicle QD | Change From Baseline in Pulse Rate | EW; n= 3,4,7,3,11,11 | -0.5 Beats per minute (bpm) | Standard Deviation 9.15 |
| Vehicle QD | Change From Baseline in Pulse Rate | Week 12; n= 36,37,32,35,28,28 | 1.3 Beats per minute (bpm) | Standard Deviation 10.76 |
| Vehicle QD | Change From Baseline in Pulse Rate | Week 4; n= 38,39,38,39,30,32 | 0.1 Beats per minute (bpm) | Standard Deviation 8.42 |
| Vehicle QD | Change From Baseline in Pulse Rate | Week 2; n= 39,39,39,39,33,32 | 1.0 Beats per minute (bpm) | Standard Deviation 10.47 |
| Vehicle QD | Change From Baseline in Pulse Rate | Week 14; n= 34,35,32,34,31,29 | 0.7 Beats per minute (bpm) | Standard Deviation 8.56 |
| Vehicle QD | Change From Baseline in Pulse Rate | Week 1; n= 38,41,39,37,38,33 | -0.4 Beats per minute (bpm) | Standard Deviation 9.82 |
| Vehicle QD | Change From Baseline in Pulse Rate | Week 8; n= 36,37,34,38,29,28 | 0.8 Beats per minute (bpm) | Standard Deviation 8.97 |
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were measured from Baseline up to follow up Visit 1 at Week 14 in semi-supine position after at least 5 minutes of rest. The Baseline value was taken at Day 1 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.
Time frame: Week 1, 2, 4, 8, 12, 14, EW (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) | DBP; Week 2; n=39,39,39,39,33,32 | -3.4 Millimeter of mercury (mmHg) | Standard Deviation 9.6 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 8; n=36,37,34,38,29,28 | -4.8 Millimeter of mercury (mmHg) | Standard Deviation 9.79 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 1; n=38,31,39,37,38,33 | -2.0 Millimeter of mercury (mmHg) | Standard Deviation 8.55 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 1; n= 38,31,39,37,38,33 | -1.6 Millimeter of mercury (mmHg) | Standard Deviation 8.89 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 12; n= 36,37,32,35,28,28 | -6.5 Millimeter of mercury (mmHg) | Standard Deviation 8.86 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 4; n= 38,39,38,39,30,32 | -1.7 Millimeter of mercury (mmHg) | Standard Deviation 10.57 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 4; n=38,39,38,39,30,32 | -3.0 Millimeter of mercury (mmHg) | Standard Deviation 12.21 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 8; n= 36,37,34,38,29,28 | -1.9 Millimeter of mercury (mmHg) | Standard Deviation 10.74 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; EW; n= 3,4,7,3,11,11 | 5.3 Millimeter of mercury (mmHg) | Standard Deviation 8.08 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 14; n=34,35,32,34,31,29 | -1.0 Millimeter of mercury (mmHg) | Standard Deviation 11.95 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 14; n= 34,35,32,34,31,29 | -5.6 Millimeter of mercury (mmHg) | Standard Deviation 9.23 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; EW; n= 3,4,7,3,11,11 | 3.3 Millimeter of mercury (mmHg) | Standard Deviation 3.06 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 12; n= 36,37,32,35,28,28 | -3.1 Millimeter of mercury (mmHg) | Standard Deviation 10.28 |
| GSK2894512 1% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 2; n=39,39,39,39,33,32 | -1.7 Millimeter of mercury (mmHg) | Standard Deviation 12.22 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 14; n=34,35,32,34,31,29 | -0.5 Millimeter of mercury (mmHg) | Standard Deviation 12.52 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 2; n=39,39,39,39,33,32 | 0.1 Millimeter of mercury (mmHg) | Standard Deviation 8.14 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 1; n=38,31,39,37,38,33 | 1.4 Millimeter of mercury (mmHg) | Standard Deviation 8.48 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 1; n= 38,31,39,37,38,33 | -2.3 Millimeter of mercury (mmHg) | Standard Deviation 11.02 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 2; n=39,39,39,39,33,32 | 0.6 Millimeter of mercury (mmHg) | Standard Deviation 10.57 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 14; n= 34,35,32,34,31,29 | -0.5 Millimeter of mercury (mmHg) | Standard Deviation 7.71 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 12; n= 36,37,32,35,28,28 | 2.6 Millimeter of mercury (mmHg) | Standard Deviation 7.02 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 4; n= 38,39,38,39,30,32 | 0.5 Millimeter of mercury (mmHg) | Standard Deviation 10 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 8; n= 36,37,34,38,29,28 | -0.5 Millimeter of mercury (mmHg) | Standard Deviation 11.27 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; EW; n= 3,4,7,3,11,11 | 1.3 Millimeter of mercury (mmHg) | Standard Deviation 3.4 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 8; n=36,37,34,38,29,28 | 1.0 Millimeter of mercury (mmHg) | Standard Deviation 8.07 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 12; n= 36,37,32,35,28,28 | -0.1 Millimeter of mercury (mmHg) | Standard Deviation 11.64 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 4; n=38,39,38,39,30,32 | 0.9 Millimeter of mercury (mmHg) | Standard Deviation 7.98 |
| GSK2894512 1% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; EW; n= 3,4,7,3,11,11 | -5.3 Millimeter of mercury (mmHg) | Standard Deviation 18.01 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 2; n=39,39,39,39,33,32 | -4.3 Millimeter of mercury (mmHg) | Standard Deviation 13.37 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 12; n= 36,37,32,35,28,28 | -2.8 Millimeter of mercury (mmHg) | Standard Deviation 8.82 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 1; n=38,31,39,37,38,33 | -1.9 Millimeter of mercury (mmHg) | Standard Deviation 8.74 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 12; n= 36,37,32,35,28,28 | -1.9 Millimeter of mercury (mmHg) | Standard Deviation 12.62 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 4; n= 38,39,38,39,30,32 | -3.8 Millimeter of mercury (mmHg) | Standard Deviation 9.05 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 4; n=38,39,38,39,30,32 | -3.1 Millimeter of mercury (mmHg) | Standard Deviation 9.31 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 2; n=39,39,39,39,33,32 | -3.7 Millimeter of mercury (mmHg) | Standard Deviation 7.63 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 1; n= 38,31,39,37,38,33 | -2.3 Millimeter of mercury (mmHg) | Standard Deviation 14.72 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 8; n=36,37,34,38,29,28 | -3.3 Millimeter of mercury (mmHg) | Standard Deviation 9.24 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 14; n= 34,35,32,34,31,29 | -2.9 Millimeter of mercury (mmHg) | Standard Deviation 9.1 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; EW; n= 3,4,7,3,11,11 | 4.9 Millimeter of mercury (mmHg) | Standard Deviation 13.63 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 8; n= 36,37,34,38,29,28 | -4.3 Millimeter of mercury (mmHg) | Standard Deviation 11.38 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 14; n=34,35,32,34,31,29 | -1.4 Millimeter of mercury (mmHg) | Standard Deviation 12.76 |
| GSK2894512 0.5% BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; EW; n= 3,4,7,3,11,11 | 0.0 Millimeter of mercury (mmHg) | Standard Deviation 10.82 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 12; n= 36,37,32,35,28,28 | -2.4 Millimeter of mercury (mmHg) | Standard Deviation 10.71 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 14; n= 34,35,32,34,31,29 | -0.4 Millimeter of mercury (mmHg) | Standard Deviation 8.49 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 1; n= 38,31,39,37,38,33 | -1.9 Millimeter of mercury (mmHg) | Standard Deviation 9.77 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 2; n=39,39,39,39,33,32 | -1.2 Millimeter of mercury (mmHg) | Standard Deviation 11.41 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 4; n= 38,39,38,39,30,32 | -1.8 Millimeter of mercury (mmHg) | Standard Deviation 11.94 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 8; n= 36,37,34,38,29,28 | -1.9 Millimeter of mercury (mmHg) | Standard Deviation 9.86 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 14; n=34,35,32,34,31,29 | -1.9 Millimeter of mercury (mmHg) | Standard Deviation 9.46 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; EW; n= 3,4,7,3,11,11 | -0.7 Millimeter of mercury (mmHg) | Standard Deviation 7.37 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 1; n=38,31,39,37,38,33 | -1.5 Millimeter of mercury (mmHg) | Standard Deviation 7.33 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 2; n=39,39,39,39,33,32 | -3.3 Millimeter of mercury (mmHg) | Standard Deviation 7.07 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 4; n=38,39,38,39,30,32 | -4.0 Millimeter of mercury (mmHg) | Standard Deviation 7.98 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 8; n=36,37,34,38,29,28 | -2.1 Millimeter of mercury (mmHg) | Standard Deviation 8.91 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 12; n= 36,37,32,35,28,28 | -4.0 Millimeter of mercury (mmHg) | Standard Deviation 9.18 |
| GSK2894512 0.5% QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; EW; n= 3,4,7,3,11,11 | -1.0 Millimeter of mercury (mmHg) | Standard Deviation 9.54 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 4; n=38,39,38,39,30,32 | -0.1 Millimeter of mercury (mmHg) | Standard Deviation 10.49 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 14; n=34,35,32,34,31,29 | 1.2 Millimeter of mercury (mmHg) | Standard Deviation 13.18 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 2; n=39,39,39,39,33,32 | -0.8 Millimeter of mercury (mmHg) | Standard Deviation 10.41 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 2; n=39,39,39,39,33,32 | -2.2 Millimeter of mercury (mmHg) | Standard Deviation 10.29 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 1; n= 38,31,39,37,38,33 | 0.8 Millimeter of mercury (mmHg) | Standard Deviation 9.32 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; EW; n= 3,4,7,3,11,11 | 2.3 Millimeter of mercury (mmHg) | Standard Deviation 3.66 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 12; n= 36,37,32,35,28,28 | 0.9 Millimeter of mercury (mmHg) | Standard Deviation 9.81 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 8; n= 36,37,34,38,29,28 | 0.0 Millimeter of mercury (mmHg) | Standard Deviation 11.29 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 14; n= 34,35,32,34,31,29 | -0.4 Millimeter of mercury (mmHg) | Standard Deviation 9.45 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 1; n=38,31,39,37,38,33 | 1.1 Millimeter of mercury (mmHg) | Standard Deviation 9.29 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 12; n= 36,37,32,35,28,28 | -0.5 Millimeter of mercury (mmHg) | Standard Deviation 10.44 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 4; n= 38,39,38,39,30,32 | 1.9 Millimeter of mercury (mmHg) | Standard Deviation 13.33 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; EW; n= 3,4,7,3,11,11 | 1.2 Millimeter of mercury (mmHg) | Standard Deviation 8.81 |
| Vehicle BID | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 8; n=36,37,34,38,29,28 | -0.2 Millimeter of mercury (mmHg) | Standard Deviation 10.1 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 14; n=34,35,32,34,31,29 | 0.3 Millimeter of mercury (mmHg) | Standard Deviation 11.29 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 2; n=39,39,39,39,33,32 | -0.9 Millimeter of mercury (mmHg) | Standard Deviation 5.97 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 12; n= 36,37,32,35,28,28 | -0.5 Millimeter of mercury (mmHg) | Standard Deviation 12.67 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 4; n=38,39,38,39,30,32 | 1.9 Millimeter of mercury (mmHg) | Standard Deviation 9.18 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 8; n= 36,37,34,38,29,28 | 1.0 Millimeter of mercury (mmHg) | Standard Deviation 17.08 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 4; n= 38,39,38,39,30,32 | -0.5 Millimeter of mercury (mmHg) | Standard Deviation 14.24 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; EW; n= 3,4,7,3,11,11 | -2.7 Millimeter of mercury (mmHg) | Standard Deviation 7.02 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 8; n=36,37,34,38,29,28 | 2.2 Millimeter of mercury (mmHg) | Standard Deviation 10.08 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 2; n=39,39,39,39,33,32 | -1.6 Millimeter of mercury (mmHg) | Standard Deviation 6.9 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; Week 1; n= 38,31,39,37,38,33 | -0.7 Millimeter of mercury (mmHg) | Standard Deviation 9.45 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 12; n= 36,37,32,35,28,28 | 1.3 Millimeter of mercury (mmHg) | Standard Deviation 8.93 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 1; n=38,31,39,37,38,33 | -0.4 Millimeter of mercury (mmHg) | Standard Deviation 7.53 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP; EW; n= 3,4,7,3,11,11 | 2.0 Millimeter of mercury (mmHg) | Standard Deviation 6.96 |
| Vehicle QD | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP; Week 14; n= 34,35,32,34,31,29 | 0.9 Millimeter of mercury (mmHg) | Standard Deviation 7.75 |
Secondary
Change From Baseline in Temperature
Temperature were measured from Baseline up to follow up Visit 1 at Week 14 in semi-supine position after at least 5 minutes of rest. The Baseline value was taken at Day 1 and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were measured.
Time frame: Week 1, 2, 4, 8, 12, 14, EW (up to week 14)
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Temperature | Week 2; n=39,39,39,39,32,32 | -0.054 Degree Celsius | Standard Deviation 0.4973 |
| GSK2894512 1% BID | Change From Baseline in Temperature | EW; n= 3,4,7,3,11,11 | -0.033 Degree Celsius | Standard Deviation 0.1528 |
| GSK2894512 1% BID | Change From Baseline in Temperature | Week 14;n=34,35,32,34,31,29 | -0.079 Degree Celsius | Standard Deviation 0.4059 |
| GSK2894512 1% BID | Change From Baseline in Temperature | Week 12; n=36,37,32,35,28,28 | 0.003 Degree Celsius | Standard Deviation 0.4212 |
| GSK2894512 1% BID | Change From Baseline in Temperature | Week 4; n= 38,39,38,39,30,32 | -0.074 Degree Celsius | Standard Deviation 0.4428 |
| GSK2894512 1% BID | Change From Baseline in Temperature | Week 8; n= 36,37,34,38,29,28 | 0.006 Degree Celsius | Standard Deviation 0.4276 |
| GSK2894512 1% BID | Change From Baseline in Temperature | Week 1; n= 38,41,39, 37,38,33 | 0.013 Degree Celsius | Standard Deviation 0.364 |
| GSK2894512 1% QD | Change From Baseline in Temperature | Week 4; n= 38,39,38,39,30,32 | -0.023 Degree Celsius | Standard Deviation 0.3256 |
| GSK2894512 1% QD | Change From Baseline in Temperature | Week 1; n= 38,41,39, 37,38,33 | -0.056 Degree Celsius | Standard Deviation 0.2618 |
| GSK2894512 1% QD | Change From Baseline in Temperature | Week 2; n=39,39,39,39,32,32 | -0.064 Degree Celsius | Standard Deviation 0.268 |
| GSK2894512 1% QD | Change From Baseline in Temperature | Week 8; n= 36,37,34,38,29,28 | -0.024 Degree Celsius | Standard Deviation 0.2671 |
| GSK2894512 1% QD | Change From Baseline in Temperature | Week 12; n=36,37,32,35,28,28 | -0.068 Degree Celsius | Standard Deviation 0.3292 |
| GSK2894512 1% QD | Change From Baseline in Temperature | Week 14;n=34,35,32,34,31,29 | -0.131 Degree Celsius | Standard Deviation 0.6416 |
| GSK2894512 1% QD | Change From Baseline in Temperature | EW; n= 3,4,7,3,11,11 | 0.000 Degree Celsius | Standard Deviation 0.3651 |
| GSK2894512 0.5% BID | Change From Baseline in Temperature | Week 2; n=39,39,39,39,32,32 | 0.005 Degree Celsius | Standard Deviation 0.3332 |
| GSK2894512 0.5% BID | Change From Baseline in Temperature | Week 14;n=34,35,32,34,31,29 | -0.059 Degree Celsius | Standard Deviation 0.3618 |
| GSK2894512 0.5% BID | Change From Baseline in Temperature | Week 4; n= 38,39,38,39,30,32 | -0.013 Degree Celsius | Standard Deviation 0.3458 |
| GSK2894512 0.5% BID | Change From Baseline in Temperature | EW; n= 3,4,7,3,11,11 | 0.100 Degree Celsius | Standard Deviation 0.2517 |
| GSK2894512 0.5% BID | Change From Baseline in Temperature | Week 8; n= 36,37,34,38,29,28 | -0.056 Degree Celsius | Standard Deviation 0.3295 |
| GSK2894512 0.5% BID | Change From Baseline in Temperature | Week 12; n=36,37,32,35,28,28 | -0.078 Degree Celsius | Standard Deviation 0.2814 |
| GSK2894512 0.5% BID | Change From Baseline in Temperature | Week 1; n= 38,41,39, 37,38,33 | 0.015 Degree Celsius | Standard Deviation 0.3689 |
| GSK2894512 0.5% QD | Change From Baseline in Temperature | Week 12; n=36,37,32,35,28,28 | -0.040 Degree Celsius | Standard Deviation 0.4532 |
| GSK2894512 0.5% QD | Change From Baseline in Temperature | Week 14;n=34,35,32,34,31,29 | -0.109 Degree Celsius | Standard Deviation 0.4876 |
| GSK2894512 0.5% QD | Change From Baseline in Temperature | Week 2; n=39,39,39,39,32,32 | -0.069 Degree Celsius | Standard Deviation 0.4691 |
| GSK2894512 0.5% QD | Change From Baseline in Temperature | Week 8; n= 36,37,34,38,29,28 | 0.045 Degree Celsius | Standard Deviation 0.4011 |
| GSK2894512 0.5% QD | Change From Baseline in Temperature | Week 1; n= 38,41,39, 37,38,33 | -0.006 Degree Celsius | Standard Deviation 0.3932 |
| GSK2894512 0.5% QD | Change From Baseline in Temperature | Week 4; n= 38,39,38,39,30,32 | -0.068 Degree Celsius | Standard Deviation 0.4902 |
| GSK2894512 0.5% QD | Change From Baseline in Temperature | EW; n= 3,4,7,3,11,11 | 0.400 Degree Celsius | Standard Deviation 0.5568 |
| Vehicle BID | Change From Baseline in Temperature | Week 12; n=36,37,32,35,28,28 | 0.043 Degree Celsius | Standard Deviation 0.7618 |
| Vehicle BID | Change From Baseline in Temperature | Week 8; n= 36,37,34,38,29,28 | 0.062 Degree Celsius | Standard Deviation 0.7566 |
| Vehicle BID | Change From Baseline in Temperature | Week 1; n= 38,41,39, 37,38,33 | -0.053 Degree Celsius | Standard Deviation 0.7928 |
| Vehicle BID | Change From Baseline in Temperature | Week 2; n=39,39,39,39,32,32 | -0.097 Degree Celsius | Standard Deviation 0.7082 |
| Vehicle BID | Change From Baseline in Temperature | EW; n= 3,4,7,3,11,11 | -0.182 Degree Celsius | Standard Deviation 0.5212 |
| Vehicle BID | Change From Baseline in Temperature | Week 14;n=34,35,32,34,31,29 | -0.013 Degree Celsius | Standard Deviation 0.874 |
| Vehicle BID | Change From Baseline in Temperature | Week 4; n= 38,39,38,39,30,32 | -0.030 Degree Celsius | Standard Deviation 0.6706 |
| Vehicle QD | Change From Baseline in Temperature | Week 14;n=34,35,32,34,31,29 | -0.052 Degree Celsius | Standard Deviation 0.3582 |
| Vehicle QD | Change From Baseline in Temperature | Week 1; n= 38,41,39, 37,38,33 | -0.024 Degree Celsius | Standard Deviation 0.2693 |
| Vehicle QD | Change From Baseline in Temperature | Week 2; n=39,39,39,39,32,32 | 0.016 Degree Celsius | Standard Deviation 0.2841 |
| Vehicle QD | Change From Baseline in Temperature | Week 8; n= 36,37,34,38,29,28 | 0.021 Degree Celsius | Standard Deviation 0.3304 |
| Vehicle QD | Change From Baseline in Temperature | Week 4; n= 38,39,38,39,30,32 | 0.013 Degree Celsius | Standard Deviation 0.2459 |
| Vehicle QD | Change From Baseline in Temperature | Week 12; n=36,37,32,35,28,28 | 0.004 Degree Celsius | Standard Deviation 0.4574 |
| Vehicle QD | Change From Baseline in Temperature | EW; n= 3,4,7,3,11,11 | 0.164 Degree Celsius | Standard Deviation 0.4985 |
Secondary
Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels
Blood samples were collected to evaluate change from Baseline in total T lympho, B lympho, T and B NK cells and (Foxp3) values at Baseline throughout the 12 weeks of study treatment. The immunophenotyping parameters included cluster of differentiation (CD)19, CD3, CD3+CD8+, CD3+CD4+, CD16+CD56+, CD3+CD4+CD25+CD127, CD3+CD4+foxP3+CD25+CD127 and T and NK lympho. CD3, CD3+CD8+ and CD3+CD4+ were also evaluated by using treg flow cytometry (cyto). 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 the category titles). Mean and SD were measured.
Time frame: Week, 4, 8 and 12
Population: Safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD19; Week 8; n=34,37,34,37,28,27 | 0.0273 GI/L | Standard Deviation 0.0951 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD16+CD56+; Week 12; n= 35,37,32,34,27,27 | -0.038 GI/L | Standard Deviation 0.0884 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+foxP3+CD25+CD127Week12;n=32,36,31,32,25,24 | 0.0076 GI/L | Standard Deviation 0.0149 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3 treg flow cyto; Week 4; n= 35,37,36,35,28,28 | -0.0277 GI/L | Standard Deviation 0.3912 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD16+CD56+; Week 8; n=34,37,34,37,28,27 | -0.013 GI/L | Standard Deviation 0.0909 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | T &B cell NK lympho;Week8;n=34,37,34,37,28,27 | 0.059 GI/L | Standard Deviation 0.443 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD19; Week 4; n= 37,38,38,37,29,32 | 0.0394 GI/L | Standard Deviation 0.1149 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+; Week 8; n= 34,37,34,37,28,27 | -0.0048 GI/L | Standard Deviation 0.1337 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+treg flow cyto;Week12;n=32,36,31,32,25,24 | -0.0179 GI/L | Standard Deviation 0.1738 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; treg flow cyto; Week 8; n=31,35,32,36,27,25 | 0.0184 GI/L | Standard Deviation 0.2929 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+ treg flow cyto;Week 8;n=31,35,32,36,27,25 | 0.0286 GI/L | Standard Deviation 0.1744 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | T &B cell NK lympho; Week12;n=35,37,32,34,27,27 | -0.041 GI/L | Standard Deviation 0.5922 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+; Week 4; n= 37,38,38,37,29,32 | -0.0272 GI/L | Standard Deviation 0.2077 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+foxP3+CD25+CD127;Week8;n=31,35,32,35,27,25 | 0.0070 GI/L | Standard Deviation 0.0184 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+foxP3+CD25+CD127;Week4;n=35,37,36,35,28,28 | 0.0009 GI/L | Standard Deviation 0.0125 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; treg flow cyto; Week 12; n= 32,36,31,32,25,24 | -0.0215 GI/L | Standard Deviation 0.412 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+; Week 4; n= 37,38,38,37,29,32 | 0.0080 GI/L | Standard Deviation 0.2066 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+CD25+CD127; Week4;n=35,37,36,35,28,28 | 0.0006 GI/L | Standard Deviation 0.0139 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+ treg flow cyto;Week 8;n=31,35,32,36,27,25 | 0.0004 GI/L | Standard Deviation 0.1228 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; Week 4; n= 37,38,38,37,29,32 | -0.0050 GI/L | Standard Deviation 0.383 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+treg flow cyto;Week 12;n=32,36,31,32,25,24 | 0.0235 GI/L | Standard Deviation 0.2508 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+ treg flow cyto;Week 4;n=35,37,36,35,28,28 | -0.0392 GI/L | Standard Deviation 0.2124 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+CD25+CD127; Week8;n=31,35,32,36,27,25 | 0.0044 GI/L | Standard Deviation 0.0199 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+; Week 8; n=34,37,34,37,28,27 | 0.0282 GI/L | Standard Deviation 0.1739 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; Week 8; n=34,37,34,37,28,27 | 0.0523 GI/L | Standard Deviation 0.3117 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD16+CD56+; Week 4; n=37,38,38,37,29,32 | -0.021 GI/L | Standard Deviation 0.0942 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD19; Week 12; n= 35,37,32,34,27,27 | 0.0111 GI/L | Standard Deviation 0.1262 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+ treg flow cyto;Week 4;n=35,37,36,35,28,28 | 0.0117 GI/L | Standard Deviation 0.2048 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | T &B cell NK lympho; Week4;n=37,38,38,37,29,32 | 0.009 GI/L | Standard Deviation 0.5461 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+; Week 12;n=35,37,32,34,27,27 | -0.0307 GI/L | Standard Deviation 0.1754 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; Week 12; n= 35,37,32,34,27,27 | -0.0045 GI/L | Standard Deviation 0.4254 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+; Week 12; n= 35,37,32,34,27,27 | 0.0243 GI/L | Standard Deviation 0.2551 |
| GSK2894512 1% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+CD25+CD127; Week12;n=32,36,31,32,25,24 | 0.0050 GI/L | Standard Deviation 0.0193 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+; Week 8; n= 34,37,34,37,28,27 | 0.0011 GI/L | Standard Deviation 0.1561 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+; Week 12; n= 35,37,32,34,27,27 | 0.0957 GI/L | Standard Deviation 0.2713 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD16+CD56+; Week 4; n=37,38,38,37,29,32 | -0.018 GI/L | Standard Deviation 0.0752 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+ treg flow cyto;Week 4;n=35,37,36,35,28,28 | 0.0575 GI/L | Standard Deviation 0.2571 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; Week 4; n= 37,38,38,37,29,32 | 0.0867 GI/L | Standard Deviation 0.3809 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+ treg flow cyto;Week 8;n=31,35,32,36,27,25 | 0.0687 GI/L | Standard Deviation 0.2923 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+treg flow cyto;Week 12;n=32,36,31,32,25,24 | 0.1058 GI/L | Standard Deviation 0.2718 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | T &B cell NK lympho; Week4;n=37,38,38,37,29,32 | 0.101 GI/L | Standard Deviation 0.5287 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; Week 8; n=34,37,34,37,28,27 | 0.0581 GI/L | Standard Deviation 0.4496 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | T &B cell NK lympho; Week12;n=35,37,32,34,27,27 | 0.174 GI/L | Standard Deviation 0.5825 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; Week 12; n= 35,37,32,34,27,27 | 0.1312 GI/L | Standard Deviation 0.4033 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+foxP3+CD25+CD127Week12;n=32,36,31,32,25,24 | 0.0003 GI/L | Standard Deviation 0.0198 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3 treg flow cyto; Week 4; n= 35,37,36,35,28,28 | 0.0643 GI/L | Standard Deviation 0.3988 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD19; Week 8; n=34,37,34,37,28,27 | 0.0343 GI/L | Standard Deviation 0.148 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+foxP3+CD25+CD127;Week8;n=31,35,32,35,27,25 | 0.0011 GI/L | Standard Deviation 0.0147 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; treg flow cyto; Week 8; n=31,35,32,36,27,25 | 0.0745 GI/L | Standard Deviation 0.4592 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; treg flow cyto; Week 12; n= 32,36,31,32,25,24 | 0.1418 GI/L | Standard Deviation 0.4318 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+foxP3+CD25+CD127;Week4;n=35,37,36,35,28,28 | 0.0001 GI/L | Standard Deviation 0.0162 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+; Week 4; n= 37,38,38,37,29,32 | 0.0248 GI/L | Standard Deviation 0.1298 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+CD25+CD127; Week12;n=32,36,31,32,25,24 | 0.0056 GI/L | Standard Deviation 0.0228 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+; Week 12;n=35,37,32,34,27,27 | 0.0270 GI/L | Standard Deviation 0.1392 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+CD25+CD127; Week8;n=31,35,32,36,27,25 | 0.0062 GI/L | Standard Deviation 0.0167 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+ treg flow cyto;Week 4;n=35,37,36,35,28,28 | 0.0211 GI/L | Standard Deviation 0.1222 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD19; Week 12; n= 35,37,32,34,27,27 | 0.0647 GI/L | Standard Deviation 0.144 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+CD25+CD127; Week4;n=35,37,36,35,28,28 | 0.0023 GI/L | Standard Deviation 0.015 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+ treg flow cyto;Week 8;n=31,35,32,36,27,25 | 0.0125 GI/L | Standard Deviation 0.135 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+treg flow cyto;Week12;n=32,36,31,32,25,24 | 0.0311 GI/L | Standard Deviation 0.1338 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD19; Week 4; n= 37,38,38,37,29,32 | 0.0407 GI/L | Standard Deviation 0.1229 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD16+CD56+; Week 12; n= 35,37,32,34,27,27 | -0.021 GI/L | Standard Deviation 0.0911 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+; Week 4; n= 37,38,38,37,29,32 | 0.0579 GI/L | Standard Deviation 0.2532 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | T &B cell NK lympho;Week8;n=34,37,34,37,28,27 | 0.083 GI/L | Standard Deviation 0.6737 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD16+CD56+; Week 8; n=34,37,34,37,28,27 | -0.012 GI/L | Standard Deviation 0.1594 |
| GSK2894512 1% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+; Week 8; n=34,37,34,37,28,27 | 0.0539 GI/L | Standard Deviation 0.2996 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+foxP3+CD25+CD127Week12;n=32,36,31,32,25,24 | 0.0052 GI/L | Standard Deviation 0.0192 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+treg flow cyto;Week12;n=32,36,31,32,25,24 | 0.0151 GI/L | Standard Deviation 0.149 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+; Week 12;n=35,37,32,34,27,27 | 0.0357 GI/L | Standard Deviation 0.1578 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; Week 8; n=34,37,34,37,28,27 | 0.0334 GI/L | Standard Deviation 0.3855 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD16+CD56+; Week 4; n=37,38,38,37,29,32 | -0.019 GI/L | Standard Deviation 0.0976 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | T &B cell NK lympho; Week4;n=37,38,38,37,29,32 | 0.092 GI/L | Standard Deviation 0.5122 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | T &B cell NK lympho; Week12;n=35,37,32,34,27,27 | 0.140 GI/L | Standard Deviation 0.5609 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD16+CD56+; Week 8; n=34,37,34,37,28,27 | -0.016 GI/L | Standard Deviation 0.1045 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+ treg flow cyto;Week 4;n=35,37,36,35,28,28 | 0.0004 GI/L | Standard Deviation 0.1117 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+ treg flow cyto;Week 4;n=35,37,36,35,28,28 | 0.0825 GI/L | Standard Deviation 0.1875 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+CD25+CD127; Week4;n=35,37,36,35,28,28 | 0.0022 GI/L | Standard Deviation 0.0172 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+; Week 12; n= 35,37,32,34,27,27 | 0.1087 GI/L | Standard Deviation 0.2795 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; Week 4; n= 37,38,38,37,29,32 | 0.0842 GI/L | Standard Deviation 0.3343 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+; Week 8; n=34,37,34,37,28,27 | 0.0072 GI/L | Standard Deviation 0.2794 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+ treg flow cyto;Week 8;n=31,35,32,36,27,25 | -0.0008 GI/L | Standard Deviation 0.1214 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD19; Week 12; n= 35,37,32,34,27,27 | 0.0317 GI/L | Standard Deviation 0.1077 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+ treg flow cyto;Week 8;n=31,35,32,36,27,25 | -0.0158 GI/L | Standard Deviation 0.2536 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; treg flow cyto; Week 12; n= 32,36,31,32,25,24 | 0.1171 GI/L | Standard Deviation 0.407 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD19; Week 4; n= 37,38,38,37,29,32 | 0.0068 GI/L | Standard Deviation 0.1532 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD16+CD56+; Week 12; n= 35,37,32,34,27,27 | -0.022 GI/L | Standard Deviation 0.0792 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+foxP3+CD25+CD127;Week4;n=35,37,36,35,28,28 | 0.0009 GI/L | Standard Deviation 0.0129 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD19; Week 8; n=34,37,34,37,28,27 | 0.0122 GI/L | Standard Deviation 0.1154 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+treg flow cyto;Week 12;n=32,36,31,32,25,24 | 0.0979 GI/L | Standard Deviation 0.2691 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+; Week 4; n= 37,38,38,37,29,32 | 0.0282 GI/L | Standard Deviation 0.1266 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; treg flow cyto; Week 8; n=31,35,32,36,27,25 | -0.0023 GI/L | Standard Deviation 0.3513 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+CD25+CD127; Week12;n=32,36,31,32,25,24 | 0.0081 GI/L | Standard Deviation 0.0229 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+; Week 4; n= 37,38,38,37,29,32 | 0.0562 GI/L | Standard Deviation 0.2652 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+foxP3+CD25+CD127;Week8;n=31,35,32,35,27,25 | 0.0021 GI/L | Standard Deviation 0.0182 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3 treg flow cyto; Week 4; n= 35,37,36,35,28,28 | 0.0682 GI/L | Standard Deviation 0.2853 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+; Week 8; n= 34,37,34,37,28,27 | 0.0242 GI/L | Standard Deviation 0.1335 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | T &B cell NK lympho;Week8;n=34,37,34,37,28,27 | 0.025 GI/L | Standard Deviation 0.5688 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; Week 12; n= 35,37,32,34,27,27 | 0.1375 GI/L | Standard Deviation 0.4003 |
| GSK2894512 0.5% BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+CD25+CD127; Week8;n=31,35,32,36,27,25 | 0.0026 GI/L | Standard Deviation 0.0223 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+treg flow cyto;Week 12;n=32,36,31,32,25,24 | 0.0141 GI/L | Standard Deviation 0.1885 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD19; Week 4; n= 37,38,38,37,29,32 | 0.0174 GI/L | Standard Deviation 0.0933 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD19; Week 8; n=34,37,34,37,28,27 | -0.0006 GI/L | Standard Deviation 0.1099 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD19; Week 12; n= 35,37,32,34,27,27 | 0.0224 GI/L | Standard Deviation 0.0927 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; Week 4; n= 37,38,38,37,29,32 | 0.0108 GI/L | Standard Deviation 0.3364 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; Week 8; n=34,37,34,37,28,27 | -0.0593 GI/L | Standard Deviation 0.3172 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; Week 12; n= 35,37,32,34,27,27 | 0.0071 GI/L | Standard Deviation 0.2729 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3 treg flow cyto; Week 4; n= 35,37,36,35,28,28 | 0.0270 GI/L | Standard Deviation 0.332 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; treg flow cyto; Week 8; n=31,35,32,36,27,25 | -0.0647 GI/L | Standard Deviation 0.3128 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; treg flow cyto; Week 12; n= 32,36,31,32,25,24 | -0.0063 GI/L | Standard Deviation 0.2771 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+; Week 4; n= 37,38,38,37,29,32 | 0.0147 GI/L | Standard Deviation 0.1194 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+; Week 8; n= 34,37,34,37,28,27 | -0.0263 GI/L | Standard Deviation 0.1145 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+; Week 12;n=35,37,32,34,27,27 | -0.0115 GI/L | Standard Deviation 0.0868 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+ treg flow cyto;Week 4;n=35,37,36,35,28,28 | 0.0038 GI/L | Standard Deviation 0.1112 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+ treg flow cyto;Week 8;n=31,35,32,36,27,25 | -0.0376 GI/L | Standard Deviation 0.115 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+treg flow cyto;Week12;n=32,36,31,32,25,24 | -0.0230 GI/L | Standard Deviation 0.0865 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+; Week 4; n= 37,38,38,37,29,32 | -0.0030 GI/L | Standard Deviation 0.2342 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+; Week 8; n=34,37,34,37,28,27 | -0.0287 GI/L | Standard Deviation 0.2054 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+; Week 12; n= 35,37,32,34,27,27 | 0.0216 GI/L | Standard Deviation 0.1929 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+ treg flow cyto;Week 4;n=35,37,36,35,28,28 | 0.0135 GI/L | Standard Deviation 0.2167 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+ treg flow cyto;Week 8;n=31,35,32,36,27,25 | -0.0284 GI/L | Standard Deviation 0.2018 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD16+CD56+; Week 4; n=37,38,38,37,29,32 | -0.004 GI/L | Standard Deviation 0.1057 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD16+CD56+; Week 8; n=34,37,34,37,28,27 | -0.009 GI/L | Standard Deviation 0.0919 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD16+CD56+; Week 12; n= 35,37,32,34,27,27 | -0.036 GI/L | Standard Deviation 0.0702 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+CD25+CD127; Week4;n=35,37,36,35,28,28 | 0.0005 GI/L | Standard Deviation 0.0174 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+CD25+CD127; Week8;n=31,35,32,36,27,25 | 0.0029 GI/L | Standard Deviation 0.0196 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+CD25+CD127; Week12;n=32,36,31,32,25,24 | 0.0054 GI/L | Standard Deviation 0.0217 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+foxP3+CD25+CD127;Week4;n=35,37,36,35,28,28 | -0.0013 GI/L | Standard Deviation 0.0164 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+foxP3+CD25+CD127;Week8;n=31,35,32,35,27,25 | -0.0015 GI/L | Standard Deviation 0.0151 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+foxP3+CD25+CD127Week12;n=32,36,31,32,25,24 | -0.0012 GI/L | Standard Deviation 0.018 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | T &B cell NK lympho; Week4;n=37,38,38,37,29,32 | 0.021 GI/L | Standard Deviation 0.4664 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | T &B cell NK lympho;Week8;n=34,37,34,37,28,27 | -0.070 GI/L | Standard Deviation 0.4141 |
| GSK2894512 0.5% QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | T &B cell NK lympho; Week12;n=35,37,32,34,27,27 | -0.009 GI/L | Standard Deviation 0.4041 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD19; Week 8; n=34,37,34,37,28,27 | -0.0282 GI/L | Standard Deviation 0.1502 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+foxP3+CD25+CD127;Week4;n=35,37,36,35,28,28 | 0.0008 GI/L | Standard Deviation 0.0099 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD16+CD56+; Week 8; n=34,37,34,37,28,27 | -0.029 GI/L | Standard Deviation 0.086 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; treg flow cyto; Week 8; n=31,35,32,36,27,25 | -0.0626 GI/L | Standard Deviation 0.4679 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+; Week 4; n= 37,38,38,37,29,32 | -0.0268 GI/L | Standard Deviation 0.2913 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3 treg flow cyto; Week 4; n= 35,37,36,35,28,28 | -0.0688 GI/L | Standard Deviation 0.4764 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+; Week 12;n=35,37,32,34,27,27 | -0.0853 GI/L | Standard Deviation 0.1818 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+foxP3+CD25+CD127;Week8;n=31,35,32,35,27,25 | 0.0032 GI/L | Standard Deviation 0.0151 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD16+CD56+; Week 12; n= 35,37,32,34,27,27 | -0.039 GI/L | Standard Deviation 0.0909 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | T &B cell NK lympho;Week8;n=34,37,34,37,28,27 | -0.109 GI/L | Standard Deviation 0.6219 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; Week 12; n= 35,37,32,34,27,27 | -0.1338 GI/L | Standard Deviation 0.5023 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+CD25+CD127; Week8;n=31,35,32,36,27,25 | -0.0049 GI/L | Standard Deviation 0.0181 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD19; Week 4; n= 37,38,38,37,29,32 | -0.0217 GI/L | Standard Deviation 0.141 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+foxP3+CD25+CD127Week12;n=32,36,31,32,25,24 | 0.0039 GI/L | Standard Deviation 0.016 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD19; Week 12; n= 35,37,32,34,27,27 | -0.0439 GI/L | Standard Deviation 0.135 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; Week 8; n=34,37,34,37,28,27 | -0.0350 GI/L | Standard Deviation 0.4403 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+; Week 8; n= 34,37,34,37,28,27 | -0.0315 GI/L | Standard Deviation 0.1677 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; Week 4; n= 37,38,38,37,29,32 | -0.0397 GI/L | Standard Deviation 0.4505 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+ treg flow cyto;Week 8;n=31,35,32,36,27,25 | -0.0351 GI/L | Standard Deviation 0.1672 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | T &B cell NK lympho; Week4;n=37,38,38,37,29,32 | -0.082 GI/L | Standard Deviation 0.6206 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+; Week 4; n= 37,38,38,37,29,32 | -0.0155 GI/L | Standard Deviation 0.1608 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+treg flow cyto;Week12;n=32,36,31,32,25,24 | -0.0689 GI/L | Standard Deviation 0.1752 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+ treg flow cyto;Week 8;n=31,35,32,36,27,25 | -0.0007 GI/L | Standard Deviation 0.2751 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+CD25+CD127; Week12;n=32,36,31,32,25,24 | 0.0007 GI/L | Standard Deviation 0.023 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+ treg flow cyto;Week 4;n=35,37,36,35,28,28 | -0.0229 GI/L | Standard Deviation 0.2878 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+treg flow cyto;Week 12;n=32,36,31,32,25,24 | -0.0403 GI/L | Standard Deviation 0.3331 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+ treg flow cyto;Week 4;n=35,37,36,35,28,28 | -0.0246 GI/L | Standard Deviation 0.1572 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | T &B cell NK lympho; Week12;n=35,37,32,34,27,27 | -0.236 GI/L | Standard Deviation 0.683 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+; Week 12; n= 35,37,32,34,27,27 | -0.0465 GI/L | Standard Deviation 0.3338 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; treg flow cyto; Week 12; n= 32,36,31,32,25,24 | -0.1402 GI/L | Standard Deviation 0.545 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+CD25+CD127; Week4;n=35,37,36,35,28,28 | -0.0050 GI/L | Standard Deviation 0.0179 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD16+CD56+; Week 4; n=37,38,38,37,29,32 | -0.009 GI/L | Standard Deviation 0.0837 |
| Vehicle BID | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+; Week 8; n=34,37,34,37,28,27 | -0.0015 GI/L | Standard Deviation 0.2803 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD16+CD56+; Week 4; n=37,38,38,37,29,32 | 0.016 GI/L | Standard Deviation 0.0999 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+; Week 4; n= 37,38,38,37,29,32 | 0.1138 GI/L | Standard Deviation 0.2308 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD16+CD56+; Week 8; n=34,37,34,37,28,27 | -0.012 GI/L | Standard Deviation 0.1131 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+treg flow cyto;Week12;n=32,36,31,32,25,24 | 0.0120 GI/L | Standard Deviation 0.1064 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+ treg flow cyto;Week 8;n=31,35,32,36,27,25 | 0.0484 GI/L | Standard Deviation 0.1417 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD19; Week 8; n=34,37,34,37,28,27 | 0.0367 GI/L | Standard Deviation 0.0966 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD16+CD56+; Week 12; n= 35,37,32,34,27,27 | -0.020 GI/L | Standard Deviation 0.0888 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+ treg flow cyto;Week 4;n=35,37,36,35,28,28 | 0.0728 GI/L | Standard Deviation 0.1175 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+CD25+CD127; Week4;n=35,37,36,35,28,28 | 0.0098 GI/L | Standard Deviation 0.0345 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+; Week 12;n=35,37,32,34,27,27 | -0.0023 GI/L | Standard Deviation 0.1097 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+; Week 8; n= 34,37,34,37,28,27 | 0.0322 GI/L | Standard Deviation 0.1721 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+CD25+CD127; Week8;n=31,35,32,36,27,25 | 0.0054 GI/L | Standard Deviation 0.0222 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD8+; Week 4; n= 37,38,38,37,29,32 | 0.0526 GI/L | Standard Deviation 0.1388 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | T &B cell NK lympho;Week8;n=34,37,34,37,28,27 | 0.132 GI/L | Standard Deviation 0.515 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+CD25+CD127; Week12;n=32,36,31,32,25,24 | 0.0055 GI/L | Standard Deviation 0.0215 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; treg flow cyto; Week 12; n= 32,36,31,32,25,24 | 0.0028 GI/L | Standard Deviation 0.3101 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; treg flow cyto; Week 8; n=31,35,32,36,27,25 | 0.1302 GI/L | Standard Deviation 0.3505 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+foxP3+CD25+CD127;Week4;n=35,37,36,35,28,28 | 0.0056 GI/L | Standard Deviation 0.0123 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3 treg flow cyto; Week 4; n= 35,37,36,35,28,28 | 0.1943 GI/L | Standard Deviation 0.3722 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD19; Week 4; n= 37,38,38,37,29,32 | 0.0406 GI/L | Standard Deviation 0.1114 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+foxP3+CD25+CD127;Week8;n=31,35,32,35,27,25 | 0.0047 GI/L | Standard Deviation 0.0166 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; Week 12; n= 35,37,32,34,27,27 | 0.0167 GI/L | Standard Deviation 0.2879 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; Week 8; n=34,37,34,37,28,27 | 0.1066 GI/L | Standard Deviation 0.3531 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+foxP3+CD25+CD127Week12;n=32,36,31,32,25,24 | 0.0059 GI/L | Standard Deviation 0.0127 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3; Week 4; n= 37,38,38,37,29,32 | 0.1678 GI/L | Standard Deviation 0.3583 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | T &B cell NK lympho; Week12;n=35,37,32,34,27,27 | -0.001 GI/L | Standard Deviation 0.3842 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | T &B cell NK lympho; Week4;n=37,38,38,37,29,32 | 0.228 GI/L | Standard Deviation 0.5116 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+ treg flow cyto;Week 8;n=31,35,32,36,27,25 | 0.0849 GI/L | Standard Deviation 0.1883 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+ treg flow cyto;Week 4;n=35,37,36,35,28,28 | 0.1215 GI/L | Standard Deviation 0.2442 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+treg flow cyto;Week 12;n=32,36,31,32,25,24 | 0.0213 GI/L | Standard Deviation 0.194 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+; Week 12; n= 35,37,32,34,27,27 | 0.0181 GI/L | Standard Deviation 0.1872 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD3+CD4+; Week 8; n=34,37,34,37,28,27 | 0.0778 GI/L | Standard Deviation 0.1826 |
| Vehicle QD | Change From Baseline in Total T Lymphocytes (Lympho), B Lympho, Natural Killer (NK) Lymphocytes and Treg (Foxp3) Levels | CD19; Week 12; n= 35,37,32,34,27,27 | 0.0041 GI/L | Standard Deviation 0.1009 |
Secondary
Mean Change From Baseline in Body Surface Area (Percent BSA)
The extent of BSA affected by AD is a general indicator of disease severity and the assessment of BSA with AD was performed separately for four body surface regions: the head (h), the upper extremities (u), the trunk (t) and the lower extremities (l), corresponding to 10, 20, 30, and 40 percent of the total body area, respectively. Mean change from Baseline in percent BSA was presented using mean and SD at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit. Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 8; n= 36, 37, 34, 38, 29, 27 | -9.23 Percentage of surface area | Standard Deviation 8.425 |
| GSK2894512 1% BID | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 2; n= 39, 39, 39, 39, 33, 32 | -4.99 Percentage of surface area | Standard Deviation 7.33 |
| GSK2894512 1% BID | Mean Change From Baseline in Body Surface Area (Percent BSA) | EW; n= 3, 4, 7, 3, 11, 11 | -2.60 Percentage of surface area | Standard Deviation 4.613 |
| GSK2894512 1% BID | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 16; n= 34, 36, 31, 35, 27, 25 | -8.19 Percentage of surface area | Standard Deviation 7.826 |
| GSK2894512 1% BID | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 14; n= 34, 35, 31, 33, 27, 25 | -9.25 Percentage of surface area | Standard Deviation 7.121 |
| GSK2894512 1% BID | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 1; n= 38, 41, 39, 37, 38, 32 | -2.37 Percentage of surface area | Standard Deviation 4.774 |
| GSK2894512 1% BID | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 12; n= 36, 37, 32, 35, 28, 25 | -11.19 Percentage of surface area | Standard Deviation 8.643 |
| GSK2894512 1% BID | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 4; n= 38, 39, 38, 39, 30, 32 | -7.37 Percentage of surface area | Standard Deviation 6.276 |
| GSK2894512 1% QD | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 12; n= 36, 37, 32, 35, 28, 25 | -11.55 Percentage of surface area | Standard Deviation 9.69 |
| GSK2894512 1% QD | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 14; n= 34, 35, 31, 33, 27, 25 | -9.85 Percentage of surface area | Standard Deviation 9.446 |
| GSK2894512 1% QD | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 4; n= 38, 39, 38, 39, 30, 32 | -9.76 Percentage of surface area | Standard Deviation 8.581 |
| GSK2894512 1% QD | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 2; n= 39, 39, 39, 39, 33, 32 | -7.07 Percentage of surface area | Standard Deviation 6.639 |
| GSK2894512 1% QD | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 1; n= 38, 41, 39, 37, 38, 32 | -3.57 Percentage of surface area | Standard Deviation 5.498 |
| GSK2894512 1% QD | Mean Change From Baseline in Body Surface Area (Percent BSA) | EW; n= 3, 4, 7, 3, 11, 11 | 4.63 Percentage of surface area | Standard Deviation 9.586 |
| GSK2894512 1% QD | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 16; n= 34, 36, 31, 35, 27, 25 | -9.93 Percentage of surface area | Standard Deviation 8.82 |
| GSK2894512 1% QD | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 8; n= 36, 37, 34, 38, 29, 27 | -11.70 Percentage of surface area | Standard Deviation 9.208 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 4; n= 38, 39, 38, 39, 30, 32 | -7.47 Percentage of surface area | Standard Deviation 7.567 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 1; n= 38, 41, 39, 37, 38, 32 | -2.44 Percentage of surface area | Standard Deviation 4.313 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 8; n= 36, 37, 34, 38, 29, 27 | -10.89 Percentage of surface area | Standard Deviation 9.692 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 12; n= 36, 37, 32, 35, 28, 25 | -12.18 Percentage of surface area | Standard Deviation 9.581 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 14; n= 34, 35, 31, 33, 27, 25 | -11.26 Percentage of surface area | Standard Deviation 10.262 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 16; n= 34, 36, 31, 35, 27, 25 | -10.92 Percentage of surface area | Standard Deviation 9.903 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 2; n= 39, 39, 39, 39, 33, 32 | -4.88 Percentage of surface area | Standard Deviation 5.243 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Body Surface Area (Percent BSA) | EW; n= 3, 4, 7, 3, 11, 11 | 5.36 Percentage of surface area | Standard Deviation 21.468 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 1; n= 38, 41, 39, 37, 38, 32 | -1.52 Percentage of surface area | Standard Deviation 6.078 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Body Surface Area (Percent BSA) | EW; n= 3, 4, 7, 3, 11, 11 | 3.20 Percentage of surface area | Standard Deviation 14.468 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 8; n= 36, 37, 34, 38, 29, 27 | -8.56 Percentage of surface area | Standard Deviation 6.217 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 4; n= 38, 39, 38, 39, 30, 32 | -7.07 Percentage of surface area | Standard Deviation 6.382 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 2; n= 39, 39, 39, 39, 33, 32 | -3.78 Percentage of surface area | Standard Deviation 5.897 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 12; n= 36, 37, 32, 35, 28, 25 | -9.81 Percentage of surface area | Standard Deviation 7.717 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 16; n= 34, 36, 31, 35, 27, 25 | -9.25 Percentage of surface area | Standard Deviation 8.399 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 14; n= 34, 35, 31, 33, 27, 25 | -9.26 Percentage of surface area | Standard Deviation 7.529 |
| Vehicle BID | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 4; n= 38, 39, 38, 39, 30, 32 | -2.93 Percentage of surface area | Standard Deviation 7.772 |
| Vehicle BID | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 2; n= 39, 39, 39, 39, 33, 32 | -2.01 Percentage of surface area | Standard Deviation 6.484 |
| Vehicle BID | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 16; n= 34, 36, 31, 35, 27, 25 | -5.66 Percentage of surface area | Standard Deviation 7.695 |
| Vehicle BID | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 1; n= 38, 41, 39, 37, 38, 32 | -0.33 Percentage of surface area | Standard Deviation 6.591 |
| Vehicle BID | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 12; n= 36, 37, 32, 35, 28, 25 | -6.00 Percentage of surface area | Standard Deviation 8.424 |
| Vehicle BID | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 8; n= 36, 37, 34, 38, 29, 27 | -5.41 Percentage of surface area | Standard Deviation 7.961 |
| Vehicle BID | Mean Change From Baseline in Body Surface Area (Percent BSA) | EW; n= 3, 4, 7, 3, 11, 11 | 3.36 Percentage of surface area | Standard Deviation 9.492 |
| Vehicle BID | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 14; n= 34, 35, 31, 33, 27, 25 | -5.60 Percentage of surface area | Standard Deviation 7.575 |
| Vehicle QD | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 4; n= 38, 39, 38, 39, 30, 32 | -2.05 Percentage of surface area | Standard Deviation 6.517 |
| Vehicle QD | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 16; n= 34, 36, 31, 35, 27, 25 | -5.53 Percentage of surface area | Standard Deviation 7.227 |
| Vehicle QD | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 2; n= 39, 39, 39, 39, 33, 32 | -0.04 Percentage of surface area | Standard Deviation 4.698 |
| Vehicle QD | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 8; n= 36, 37, 34, 38, 29, 27 | -3.33 Percentage of surface area | Standard Deviation 7.264 |
| Vehicle QD | Mean Change From Baseline in Body Surface Area (Percent BSA) | EW; n= 3, 4, 7, 3, 11, 11 | 7.50 Percentage of surface area | Standard Deviation 18.476 |
| Vehicle QD | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 1; n= 38, 41, 39, 37, 38, 32 | -0.25 Percentage of surface area | Standard Deviation 4.411 |
| Vehicle QD | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 12; n= 36, 37, 32, 35, 28, 25 | -5.44 Percentage of surface area | Standard Deviation 8.079 |
| Vehicle QD | Mean Change From Baseline in Body Surface Area (Percent BSA) | Week 14; n= 34, 35, 31, 33, 27, 25 | -5.80 Percentage of surface area | Standard Deviation 6.987 |
Secondary
Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score
The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale (0 \[absent\] to 3 \[severe\]) for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Body area involvement ranged from 0 (0%) to 6 (90-100%). Total EASI score was calculated as a sum of scores of all 4 specified body region. Range for EASI total score is 0 (absent) to 72 (severe). Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean change from Baseline was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Week 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | EW; n= 3,4,7,3,11,11 | -1.03 Scores on a scale | Standard Deviation 5.523 |
| GSK2894512 1% BID | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 2; n= 39,39,39,39,33,32 | -4.89 Scores on a scale | Standard Deviation 4.052 |
| GSK2894512 1% BID | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 14; n= 34,35,31,33,27,25 | -7.08 Scores on a scale | Standard Deviation 3.955 |
| GSK2894512 1% BID | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 12; n= 36,37,32,35,28,25 | -7.85 Scores on a scale | Standard Deviation 5 |
| GSK2894512 1% BID | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 8; n= 36,37,34,38,29,27 | -7.00 Scores on a scale | Standard Deviation 4.759 |
| GSK2894512 1% BID | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 4; n= 38,39,38,39,30,32 | -6.55 Scores on a scale | Standard Deviation 3.808 |
| GSK2894512 1% BID | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 1; n= 38,41,39,37,38,32 | -2.58 Scores on a scale | Standard Deviation 3.965 |
| GSK2894512 1% BID | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 16; n= 34,36,31,35,27,25 | -6.45 Scores on a scale | Standard Deviation 4.245 |
| GSK2894512 1% QD | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | EW; n= 3,4,7,3,11,11 | 3.40 Scores on a scale | Standard Deviation 4.023 |
| GSK2894512 1% QD | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 16; n= 34,36,31,35,27,25 | -7.45 Scores on a scale | Standard Deviation 5.106 |
| GSK2894512 1% QD | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 4; n= 38,39,38,39,30,32 | -7.18 Scores on a scale | Standard Deviation 4.534 |
| GSK2894512 1% QD | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 12; n= 36,37,32,35,28,25 | -8.16 Scores on a scale | Standard Deviation 4.931 |
| GSK2894512 1% QD | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 8; n= 36,37,34,38,29,27 | -8.12 Scores on a scale | Standard Deviation 4.924 |
| GSK2894512 1% QD | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 2; n= 39,39,39,39,33,32 | -5.69 Scores on a scale | Standard Deviation 3.996 |
| GSK2894512 1% QD | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 14; n= 34,35,31,33,27,25 | -7.36 Scores on a scale | Standard Deviation 4.683 |
| GSK2894512 1% QD | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 1; n= 38,41,39,37,38,32 | -3.83 Scores on a scale | Standard Deviation 4.41 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 1; n= 38,41,39,37,38,32 | -3.22 Scores on a scale | Standard Deviation 3.585 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 12; n= 36,37,32,35,28,25 | -10.12 Scores on a scale | Standard Deviation 4.665 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 14; n= 34,35,31,33,27,25 | -9.07 Scores on a scale | Standard Deviation 5.367 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 16; n= 34,36,31,35,27,25 | -8.85 Scores on a scale | Standard Deviation 5.654 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | EW; n= 3,4,7,3,11,11 | 3.11 Scores on a scale | Standard Deviation 9.042 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 8; n= 36,37,34,38,29,27 | -8.67 Scores on a scale | Standard Deviation 5.039 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 2; n= 39,39,39,39,33,32 | -5.27 Scores on a scale | Standard Deviation 3.848 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 4; n= 38,39,38,39,30,32 | -7.42 Scores on a scale | Standard Deviation 3.749 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 16; n= 34,36,31,35,27,25 | -7.67 Scores on a scale | Standard Deviation 4.405 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 8; n= 36,37,34,38,29,27 | -7.62 Scores on a scale | Standard Deviation 4.539 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 12; n= 36,37,32,35,28,25 | -8.16 Scores on a scale | Standard Deviation 5.077 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | EW; n= 3,4,7,3,11,11 | -2.97 Scores on a scale | Standard Deviation 6.661 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 14; n= 34,35,31,33,27,25 | -7.42 Scores on a scale | Standard Deviation 4.798 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 2; n= 39,39,39,39,33,32 | -4.21 Scores on a scale | Standard Deviation 3.337 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 4; n= 38,39,38,39,30,32 | -6.19 Scores on a scale | Standard Deviation 3.588 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 1; n= 38,41,39,37,38,32 | -2.51 Scores on a scale | Standard Deviation 3.24 |
| Vehicle BID | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 4; n= 38,39,38,39,30,32 | -4.45 Scores on a scale | Standard Deviation 4.18 |
| Vehicle BID | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | EW; n= 3,4,7,3,11,11 | 2.01 Scores on a scale | Standard Deviation 4.418 |
| Vehicle BID | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 14; n= 34,35,31,33,27,25 | -6.28 Scores on a scale | Standard Deviation 5.335 |
| Vehicle BID | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 1; n= 38,41,39,37,38,32 | -1.84 Scores on a scale | Standard Deviation 2.73 |
| Vehicle BID | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 12; n= 36,37,32,35,28,25 | -6.05 Scores on a scale | Standard Deviation 5.937 |
| Vehicle BID | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 8; n= 36,37,34,38,29,27 | -5.24 Scores on a scale | Standard Deviation 5.267 |
| Vehicle BID | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 2; n= 39,39,39,39,33,32 | -3.18 Scores on a scale | Standard Deviation 3.545 |
| Vehicle BID | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 16; n= 34,36,31,35,27,25 | -6.29 Scores on a scale | Standard Deviation 6.158 |
| Vehicle QD | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 12; n= 36,37,32,35,28,25 | -5.58 Scores on a scale | Standard Deviation 5.668 |
| Vehicle QD | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 8; n= 36,37,34,38,29,27 | -4.15 Scores on a scale | Standard Deviation 5.19 |
| Vehicle QD | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 1; n= 38,41,39,37,38,32 | -1.06 Scores on a scale | Standard Deviation 3.66 |
| Vehicle QD | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 4; n= 38,39,38,39,30,32 | -2.94 Scores on a scale | Standard Deviation 3.788 |
| Vehicle QD | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 14; n= 34,35,31,33,27,25 | -5.44 Scores on a scale | Standard Deviation 5.05 |
| Vehicle QD | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 16; n= 34,36,31,35,27,25 | -5.40 Scores on a scale | Standard Deviation 5.315 |
| Vehicle QD | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | EW; n= 3,4,7,3,11,11 | 3.38 Scores on a scale | Standard Deviation 9.746 |
| Vehicle QD | Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score | Week 2; n= 39,39,39,39,33,32 | -1.67 Scores on a scale | Standard Deviation 3.079 |
Secondary
Mean Change From Baseline in IGA Score
The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. Score ranges from 0 (clear) to 4 (severe). Higher values represent a severe disease. Mean change from Baseline in IGA score was presented using mean and SD at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit. Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Mean Change From Baseline in IGA Score | Week 4; n= 38, 39, 38, 39, 30, 32 | -1.3 Scores on a scale | Standard Deviation 0.86 |
| GSK2894512 1% BID | Mean Change From Baseline in IGA Score | Week 12; n= 36, 37, 32, 35, 28, 25 | -1.7 Scores on a scale | Standard Deviation 0.96 |
| GSK2894512 1% BID | Mean Change From Baseline in IGA Score | Week 14; n= 34, 35, 31, 33, 27, 25 | -1.5 Scores on a scale | Standard Deviation 1.08 |
| GSK2894512 1% BID | Mean Change From Baseline in IGA Score | Week 2; n= 39, 39, 39, 39, 33, 32 | -1.0 Scores on a scale | Standard Deviation 0.69 |
| GSK2894512 1% BID | Mean Change From Baseline in IGA Score | Week 1; n= 38, 41, 39, 37, 38, 32 | -0.5 Scores on a scale | Standard Deviation 0.6 |
| GSK2894512 1% BID | Mean Change From Baseline in IGA Score | Week 8; n= 36, 37, 34, 38, 29, 27 | -1.4 Scores on a scale | Standard Deviation 0.83 |
| GSK2894512 1% BID | Mean Change From Baseline in IGA Score | EW; n= 3, 4, 7, 3, 11, 11 | -1.3 Scores on a scale | Standard Deviation 1.53 |
| GSK2894512 1% BID | Mean Change From Baseline in IGA Score | Week 16; n= 34, 36, 31, 35, 27, 25 | -1.2 Scores on a scale | Standard Deviation 1.07 |
| GSK2894512 1% QD | Mean Change From Baseline in IGA Score | Week 16; n= 34, 36, 31, 35, 27, 25 | -1.2 Scores on a scale | Standard Deviation 0.74 |
| GSK2894512 1% QD | Mean Change From Baseline in IGA Score | Week 4; n= 38, 39, 38, 39, 30, 32 | -1.4 Scores on a scale | Standard Deviation 0.81 |
| GSK2894512 1% QD | Mean Change From Baseline in IGA Score | Week 12; n= 36, 37, 32, 35, 28, 25 | -1.6 Scores on a scale | Standard Deviation 0.83 |
| GSK2894512 1% QD | Mean Change From Baseline in IGA Score | Week 14; n= 34, 35, 31, 33, 27, 25 | -1.4 Scores on a scale | Standard Deviation 0.77 |
| GSK2894512 1% QD | Mean Change From Baseline in IGA Score | Week 8; n= 36, 37, 34, 38, 29, 27 | -1.6 Scores on a scale | Standard Deviation 0.82 |
| GSK2894512 1% QD | Mean Change From Baseline in IGA Score | Week 2; n= 39, 39, 39, 39, 33, 32 | -0.9 Scores on a scale | Standard Deviation 0.7 |
| GSK2894512 1% QD | Mean Change From Baseline in IGA Score | EW; n= 3, 4, 7, 3, 11, 11 | 0.3 Scores on a scale | Standard Deviation 0.5 |
| GSK2894512 1% QD | Mean Change From Baseline in IGA Score | Week 1; n= 38, 41, 39, 37, 38, 32 | -0.6 Scores on a scale | Standard Deviation 0.67 |
| GSK2894512 0.5% BID | Mean Change From Baseline in IGA Score | Week 1; n= 38, 41, 39, 37, 38, 32 | -0.3 Scores on a scale | Standard Deviation 0.48 |
| GSK2894512 0.5% BID | Mean Change From Baseline in IGA Score | Week 2; n= 39, 39, 39, 39, 33, 32 | -0.6 Scores on a scale | Standard Deviation 0.67 |
| GSK2894512 0.5% BID | Mean Change From Baseline in IGA Score | Week 4; n= 38, 39, 38, 39, 30, 32 | -1.1 Scores on a scale | Standard Deviation 0.77 |
| GSK2894512 0.5% BID | Mean Change From Baseline in IGA Score | Week 8; n= 36, 37, 34, 38, 29, 27 | -1.3 Scores on a scale | Standard Deviation 0.84 |
| GSK2894512 0.5% BID | Mean Change From Baseline in IGA Score | Week 14; n= 34, 35, 31, 33, 27, 25 | -1.5 Scores on a scale | Standard Deviation 0.99 |
| GSK2894512 0.5% BID | Mean Change From Baseline in IGA Score | Week 16; n= 34, 36, 31, 35, 27, 25 | -1.4 Scores on a scale | Standard Deviation 0.91 |
| GSK2894512 0.5% BID | Mean Change From Baseline in IGA Score | EW; n= 3, 4, 7, 3, 11, 11 | -0.6 Scores on a scale | Standard Deviation 0.98 |
| GSK2894512 0.5% BID | Mean Change From Baseline in IGA Score | Week 12; n= 36, 37, 32, 35, 28, 25 | -1.6 Scores on a scale | Standard Deviation 0.76 |
| GSK2894512 0.5% QD | Mean Change From Baseline in IGA Score | Week 12; n= 36, 37, 32, 35, 28, 25 | -1.5 Scores on a scale | Standard Deviation 0.95 |
| GSK2894512 0.5% QD | Mean Change From Baseline in IGA Score | Week 2; n= 39, 39, 39, 39, 33, 32 | -0.7 Scores on a scale | Standard Deviation 0.79 |
| GSK2894512 0.5% QD | Mean Change From Baseline in IGA Score | Week 4; n= 38, 39, 38, 39, 30, 32 | -1.0 Scores on a scale | Standard Deviation 0.81 |
| GSK2894512 0.5% QD | Mean Change From Baseline in IGA Score | EW; n= 3, 4, 7, 3, 11, 11 | -1.0 Scores on a scale | Standard Deviation 1 |
| GSK2894512 0.5% QD | Mean Change From Baseline in IGA Score | Week 8; n= 36, 37, 34, 38, 29, 27 | -1.4 Scores on a scale | Standard Deviation 0.85 |
| GSK2894512 0.5% QD | Mean Change From Baseline in IGA Score | Week 14; n= 34, 35, 31, 33, 27, 25 | -1.3 Scores on a scale | Standard Deviation 0.92 |
| GSK2894512 0.5% QD | Mean Change From Baseline in IGA Score | Week 1; n= 38, 41, 39, 37, 38, 32 | -0.4 Scores on a scale | Standard Deviation 0.55 |
| GSK2894512 0.5% QD | Mean Change From Baseline in IGA Score | Week 16; n= 34, 36, 31, 35, 27, 25 | -1.3 Scores on a scale | Standard Deviation 0.94 |
| Vehicle BID | Mean Change From Baseline in IGA Score | Week 8; n= 36, 37, 34, 38, 29, 27 | -1.2 Scores on a scale | Standard Deviation 0.6 |
| Vehicle BID | Mean Change From Baseline in IGA Score | Week 14; n= 34, 35, 31, 33, 27, 25 | -1.2 Scores on a scale | Standard Deviation 0.85 |
| Vehicle BID | Mean Change From Baseline in IGA Score | Week 4; n= 38, 39, 38, 39, 30, 32 | -1.0 Scores on a scale | Standard Deviation 0.72 |
| Vehicle BID | Mean Change From Baseline in IGA Score | Week 16; n= 34, 36, 31, 35, 27, 25 | -1.3 Scores on a scale | Standard Deviation 0.9 |
| Vehicle BID | Mean Change From Baseline in IGA Score | EW; n= 3, 4, 7, 3, 11, 11 | 0.1 Scores on a scale | Standard Deviation 0.3 |
| Vehicle BID | Mean Change From Baseline in IGA Score | Week 2; n= 39, 39, 39, 39, 33, 32 | -0.7 Scores on a scale | Standard Deviation 0.72 |
| Vehicle BID | Mean Change From Baseline in IGA Score | Week 1; n= 38, 41, 39, 37, 38, 32 | -0.3 Scores on a scale | Standard Deviation 0.58 |
| Vehicle BID | Mean Change From Baseline in IGA Score | Week 12; n= 36, 37, 32, 35, 28, 25 | -1.3 Scores on a scale | Standard Deviation 0.72 |
| Vehicle QD | Mean Change From Baseline in IGA Score | Week 1; n= 38, 41, 39, 37, 38, 32 | -0.4 Scores on a scale | Standard Deviation 0.62 |
| Vehicle QD | Mean Change From Baseline in IGA Score | Week 14; n= 34, 35, 31, 33, 27, 25 | -1.2 Scores on a scale | Standard Deviation 0.75 |
| Vehicle QD | Mean Change From Baseline in IGA Score | Week 4; n= 38, 39, 38, 39, 30, 32 | -0.7 Scores on a scale | Standard Deviation 0.82 |
| Vehicle QD | Mean Change From Baseline in IGA Score | Week 8; n= 36, 37, 34, 38, 29, 27 | -1.0 Scores on a scale | Standard Deviation 0.88 |
| Vehicle QD | Mean Change From Baseline in IGA Score | EW; n= 3, 4, 7, 3, 11, 11 | 0.0 Scores on a scale | Standard Deviation 0.89 |
| Vehicle QD | Mean Change From Baseline in IGA Score | Week 2; n= 39, 39, 39, 39, 33, 32 | -0.5 Scores on a scale | Standard Deviation 0.72 |
| Vehicle QD | Mean Change From Baseline in IGA Score | Week 16; n= 34, 36, 31, 35, 27, 25 | -1.1 Scores on a scale | Standard Deviation 0.73 |
| Vehicle QD | Mean Change From Baseline in IGA Score | Week 12; n= 36, 37, 32, 35, 28, 25 | -1.2 Scores on a scale | Standard Deviation 0.78 |
Secondary
Mean Change From Baseline in Individual Signs of TSS
The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe) and TSS (maximum score 15) was calculated based on these signs. Mean change from Baseline in individual signs of TSS was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. If the participant had more than 3 missing days during the week, then the weekly average was not calculated and treated as missing data and excluded from the analysis. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 1; n= 38, 41, 39, 37, 38, 32 | -0.6 Scores on a scale | Standard Deviation 0.55 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 4;n=38,39,38,39,30,32 | -0.6 Scores on a scale | Standard Deviation 0.65 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 8;n=36,37,34,38,29,27 | -0.9 Scores on a scale | Standard Deviation 0.83 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 2;n=39,39,39,39,33,32 | -0.5 Scores on a scale | Standard Deviation 0.6 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 14;n=34,35,31,33,27,25 | -1.2 Scores on a scale | Standard Deviation 0.84 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 16;n=34,36,31,35,27,25 | -1.0 Scores on a scale | Standard Deviation 0.9 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 1;n=38,41,39,37,38,32 | -0.2 Scores on a scale | Standard Deviation 0.47 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 16;n=34,36,31,35,27,25 | -1.1 Scores on a scale | Standard Deviation 0.98 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 12; n= 36, 37, 32, 35, 28, 25 | -1.5 Scores on a scale | Standard Deviation 0.84 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Lichenification; EW;n= 3,4,7,3,11,11 | -0.7 Scores on a scale | Standard Deviation 1.15 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 14; n= 34, 35, 31, 33, 27, 25 | -1.5 Scores on a scale | Standard Deviation 0.83 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 14;n=34,35,31,33,27,25 | -1.0 Scores on a scale | Standard Deviation 0.85 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 16; n= 34, 36 , 31, 35, 27, 25 | -1.5 Scores on a scale | Standard Deviation 0.83 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 2; n= 39, 39, 39, 39, 33, 32 | -1.1 Scores on a scale | Standard Deviation 0.7 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Erythema; EW; n= 3, 4, 7, 3, 11, 11 | -0.7 Scores on a scale | Standard Deviation 1.15 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 12;n=36,37,32,35,28,25 | -1.1 Scores on a scale | Standard Deviation 0.83 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 1; n=38,41,39,37,38,32 | -0.3 Scores on a scale | Standard Deviation 0.48 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 8;n=36,37,34,38,29,27 | -0.8 Scores on a scale | Standard Deviation 0.79 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 4;n=38,39,38,39,30,32 | -0.8 Scores on a scale | Standard Deviation 0.78 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 4;n= 38,39,38,39,30,32 | -1.0 Scores on a scale | Standard Deviation 0.82 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 8;n= 36,37,34,38,29,27 | -1.1 Scores on a scale | Standard Deviation 0.65 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 1;n=38,41,39,37,38,32 | -0.3 Scores on a scale | Standard Deviation 0.85 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 12;n=36,37,32,35,28,25 | -1.2 Scores on a scale | Standard Deviation 0.91 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 2;n= 39,39,39,39,33,32 | -0.6 Scores on a scale | Standard Deviation 0.82 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 4; n= 38, 39, 38, 39, 30, 32 | -1.1 Scores on a scale | Standard Deviation 0.69 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; EW;n=3,4,7,3,11,11 | -0.3 Scores on a scale | Standard Deviation 0.58 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 2;n= 39,39,39,39,33,32 | -0.8 Scores on a scale | Standard Deviation 0.73 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 12;n=36,37,32,35,28,25 | -1.4 Scores on a scale | Standard Deviation 0.87 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 14;n=34,35,31,33,27,25 | -1.3 Scores on a scale | Standard Deviation 0.86 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 16;n=34,36,31,35,27,25 | -0.6 Scores on a scale | Standard Deviation 0.61 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 16;n=34,36,31,35,27,25 | -1.2 Scores on a scale | Standard Deviation 0.82 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 14;n=34,35,31,33,27,25 | -0.6 Scores on a scale | Standard Deviation 0.65 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation; EW; n= 3,4,7,3,11,11 | -0.3 Scores on a scale | Standard Deviation 1.53 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Scaling; EW;n=3,4,7,3,11,11 | -0.3 Scores on a scale | Standard Deviation 0.58 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 12;n=36,37,32,35,28,25 | -0.6 Scores on a scale | Standard Deviation 0.6 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 1;n=38,41,39,37,38,32 | -0.3 Scores on a scale | Standard Deviation 0.63 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 2;n=39,39,39,39,33,32 | -0.6 Scores on a scale | Standard Deviation 0.81 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 8; n= 36, 37, 34, 38, 29, 27 | -1.3 Scores on a scale | Standard Deviation 0.7 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 8;n=36,37,34,38,29,27 | -0.6 Scores on a scale | Standard Deviation 0.64 |
| GSK2894512 1% BID | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 4;n=38,39,38,39,30,32 | -0.8 Scores on a scale | Standard Deviation 0.81 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Erythema; EW; n= 3, 4, 7, 3, 11, 11 | -0.3 Scores on a scale | Standard Deviation 0.96 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 2; n= 39, 39, 39, 39, 33, 32 | -1.1 Scores on a scale | Standard Deviation 0.84 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 1; n= 38, 41, 39, 37, 38, 32 | -0.8 Scores on a scale | Standard Deviation 0.88 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 8;n=36,37,34,38,29,27 | -0.9 Scores on a scale | Standard Deviation 0.66 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 14;n=34,35,31,33,27,25 | -0.5 Scores on a scale | Standard Deviation 0.78 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 1; n=38,41,39,37,38,32 | -0.6 Scores on a scale | Standard Deviation 0.77 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 2;n=39,39,39,39,33,32 | -0.8 Scores on a scale | Standard Deviation 0.78 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 2;n= 39,39,39,39,33,32 | -1.0 Scores on a scale | Standard Deviation 0.87 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 4;n=38,39,38,39,30,32 | -0.7 Scores on a scale | Standard Deviation 0.69 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation; EW; n= 3,4,7,3,11,11 | 0.0 Scores on a scale | Standard Deviation 0.82 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 4;n= 38,39,38,39,30,32 | -1.2 Scores on a scale | Standard Deviation 0.86 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 2;n= 39,39,39,39,33,32 | -0.7 Scores on a scale | Standard Deviation 0.68 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 8;n= 36,37,34,38,29,27 | -1.2 Scores on a scale | Standard Deviation 1 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Scaling; EW;n=3,4,7,3,11,11 | 0.0 Scores on a scale | Standard Deviation 1.41 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 1;n=38,41,39,37,38,32 | -0.4 Scores on a scale | Standard Deviation 0.7 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 4;n=38,39,38,39,30,32 | -0.9 Scores on a scale | Standard Deviation 0.7 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 12;n=36,37,32,35,28,25 | -0.6 Scores on a scale | Standard Deviation 0.72 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 14;n=34,35,31,33,27,25 | -1.0 Scores on a scale | Standard Deviation 0.71 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 16;n=34,36,31,35,27,25 | -1.0 Scores on a scale | Standard Deviation 0.7 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; EW;n=3,4,7,3,11,11 | 0.8 Scores on a scale | Standard Deviation 1.5 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 1;n=38,41,39,37,38,32 | -0.5 Scores on a scale | Standard Deviation 0.81 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 12;n=36,37,32,35,28,25 | -1.4 Scores on a scale | Standard Deviation 0.86 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 8;n=36,37,34,38,29,27 | -1.1 Scores on a scale | Standard Deviation 0.8 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 12; n= 36, 37, 32, 35, 28, 25 | -1.5 Scores on a scale | Standard Deviation 0.8 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 2;n=39,39,39,39,33,32 | -0.4 Scores on a scale | Standard Deviation 0.55 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 12;n=36,37,32,35,28,25 | -1.1 Scores on a scale | Standard Deviation 0.75 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 16;n=34,36,31,35,27,25 | -0.8 Scores on a scale | Standard Deviation 0.75 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 4; n= 38, 39, 38, 39, 30, 32 | -1.3 Scores on a scale | Standard Deviation 0.75 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 16;n=34,36,31,35,27,25 | -0.6 Scores on a scale | Standard Deviation 0.77 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 1;n=38,41,39,37,38,32 | -0.4 Scores on a scale | Standard Deviation 0.62 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 14;n=34,35,31,33,27,25 | -1.3 Scores on a scale | Standard Deviation 0.64 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Lichenification; EW;n= 3,4,7,3,11,11 | 0.0 Scores on a scale | Standard Deviation 0.82 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 8; n= 36, 37, 34, 38, 29, 27 | -1.5 Scores on a scale | Standard Deviation 0.77 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 8;n=36,37,34,38,29,27 | -0.6 Scores on a scale | Standard Deviation 0.75 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 14; n= 34, 35, 31, 33, 27, 25 | -1.4 Scores on a scale | Standard Deviation 0.77 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 4;n=38,39,38,39,30,32 | -0.5 Scores on a scale | Standard Deviation 0.64 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 14;n=34,35,31,33,27,25 | -0.9 Scores on a scale | Standard Deviation 0.73 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 16; n= 34, 36 , 31, 35, 27, 25 | -1.3 Scores on a scale | Standard Deviation 0.82 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 16;n=34,36,31,35,27,25 | -1.2 Scores on a scale | Standard Deviation 0.74 |
| GSK2894512 1% QD | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 12;n=36,37,32,35,28,25 | -0.9 Scores on a scale | Standard Deviation 0.7 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 16;n=34,36,31,35,27,25 | -1.0 Scores on a scale | Standard Deviation 0.68 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Erythema; EW; n= 3, 4, 7, 3, 11, 11 | -0.4 Scores on a scale | Standard Deviation 0.98 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Lichenification; EW;n= 3,4,7,3,11,11 | -0.4 Scores on a scale | Standard Deviation 0.98 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 12;n=36,37,32,35,28,25 | -1.6 Scores on a scale | Standard Deviation 0.72 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 16;n=34,36,31,35,27,25 | -1.4 Scores on a scale | Standard Deviation 0.75 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 8;n=36,37,34,38,29,27 | -1.2 Scores on a scale | Standard Deviation 0.67 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 4; n= 38, 39, 38, 39, 30, 32 | -1.2 Scores on a scale | Standard Deviation 0.79 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 1; n=38,41,39,37,38,32 | -0.5 Scores on a scale | Standard Deviation 0.68 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 2; n= 39, 39, 39, 39, 33, 32 | -0.8 Scores on a scale | Standard Deviation 0.76 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 2;n=39,39,39,39,33,32 | -0.7 Scores on a scale | Standard Deviation 0.79 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 4;n=38,39,38,39,30,32 | -0.8 Scores on a scale | Standard Deviation 0.75 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 12; n= 36, 37, 32, 35, 28, 25 | -1.7 Scores on a scale | Standard Deviation 0.69 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 2;n= 39,39,39,39,33,32 | -0.8 Scores on a scale | Standard Deviation 0.84 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 1; n= 38, 41, 39, 37, 38, 32 | -0.4 Scores on a scale | Standard Deviation 0.63 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 14;n=34,35,31,33,27,25 | -0.8 Scores on a scale | Standard Deviation 1 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 2;n=39,39,39,39,33,32 | -0.7 Scores on a scale | Standard Deviation 0.66 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 12;n=36,37,32,35,28,25 | -1.5 Scores on a scale | Standard Deviation 0.57 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 14;n=34,35,31,33,27,25 | -1.0 Scores on a scale | Standard Deviation 0.8 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 4;n= 38,39,38,39,30,32 | -1.1 Scores on a scale | Standard Deviation 0.78 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Scaling; EW;n=3,4,7,3,11,11 | 0.0 Scores on a scale | Standard Deviation 0.82 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 8; n= 36, 37, 34, 38, 29, 27 | -1.4 Scores on a scale | Standard Deviation 0.61 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 1;n=38,41,39,37,38,32 | -0.4 Scores on a scale | Standard Deviation 0.68 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation; EW; n= 3,4,7,3,11,11 | -0.1 Scores on a scale | Standard Deviation 1.35 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 1;n=38,41,39,37,38,32 | -0.4 Scores on a scale | Standard Deviation 0.63 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 8;n= 36,37,34,38,29,27 | -1.4 Scores on a scale | Standard Deviation 0.66 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 16;n=34,36,31,35,27,25 | -1.0 Scores on a scale | Standard Deviation 1.03 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 14;n=34,35,31,33,27,25 | -1.2 Scores on a scale | Standard Deviation 0.83 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 12;n=36,37,32,35,28,25 | -1.2 Scores on a scale | Standard Deviation 0.72 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 14; n= 34, 35, 31, 33, 27, 25 | -1.3 Scores on a scale | Standard Deviation 0.97 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 8;n=36,37,34,38,29,27 | -1.0 Scores on a scale | Standard Deviation 0.9 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 16; n= 34, 36 , 31, 35, 27, 25 | -1.4 Scores on a scale | Standard Deviation 0.92 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 12;n=36,37,32,35,28,25 | -1.1 Scores on a scale | Standard Deviation 0.93 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; EW;n=3,4,7,3,11,11 | 0.6 Scores on a scale | Standard Deviation 1.4 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 4;n=38,39,38,39,30,32 | -1.1 Scores on a scale | Standard Deviation 0.73 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 2;n= 39,39,39,39,33,32 | -0.6 Scores on a scale | Standard Deviation 0.67 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 4;n=38,39,38,39,30,32 | -0.8 Scores on a scale | Standard Deviation 0.86 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 16;n=34,36,31,35,27,25 | -1.3 Scores on a scale | Standard Deviation 0.73 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 8;n=36,37,34,38,29,27 | -1.1 Scores on a scale | Standard Deviation 0.71 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 14;n=34,35,31,33,27,25 | -1.3 Scores on a scale | Standard Deviation 0.73 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 1;n=38,41,39,37,38,32 | -0.4 Scores on a scale | Standard Deviation 0.6 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 14; n= 34, 35, 31, 33, 27, 25 | -1.0 Scores on a scale | Standard Deviation 0.75 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 1; n= 38, 41, 39, 37, 38, 32 | -0.4 Scores on a scale | Standard Deviation 0.55 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 2; n= 39, 39, 39, 39, 33, 32 | -0.7 Scores on a scale | Standard Deviation 0.75 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 4; n= 38, 39, 38, 39, 30, 32 | -0.9 Scores on a scale | Standard Deviation 0.79 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 8; n= 36, 37, 34, 38, 29, 27 | -1.2 Scores on a scale | Standard Deviation 0.73 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 12; n= 36, 37, 32, 35, 28, 25 | -1.3 Scores on a scale | Standard Deviation 0.84 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 16; n= 34, 36 , 31, 35, 27, 25 | -1.1 Scores on a scale | Standard Deviation 0.77 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Erythema; EW; n= 3, 4, 7, 3, 11, 11 | -1.0 Scores on a scale | Standard Deviation 1 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 1; n=38,41,39,37,38,32 | -0.4 Scores on a scale | Standard Deviation 0.6 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 2;n= 39,39,39,39,33,32 | -0.8 Scores on a scale | Standard Deviation 0.73 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 4;n= 38,39,38,39,30,32 | -0.9 Scores on a scale | Standard Deviation 0.83 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 8;n= 36,37,34,38,29,27 | -1.2 Scores on a scale | Standard Deviation 0.69 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 2;n= 39,39,39,39,33,32 | -0.6 Scores on a scale | Standard Deviation 0.71 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 12;n=36,37,32,35,28,25 | -1.2 Scores on a scale | Standard Deviation 0.73 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 14;n=34,35,31,33,27,25 | -0.9 Scores on a scale | Standard Deviation 0.83 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 16;n=34,36,31,35,27,25 | -1.2 Scores on a scale | Standard Deviation 0.82 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation; EW; n= 3,4,7,3,11,11 | 0.0 Scores on a scale | Standard Deviation 1 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 1;n=38,41,39,37,38,32 | -0.4 Scores on a scale | Standard Deviation 0.54 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 2;n=39,39,39,39,33,32 | -0.7 Scores on a scale | Standard Deviation 0.73 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 4;n=38,39,38,39,30,32 | -0.9 Scores on a scale | Standard Deviation 0.84 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 8;n=36,37,34,38,29,27 | -1.1 Scores on a scale | Standard Deviation 0.74 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 12;n=36,37,32,35,28,25 | -1.2 Scores on a scale | Standard Deviation 0.75 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 14;n=34,35,31,33,27,25 | -1.1 Scores on a scale | Standard Deviation 0.7 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 16;n=34,36,31,35,27,25 | -1.1 Scores on a scale | Standard Deviation 0.72 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Lichenification; EW;n= 3,4,7,3,11,11 | -1.0 Scores on a scale | Standard Deviation 1 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 1;n=38,41,39,37,38,32 | -0.3 Scores on a scale | Standard Deviation 0.47 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 2;n=39,39,39,39,33,32 | -0.4 Scores on a scale | Standard Deviation 0.55 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 4;n=38,39,38,39,30,32 | -0.6 Scores on a scale | Standard Deviation 0.67 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 8;n=36,37,34,38,29,27 | -0.7 Scores on a scale | Standard Deviation 0.65 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 12;n=36,37,32,35,28,25 | -0.7 Scores on a scale | Standard Deviation 0.66 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 14;n=34,35,31,33,27,25 | -0.5 Scores on a scale | Standard Deviation 0.94 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 16;n=34,36,31,35,27,25 | -0.7 Scores on a scale | Standard Deviation 0.62 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; EW;n=3,4,7,3,11,11 | 0.0 Scores on a scale | Standard Deviation 0 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 1;n=38,41,39,37,38,32 | -0.3 Scores on a scale | Standard Deviation 0.78 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 4;n=38,39,38,39,30,32 | -0.8 Scores on a scale | Standard Deviation 0.81 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 8;n=36,37,34,38,29,27 | -0.9 Scores on a scale | Standard Deviation 0.71 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 12;n=36,37,32,35,28,25 | -1.0 Scores on a scale | Standard Deviation 0.8 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 14;n=34,35,31,33,27,25 | -0.8 Scores on a scale | Standard Deviation 0.87 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 16;n=34,36,31,35,27,25 | -0.9 Scores on a scale | Standard Deviation 0.74 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Individual Signs of TSS | Scaling; EW;n=3,4,7,3,11,11 | -0.7 Scores on a scale | Standard Deviation 0.58 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 8;n=36,37,34,38,29,27 | -0.6 Scores on a scale | Standard Deviation 0.78 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 4;n= 38,39,38,39,30,32 | -0.7 Scores on a scale | Standard Deviation 0.75 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 2;n= 39,39,39,39,33,32 | -0.6 Scores on a scale | Standard Deviation 0.78 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 14;n=34,35,31,33,27,25 | -0.8 Scores on a scale | Standard Deviation 0.79 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 2;n= 39,39,39,39,33,32 | -0.6 Scores on a scale | Standard Deviation 0.87 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 4;n=38,39,38,39,30,32 | -0.6 Scores on a scale | Standard Deviation 0.89 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 14;n=34,35,31,33,27,25 | -0.9 Scores on a scale | Standard Deviation 0.75 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 4;n=38,39,38,39,30,32 | -0.7 Scores on a scale | Standard Deviation 0.71 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 2;n=39,39,39,39,33,32 | -0.7 Scores on a scale | Standard Deviation 0.78 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 1; n=38,41,39,37,38,32 | -0.3 Scores on a scale | Standard Deviation 0.65 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 12;n=36,37,32,35,28,25 | -0.8 Scores on a scale | Standard Deviation 0.79 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Scaling; EW;n=3,4,7,3,11,11 | -0.1 Scores on a scale | Standard Deviation 1.04 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 8;n=36,37,34,38,29,27 | -1.0 Scores on a scale | Standard Deviation 0.76 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Erythema; EW; n= 3, 4, 7, 3, 11, 11 | -0.4 Scores on a scale | Standard Deviation 1.12 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 4; n= 38, 39, 38, 39, 30, 32 | -0.8 Scores on a scale | Standard Deviation 0.73 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 16; n= 34, 36 , 31, 35, 27, 25 | -1.1 Scores on a scale | Standard Deviation 0.87 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 16;n=34,36,31,35,27,25 | -0.8 Scores on a scale | Standard Deviation 0.75 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 12;n=36,37,32,35,28,25 | -1.0 Scores on a scale | Standard Deviation 0.67 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation; EW; n= 3,4,7,3,11,11 | -0.3 Scores on a scale | Standard Deviation 1.19 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 16;n=34,36,31,35,27,25 | -1.1 Scores on a scale | Standard Deviation 0.7 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 14; n= 34, 35, 31, 33, 27, 25 | -1.2 Scores on a scale | Standard Deviation 0.74 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 12; n= 36, 37, 32, 35, 28, 25 | -1.1 Scores on a scale | Standard Deviation 0.77 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 12;n=36,37,32,35,28,25 | -0.7 Scores on a scale | Standard Deviation 0.81 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 14;n=34,35,31,33,27,25 | -1.0 Scores on a scale | Standard Deviation 0.81 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 1;n=38,41,39,37,38,32 | -0.4 Scores on a scale | Standard Deviation 0.72 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 16;n=34,36,31,35,27,25 | -1.0 Scores on a scale | Standard Deviation 0.76 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 4;n=38,39,38,39,30,32 | -0.6 Scores on a scale | Standard Deviation 0.82 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Lichenification; EW;n= 3,4,7,3,11,11 | -0.4 Scores on a scale | Standard Deviation 0.81 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; EW;n=3,4,7,3,11,11 | 0.0 Scores on a scale | Standard Deviation 0.77 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 1;n=38,41,39,37,38,32 | -0.4 Scores on a scale | Standard Deviation 0.63 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 14;n=34,35,31,33,27,25 | -1.0 Scores on a scale | Standard Deviation 0.85 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 16;n=34,36,31,35,27,25 | -0.8 Scores on a scale | Standard Deviation 0.68 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 8;n= 36,37,34,38,29,27 | -1.0 Scores on a scale | Standard Deviation 0.76 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 1;n=38,41,39,37,38,32 | -0.3 Scores on a scale | Standard Deviation 0.91 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 1; n= 38, 41, 39, 37, 38, 32 | -0.4 Scores on a scale | Standard Deviation 0.76 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 12;n=36,37,32,35,28,25 | -1.0 Scores on a scale | Standard Deviation 0.67 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 2; n= 39, 39, 39, 39, 33, 32 | -0.6 Scores on a scale | Standard Deviation 0.78 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 8;n=36,37,34,38,29,27 | -0.9 Scores on a scale | Standard Deviation 0.65 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 8; n= 36, 37, 34, 38, 29, 27 | -1.2 Scores on a scale | Standard Deviation 0.85 |
| Vehicle BID | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 2;n=39,39,39,39,33,32 | -0.5 Scores on a scale | Standard Deviation 0.75 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 14;n=34,35,31,33,27,25 | -1.2 Scores on a scale | Standard Deviation 0.82 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 4;n=38,39,38,39,30,32 | -0.6 Scores on a scale | Standard Deviation 0.88 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 2;n=39,39,39,39,33,32 | -0.4 Scores on a scale | Standard Deviation 0.76 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 4; n= 38, 39, 38, 39, 30, 32 | -0.6 Scores on a scale | Standard Deviation 0.87 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 4;n=38,39,38,39,30,32 | -0.5 Scores on a scale | Standard Deviation 0.8 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 1;n=38,41,39,37,38,32 | -0.2 Scores on a scale | Standard Deviation 0.42 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 8;n=36,37,34,38,29,27 | -0.7 Scores on a scale | Standard Deviation 0.82 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation; EW; n= 3,4,7,3,11,11 | 0.1 Scores on a scale | Standard Deviation 1.38 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 12;n=36,37,32,35,28,25 | -0.8 Scores on a scale | Standard Deviation 0.94 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 16;n=34,36,31,35,27,25 | -1.1 Scores on a scale | Standard Deviation 0.91 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 14;n=34,35,31,33,27,25 | -1.1 Scores on a scale | Standard Deviation 0.83 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 16;n=34,36,31,35,27,25 | -0.8 Scores on a scale | Standard Deviation 0.8 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 14;n=34,35,31,33,27,25 | -0.9 Scores on a scale | Standard Deviation 0.83 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 12;n=36,37,32,35,28,25 | -1.1 Scores on a scale | Standard Deviation 0.86 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 16;n=34,36,31,35,27,25 | -0.8 Scores on a scale | Standard Deviation 0.87 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 8;n=36,37,34,38,29,27 | -0.8 Scores on a scale | Standard Deviation 0.88 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 2;n= 39,39,39,39,33,32 | -0.3 Scores on a scale | Standard Deviation 0.63 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 2; n= 39, 39, 39, 39, 33, 32 | -0.3 Scores on a scale | Standard Deviation 0.93 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; EW;n=3,4,7,3,11,11 | 0.1 Scores on a scale | Standard Deviation 0.7 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 8;n= 36,37,34,38,29,27 | -0.9 Scores on a scale | Standard Deviation 0.75 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 4;n= 38,39,38,39,30,32 | -0.7 Scores on a scale | Standard Deviation 0.79 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 1;n=38,41,39,37,38,32 | -0.2 Scores on a scale | Standard Deviation 0.63 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 2;n= 39,39,39,39,33,32 | -0.4 Scores on a scale | Standard Deviation 0.87 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 1; n=38,41,39,37,38,32 | -0.1 Scores on a scale | Standard Deviation 0.55 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 12; n= 36, 37, 32, 35, 28, 25 | -1.0 Scores on a scale | Standard Deviation 0.89 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 4;n=38,39,38,39,30,32 | -0.6 Scores on a scale | Standard Deviation 0.87 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Erythema; EW; n= 3, 4, 7, 3, 11, 11 | -0.1 Scores on a scale | Standard Deviation 1.38 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 16; n= 34, 36 , 31, 35, 27, 25 | -1.0 Scores on a scale | Standard Deviation 0.68 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Scaling; EW;n=3,4,7,3,11,11 | 0.0 Scores on a scale | Standard Deviation 0.89 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 12;n=36,37,32,35,28,25 | -0.9 Scores on a scale | Standard Deviation 0.91 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 14; n= 34, 35, 31, 33, 27, 25 | -1.0 Scores on a scale | Standard Deviation 0.79 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 1; n= 38, 41, 39, 37, 38, 32 | -0.2 Scores on a scale | Standard Deviation 0.66 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 16;n=34,36,31,35,27,25 | -1.2 Scores on a scale | Standard Deviation 0.65 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Scaling; Week 14;n=34,35,31,33,27,25 | -0.9 Scores on a scale | Standard Deviation 0.88 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Lichenification; EW;n= 3,4,7,3,11,11 | -0.2 Scores on a scale | Standard Deviation 0.98 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 2;n=39,39,39,39,33,32 | -0.4 Scores on a scale | Standard Deviation 0.66 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 12;n=36,37,32,35,28,25 | -1.3 Scores on a scale | Standard Deviation 0.74 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Erythema; Week 8; n= 36, 37, 34, 38, 29, 27 | -0.9 Scores on a scale | Standard Deviation 1.01 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 1;n=38,41,39,37,38,32 | -0.2 Scores on a scale | Standard Deviation 0.68 |
| Vehicle QD | Mean Change From Baseline in Individual Signs of TSS | Lichenification; Week 8;n=36,37,34,38,29,27 | -1.0 Scores on a scale | Standard Deviation 0.76 |
Secondary
Mean Change From Baseline in Total Severity Score (TSS)
A target lesion of at least 3 centimeter square (cm\^2) was selected at Baseline. The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe), with higher values indicating greater severity of symptoms. TSS (maximum score 15) was calculated based on these signs. Mean change from Baseline in TSS at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Mean Change From Baseline in Total Severity Score (TSS) | Week 4; n= 38, 39, 38, 39, 30, 32 | -4.2 Scores on a scale | Standard Deviation 2.48 |
| GSK2894512 1% BID | Mean Change From Baseline in Total Severity Score (TSS) | Week 14; n= 34, 35, 31, 33, 27, 25 | -5.6 Scores on a scale | Standard Deviation 2.67 |
| GSK2894512 1% BID | Mean Change From Baseline in Total Severity Score (TSS) | Week 8; n= 36, 37, 34, 38, 29, 27 | -4.7 Scores on a scale | Standard Deviation 2.37 |
| GSK2894512 1% BID | Mean Change From Baseline in Total Severity Score (TSS) | Week 12; n= 36, 37, 32, 35, 28, 25 | -5.8 Scores on a scale | Standard Deviation 2.92 |
| GSK2894512 1% BID | Mean Change From Baseline in Total Severity Score (TSS) | Week 16; n= 34, 36, 31, 35, 27, 25 | -5.4 Scores on a scale | Standard Deviation 2.98 |
| GSK2894512 1% BID | Mean Change From Baseline in Total Severity Score (TSS) | EW; n= 3, 4, 7, 3, 11, 11 | -2.3 Scores on a scale | Standard Deviation 4.93 |
| GSK2894512 1% BID | Mean Change From Baseline in Total Severity Score (TSS) | Week 1; n= 38, 41, 39, 37, 38, 32 | -1.8 Scores on a scale | Standard Deviation 2.04 |
| GSK2894512 1% BID | Mean Change From Baseline in Total Severity Score (TSS) | Week 2; n= 39, 39, 39, 39, 33, 32 | -3.6 Scores on a scale | Standard Deviation 2.5 |
| GSK2894512 1% QD | Mean Change From Baseline in Total Severity Score (TSS) | Week 16; n= 34, 36, 31, 35, 27, 25 | -4.9 Scores on a scale | Standard Deviation 2.27 |
| GSK2894512 1% QD | Mean Change From Baseline in Total Severity Score (TSS) | EW; n= 3, 4, 7, 3, 11, 11 | 0.5 Scores on a scale | Standard Deviation 5.26 |
| GSK2894512 1% QD | Mean Change From Baseline in Total Severity Score (TSS) | Week 4; n= 38, 39, 38, 39, 30, 32 | -4.5 Scores on a scale | Standard Deviation 2.39 |
| GSK2894512 1% QD | Mean Change From Baseline in Total Severity Score (TSS) | Week 1; n= 38, 41, 39, 37, 38, 32 | -2.7 Scores on a scale | Standard Deviation 2.75 |
| GSK2894512 1% QD | Mean Change From Baseline in Total Severity Score (TSS) | Week 8; n= 36, 37, 34, 38, 29, 27 | -5.4 Scores on a scale | Standard Deviation 2.65 |
| GSK2894512 1% QD | Mean Change From Baseline in Total Severity Score (TSS) | Week 12; n= 36, 37, 32, 35, 28, 25 | -5.5 Scores on a scale | Standard Deviation 2.64 |
| GSK2894512 1% QD | Mean Change From Baseline in Total Severity Score (TSS) | Week 2; n= 39, 39, 39, 39, 33, 32 | -4.0 Scores on a scale | Standard Deviation 2.42 |
| GSK2894512 1% QD | Mean Change From Baseline in Total Severity Score (TSS) | Week 14; n= 34, 35, 31, 33, 27, 25 | -5.1 Scores on a scale | Standard Deviation 2.19 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Total Severity Score (TSS) | Week 2; n= 39, 39, 39, 39, 33, 32 | -3.7 Scores on a scale | Standard Deviation 2.45 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Total Severity Score (TSS) | Week 12; n= 36, 37, 32, 35, 28, 25 | -7.0 Scores on a scale | Standard Deviation 2.38 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Total Severity Score (TSS) | Week 16; n= 34, 36, 31, 35, 27, 25 | -6.0 Scores on a scale | Standard Deviation 2.91 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Total Severity Score (TSS) | Week 1; n= 38, 41, 39, 37, 38, 32 | -2.1 Scores on a scale | Standard Deviation 1.81 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Total Severity Score (TSS) | Week 14; n= 34, 35, 31, 33, 27, 25 | -5.5 Scores on a scale | Standard Deviation 3.22 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Total Severity Score (TSS) | Week 4; n= 38, 39, 38, 39, 30, 32 | -5.1 Scores on a scale | Standard Deviation 2.58 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Total Severity Score (TSS) | EW; n= 3, 4, 7, 3, 11, 11 | -0.4 Scores on a scale | Standard Deviation 4.83 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Total Severity Score (TSS) | Week 8; n= 36, 37, 34, 38, 29, 27 | -6.1 Scores on a scale | Standard Deviation 2.17 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Total Severity Score (TSS) | EW; n= 3, 4, 7, 3, 11, 11 | -2.7 Scores on a scale | Standard Deviation 3.51 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Total Severity Score (TSS) | Week 1; n= 38, 41, 39, 37, 38, 32 | -1.8 Scores on a scale | Standard Deviation 2.02 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Total Severity Score (TSS) | Week 2; n= 39, 39, 39, 39, 33, 32 | -3.3 Scores on a scale | Standard Deviation 2.46 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Total Severity Score (TSS) | Week 12; n= 36, 37, 32, 35, 28, 25 | -5.5 Scores on a scale | Standard Deviation 2.58 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Total Severity Score (TSS) | Week 8; n= 36, 37, 34, 38, 29, 27 | -5.1 Scores on a scale | Standard Deviation 2.34 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Total Severity Score (TSS) | Week 16; n= 34, 36, 31, 35, 27, 25 | -5.1 Scores on a scale | Standard Deviation 2.65 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Total Severity Score (TSS) | Week 4; n= 38, 39, 38, 39, 30, 32 | -4.1 Scores on a scale | Standard Deviation 2.64 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Total Severity Score (TSS) | Week 14; n= 34, 35, 31, 33, 27, 25 | -4.4 Scores on a scale | Standard Deviation 3.09 |
| Vehicle BID | Mean Change From Baseline in Total Severity Score (TSS) | Week 1; n= 38, 41, 39, 37, 38, 32 | -1.9 Scores on a scale | Standard Deviation 2.6 |
| Vehicle BID | Mean Change From Baseline in Total Severity Score (TSS) | Week 2; n= 39, 39, 39, 39, 33, 32 | -3.1 Scores on a scale | Standard Deviation 2.73 |
| Vehicle BID | Mean Change From Baseline in Total Severity Score (TSS) | Week 8; n= 36, 37, 34, 38, 29, 27 | -4.7 Scores on a scale | Standard Deviation 2.68 |
| Vehicle BID | Mean Change From Baseline in Total Severity Score (TSS) | Week 12; n= 36, 37, 32, 35, 28, 25 | -4.6 Scores on a scale | Standard Deviation 2.64 |
| Vehicle BID | Mean Change From Baseline in Total Severity Score (TSS) | Week 14; n= 34, 35, 31, 33, 27, 25 | -5.0 Scores on a scale | Standard Deviation 2.72 |
| Vehicle BID | Mean Change From Baseline in Total Severity Score (TSS) | Week 16; n= 34, 36, 31, 35, 27, 25 | -4.8 Scores on a scale | Standard Deviation 2.62 |
| Vehicle BID | Mean Change From Baseline in Total Severity Score (TSS) | EW; n= 3, 4, 7, 3, 11, 11 | -1.1 Scores on a scale | Standard Deviation 3.65 |
| Vehicle BID | Mean Change From Baseline in Total Severity Score (TSS) | Week 4; n= 38, 39, 38, 39, 30, 32 | -3.3 Scores on a scale | Standard Deviation 2.68 |
| Vehicle QD | Mean Change From Baseline in Total Severity Score (TSS) | Week 12; n= 36, 37, 32, 35, 28, 25 | -5.2 Scores on a scale | Standard Deviation 2.97 |
| Vehicle QD | Mean Change From Baseline in Total Severity Score (TSS) | Week 1; n= 38, 41, 39, 37, 38, 32 | -0.9 Scores on a scale | Standard Deviation 2.21 |
| Vehicle QD | Mean Change From Baseline in Total Severity Score (TSS) | EW; n= 3, 4, 7, 3, 11, 11 | -0.1 Scores on a scale | Standard Deviation 4.04 |
| Vehicle QD | Mean Change From Baseline in Total Severity Score (TSS) | Week 8; n= 36, 37, 34, 38, 29, 27 | -4.3 Scores on a scale | Standard Deviation 3.01 |
| Vehicle QD | Mean Change From Baseline in Total Severity Score (TSS) | Week 4; n= 38, 39, 38, 39, 30, 32 | -3.0 Scores on a scale | Standard Deviation 3.03 |
| Vehicle QD | Mean Change From Baseline in Total Severity Score (TSS) | Week 2; n= 39, 39, 39, 39, 33, 32 | -1.8 Scores on a scale | Standard Deviation 2.73 |
| Vehicle QD | Mean Change From Baseline in Total Severity Score (TSS) | Week 16; n= 34, 36, 31, 35, 27, 25 | -4.9 Scores on a scale | Standard Deviation 2.74 |
| Vehicle QD | Mean Change From Baseline in Total Severity Score (TSS) | Week 14; n= 34, 35, 31, 33, 27, 25 | -5.0 Scores on a scale | Standard Deviation 2.88 |
Secondary
Mean Change From Baseline in Weekly Average of Daily Itch/Pruritus (Numeric Rating Scale [NRS]) Score
NRS is a 11-point tool ranging from 0 (absent) to 10 (worst imaginable) to assess the severity of 11 disease-related signs and symptoms including itching, discoloration, bleeding, oozing, cracking, scaling, flaking, dry/rough, painful, burning, and stinging. Participants were asked to complete the self-administered sign and symptom severity diary containing NRS using a recall period of the past 24 hours. Question 1 of the diary was used to assess itch. Mean change from Baseline to Week 12 in weekly average of daily itch/pruritus based on the NRS was presented using mean and standard deviation (SD). Baseline was defined as the latest assessment prior to first dose and Change from Baseline was defined as post-dose weekly average value minus Baseline value.
Time frame: Baseline and up to Week 12
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GSK2894512 1% BID | Mean Change From Baseline in Weekly Average of Daily Itch/Pruritus (Numeric Rating Scale [NRS]) Score | -3.06 Scores on a scale | Standard Deviation 2.657 |
| GSK2894512 1% QD | Mean Change From Baseline in Weekly Average of Daily Itch/Pruritus (Numeric Rating Scale [NRS]) Score | -3.10 Scores on a scale | Standard Deviation 2.493 |
| GSK2894512 0.5% BID | Mean Change From Baseline in Weekly Average of Daily Itch/Pruritus (Numeric Rating Scale [NRS]) Score | -3.52 Scores on a scale | Standard Deviation 2.307 |
| GSK2894512 0.5% QD | Mean Change From Baseline in Weekly Average of Daily Itch/Pruritus (Numeric Rating Scale [NRS]) Score | -3.39 Scores on a scale | Standard Deviation 2.297 |
| Vehicle BID | Mean Change From Baseline in Weekly Average of Daily Itch/Pruritus (Numeric Rating Scale [NRS]) Score | -0.95 Scores on a scale | Standard Deviation 2.107 |
| Vehicle QD | Mean Change From Baseline in Weekly Average of Daily Itch/Pruritus (Numeric Rating Scale [NRS]) Score | -3.50 Scores on a scale | Standard Deviation 2.742 |
Secondary
Mean Percent Change From Baseline in EASI Score
The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale (0 \[absent\] to 3 \[severe\]) for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Body area involvement ranged from 0 (0%) to 6 (90-100%). Total EASI score was calculated as a sum of scores of all 4 specified body region. Range for EASI total score is 0 (absent) to 72 (severe). Baseline was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Mean percent change from Baseline was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Mean Percent Change From Baseline in EASI Score | Week 4; n= 38,39,38,39,30,32 | -64.95 Percentage Change | Standard Deviation 23.948 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in EASI Score | Week 2; n= 39,39,39,39,33,32 | -48.70 Percentage Change | Standard Deviation 33.089 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in EASI Score | Week 1; n= 38,41,39,37,38,32 | -23.83 Percentage Change | Standard Deviation 42.885 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in EASI Score | Week 8; n= 36,37,34,38,29,27 | -68.14 Percentage Change | Standard Deviation 28.052 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in EASI Score | Week 12; n= 36,37,32,35,28,25 | -77.19 Percentage Change | Standard Deviation 28.152 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in EASI Score | Week 14; n= 34,35,31,33,27,25 | -71.15 Percentage Change | Standard Deviation 27.875 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in EASI Score | Week 16; n= 34,36,31,35,27,25 | -63.59 Percentage Change | Standard Deviation 36.461 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in EASI Score | EW; n= 3,4,7,3,11,11 | -0.83 Percentage Change | Standard Deviation 98.753 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in EASI Score | Week 8; n= 36,37,34,38,29,27 | -73.57 Percentage Change | Standard Deviation 27.204 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in EASI Score | EW; n= 3,4,7,3,11,11 | 42.27 Percentage Change | Standard Deviation 43.95 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in EASI Score | Week 1; n= 38,41,39,37,38,32 | -34.76 Percentage Change | Standard Deviation 32.718 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in EASI Score | Week 16; n= 34,36,31,35,27,25 | -63.70 Percentage Change | Standard Deviation 25.833 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in EASI Score | Week 14; n= 34,35,31,33,27,25 | -65.53 Percentage Change | Standard Deviation 29.777 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in EASI Score | Week 4; n= 38,39,38,39,30,32 | -66.40 Percentage Change | Standard Deviation 30.182 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in EASI Score | Week 2; n= 39,39,39,39,33,32 | -54.21 Percentage Change | Standard Deviation 29.107 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in EASI Score | Week 12; n= 36,37,32,35,28,25 | -73.02 Percentage Change | Standard Deviation 25.068 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in EASI Score | Week 2; n= 39,39,39,39,33,32 | -42.60 Percentage Change | Standard Deviation 26.428 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in EASI Score | Week 4; n= 38,39,38,39,30,32 | -60.07 Percentage Change | Standard Deviation 23.967 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in EASI Score | Week 8; n= 36,37,34,38,29,27 | -70.52 Percentage Change | Standard Deviation 25.062 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in EASI Score | EW; n= 3,4,7,3,11,11 | 8.74 Percentage Change | Standard Deviation 87.714 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in EASI Score | Week 12; n= 36,37,32,35,28,25 | -80.13 Percentage Change | Standard Deviation 18.602 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in EASI Score | Week 14; n= 34,35,31,33,27,25 | -70.37 Percentage Change | Standard Deviation 31.907 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in EASI Score | Week 16; n= 34,36,31,35,27,25 | -69.89 Percentage Change | Standard Deviation 32.687 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in EASI Score | Week 1; n= 38,41,39,37,38,32 | -24.19 Percentage Change | Standard Deviation 21.716 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in EASI Score | Week 16; n= 34,36,31,35,27,25 | -67.28 Percentage Change | Standard Deviation 25.745 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in EASI Score | Week 14; n= 34,35,31,33,27,25 | -64.72 Percentage Change | Standard Deviation 25.594 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in EASI Score | Week 12; n= 36,37,32,35,28,25 | -69.49 Percentage Change | Standard Deviation 24.805 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in EASI Score | Week 1; n= 38,41,39,37,38,32 | -25.81 Percentage Change | Standard Deviation 28.724 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in EASI Score | Week 4; n= 38,39,38,39,30,32 | -55.38 Percentage Change | Standard Deviation 24.465 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in EASI Score | Week 8; n= 36,37,34,38,29,27 | -65.12 Percentage Change | Standard Deviation 26.089 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in EASI Score | EW; n= 3,4,7,3,11,11 | -35.40 Percentage Change | Standard Deviation 66.349 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in EASI Score | Week 2; n= 39,39,39,39,33,32 | -40.41 Percentage Change | Standard Deviation 30.835 |
| Vehicle BID | Mean Percent Change From Baseline in EASI Score | EW; n= 3,4,7,3,11,11 | 13.69 Percentage Change | Standard Deviation 32.424 |
| Vehicle BID | Mean Percent Change From Baseline in EASI Score | Week 1; n= 38,41,39,37,38,32 | -16.79 Percentage Change | Standard Deviation 25.777 |
| Vehicle BID | Mean Percent Change From Baseline in EASI Score | Week 12; n= 36,37,32,35,28,25 | -56.73 Percentage Change | Standard Deviation 38.234 |
| Vehicle BID | Mean Percent Change From Baseline in EASI Score | Week 14; n= 34,35,31,33,27,25 | -60.26 Percentage Change | Standard Deviation 31.632 |
| Vehicle BID | Mean Percent Change From Baseline in EASI Score | Week 16; n= 34,36,31,35,27,25 | -57.52 Percentage Change | Standard Deviation 47.14 |
| Vehicle BID | Mean Percent Change From Baseline in EASI Score | Week 2; n= 39,39,39,39,33,32 | -32.03 Percentage Change | Standard Deviation 32.737 |
| Vehicle BID | Mean Percent Change From Baseline in EASI Score | Week 4; n= 38,39,38,39,30,32 | -40.74 Percentage Change | Standard Deviation 30.097 |
| Vehicle BID | Mean Percent Change From Baseline in EASI Score | Week 8; n= 36,37,34,38,29,27 | -50.78 Percentage Change | Standard Deviation 33.026 |
| Vehicle QD | Mean Percent Change From Baseline in EASI Score | EW; n= 3,4,7,3,11,11 | 32.55 Percentage Change | Standard Deviation 86.387 |
| Vehicle QD | Mean Percent Change From Baseline in EASI Score | Week 12; n= 36,37,32,35,28,25 | -60.29 Percentage Change | Standard Deviation 34.253 |
| Vehicle QD | Mean Percent Change From Baseline in EASI Score | Week 4; n= 38,39,38,39,30,32 | -30.54 Percentage Change | Standard Deviation 36.196 |
| Vehicle QD | Mean Percent Change From Baseline in EASI Score | Week 8; n= 36,37,34,38,29,27 | -43.15 Percentage Change | Standard Deviation 41.388 |
| Vehicle QD | Mean Percent Change From Baseline in EASI Score | Week 14; n= 34,35,31,33,27,25 | -55.21 Percentage Change | Standard Deviation 31.514 |
| Vehicle QD | Mean Percent Change From Baseline in EASI Score | Week 2; n= 39,39,39,39,33,32 | -13.98 Percentage Change | Standard Deviation 38.616 |
| Vehicle QD | Mean Percent Change From Baseline in EASI Score | Week 16; n= 34,36,31,35,27,25 | -52.47 Percentage Change | Standard Deviation 38.236 |
| Vehicle QD | Mean Percent Change From Baseline in EASI Score | Week 1; n= 38,41,39,37,38,32 | -7.51 Percentage Change | Standard Deviation 36.549 |
Secondary
Mean Percent Change From Baseline in Individual Signs of TSS
The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe) and TSS (maximum score 15) was calculated based on these signs. Mean percent change from Baseline in individual signs of TSS was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. NA indicates that data were not available. If the participant had more than 3 missing days during the week, then the weekly average was not calculated and treated as missing data and excluded from the analysis. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Week 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 4;n=34,36,37,39,29,32 | -47.1 Percentage Change | Standard Deviation 48.8 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 1;n=34,37,38,37,37,32 | -22.1 Percentage Change | Standard Deviation 39.51 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 8;n=33,35,33,38,28,27 | -53.5 Percentage Change | Standard Deviation 47.1 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 12;n=33,32,29,33,26,23 | -75.8 Percentage Change | Standard Deviation 41.69 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 8;n=33,32,30,36,27,25 | -57.6 Percentage Change | Standard Deviation 50.19 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 14;n=22,19,23,23,21,19 | -86.4 Percentage Change | Standard Deviation 35.13 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation; EW; n= 3,4,6,3,11,11 | 0.0 Percentage Change | Standard Deviation 100 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 12;n=33,35,31,35,27,25 | -71.7 Percentage Change | Standard Deviation 41.56 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 16;n=31,34,30,35,26,25 | -65.6 Percentage Change | Standard Deviation 45.12 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 4;n= 38,38,36,39,30,32 | -49.1 Percentage Change | Standard Deviation 45.84 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 8;n=23,20,25,27,21,21 | -82.6 Percentage Change | Standard Deviation 38.76 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 16;n=22,20,23,25,21,19 | -79.5 Percentage Change | Standard Deviation 39.82 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; EW;n=2,4,5,3,9,9 | -50.0 Percentage Change | Standard Deviation 70.71 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 4;n=35,34,34,37,28,30 | -57.1 Percentage Change | Standard Deviation 45.61 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 16; n= 34, 36 , 31, 34, 27, 23 | -67.2 Percentage Change | Standard Deviation 36.58 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 2;n= 35,34,34,37,31,30 | -47.1 Percentage Change | Standard Deviation 45.28 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 12; n= 36, 37, 32, 34, 28, 23 | -69.9 Percentage Change | Standard Deviation 36.69 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; EW;n=1,1,4,2,5,5 | -100.0 Percentage Change | — |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 16;n=31,31,28,33,25,23 | -75.8 Percentage Change | Standard Deviation 48.08 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; EW;n= 2,2,7,3,11,11 | -50.0 Percentage Change | Standard Deviation 70.71 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 8;n= 36,36,33,38,29,27 | -57.9 Percentage Change | Standard Deviation 35.07 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 12;n=36,36,31,35,28,25 | -72.2 Percentage Change | Standard Deviation 46.97 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 14;n=31,33,30,33,26,25 | -73.7 Percentage Change | Standard Deviation 38.19 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 1;n=34,36,34,35,36,29 | -28.4 Percentage Change | Standard Deviation 52.79 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 8; n= 36, 37, 34, 37, 29, 25 | -58.8 Percentage Change | Standard Deviation 31.24 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 1;n=24,21,26,27,27,22 | -29.2 Percentage Change | Standard Deviation 52.99 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; EW; n= 3, 4, 7, 3, 11, 11 | -33.3 Percentage Change | Standard Deviation 57.74 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 2; n= 39, 39, 39, 38, 33, 30 | -49.6 Percentage Change | Standard Deviation 34.3 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 2;n=24,21,27,28,22,23 | -64.6 Percentage Change | Standard Deviation 47.73 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 16;n=34,35,30,35,27,25 | -65.7 Percentage Change | Standard Deviation 42.43 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 14;n=31,30,28,31,25,23 | -74.2 Percentage Change | Standard Deviation 40.56 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 1; n= 38, 41, 39, 36, 38, 30 | -25.9 Percentage Change | Standard Deviation 26.76 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 1; n=38,40,37,37,38,32 | -18.0 Percentage Change | Standard Deviation 26.67 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 4; n= 38, 39, 38, 38, 30, 30 | -51.3 Percentage Change | Standard Deviation 32.74 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 14;n=34,34,30,33,27,25 | -65.7 Percentage Change | Standard Deviation 44.18 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 12;n=23,20,23,25,21,19 | -84.8 Percentage Change | Standard Deviation 35.15 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 4;n= 24,21,27,28,21,24 | -75.0 Percentage Change | Standard Deviation 44.23 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 2;n=35,36,38,39,32,32 | -38.1 Percentage Change | Standard Deviation 45.83 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 2;n= 39,38,37,39,33,32 | -43.2 Percentage Change | Standard Deviation 40.05 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 14; n= 34, 35, 31, 32, 27, 23 | -70.6 Percentage Change | Standard Deviation 36.71 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 14;n=31,30,28,31,25,23 | -73.3 Percentage Change | Standard Deviation 48.66 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 4;n=34,36,37,39,29,32 | -51.9 Percentage Change | Standard Deviation 36.47 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 8; n= 36, 37, 34, 37, 29, 25 | -69.8 Percentage Change | Standard Deviation 33.06 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 8;n=23,20,25,27,21,21 | -97.5 Percentage Change | Standard Deviation 11.18 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 2;n=24,21,27,28,22,23 | -64.3 Percentage Change | Standard Deviation 42.26 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 12; n= 36, 37, 32, 34, 28, 23 | -69.4 Percentage Change | Standard Deviation 37.37 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 1; n= 38, 41, 39, 36, 38, 30 | -35.4 Percentage Change | Standard Deviation 37.86 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 14; n= 34, 35, 31, 32, 27, 23 | -66.2 Percentage Change | Standard Deviation 37.37 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 16; n= 34, 36 , 31, 34, 27, 23 | -59.7 Percentage Change | Standard Deviation 39.11 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 16;n=31,34,30,35,26,25 | -60.3 Percentage Change | Standard Deviation 43.81 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; EW; n= 3, 4, 7, 3, 11, 11 | -8.3 Percentage Change | Standard Deviation 44.1 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 8;n=33,32,30,36,27,25 | -81.3 Percentage Change | Standard Deviation 35.36 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 2;n=35,36,38,39,32,32 | -46.3 Percentage Change | Standard Deviation 42.56 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 1; n=38,40,37,37,38,32 | -28.3 Percentage Change | Standard Deviation 33.16 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 2;n= 39,38,37,39,33,32 | -46.9 Percentage Change | Standard Deviation 38.91 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 12;n=23,20,23,25,21,19 | -87.5 Percentage Change | Standard Deviation 31.93 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 8;n= 36,36,33,38,29,27 | -58.8 Percentage Change | Standard Deviation 43.37 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 14;n=22,19,23,23,21,19 | -73.7 Percentage Change | Standard Deviation 56.2 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 1;n=34,36,34,35,36,29 | -36.1 Percentage Change | Standard Deviation 47.22 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 16;n=22,20,23,25,21,19 | -80.0 Percentage Change | Standard Deviation 41.04 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 4;n= 38,38,36,39,30,32 | -61.0 Percentage Change | Standard Deviation 38.22 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 14;n=31,33,30,33,26,25 | -62.6 Percentage Change | Standard Deviation 43.71 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; EW;n=1,1,4,2,5,5 | 0.0 Percentage Change | — |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 1;n=34,37,38,37,37,32 | -30.6 Percentage Change | Standard Deviation 40.73 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 12;n=36,36,31,35,28,25 | -68.5 Percentage Change | Standard Deviation 43.6 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 2;n= 35,34,34,37,31,30 | -64.7 Percentage Change | Standard Deviation 45.28 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; EW;n= 2,2,7,3,11,11 | -25.0 Percentage Change | Standard Deviation 106.07 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 4;n=35,34,34,37,28,30 | -69.1 Percentage Change | Standard Deviation 40.85 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 12;n=33,35,31,35,27,25 | -69.0 Percentage Change | Standard Deviation 36.86 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 12;n=33,32,29,33,26,23 | -84.4 Percentage Change | Standard Deviation 32.22 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 14;n=34,34,30,33,27,25 | -73.5 Percentage Change | Standard Deviation 31.55 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 16;n=31,31,28,33,25,23 | -66.1 Percentage Change | Standard Deviation 50.64 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 4;n= 24,21,27,28,21,24 | -69.0 Percentage Change | Standard Deviation 43.23 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 1;n=24,21,26,27,27,22 | -61.9 Percentage Change | Standard Deviation 47.18 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 8;n=33,35,33,38,28,27 | -62.9 Percentage Change | Standard Deviation 38.58 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; EW;n=2,4,5,3,9,9 | 0.0 Percentage Change | Standard Deviation 141.42 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation; EW; n= 3,4,6,3,11,11 | -12.5 Percentage Change | Standard Deviation 62.92 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 2; n= 39, 39, 39, 38, 33, 30 | -49.1 Percentage Change | Standard Deviation 35.86 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 16;n=34,35,30,35,27,25 | -62.4 Percentage Change | Standard Deviation 38.84 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 4; n= 38, 39, 38, 38, 30, 30 | -59.0 Percentage Change | Standard Deviation 32.86 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 8;n= 36,36,33,38,29,27 | -70.7 Percentage Change | Standard Deviation 27.96 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 14;n=22,19,23,23,21,19 | -84.8 Percentage Change | Standard Deviation 32.14 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 16;n=31,34,30,35,26,25 | -66.1 Percentage Change | Standard Deviation 34.04 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation; EW; n= 3,4,6,3,11,11 | -16.7 Percentage Change | Standard Deviation 68.31 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 12;n=33,32,29,33,26,23 | -82.8 Percentage Change | Standard Deviation 30.69 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 12;n=23,20,23,25,21,19 | -97.8 Percentage Change | Standard Deviation 10.43 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 1; n=38,40,37,37,38,32 | -21.6 Percentage Change | Standard Deviation 26.02 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 12; n= 36, 37, 32, 34, 28, 23 | -77.1 Percentage Change | Standard Deviation 25.66 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 8;n=33,32,30,36,27,25 | -81.7 Percentage Change | Standard Deviation 30.75 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; EW; n= 3, 4, 7, 3, 11, 11 | -21.4 Percentage Change | Standard Deviation 48.8 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 14;n=31,30,28,31,25,23 | -70.2 Percentage Change | Standard Deviation 39.11 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 14;n=34,34,30,33,27,25 | -63.9 Percentage Change | Standard Deviation 32.48 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 2;n=35,36,38,39,32,32 | -36.8 Percentage Change | Standard Deviation 37.6 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 8;n=33,35,33,38,28,27 | -62.1 Percentage Change | Standard Deviation 32.62 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 16; n= 34, 36 , 31, 34, 27, 23 | -60.2 Percentage Change | Standard Deviation 44.03 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 1;n=34,37,38,37,37,32 | -24.6 Percentage Change | Standard Deviation 39.85 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 2; n= 39, 39, 39, 38, 33, 30 | -35.5 Percentage Change | Standard Deviation 33.15 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 4; n= 38, 39, 38, 38, 30, 30 | -55.7 Percentage Change | Standard Deviation 34.28 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 16;n=34,35,30,35,27,25 | -67.8 Percentage Change | Standard Deviation 35.81 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 2;n= 39,38,37,39,33,32 | -41.0 Percentage Change | Standard Deviation 40.37 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 4;n=34,36,37,39,29,32 | -56.3 Percentage Change | Standard Deviation 37.34 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; EW;n=2,4,5,3,9,9 | -10.0 Percentage Change | Standard Deviation 74.16 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 8;n=23,20,25,27,21,21 | -84.7 Percentage Change | Standard Deviation 33.99 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 1;n=24,21,26,27,27,22 | -40.4 Percentage Change | Standard Deviation 46.95 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 1;n=34,36,34,35,36,29 | -32.8 Percentage Change | Standard Deviation 47.76 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 16;n=31,31,28,33,25,23 | -72.0 Percentage Change | Standard Deviation 36.87 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; EW;n=1,1,4,2,5,5 | -12.5 Percentage Change | Standard Deviation 103.08 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 14; n= 34, 35, 31, 32, 27, 23 | -55.9 Percentage Change | Standard Deviation 46.66 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 14;n=31,33,30,33,26,25 | -59.4 Percentage Change | Standard Deviation 43.92 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 1; n= 38, 41, 39, 36, 38, 30 | -17.1 Percentage Change | Standard Deviation 28.74 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 2;n= 35,34,34,37,31,30 | -53.4 Percentage Change | Standard Deviation 42.6 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 12;n=36,36,31,35,28,25 | -79.6 Percentage Change | Standard Deviation 26.77 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 2;n=24,21,27,28,22,23 | -75.9 Percentage Change | Standard Deviation 37.65 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 12;n=33,35,31,35,27,25 | -78.5 Percentage Change | Standard Deviation 23.25 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 16;n=22,20,23,25,21,19 | -84.8 Percentage Change | Standard Deviation 35.15 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 4;n= 24,21,27,28,21,24 | -79.0 Percentage Change | Standard Deviation 44.96 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 4;n=35,34,34,37,28,30 | -68.1 Percentage Change | Standard Deviation 47.38 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 4;n= 38,38,36,39,30,32 | -56.5 Percentage Change | Standard Deviation 32.68 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; EW;n= 2,2,7,3,11,11 | -21.4 Percentage Change | Standard Deviation 69.86 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 8; n= 36, 37, 34, 37, 29, 25 | -65.7 Percentage Change | Standard Deviation 26.89 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 2;n=35,36,38,39,32,32 | -38.5 Percentage Change | Standard Deviation 41.56 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 2;n= 39,38,37,39,33,32 | -40.6 Percentage Change | Standard Deviation 43.05 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 1;n=34,37,38,37,37,32 | -16.7 Percentage Change | Standard Deviation 33.1 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 4;n= 38,38,36,39,30,32 | -43.6 Percentage Change | Standard Deviation 51.24 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 8;n= 36,36,33,38,29,27 | -65.8 Percentage Change | Standard Deviation 36.55 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 4;n= 24,21,27,28,21,24 | -76.8 Percentage Change | Standard Deviation 41.9 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 12;n=36,36,31,35,28,25 | -65.2 Percentage Change | Standard Deviation 34.39 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 14;n=34,34,30,33,27,25 | -46.5 Percentage Change | Standard Deviation 39.69 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation; EW; n= 3,4,6,3,11,11 | 0.0 Percentage Change | Standard Deviation 100 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 16;n=34,35,30,35,27,25 | -61.0 Percentage Change | Standard Deviation 38.97 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 8;n=23,20,25,27,21,21 | -85.2 Percentage Change | Standard Deviation 36.2 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 12;n=23,20,23,25,21,19 | -86.0 Percentage Change | Standard Deviation 33.91 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 14;n=22,19,23,23,21,19 | -80.4 Percentage Change | Standard Deviation 39.14 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 16;n=31,34,30,35,26,25 | -60.0 Percentage Change | Standard Deviation 37.31 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 16;n=22,20,23,25,21,19 | -84.0 Percentage Change | Standard Deviation 34.52 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; EW;n=1,1,4,2,5,5 | 0.0 Percentage Change | Standard Deviation 0 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 1;n=34,36,34,35,36,29 | -19.5 Percentage Change | Standard Deviation 58.23 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 12;n=33,35,31,35,27,25 | -64.8 Percentage Change | Standard Deviation 37.44 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 2;n= 35,34,34,37,31,30 | -44.1 Percentage Change | Standard Deviation 51.1 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 4;n=35,34,34,37,28,30 | -51.8 Percentage Change | Standard Deviation 52.08 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; EW;n= 2,2,7,3,11,11 | -50.0 Percentage Change | Standard Deviation 50 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 12;n=33,32,29,33,26,23 | -71.2 Percentage Change | Standard Deviation 48.46 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 14;n=31,33,30,33,26,25 | -56.6 Percentage Change | Standard Deviation 36.07 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 8;n=33,35,33,38,28,27 | -60.1 Percentage Change | Standard Deviation 39.24 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 14;n=31,30,28,31,25,23 | -60.2 Percentage Change | Standard Deviation 63.78 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 16;n=31,31,28,33,25,23 | -65.7 Percentage Change | Standard Deviation 44.08 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; EW;n=2,4,5,3,9,9 | -50.0 Percentage Change | Standard Deviation 50 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 1; n= 38, 41, 39, 36, 38, 30 | -19.9 Percentage Change | Standard Deviation 27.26 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 4;n=34,36,37,39,29,32 | -45.3 Percentage Change | Standard Deviation 40.64 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 2; n= 39, 39, 39, 38, 33, 30 | -36.0 Percentage Change | Standard Deviation 36.46 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 8;n=33,32,30,36,27,25 | -67.1 Percentage Change | Standard Deviation 43 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 4; n= 38, 39, 38, 38, 30, 30 | -45.6 Percentage Change | Standard Deviation 38.1 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 8; n= 36, 37, 34, 37, 29, 25 | -58.6 Percentage Change | Standard Deviation 35.05 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 12; n= 36, 37, 32, 34, 28, 23 | -66.7 Percentage Change | Standard Deviation 34.33 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 14; n= 34, 35, 31, 32, 27, 23 | -49.5 Percentage Change | Standard Deviation 34.26 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 2;n=24,21,27,28,22,23 | -51.8 Percentage Change | Standard Deviation 48.08 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 16; n= 34, 36 , 31, 34, 27, 23 | -58.8 Percentage Change | Standard Deviation 36.29 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 1;n=24,21,26,27,27,22 | -40.7 Percentage Change | Standard Deviation 48.11 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; EW; n= 3, 4, 7, 3, 11, 11 | -50.0 Percentage Change | Standard Deviation 50 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 1; n=38,40,37,37,38,32 | -18.0 Percentage Change | Standard Deviation 25.27 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 2;n=35,36,38,39,32,32 | -39.1 Percentage Change | Standard Deviation 39.85 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 14;n=31,33,30,33,26,25 | -54.5 Percentage Change | Standard Deviation 40.15 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 16;n=31,34,30,35,26,25 | -57.7 Percentage Change | Standard Deviation 39.79 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; EW;n= 2,2,7,3,11,11 | -16.7 Percentage Change | Standard Deviation 39.44 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 1;n=24,21,26,27,27,22 | -44.4 Percentage Change | Standard Deviation 65.54 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 2;n=24,21,27,28,22,23 | -62.9 Percentage Change | Standard Deviation 44.52 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 4;n= 24,21,27,28,21,24 | -68.3 Percentage Change | Standard Deviation 43.75 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 8;n=23,20,25,27,21,21 | -65.9 Percentage Change | Standard Deviation 43.29 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 12;n=23,20,23,25,21,19 | -74.6 Percentage Change | Standard Deviation 40.35 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 14;n=22,19,23,23,21,19 | -84.9 Percentage Change | Standard Deviation 33.29 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 16;n=22,20,23,25,21,19 | -75.4 Percentage Change | Standard Deviation 41.37 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; EW;n=1,1,4,2,5,5 | -20.0 Percentage Change | Standard Deviation 44.72 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 1;n=34,36,34,35,36,29 | -24.1 Percentage Change | Standard Deviation 41.87 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 2;n= 35,34,34,37,31,30 | -36.6 Percentage Change | Standard Deviation 40.69 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 4;n=35,34,34,37,28,30 | -38.1 Percentage Change | Standard Deviation 36.81 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 8;n=33,32,30,36,27,25 | -59.3 Percentage Change | Standard Deviation 38.49 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 12;n=33,32,29,33,26,23 | -64.7 Percentage Change | Standard Deviation 37.51 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 14;n=31,30,28,31,25,23 | -62.0 Percentage Change | Standard Deviation 39.24 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 16;n=31,31,28,33,25,23 | -70.7 Percentage Change | Standard Deviation 35.45 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; EW;n=2,4,5,3,9,9 | -5.6 Percentage Change | Standard Deviation 76.83 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 1; n= 38, 41, 39, 36, 38, 30 | -19.3 Percentage Change | Standard Deviation 34.12 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 2; n= 39, 39, 39, 38, 33, 30 | -26.3 Percentage Change | Standard Deviation 39.75 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 4; n= 38, 39, 38, 38, 30, 30 | -33.3 Percentage Change | Standard Deviation 37.14 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 8; n= 36, 37, 34, 37, 29, 25 | -55.2 Percentage Change | Standard Deviation 40.36 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 12; n= 36, 37, 32, 34, 28, 23 | -51.2 Percentage Change | Standard Deviation 36.55 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 14; n= 34, 35, 31, 32, 27, 23 | -56.2 Percentage Change | Standard Deviation 35.55 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 16; n= 34, 36 , 31, 34, 27, 23 | -50.6 Percentage Change | Standard Deviation 40.95 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; EW; n= 3, 4, 7, 3, 11, 11 | -10.6 Percentage Change | Standard Deviation 42.99 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 1; n=38,40,37,37,38,32 | -12.7 Percentage Change | Standard Deviation 41.27 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 2;n= 39,38,37,39,33,32 | -22.7 Percentage Change | Standard Deviation 47.47 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 4;n= 38,38,36,39,30,32 | -31.1 Percentage Change | Standard Deviation 32.38 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 8;n= 36,36,33,38,29,27 | -54.0 Percentage Change | Standard Deviation 46.64 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 12;n=36,36,31,35,28,25 | -41.7 Percentage Change | Standard Deviation 47.9 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 14;n=34,34,30,33,27,25 | -50.0 Percentage Change | Standard Deviation 48.48 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 16;n=34,35,30,35,27,25 | -51.2 Percentage Change | Standard Deviation 43.1 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation; EW; n= 3,4,6,3,11,11 | -4.5 Percentage Change | Standard Deviation 56.81 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 1;n=34,37,38,37,37,32 | -19.8 Percentage Change | Standard Deviation 29.88 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 4;n=34,36,37,39,29,32 | -32.2 Percentage Change | Standard Deviation 46.91 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 8;n=33,35,33,38,28,27 | -53.0 Percentage Change | Standard Deviation 36.59 |
| Vehicle BID | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 12;n=33,35,31,35,27,25 | -57.4 Percentage Change | Standard Deviation 36.5 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 8;n= 36,36,33,38,29,27 | -44.4 Percentage Change | Standard Deviation 43.85 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 4;n= 38,38,36,39,30,32 | -31.8 Percentage Change | Standard Deviation 43.04 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 2;n= 39,38,37,39,33,32 | -14.6 Percentage Change | Standard Deviation 55.48 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 16;n=31,34,30,35,26,25 | -68.7 Percentage Change | Standard Deviation 33.44 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 1;n=34,37,38,37,37,32 | -13.5 Percentage Change | Standard Deviation 28.54 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 1; n=38,40,37,37,38,32 | -3.1 Percentage Change | Standard Deviation 35.78 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; EW; n= 3, 4, 7, 3, 11, 11 | 18.2 Percentage Change | Standard Deviation 87.39 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 16; n= 34, 36 , 31, 34, 27, 23 | -50.0 Percentage Change | Standard Deviation 30.57 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 14; n= 34, 35, 31, 32, 27, 23 | -48.6 Percentage Change | Standard Deviation 34.05 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 12; n= 36, 37, 32, 34, 28, 23 | -52.2 Percentage Change | Standard Deviation 38.7 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 2;n=35,36,38,39,32,32 | -19.3 Percentage Change | Standard Deviation 46.97 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 8; n= 36, 37, 34, 37, 29, 25 | -44.0 Percentage Change | Standard Deviation 48.8 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 4; n= 38, 39, 38, 38, 30, 30 | -30.6 Percentage Change | Standard Deviation 42.23 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 2; n= 39, 39, 39, 38, 33, 30 | -12.8 Percentage Change | Standard Deviation 56.34 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Erythema; Week 1; n= 38, 41, 39, 36, 38, 30 | -8.9 Percentage Change | Standard Deviation 37.07 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; EW;n= 2,2,7,3,11,11 | -9.1 Percentage Change | Standard Deviation 62.52 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 4;n=34,36,37,39,29,32 | -23.4 Percentage Change | Standard Deviation 48.61 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; EW;n=2,4,5,3,9,9 | 0.0 Percentage Change | Standard Deviation 70.71 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 16;n=31,31,28,33,25,23 | -51.4 Percentage Change | Standard Deviation 51.23 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 14;n=31,30,28,31,25,23 | -52.2 Percentage Change | Standard Deviation 43.9 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 12;n=33,32,29,33,26,23 | -54.3 Percentage Change | Standard Deviation 52.03 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 14;n=31,33,30,33,26,25 | -60.7 Percentage Change | Standard Deviation 36.92 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 8;n=33,35,33,38,28,27 | -49.4 Percentage Change | Standard Deviation 37.12 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 8;n=33,32,30,36,27,25 | -50.0 Percentage Change | Standard Deviation 52.04 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 4;n=35,34,34,37,28,30 | -33.3 Percentage Change | Standard Deviation 53.07 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 2;n= 35,34,34,37,31,30 | -12.8 Percentage Change | Standard Deviation 43.04 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Scaling; Week 1;n=34,36,34,35,36,29 | -8.6 Percentage Change | Standard Deviation 42.4 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 4;n= 24,21,27,28,21,24 | -45.8 Percentage Change | Standard Deviation 55 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Lichenification; Week 12;n=33,35,31,35,27,25 | -67.3 Percentage Change | Standard Deviation 35.84 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; EW;n=1,1,4,2,5,5 | -20.0 Percentage Change | Standard Deviation 44.72 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 16;n=22,20,23,25,21,19 | -71.1 Percentage Change | Standard Deviation 56.06 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 14;n=22,19,23,23,21,19 | -76.3 Percentage Change | Standard Deviation 42.06 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 12;n=23,20,23,25,21,19 | -73.7 Percentage Change | Standard Deviation 71.43 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 8;n=23,20,25,27,21,21 | -59.5 Percentage Change | Standard Deviation 56.17 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 2;n=24,21,27,28,22,23 | -37.0 Percentage Change | Standard Deviation 43.22 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 16;n=34,35,30,35,27,25 | -52.0 Percentage Change | Standard Deviation 49.14 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 14;n=34,34,30,33,27,25 | -56.0 Percentage Change | Standard Deviation 39.35 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Oozing/crusting; Week 1;n=24,21,26,27,27,22 | -20.5 Percentage Change | Standard Deviation 50.38 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation; EW; n= 3,4,6,3,11,11 | 27.3 Percentage Change | Standard Deviation 103.35 |
| Vehicle QD | Mean Percent Change From Baseline in Individual Signs of TSS | Induration/Papulation;Week 12;n=36,36,31,35,28,25 | -54.7 Percentage Change | Standard Deviation 40.69 |
Secondary
Mean Percent Change From Baseline in TSS
A target lesion of at least 3 cm\^2 was selected at Baseline. The severity of the following signs: erythema, induration/papulation, lichenification, oozing/crusting, and scaling was assessed on a 4-point scale ranging from 0 (absent) to 3 (severe) , with higher values indicating greater severity of symptoms. TSS (maximum score 15) was calculated based on these signs. Mean percent change from Baseline in TSS at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit was presented using mean and SD. Baseline value was defined as the latest assessment prior to first dose and change from Baseline was defined as post dose visit value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Week 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2894512 1% BID | Mean Percent Change From Baseline in TSS | Week 14; n= 34, 35, 31, 33, 27, 25 | -73.5 Percentage Change | Standard Deviation 30.31 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in TSS | Week 8; n= 36, 37, 34, 38, 29, 27 | -61.7 Percentage Change | Standard Deviation 28.14 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in TSS | Week 4; n= 38, 39, 38, 39, 30, 32 | -55.8 Percentage Change | Standard Deviation 31.18 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in TSS | Week 12; n= 36, 37, 32, 35, 28, 25 | -74.3 Percentage Change | Standard Deviation 31.61 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in TSS | Week 1; n= 38, 41, 39, 37, 38, 32 | -23.5 Percentage Change | Standard Deviation 27.99 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in TSS | Week 16; n= 34, 36, 31, 35, 27, 25 | -69.3 Percentage Change | Standard Deviation 33.2 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in TSS | Week 2; n= 39, 39, 39, 39, 33, 32 | -46.7 Percentage Change | Standard Deviation 32.75 |
| GSK2894512 1% BID | Mean Percent Change From Baseline in TSS | EW; n= 3, 4, 7, 3, 11, 11 | -26.7 Percentage Change | Standard Deviation 64.29 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in TSS | Week 16; n= 34, 36, 31, 35, 27, 25 | -66.0 Percentage Change | Standard Deviation 30.03 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in TSS | Week 1; n= 38, 41, 39, 37, 38, 32 | -33.7 Percentage Change | Standard Deviation 31.01 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in TSS | Week 2; n= 39, 39, 39, 39, 33, 32 | -52.8 Percentage Change | Standard Deviation 28.45 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in TSS | Week 4; n= 38, 39, 38, 39, 30, 32 | -60.1 Percentage Change | Standard Deviation 28.58 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in TSS | Week 8; n= 36, 37, 34, 38, 29, 27 | -69.1 Percentage Change | Standard Deviation 27.56 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in TSS | Week 12; n= 36, 37, 32, 35, 28, 25 | -73.1 Percentage Change | Standard Deviation 31.69 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in TSS | Week 14; n= 34, 35, 31, 33, 27, 25 | -71.1 Percentage Change | Standard Deviation 29.53 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in TSS | EW; n= 3, 4, 7, 3, 11, 11 | 1.4 Percentage Change | Standard Deviation 82.2 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in TSS | Week 16; n= 34, 36, 31, 35, 27, 25 | -68.8 Percentage Change | Standard Deviation 30.66 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in TSS | Week 12; n= 36, 37, 32, 35, 28, 25 | -80.9 Percentage Change | Standard Deviation 18.59 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in TSS | Week 8; n= 36, 37, 34, 38, 29, 27 | -71.0 Percentage Change | Standard Deviation 20.75 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in TSS | Week 14; n= 34, 35, 31, 33, 27, 25 | -63.0 Percentage Change | Standard Deviation 32.96 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in TSS | Week 2; n= 39, 39, 39, 39, 33, 32 | -44.5 Percentage Change | Standard Deviation 26.15 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in TSS | Week 4; n= 38, 39, 38, 39, 30, 32 | -60.3 Percentage Change | Standard Deviation 27.68 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in TSS | EW; n= 3, 4, 7, 3, 11, 11 | -2.9 Percentage Change | Standard Deviation 75.44 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in TSS | Week 1; n= 38, 41, 39, 37, 38, 32 | -25.8 Percentage Change | Standard Deviation 21.94 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in TSS | Week 4; n= 38, 39, 38, 39, 30, 32 | -52.1 Percentage Change | Standard Deviation 33.85 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in TSS | Week 2; n= 39, 39, 39, 39, 33, 32 | -42.4 Percentage Change | Standard Deviation 33.54 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in TSS | Week 1; n= 38, 41, 39, 37, 38, 32 | -22.6 Percentage Change | Standard Deviation 24.78 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in TSS | Week 8; n= 36, 37, 34, 38, 29, 27 | -65.3 Percentage Change | Standard Deviation 28.31 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in TSS | Week 12; n= 36, 37, 32, 35, 28, 25 | -68.6 Percentage Change | Standard Deviation 27.17 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in TSS | Week 16; n= 34, 36, 31, 35, 27, 25 | -63.5 Percentage Change | Standard Deviation 29.78 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in TSS | Week 14; n= 34, 35, 31, 33, 27, 25 | -53.7 Percentage Change | Standard Deviation 35.25 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in TSS | EW; n= 3, 4, 7, 3, 11, 11 | -40.3 Percentage Change | Standard Deviation 56.57 |
| Vehicle BID | Mean Percent Change From Baseline in TSS | Week 12; n= 36, 37, 32, 35, 28, 25 | -56.2 Percentage Change | Standard Deviation 30.53 |
| Vehicle BID | Mean Percent Change From Baseline in TSS | Week 1; n= 38, 41, 39, 37, 38, 32 | -22.0 Percentage Change | Standard Deviation 27.47 |
| Vehicle BID | Mean Percent Change From Baseline in TSS | Week 14; n= 34, 35, 31, 33, 27, 25 | -59.7 Percentage Change | Standard Deviation 34.87 |
| Vehicle BID | Mean Percent Change From Baseline in TSS | Week 16; n= 34, 36, 31, 35, 27, 25 | -59.8 Percentage Change | Standard Deviation 33.68 |
| Vehicle BID | Mean Percent Change From Baseline in TSS | Week 8; n= 36, 37, 34, 38, 29, 27 | -57.4 Percentage Change | Standard Deviation 31.55 |
| Vehicle BID | Mean Percent Change From Baseline in TSS | Week 4; n= 38, 39, 38, 39, 30, 32 | -37.4 Percentage Change | Standard Deviation 27.29 |
| Vehicle BID | Mean Percent Change From Baseline in TSS | EW; n= 3, 4, 7, 3, 11, 11 | -7.9 Percentage Change | Standard Deviation 41.91 |
| Vehicle BID | Mean Percent Change From Baseline in TSS | Week 2; n= 39, 39, 39, 39, 33, 32 | -35.1 Percentage Change | Standard Deviation 29.29 |
| Vehicle QD | Mean Percent Change From Baseline in TSS | Week 4; n= 38, 39, 38, 39, 30, 32 | -33.5 Percentage Change | Standard Deviation 36.16 |
| Vehicle QD | Mean Percent Change From Baseline in TSS | Week 14; n= 34, 35, 31, 33, 27, 25 | -60.2 Percentage Change | Standard Deviation 29.97 |
| Vehicle QD | Mean Percent Change From Baseline in TSS | Week 1; n= 38, 41, 39, 37, 38, 32 | -9.8 Percentage Change | Standard Deviation 28.06 |
| Vehicle QD | Mean Percent Change From Baseline in TSS | Week 12; n= 36, 37, 32, 35, 28, 25 | -62.6 Percentage Change | Standard Deviation 30.39 |
| Vehicle QD | Mean Percent Change From Baseline in TSS | EW; n= 3, 4, 7, 3, 11, 11 | 5.0 Percentage Change | Standard Deviation 59.63 |
| Vehicle QD | Mean Percent Change From Baseline in TSS | Week 2; n= 39, 39, 39, 39, 33, 32 | -17.6 Percentage Change | Standard Deviation 40.06 |
| Vehicle QD | Mean Percent Change From Baseline in TSS | Week 16; n= 34, 36, 31, 35, 27, 25 | -60.3 Percentage Change | Standard Deviation 31.16 |
| Vehicle QD | Mean Percent Change From Baseline in TSS | Week 8; n= 36, 37, 34, 38, 29, 27 | -50.0 Percentage Change | Standard Deviation 35.53 |
Secondary
Mean Percent Change From Baseline in Weekly Average of Daily Itch/Pruritus NRS Score
NRS is a 11-point tool ranging from 0 (absent) to 10 (worst imaginable) to assess the severity of 11 disease-related signs and symptoms including itching, discoloration, bleeding, oozing, cracking, scaling, flaking, dry/rough, painful, burning, and stinging. Participants were asked to complete the self-administered sign and symptom severity diary containing NRS using a recall period of the past 24 hours. Question 1 of the diary was used to assess itch. Mean percent change in weekly average of daily itch/pruritus based on the NRS was presented using mean and SD from Baseline to Week 12. Baseline was defined as the latest assessment prior to first dose and Change from Baseline was defined as post-dose weekly average value minus Baseline value.
Time frame: Baseline and up to Week 12
Population: ITT Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GSK2894512 1% BID | Mean Percent Change From Baseline in Weekly Average of Daily Itch/Pruritus NRS Score | -64.69 Percentage Change | Standard Deviation 36.916 |
| GSK2894512 1% QD | Mean Percent Change From Baseline in Weekly Average of Daily Itch/Pruritus NRS Score | -58.34 Percentage Change | Standard Deviation 45.632 |
| GSK2894512 0.5% BID | Mean Percent Change From Baseline in Weekly Average of Daily Itch/Pruritus NRS Score | -60.39 Percentage Change | Standard Deviation 44.314 |
| GSK2894512 0.5% QD | Mean Percent Change From Baseline in Weekly Average of Daily Itch/Pruritus NRS Score | -61.40 Percentage Change | Standard Deviation 34.958 |
| Vehicle BID | Mean Percent Change From Baseline in Weekly Average of Daily Itch/Pruritus NRS Score | -29.16 Percentage Change | Standard Deviation 55.251 |
| Vehicle QD | Mean Percent Change From Baseline in Weekly Average of Daily Itch/Pruritus NRS Score | -55.62 Percentage Change | Standard Deviation 40.32 |
Secondary
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Single measurements of 12-lead ECGs were obtained at Baseline , Week 1, Week 12, Week 14 (follow up 1), EW and at any time post-screen using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc). Baseline was defined as the latest assessment prior to the first dose. For multiple ECGs at one visit, or Any visit post-screen, a participant was categorized as Abnormal if \>=1 assessment was abnormal. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline, Week 1, 12, 14, EW ( up to Week 14), post-screen
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2894512 1% BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 12; n= 36,37,32,35,28,28 | 7 Participants |
| GSK2894512 1% BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 1; n= 37,41,39,37,38,33 | 8 Participants |
| GSK2894512 1% BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | post-screen; n= 40,41,41,39,41,40 | 12 Participants |
| GSK2894512 1% BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Baseline; n= 40,41,43,41,42,40 | 8 Participants |
| GSK2894512 1% BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | EW; n= 3,3,7,3,10,11 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 14; n= 34,34,32,34,31,29 | 8 Participants |
| GSK2894512 1% QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 12; n= 36,37,32,35,28,28 | 6 Participants |
| GSK2894512 1% QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Baseline; n= 40,41,43,41,42,40 | 6 Participants |
| GSK2894512 1% QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 1; n= 37,41,39,37,38,33 | 8 Participants |
| GSK2894512 1% QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 14; n= 34,34,32,34,31,29 | 4 Participants |
| GSK2894512 1% QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | EW; n= 3,3,7,3,10,11 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | post-screen; n= 40,41,41,39,41,40 | 10 Participants |
| GSK2894512 0.5% BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Baseline; n= 40,41,43,41,42,40 | 4 Participants |
| GSK2894512 0.5% BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 12; n= 36,37,32,35,28,28 | 4 Participants |
| GSK2894512 0.5% BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | EW; n= 3,3,7,3,10,11 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 1; n= 37,41,39,37,38,33 | 4 Participants |
| GSK2894512 0.5% BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 14; n= 34,34,32,34,31,29 | 5 Participants |
| GSK2894512 0.5% BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | post-screen; n= 40,41,41,39,41,40 | 5 Participants |
| GSK2894512 0.5% QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Baseline; n= 40,41,43,41,42,40 | 5 Participants |
| GSK2894512 0.5% QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | post-screen; n= 40,41,41,39,41,40 | 8 Participants |
| GSK2894512 0.5% QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 12; n= 36,37,32,35,28,28 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | EW; n= 3,3,7,3,10,11 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 14; n= 34,34,32,34,31,29 | 6 Participants |
| GSK2894512 0.5% QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 1; n= 37,41,39,37,38,33 | 5 Participants |
| Vehicle BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 1; n= 37,41,39,37,38,33 | 5 Participants |
| Vehicle BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Baseline; n= 40,41,43,41,42,40 | 5 Participants |
| Vehicle BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 12; n= 36,37,32,35,28,28 | 1 Participants |
| Vehicle BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 14; n= 34,34,32,34,31,29 | 1 Participants |
| Vehicle BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | post-screen; n= 40,41,41,39,41,40 | 5 Participants |
| Vehicle BID | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | EW; n= 3,3,7,3,10,11 | 0 Participants |
| Vehicle QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | EW; n= 3,3,7,3,10,11 | 1 Participants |
| Vehicle QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | post-screen; n= 40,41,41,39,41,40 | 9 Participants |
| Vehicle QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Baseline; n= 40,41,43,41,42,40 | 5 Participants |
| Vehicle QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 14; n= 34,34,32,34,31,29 | 5 Participants |
| Vehicle QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 12; n= 36,37,32,35,28,28 | 4 Participants |
| Vehicle QD | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Week 1; n= 37,41,39,37,38,33 | 6 Participants |
Secondary
Number of Participants With Chemistry Data of Potential Clinical Importance
Blood samples were collected from participants for evaluation of clinical chemistry parameters by Potential Clinical Importance Criteria from Baseline to Week 14, EW and any visit post-screen. The vital signs included alk.phosph., ALT, AST, bilirubin, calcium, CO2, creatinine, glucose and potassium. 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 the category titles).
Time frame: Week 2, 4, 8, 12, 14, EW (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 | Bilirubin; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; post-screen; n= 40, 40,40,39,39,40 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; Week 8; n= 35, 37, 34, 38, 29, 28 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 12; n=36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph;Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Post-screen; n= 40, 40,40,39,39,40 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 14; n= 33, 35, 32, 34, 31, 29 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 2; n=38,39,38,39,33,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 8; n= 35, 37, 34, 38, 29, 28 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Post-screen; n= 40, 40,40,39,39,40 | 3 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 2; n=38,39,38,39,33,32 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; Week 12; n= 36, 37, 32, 35, 28, 28 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; post-screen; n= 40, 40,40,39,39,40 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 12; n= 36, 37, 32, 35, 28, 28 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phosph.; post-screen; n= 40, 40,40,39,39,40 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium;EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 8; n=35, 37, 34, 38, 29, 28 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 2; n= 38,39,38,39,33,32 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 4; n= 38,39, 38,38,30,32 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 2; n= 38,39,38,39,33,32 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph; Week 2; n= 38,39,38,39,33,32 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 14; n= 33, 35, 32, 34, 31, 29 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 8; n=35, 37, 34, 38, 29, 28 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 8; n= 35, 37, 34, 38, 29, 28 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 14; n=33, 35, 32, 34, 31, 29 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; n= Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 2; n=38,39,38,39,33,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 12; n= 36, 37, 32, 35, 28, 28 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph;Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 8; n=35, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 14; n=33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 2; n=38,39,38,39,33,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 2; n=38,39,38,39,33,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 8; n= 35, 37, 34, 38, 29, 28 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; post-screen; n= 40, 40,40,39,39,40 | 4 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium;EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phosph.; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 12; n=36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Baseline; n= 40,41,43,41,42,40 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Baseline; n= 40,41,43,41,42,40 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 2; n=38,39,38,39,33,32 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Post-screen; n= 40, 40,40,39,39,40 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 2; n= 38,39,38,39,33,32 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 8; n=35, 37, 34, 38, 29, 28 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 12; n= 36, 37, 32, 35, 28, 28 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; n= Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 4; n= 38,39, 38,38,30,32 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 14; n= 33, 35, 32, 34, 31, 29 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 4; n= 38,39, 38,38,30,32 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph;Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium;EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 8; n=35, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; post-screen; n= 40, 40,40,39,39,40 | 2 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 2; n= 38,39,38,39,33,32 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; post-screen; n= 40, 40,40,39,39,40 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 14; n= 33, 35, 32, 34, 31, 29 | 2 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Post-screen; n= 40, 40,40,39,39,40 | 4 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 12; n= 36, 37, 32, 35, 28, 28 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; EW; n= 3, 3, 7, 3, 11, 11 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Week 14; n= 33, 35, 32, 34, 31, 29 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 8; n=35, 37, 34, 38, 29, 28 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Week 4; n= 38,39, 38,38,30,32 | 2 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 2; n=38,39,38,39,33,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 14; n= 33, 35, 32, 34, 31, 29 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; post-screen; n= 40, 40,40,39,39,40 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 2; n=38,39,38,39,33,32 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Week 8; n= 35, 37, 34, 38, 29, 28 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Baseline; n= 40,41,43,41,42,40 | 2 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 14; n= 33, 35, 32, 34, 31, 29 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; n= Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 12; n=36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; post-screen; n= 40, 40,40,39,39,40 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 14; n=33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phosph.; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; post-screen; n= 40, 40,40,39,39,40 | 2 Participants |
| GSK2894512 0.5% BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 2; n=38,39,38,39,33,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium;EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 8; n=35, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 8; n= 35, 37, 34, 38, 29, 28 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; post-screen; n= 40, 40,40,39,39,40 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 12; n= 36, 37, 32, 35, 28, 28 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Post-screen; n= 40, 40,40,39,39,40 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 4; n= 38,39, 38,38,30,32 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 2; n= 38,39,38,39,33,32 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 12; n= 36, 37, 32, 35, 28, 28 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Week 2; n= 38,39,38,39,33,32 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph;Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phosph.; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 14; n=33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 12; n=36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 14; n= 33, 35, 32, 34, 31, 29 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Baseline; n= 40,41,43,41,42,40 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 2; n=38,39,38,39,33,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Baseline; n= 40,41,43,41,42,40 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; EW; n= 3, 3, 7, 3, 11, 11 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 2; n=38,39,38,39,33,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 14; n= 33, 35, 32, 34, 31, 29 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; n= Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; post-screen; n= 40, 40,40,39,39,40 | 6 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 8; n=35, 37, 34, 38, 29, 28 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 2; n=38,39,38,39,33,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 8; n=35, 37, 34, 38, 29, 28 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Week 14; n= 33, 35, 32, 34, 31, 29 | 1 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Week 2; n= 38,39,38,39,33,32 | 1 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Baseline; n= 40,41,43,41,42,40 | 1 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 8; n=35, 37, 34, 38, 29, 28 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 2; n=38,39,38,39,33,32 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Baseline; n= 40,41,43,41,42,40 | 1 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Post-screen; n= 40, 40,40,39,39,40 | 1 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 2; n=38,39,38,39,33,32 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; post-screen; n= 40, 40,40,39,39,40 | 1 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 2; n=38,39,38,39,33,32 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 14; n= 33, 35, 32, 34, 31, 29 | 1 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium;EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; n= Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 14; n=33, 35, 32, 34, 31, 29 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phosph.; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 12; n=36, 37, 32, 35, 28, 28 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph;Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| Vehicle BID | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk. Phosph.; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 8; n=35, 37, 34, 38, 29, 28 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium;EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; n= Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 14; n= 33, 35, 32, 34, 31, 29 | 1 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; post-screen; n= 40, 40,40,39,39,40 | 1 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Baseline; n= 40,41,43,41,42,40 | 2 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 2; n=38,39,38,39,33,32 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 2; n=38,39,38,39,33,32 | 1 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 4; n= 38,39, 38,38,30,32 | 1 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 12; n=36, 37, 32, 35, 28, 28 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 14; n=33, 35, 32, 34, 31, 29 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Week 4; n= 38,39, 38,38,30,32 | 1 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Calcium; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 8; n=35, 37, 34, 38, 29, 28 | 2 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph.; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 2; n=38,39,38,39,33,32 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; post-screen; n= 40, 40,40,39,39,40 | 1 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Post-screen; n= 40, 40,40,39,39,40 | 3 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 14; n= 33, 35, 32, 34, 31, 29 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 12; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Creatinine; Week 2; n= 38,39,38,39,33,32 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Bilirubin; EW; n= 3, 3, 7, 3, 11, 11 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Alk.Phosph;Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 2; n= 38,39,38,39,33,32 | 2 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 8; n= 35, 37, 34, 38, 29, 28 | 2 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 4; n= 38,39, 38,38,30,32 | 3 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | AST; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; Week 12; n= 36, 37, 32, 35, 28, 28 | 2 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Glucose; post-screen; n= 40, 40,40,39,39,40 | 5 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; Week 8; n= 35, 37, 34, 38, 29, 28 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | ALT; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | CO2; Week 4; n= 38,39, 38,38,30,32 | 0 Participants |
| Vehicle QD | Number of Participants With Chemistry Data of Potential Clinical Importance | Potassium; post-screen; n= 40, 40,40,39,39,40 | 0 Participants |
Secondary
Number of Participants With Hematology Data of Potential Clinical Importance
Blood samples were collected from participants for evaluation of hematology parameters by Potential Clinical Importance Criteria from Baseline to Week 14, EW and any visit post-screen. The vital signs included hematocrit, hemoglobin, lymphocytes, neutrophils, platelet and leukocytes. 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 the category titles).
Time frame: Baseline, Week 2, 4, 8, 12, 14, early withdrawal, and post screen (up to Week 16)
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 4; n= 38, 39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 4; n=37,39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 4; n= 38, 39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes;Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; EW;n= 3,3,7,3,10,10 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 2; n= 37, 39, 38, 38, 33, 31 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; n= EW; n=3,3,7,3,10,10 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 8; n= 34,36,34,38,29,28 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; Week 2; n= 37, 39, 38, 38, 33, 31 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 12; n= 36, 37, 32, 35, 28,28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; EW; n= 3,3,7,3,10,10 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 12; n= 36, 37, 32, 35, 28,28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 2; n= 37, 39, 38, 38, 33, 31 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; Week 14; n= 33,34,32,33,31,28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymhocytes; Week 4; n= 38, 39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 14; n= 33,34,32,33,31,29 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; post-screen; n= 40,40,40,39,39,40 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; Week 12; n=36, 37, 32, 35, 28,28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 8; n= 34,36,34,38,29,28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; Week 8; n= 34,36,34,38,29,28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; post-screen; n= 40,40,40,39,39,40 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 4; n=38, 39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; EW; n=3,3,7,3,10,10 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 14; n=33,34,32,33,31,29 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 8; n= 34,36,34,38,29,28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 12; n= 35,37,32,35,28,28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 2; n= :37,38,38,38,33,31 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 8; n=34,36,34,38,29,28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 4; n= 38, 39, 38,38,30,32 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 12; n= 36, 37, 32, 35, 28,28 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 14; n=33,34,32,33,31,29 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 2; n=37, 39, 38, 38, 33, 31 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Baseline;n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 2; n= 37, 39, 38, 38, 33, 31 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 12; n= 36, 37, 32, 35, 28,28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 14; n=33,34,32,33,31,29 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; EW; n= 3,3,7,3,10,10 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; post-screen;n= 40,40,40,39,39,40 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Baseline; n= 40, 40, 43, 40, 42, 39 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; post-screen; n= 40,40,40,39,39,40 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 8; n=34,36,34,38,29,28 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 14; n=33,34,32,33,31,28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; post-screen; n= 40,40,40,39,39,40 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; EW; n=3,3,7,3,10,10 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; post-screen; n= 40,40,40,39,39,40 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Baseline;n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; post-screen; n= 40,40,40,39,39,40 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 2; n= :37,38,38,38,33,31 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; EW; n=3,3,7,3,10,10 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 4; n=37,39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 14; n=33,34,32,33,31,29 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 8; n= 34,36,34,38,29,28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 12; n= 36, 37, 32, 35, 28,28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 12; n= 35,37,32,35,28,28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 12; n= 36, 37, 32, 35, 28,28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 14; n=33,34,32,33,31,29 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 8; n=34,36,34,38,29,28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; EW; n= 3,3,7,3,10,10 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; post-screen; n= 40,40,40,39,39,40 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 4; n= 38, 39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes;Baseline; n= 40, 40, 43, 40, 42, 39 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 2; n= 37, 39, 38, 38, 33, 31 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; Week 2; n= 37, 39, 38, 38, 33, 31 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 2; n= 37, 39, 38, 38, 33, 31 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymhocytes; Week 4; n= 38, 39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; Week 8; n= 34,36,34,38,29,28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; post-screen; n= 40,40,40,39,39,40 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; post-screen; n= 40,40,40,39,39,40 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; Week 12; n=36, 37, 32, 35, 28,28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; EW; n= 3,3,7,3,10,10 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; Week 14; n= 33,34,32,33,31,28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; n= EW; n=3,3,7,3,10,10 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; EW;n= 3,3,7,3,10,10 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 14; n=33,34,32,33,31,28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; post-screen; n= 40,40,40,39,39,40 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 4; n= 38, 39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 12; n= 36, 37, 32, 35, 28,28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 2; n= 37, 39, 38, 38, 33, 31 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 8; n=34,36,34,38,29,28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 4; n= 38, 39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 8; n= 34,36,34,38,29,28 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 14; n= 33,34,32,33,31,29 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 4; n=38, 39, 38,38,30,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 12; n= 36, 37, 32, 35, 28,28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 2; n=37, 39, 38, 38, 33, 31 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 14; n=33,34,32,33,31,29 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 8; n= 34,36,34,38,29,28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; EW; n=3,3,7,3,10,10 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; post-screen;n= 40,40,40,39,39,40 | 2 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 8; n= 34,36,34,38,29,28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 4; n= 38, 39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 12; n= 36, 37, 32, 35, 28,28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; EW; n= 3,3,7,3,10,10 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 12; n= 36, 37, 32, 35, 28,28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 4; n= 38, 39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; post-screen;n= 40,40,40,39,39,40 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 8; n=34,36,34,38,29,28 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; post-screen; n= 40,40,40,39,39,40 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 14; n=33,34,32,33,31,29 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 2; n= 37, 39, 38, 38, 33, 31 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 14; n=33,34,32,33,31,29 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 8; n=34,36,34,38,29,28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Baseline;n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 2; n= :37,38,38,38,33,31 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 4; n= 38, 39, 38,38,30,32 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 14; n= 33,34,32,33,31,29 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 12; n= 36, 37, 32, 35, 28,28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 4; n=38, 39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 12; n= 35,37,32,35,28,28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; Week 8; n= 34,36,34,38,29,28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 8; n= 34,36,34,38,29,28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; post-screen; n= 40,40,40,39,39,40 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; EW; n=3,3,7,3,10,10 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 2; n= 37, 39, 38, 38, 33, 31 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; post-screen; n= 40,40,40,39,39,40 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; Week 12; n=36, 37, 32, 35, 28,28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 8; n= 34,36,34,38,29,28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymhocytes; Week 4; n= 38, 39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; n= EW; n=3,3,7,3,10,10 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 14; n=33,34,32,33,31,29 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; Week 14; n= 33,34,32,33,31,28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; Week 2; n= 37, 39, 38, 38, 33, 31 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; EW; n=3,3,7,3,10,10 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 2; n= 37, 39, 38, 38, 33, 31 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes;Baseline; n= 40, 40, 43, 40, 42, 39 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 12; n= 36, 37, 32, 35, 28,28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; EW;n= 3,3,7,3,10,10 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; EW; n= 3,3,7,3,10,10 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 14; n=33,34,32,33,31,28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 4; n=37,39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; post-screen; n= 40,40,40,39,39,40 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 2; n=37, 39, 38, 38, 33, 31 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; post-screen; n= 40,40,40,39,39,40 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; n= EW; n=3,3,7,3,10,10 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Baseline;n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 2; n= 37, 39, 38, 38, 33, 31 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 4; n= 38, 39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 8; n= 34,36,34,38,29,28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 12; n= 36, 37, 32, 35, 28,28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 14; n=33,34,32,33,31,29 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; EW; n= 3,3,7,3,10,10 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; post-screen; n= 40,40,40,39,39,40 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes;Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; Week 2; n= 37, 39, 38, 38, 33, 31 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymhocytes; Week 4; n= 38, 39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; Week 8; n= 34,36,34,38,29,28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; Week 12; n=36, 37, 32, 35, 28,28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; Week 14; n= 33,34,32,33,31,28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; EW;n= 3,3,7,3,10,10 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; post-screen; n= 40,40,40,39,39,40 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 2; n= 37, 39, 38, 38, 33, 31 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 4; n= 38, 39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 8; n= 34,36,34,38,29,28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 12; n= 36, 37, 32, 35, 28,28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 14; n=33,34,32,33,31,29 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; EW; n=3,3,7,3,10,10 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; post-screen;n= 40,40,40,39,39,40 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 2; n= :37,38,38,38,33,31 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 4; n=37,39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 8; n= 34,36,34,38,29,28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 12; n= 35,37,32,35,28,28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 14; n=33,34,32,33,31,29 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; EW; n=3,3,7,3,10,10 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; post-screen; n= 40,40,40,39,39,40 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 2; n=37, 39, 38, 38, 33, 31 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 4; n=38, 39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 8; n=34,36,34,38,29,28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 12; n= 36, 37, 32, 35, 28,28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 14; n=33,34,32,33,31,28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; post-screen; n= 40,40,40,39,39,40 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 2; n= 37, 39, 38, 38, 33, 31 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 4; n= 38, 39, 38,38,30,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 8; n=34,36,34,38,29,28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 12; n= 36, 37, 32, 35, 28,28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 14; n= 33,34,32,33,31,29 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; EW; n= 3,3,7,3,10,10 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; post-screen; n= 40,40,40,39,39,40 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; post-screen;n= 40,40,40,39,39,40 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; post-screen; n= 40,40,40,39,39,40 | 1 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; EW; n=3,3,7,3,10,10 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 14; n=33,34,32,33,31,29 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 12; n= 36, 37, 32, 35, 28,28 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 4; n= 38, 39, 38,38,30,32 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 2; n=37, 39, 38, 38, 33, 31 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 8; n= 34,36,34,38,29,28 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 4; n=38, 39, 38,38,30,32 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 4; n= 38, 39, 38,38,30,32 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 2; n= 37, 39, 38, 38, 33, 31 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 14; n= 33,34,32,33,31,29 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 8; n=34,36,34,38,29,28 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 12; n= 36, 37, 32, 35, 28,28 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; post-screen; n= 40,40,40,39,39,40 | 1 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; EW;n= 3,3,7,3,10,10 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 14; n=33,34,32,33,31,28 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; Week 14; n= 33,34,32,33,31,28 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; n= EW; n=3,3,7,3,10,10 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; Week 12; n=36, 37, 32, 35, 28,28 | 1 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; Week 8; n= 34,36,34,38,29,28 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 2; n= 37, 39, 38, 38, 33, 31 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; post-screen; n= 40,40,40,39,39,40 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymhocytes; Week 4; n= 38, 39, 38,38,30,32 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; Week 2; n= 37, 39, 38, 38, 33, 31 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes;Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; post-screen; n= 40,40,40,39,39,40 | 1 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 2; n= 37, 39, 38, 38, 33, 31 | 1 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; post-screen; n= 40,40,40,39,39,40 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; EW; n= 3,3,7,3,10,10 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 4; n= 38, 39, 38,38,30,32 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; EW; n= 3,3,7,3,10,10 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 14; n=33,34,32,33,31,29 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 8; n=34,36,34,38,29,28 | 1 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 12; n= 36, 37, 32, 35, 28,28 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Baseline;n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 12; n= 35,37,32,35,28,28 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 8; n= 34,36,34,38,29,28 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 4; n=37,39, 38,38,30,32 | 1 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 12; n= 36, 37, 32, 35, 28,28 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 14; n=33,34,32,33,31,29 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 2; n= :37,38,38,38,33,31 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; EW; n=3,3,7,3,10,10 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| Vehicle BID | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 8; n= 34,36,34,38,29,28 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 12; n= 36, 37, 32, 35, 28,28 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; post-screen; n= 40,40,40,39,39,40 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; post-screen; n= 40,40,40,39,39,40 | 1 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; EW; n=3,3,7,3,10,10 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymhocytes; Week 4; n= 38, 39, 38,38,30,32 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 14; n=33,34,32,33,31,29 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 4; n= 38, 39, 38,38,30,32 | 1 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 8; n=34,36,34,38,29,28 | 1 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; Week 2; n= 37, 39, 38, 38, 33, 31 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 12; n= 36, 37, 32, 35, 28,28 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Baseline;n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 12; n= 36, 37, 32, 35, 28,28 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 2; n=37, 39, 38, 38, 33, 31 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 8; n= 34,36,34,38,29,28 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; post-screen;n= 40,40,40,39,39,40 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 4; n= 38, 39, 38,38,30,32 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; post-screen; n= 40,40,40,39,39,40 | 2 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes;Baseline; n= 40, 40, 43, 40, 42, 39 | 1 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 4; n=38, 39, 38,38,30,32 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 8; n= 34,36,34,38,29,28 | 1 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Week 2; n= 37, 39, 38, 38, 33, 31 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 8; n= 34,36,34,38,29,28 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 14; n=33,34,32,33,31,29 | 1 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 2; n= 37, 39, 38, 38, 33, 31 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 8; n=34,36,34,38,29,28 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Neutrophils; Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; post-screen; n= 40,40,40,39,39,40 | 1 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; post-screen; n= 40,40,40,39,39,40 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 14; n= 33,34,32,33,31,29 | 2 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 2; n= :37,38,38,38,33,31 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 12; n= 36, 37, 32, 35, 28,28 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; EW; n= 3,3,7,3,10,10 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; EW;n= 3,3,7,3,10,10 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 12; n= 35,37,32,35,28,28 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 2; n= 37, 39, 38, 38, 33, 31 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; EW; n=3,3,7,3,10,10 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; Week 14; n=33,34,32,33,31,28 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; Week 14; n= 33,34,32,33,31,28 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; Week 4; n= 38, 39, 38,38,30,32 | 1 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; Week 12; n=36, 37, 32, 35, 28,28 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Week 4; n=37,39, 38,38,30,32 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Leukocytes; n= EW; n=3,3,7,3,10,10 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hemoglobin; Week 14; n=33,34,32,33,31,29 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Lymphocytes; Week 8; n= 34,36,34,38,29,28 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Platelets; Baseline; n= 40, 40, 43, 40, 42, 39 | 0 Participants |
| Vehicle QD | Number of Participants With Hematology Data of Potential Clinical Importance | Hematocrit; EW; n= 3,3,7,3,10,10 | 0 Participants |
Secondary
Number of Participants With Immunoglobulin Data Outside the Reference Range
Blood samples were collected from participants for evaluation of immunoglobulin data outside the reference range at Baseline, Week 4, Week 8, Week 12 and any visit post-screen. The immunoglobulin parameters included IgA, IgG and Ig M. 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 the category titles).
Time frame: Baseline, Week, 4, 8, 12, post-screen (up to Week 16)
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2894512 1% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; Week 4; n= 37,38,38,38,30,32 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM; Week 8; n= 35,37,34,38,29,28 | 3 Participants |
| GSK2894512 1% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; Week 12; n= 36,37,32,35,28,27 | 3 Participants |
| GSK2894512 1% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; Week 8; n= 35,37,34,38,29,28 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM; Week 4; n=37,38,38,38,30,32 | 3 Participants |
| GSK2894512 1% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; Baseline; n=40,41,43,41,42,40 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM; post-screen; n=38,39,38,39,30,32 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM;Baseline; n= 40,41,43,41,42,40 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; post screen; n= 38,39,38,39,30,32 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; Baseline; n= 40,41,43,41,42,40 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM; Week12; n= 36,37,32,35,28,27 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; Week 12; n=36,37,32,35,28,27 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; Week 8; n=35,37,34,38,29,28 | 3 Participants |
| GSK2894512 1% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; Week 4; n= 37,38,38,38,30,32 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; post-screen; n= 38,39,38,39,30,32 | 4 Participants |
| GSK2894512 1% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; post-screen; n= 38,39,38,39,30,32 | 3 Participants |
| GSK2894512 1% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; Baseline; n=40,41,43,41,42,40 | 5 Participants |
| GSK2894512 1% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; Baseline; n= 40,41,43,41,42,40 | 3 Participants |
| GSK2894512 1% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; Week 4; n= 37,38,38,38,30,32 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; Week 8; n= 35,37,34,38,29,28 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; Week 12; n= 36,37,32,35,28,27 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; Week 4; n= 37,38,38,38,30,32 | 3 Participants |
| GSK2894512 1% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; Week 8; n=35,37,34,38,29,28 | 3 Participants |
| GSK2894512 1% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; Week 12; n=36,37,32,35,28,27 | 5 Participants |
| GSK2894512 1% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; post screen; n= 38,39,38,39,30,32 | 6 Participants |
| GSK2894512 1% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM;Baseline; n= 40,41,43,41,42,40 | 7 Participants |
| GSK2894512 1% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM; Week 4; n=37,38,38,38,30,32 | 5 Participants |
| GSK2894512 1% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM; Week 8; n= 35,37,34,38,29,28 | 4 Participants |
| GSK2894512 1% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM; Week12; n= 36,37,32,35,28,27 | 5 Participants |
| GSK2894512 1% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM; post-screen; n=38,39,38,39,30,32 | 5 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM; Week12; n= 36,37,32,35,28,27 | 7 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; Baseline; n=40,41,43,41,42,40 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM;Baseline; n= 40,41,43,41,42,40 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM; Week 4; n=37,38,38,38,30,32 | 6 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM; post-screen; n=38,39,38,39,30,32 | 10 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; Week 4; n= 37,38,38,38,30,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; Week 8; n=35,37,34,38,29,28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; Week 12; n= 36,37,32,35,28,27 | 4 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; Week 8; n= 35,37,34,38,29,28 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; Baseline; n= 40,41,43,41,42,40 | 2 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; Week 12; n=36,37,32,35,28,27 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; Week 4; n= 37,38,38,38,30,32 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM; Week 8; n= 35,37,34,38,29,28 | 7 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; post-screen; n= 38,39,38,39,30,32 | 4 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; post screen; n= 38,39,38,39,30,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM; Week 8; n= 35,37,34,38,29,28 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; Week 8; n=35,37,34,38,29,28 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM; post-screen; n=38,39,38,39,30,32 | 4 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; Week 12; n=36,37,32,35,28,27 | 5 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM;Baseline; n= 40,41,43,41,42,40 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM; Week12; n= 36,37,32,35,28,27 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM; Week 4; n=37,38,38,38,30,32 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; post screen; n= 38,39,38,39,30,32 | 5 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; post-screen; n= 38,39,38,39,30,32 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; Week 4; n= 37,38,38,38,30,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; Week 4; n= 37,38,38,38,30,32 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; Baseline; n=40,41,43,41,42,40 | 4 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; Week 8; n= 35,37,34,38,29,28 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; Baseline; n= 40,41,43,41,42,40 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; Week 12; n= 36,37,32,35,28,27 | 1 Participants |
| Vehicle BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM; Week12; n= 36,37,32,35,28,27 | 3 Participants |
| Vehicle BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; Week 12; n= 36,37,32,35,28,27 | 1 Participants |
| Vehicle BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; Baseline; n=40,41,43,41,42,40 | 3 Participants |
| Vehicle BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; Baseline; n= 40,41,43,41,42,40 | 4 Participants |
| Vehicle BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; Week 4; n= 37,38,38,38,30,32 | 3 Participants |
| Vehicle BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; Week 8; n=35,37,34,38,29,28 | 4 Participants |
| Vehicle BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; Week 12; n=36,37,32,35,28,27 | 4 Participants |
| Vehicle BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; post screen; n= 38,39,38,39,30,32 | 6 Participants |
| Vehicle BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM;Baseline; n= 40,41,43,41,42,40 | 6 Participants |
| Vehicle BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM; Week 4; n=37,38,38,38,30,32 | 2 Participants |
| Vehicle BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; post-screen; n= 38,39,38,39,30,32 | 3 Participants |
| Vehicle BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM; Week 8; n= 35,37,34,38,29,28 | 3 Participants |
| Vehicle BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; Week 4; n= 37,38,38,38,30,32 | 3 Participants |
| Vehicle BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM; post-screen; n=38,39,38,39,30,32 | 3 Participants |
| Vehicle BID | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; Week 8; n= 35,37,34,38,29,28 | 1 Participants |
| Vehicle QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; post screen; n= 38,39,38,39,30,32 | 3 Participants |
| Vehicle QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; Week 8; n= 35,37,34,38,29,28 | 2 Participants |
| Vehicle QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM; Week 8; n= 35,37,34,38,29,28 | 5 Participants |
| Vehicle QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; Week 12; n=36,37,32,35,28,27 | 2 Participants |
| Vehicle QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; Baseline; n=40,41,43,41,42,40 | 3 Participants |
| Vehicle QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; Week 4; n= 37,38,38,38,30,32 | 2 Participants |
| Vehicle QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM; Week12; n= 36,37,32,35,28,27 | 6 Participants |
| Vehicle QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; Baseline; n= 40,41,43,41,42,40 | 2 Participants |
| Vehicle QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; Week 8; n=35,37,34,38,29,28 | 2 Participants |
| Vehicle QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; post-screen; n= 38,39,38,39,30,32 | 3 Participants |
| Vehicle QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM;Baseline; n= 40,41,43,41,42,40 | 4 Participants |
| Vehicle QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgG; Week 4; n= 37,38,38,38,30,32 | 2 Participants |
| Vehicle QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM; Week 4; n=37,38,38,38,30,32 | 6 Participants |
| Vehicle QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgA; Week 12; n= 36,37,32,35,28,27 | 2 Participants |
| Vehicle QD | Number of Participants With Immunoglobulin Data Outside the Reference Range | IgM; post-screen; n=38,39,38,39,30,32 | 6 Participants |
Secondary
Number of Participants With Immunopheotyping Data Outside the Reference Range
Blood samples were collected from participants for evaluation of immunophenotyping parameters by Potential Clinical Importance Criteria at Baseline, Week 4, Week 8, Week 12 nd any visit post-screen. The immunophenotyping parameters included CD 19, CD3, CD3+CD8+, CD3+CD4+, CD16+CD56+, CD3+CD4+CD25+CD127, CD3+CD4+foxP3+CD25+CD127 and T and NK lympho. CD3, CD3+CD8+ and CD3+CD4+ were also evaluated by using treg flow cyto. 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 the category titles).
Time frame: Baseline, Week, 4, 8, 12 and post-screen (up to Week 16)
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; post-screen; n=38,39,38,39,30,32 | 8 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; Week 4; n=37,38,38,38,30,32 | 5 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcyto;Week12;n=34,37,32,34,27,25 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcyto;Week4;n=37,38,37,37,30,30 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;Week8;n=33,36,33,38,29,26 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3 treg flow cyto;Baseline; n=38,40,42,39,40,37 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; post-screen; n= 38,39,38,39,30,32 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;Week4;n=37,38,38,38,30,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow cyto;Week8;n=33,36,33,38,29,26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;postscreen;n=38,39,38,39,30,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;Week8;n=34,37,34,38,29,27 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3 treg flow cyto; Week 4; n=37,38,37,37,30,30 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;post;n=38,39,38,39,30,32 | 19 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;Base;n=38,40,42,39,40,37 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcytopostscreen;n=38,39,38,39,30,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; Week 8; n= 34,37,34,38,29,27 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow cyto;Week4;n=37,38,37,37, 30,30 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3 treg flow cyto; Week8; n=33,36,33,38,29,26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;Baseline; n=40,41,43,40,41,40 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;Week 4;n=37,38,37,37,30,30 | 3 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;Week8;n=33,36,33,37,29,26 | 9 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcyto;Baseline;n= 38,40,42,39,40,37 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; Week 8; n=34,37,34,38,29,27 | 5 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3 treg flow cyto; Week 12; n= 34,37,32,34,27,25 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;postscreen;n=38,39,38,39,30,32 | 7 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;Week12;n=34,37,32,34,27,25 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; Baseline; n=40,41,43,41,41,40 | 8 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; Baseline; n=40,41,43,40,41,40 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; Week 12; n= 35,37,32,35,28,27 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3treg flow cyto; postscreen; n=38,39,38,39,30,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;postscreen;n=38,39,38,39,30,32 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow;postscreen;n=38,39,38,39,30,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; Week 8; n=34,37,34,38,29,27 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;Baseline;n=40,41,43,40,41,40 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;Week4; n=37,38,38,38,30,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; Baseline; n= 40,41,43,40,41,40 | 9 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;Baseline;n=38,40,42,39,40,37 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcyto;Week8;n=33,36,33,38,29,26 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow cyto;Baseline;n=38,40,42,39,40,37 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;Week12;n=35,37,32,35,28,27 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;Week12;n=35,37,32,35,28,27 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; Week 4; n=37,38,38,38,30,32 | 5 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; Week 12; n=35,37,32,35,28,27 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;Week8;n=34,37,34,38,29,27 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; post-screen;n=38,39,38,39,30,32 | 8 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;Week12;34,37,32,34,27,25 | 10 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; Week 4; n=37,38,38,38,30,32 | 6 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; Week 8; n=34,37,34,38,29,27 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; Week 4; n= 37,38,38,38,30,32 | 3 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;Week4;n=37,38,37,37,30,30 | 10 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; Week 12; n= 35,37,32,35,28,27 | 5 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow cyto;Week12;n=34,37,32,34,27,25 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; Baseline;n=40,41,43,40,41,40 | 8 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; Week 12; n= 35,37,32,35,28,27 | 3 Participants |
| GSK2894512 1% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; post-screen; n=38,39,38,39,30,32 | 8 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; Week 12; n= 35,37,32,35,28,27 | 3 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;Baseline; n=40,41,43,40,41,40 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; post-screen; n=38,39,38,39,30,32 | 4 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; Week 4; n=37,38,38,38,30,32 | 3 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; Week 12; n= 35,37,32,35,28,27 | 3 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcyto;Baseline;n= 38,40,42,39,40,37 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;Baseline;n=40,41,43,40,41,40 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; Week 4; n=37,38,38,38,30,32 | 4 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;Base;n=38,40,42,39,40,37 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcyto;Week4;n=37,38,37,37,30,30 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;postscreen;n=38,39,38,39,30,32 | 6 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; post-screen; n= 38,39,38,39,30,32 | 3 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; Baseline;n=40,41,43,40,41,40 | 5 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcyto;Week8;n=33,36,33,38,29,26 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; Baseline; n=40,41,43,40,41,40 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;post;n=38,39,38,39,30,32 | 19 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcyto;Week12;n=34,37,32,34,27,25 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcytopostscreen;n=38,39,38,39,30,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow;postscreen;n=38,39,38,39,30,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;Week12;n=34,37,32,34,27,25 | 4 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; Week 8; n=34,37,34,38,29,27 | 3 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;postscreen;n=38,39,38,39,30,32 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;Week4;n=37,38,37,37,30,30 | 10 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; Week 12; n=35,37,32,35,28,27 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow cyto;Week12;n=34,37,32,34,27,25 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;Week4;n=37,38,38,38,30,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; post-screen; n=38,39,38,39,30,32 | 5 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;Baseline;n=38,40,42,39,40,37 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow cyto;Week8;n=33,36,33,38,29,26 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;Week12;n=35,37,32,35,28,27 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;Week8;n=34,37,34,38,29,27 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3 treg flow cyto;Baseline; n=38,40,42,39,40,37 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; Week 4; n= 37,38,38,38,30,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3 treg flow cyto; Week 4; n=37,38,37,37,30,30 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; Baseline; n=40,41,43,41,41,40 | 3 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3 treg flow cyto; Week8; n=33,36,33,38,29,26 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; Week 8; n= 34,37,34,38,29,27 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;Week 4;n=37,38,37,37,30,30 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3 treg flow cyto; Week 12; n= 34,37,32,34,27,25 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;Week8;n=34,37,34,38,29,27 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;Week4; n=37,38,38,38,30,32 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3treg flow cyto; postscreen; n=38,39,38,39,30,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;Week12;n=35,37,32,35,28,27 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow cyto;Baseline;n=38,40,42,39,40,37 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; Baseline; n= 40,41,43,40,41,40 | 3 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;Week8;n=33,36,33,38,29,26 | 3 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;Week8;n=33,36,33,37,29,26 | 8 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; post-screen;n=38,39,38,39,30,32 | 8 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; Week 4; n=37,38,38,38,30,32 | 3 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; Week 12; n= 35,37,32,35,28,27 | 6 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;Week12;34,37,32,34,27,25 | 9 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; Week 8; n=34,37,34,38,29,27 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;postscreen;n=38,39,38,39,30,32 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; Week 8; n=34,37,34,38,29,27 | 6 Participants |
| GSK2894512 1% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow cyto;Week4;n=37,38,37,37, 30,30 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;Week8;n=34,37,34,38,29,27 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;Week12;n=35,37,32,35,28,27 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; Week 4; n=37,38,38,38,30,32 | 6 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;postscreen;n=38,39,38,39,30,32 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;Baseline;n=38,40,42,39,40,37 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;Week 4;n=37,38,37,37,30,30 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;Week8;n=33,36,33,38,29,26 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow cyto;Week8;n=33,36,33,38,29,26 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;postscreen;n=38,39,38,39,30,32 | 8 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;Week12;n=34,37,32,34,27,25 | 6 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; Week 8; n=34,37,34,38,29,27 | 5 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; Week 4; n= 37,38,38,38,30,32 | 5 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; Week 12; n=35,37,32,35,28,27 | 5 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;Week8;n=34,37,34,38,29,27 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; post-screen; n=38,39,38,39,30,32 | 9 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; Baseline; n=40,41,43,40,41,40 | 5 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3 treg flow cyto;Baseline; n=38,40,42,39,40,37 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;postscreen;n=38,39,38,39,30,32 | 2 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3 treg flow cyto; Week 4; n=37,38,37,37,30,30 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3 treg flow cyto; Week8; n=33,36,33,38,29,26 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;Week4; n=37,38,38,38,30,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3 treg flow cyto; Week 12; n= 34,37,32,34,27,25 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3treg flow cyto; postscreen; n=38,39,38,39,30,32 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; Week 8; n= 34,37,34,38,29,27 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; Baseline; n= 40,41,43,40,41,40 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; Week 4; n=37,38,38,38,30,32 | 4 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;Baseline; n=40,41,43,40,41,40 | 2 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; Week 8; n=34,37,34,38,29,27 | 4 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; Week 12; n= 35,37,32,35,28,27 | 4 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; post-screen; n=38,39,38,39,30,32 | 8 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcyto;Baseline;n= 38,40,42,39,40,37 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; Week 12; n= 35,37,32,35,28,27 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcyto;Week4;n=37,38,37,37,30,30 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;post;n=38,39,38,39,30,32 | 21 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcyto;Week8;n=33,36,33,38,29,26 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcyto;Week12;n=34,37,32,34,27,25 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcytopostscreen;n=38,39,38,39,30,32 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; Baseline;n=40,41,43,40,41,40 | 6 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;Week12;34,37,32,34,27,25 | 9 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; Week 4; n=37,38,38,38,30,32 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; post-screen; n= 38,39,38,39,30,32 | 7 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; Week 8; n=34,37,34,38,29,27 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; Week 12; n= 35,37,32,35,28,27 | 5 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;Week8;n=33,36,33,37,29,26 | 14 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; post-screen;n=38,39,38,39,30,32 | 7 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow cyto;Baseline;n=38,40,42,39,40,37 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow cyto;Week4;n=37,38,37,37, 30,30 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; Baseline; n=40,41,43,41,41,40 | 6 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;Week4;n=37,38,37,37,30,30 | 7 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow cyto;Week12;n=34,37,32,34,27,25 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow;postscreen;n=38,39,38,39,30,32 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;Baseline;n=40,41,43,40,41,40 | 2 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;Week12;n=35,37,32,35,28,27 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;Week4;n=37,38,38,38,30,32 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;Base;n=38,40,42,39,40,37 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; Week 8; n=34,37,34,38,29,27 | 5 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; post-screen; n= 38,39,38,39,30,32 | 7 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;Week8;n=33,36,33,37,29,26 | 9 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; Week 8; n=34,37,34,38,29,27 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; Baseline; n=40,41,43,40,41,40 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;postscreen;n=38,39,38,39,30,32 | 9 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; Week 12; n= 35,37,32,35,28,27 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;postscreen;n=38,39,38,39,30,32 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;postscreen;n=38,39,38,39,30,32 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; Week 4; n=37,38,38,38,30,32 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;Baseline; n=40,41,43,40,41,40 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;Baseline;n=40,41,43,40,41,40 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;Week12;n=35,37,32,35,28,27 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; Week 8; n= 34,37,34,38,29,27 | 4 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; Baseline; n= 40,41,43,40,41,40 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3treg flow cyto; postscreen; n=38,39,38,39,30,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;Week8;n=34,37,34,38,29,27 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow cyto;Baseline;n=38,40,42,39,40,37 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3 treg flow cyto; Week 12; n= 34,37,32,34,27,25 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3 treg flow cyto; Week8; n=33,36,33,38,29,26 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;Week4; n=37,38,38,38,30,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;Base;n=38,40,42,39,40,37 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow cyto;Week4;n=37,38,37,37, 30,30 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3 treg flow cyto; Week 4; n=37,38,37,37,30,30 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;Week4;n=37,38,37,37,30,30 | 11 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3 treg flow cyto;Baseline; n=38,40,42,39,40,37 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; post-screen; n=38,39,38,39,30,32 | 4 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow cyto;Week8;n=33,36,33,38,29,26 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;Baseline;n=38,40,42,39,40,37 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; Week 4; n=37,38,38,38,30,32 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; Week 4; n= 37,38,38,38,30,32 | 4 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; Week 12; n=35,37,32,35,28,27 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;Week12;n=35,37,32,35,28,27 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow cyto;Week12;n=34,37,32,34,27,25 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; Baseline; n=40,41,43,41,41,40 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; Week 8; n=34,37,34,38,29,27 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;Week12;n=34,37,32,34,27,25 | 6 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcytopostscreen;n=38,39,38,39,30,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcyto;Week12;n=34,37,32,34,27,25 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;Week12;34,37,32,34,27,25 | 14 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcyto;Week8;n=33,36,33,38,29,26 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; Week 12; n= 35,37,32,35,28,27 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;Week8;n=33,36,33,38,29,26 | 6 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; Baseline;n=40,41,43,40,41,40 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcyto;Week4;n=37,38,37,37,30,30 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;Week4;n=37,38,38,38,30,32 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;post;n=38,39,38,39,30,32 | 22 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcyto;Baseline;n= 38,40,42,39,40,37 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow;postscreen;n=38,39,38,39,30,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; Week 4; n=37,38,38,38,30,32 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;Week 4;n=37,38,37,37,30,30 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; post-screen; n=38,39,38,39,30,32 | 4 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; Week 12; n= 35,37,32,35,28,27 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;Week8;n=34,37,34,38,29,27 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; post-screen;n=38,39,38,39,30,32 | 7 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3 treg flow cyto; Week 12; n= 34,37,32,34,27,25 | 0 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; Baseline; n=40,41,43,40,41,40 | 1 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; Week 4; n= 37,38,38,38,30,32 | 1 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; Week 8; n= 34,37,34,38,29,27 | 3 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; Week 12; n= 35,37,32,35,28,27 | 0 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; post-screen; n= 38,39,38,39,30,32 | 3 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; Baseline; n=40,41,43,41,41,40 | 4 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; Week 4; n=37,38,38,38,30,32 | 4 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; Week 8; n=34,37,34,38,29,27 | 2 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; Week 12; n=35,37,32,35,28,27 | 2 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; post-screen; n=38,39,38,39,30,32 | 6 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3 treg flow cyto;Baseline; n=38,40,42,39,40,37 | 0 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3 treg flow cyto; Week 4; n=37,38,37,37,30,30 | 0 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3 treg flow cyto; Week8; n=33,36,33,38,29,26 | 0 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3treg flow cyto; postscreen; n=38,39,38,39,30,32 | 0 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; Baseline; n= 40,41,43,40,41,40 | 5 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; Week 4; n=37,38,38,38,30,32 | 3 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; Week 8; n=34,37,34,38,29,27 | 1 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; Week 12; n= 35,37,32,35,28,27 | 1 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; post-screen; n=38,39,38,39,30,32 | 5 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcyto;Baseline;n= 38,40,42,39,40,37 | 0 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcyto;Week4;n=37,38,37,37,30,30 | 0 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcyto;Week8;n=33,36,33,38,29,26 | 0 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcyto;Week12;n=34,37,32,34,27,25 | 0 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcytopostscreen;n=38,39,38,39,30,32 | 0 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; Baseline;n=40,41,43,40,41,40 | 4 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; Week 4; n=37,38,38,38,30,32 | 3 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; Week 8; n=34,37,34,38,29,27 | 6 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; Week 12; n= 35,37,32,35,28,27 | 7 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; post-screen;n=38,39,38,39,30,32 | 9 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow cyto;Baseline;n=38,40,42,39,40,37 | 0 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow cyto;Week4;n=37,38,37,37, 30,30 | 0 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow cyto;Week8;n=33,36,33,38,29,26 | 0 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow cyto;Week12;n=34,37,32,34,27,25 | 0 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow;postscreen;n=38,39,38,39,30,32 | 0 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;Baseline;n=40,41,43,40,41,40 | 1 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;Week4;n=37,38,38,38,30,32 | 1 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;Week8;n=34,37,34,38,29,27 | 0 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;Week12;n=35,37,32,35,28,27 | 0 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;postscreen;n=38,39,38,39,30,32 | 1 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;Baseline;n=38,40,42,39,40,37 | 0 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;Week 4;n=37,38,37,37,30,30 | 4 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;Week8;n=33,36,33,38,29,26 | 2 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;Week12;n=34,37,32,34,27,25 | 5 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;postscreen;n=38,39,38,39,30,32 | 9 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;Base;n=38,40,42,39,40,37 | 0 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;Week4;n=37,38,37,37,30,30 | 6 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;Week8;n=33,36,33,37,29,26 | 6 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;Week12;34,37,32,34,27,25 | 8 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;post;n=38,39,38,39,30,32 | 16 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;Baseline; n=40,41,43,40,41,40 | 0 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;Week4; n=37,38,38,38,30,32 | 2 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;Week8;n=34,37,34,38,29,27 | 0 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;Week12;n=35,37,32,35,28,27 | 3 Participants |
| Vehicle BID | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;postscreen;n=38,39,38,39,30,32 | 5 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; Baseline; n=40,41,43,41,41,40 | 3 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;Base;n=38,40,42,39,40,37 | 0 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow;postscreen;n=38,39,38,39,30,32 | 0 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow cyto;Week12;n=34,37,32,34,27,25 | 0 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow cyto;Week8;n=33,36,33,38,29,26 | 0 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow cyto;Week4;n=37,38,37,37, 30,30 | 0 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; post-screen; n= 38,39,38,39,30,32 | 4 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;Week4;n=37,38,37,37,30,30 | 7 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+tregflow cyto;Baseline;n=38,40,42,39,40,37 | 0 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; post-screen;n=38,39,38,39,30,32 | 7 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; Week 12; n= 35,37,32,35,28,27 | 4 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; Week 8; n=34,37,34,38,29,27 | 3 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;postscreen;n=38,39,38,39,30,32 | 0 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;Week8;n=33,36,33,37,29,26 | 9 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; Week 4; n=37,38,38,38,30,32 | 1 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+; Baseline;n=40,41,43,40,41,40 | 2 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcytopostscreen;n=38,39,38,39,30,32 | 0 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;Week12;n=35,37,32,35,28,27 | 0 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;Week12;34,37,32,34,27,25 | 6 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcyto;Week12;n=34,37,32,34,27,25 | 0 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcyto;Week8;n=33,36,33,38,29,26 | 0 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcyto;Week4;n=37,38,37,37,30,30 | 0 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+tregflowcyto;Baseline;n= 38,40,42,39,40,37 | 0 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; Week 12; n= 35,37,32,35,28,27 | 1 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+foxP3+CD25+CD127;post;n=38,39,38,39,30,32 | 13 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; post-screen; n=38,39,38,39,30,32 | 6 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; Week 12; n= 35,37,32,35,28,27 | 4 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; Week 8; n=34,37,34,38,29,27 | 3 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; Week 4; n=37,38,38,38,30,32 | 3 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD8+; Baseline; n= 40,41,43,40,41,40 | 4 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; Week 8; n= 34,37,34,38,29,27 | 2 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;Baseline; n=40,41,43,40,41,40 | 1 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3treg flow cyto; postscreen; n=38,39,38,39,30,32 | 0 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3 treg flow cyto; Week 12; n= 34,37,32,34,27,25 | 0 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3 treg flow cyto; Week8; n=33,36,33,38,29,26 | 0 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3 treg flow cyto; Week 4; n=37,38,37,37,30,30 | 0 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; Week 4; n= 37,38,38,38,30,32 | 2 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;Week4; n=37,38,38,38,30,32 | 0 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3 treg flow cyto;Baseline; n=38,40,42,39,40,37 | 0 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; post-screen; n=38,39,38,39,30,32 | 7 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; Week 12; n=35,37,32,35,28,27 | 2 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD19; Baseline; n=40,41,43,40,41,40 | 2 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | T-B cell NK lympho;Week8;n=34,37,34,38,29,27 | 0 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; Week 8; n=34,37,34,38,29,27 | 4 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;Week12;n=34,37,32,34,27,25 | 5 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;Week8;n=33,36,33,38,29,26 | 4 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;postscreen;n=38,39,38,39,30,32 | 1 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;Week8;n=34,37,34,38,29,27 | 1 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;Week 4;n=37,38,37,37,30,30 | 1 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3; Week 4; n=37,38,38,38,30,32 | 1 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;postscreen;n=38,39,38,39,30,32 | 7 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD3+CD4+CD25+CD127;Baseline;n=38,40,42,39,40,37 | 0 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;Week12;n=35,37,32,35,28,27 | 0 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;Week4;n=37,38,38,38,30,32 | 1 Participants |
| Vehicle QD | Number of Participants With Immunopheotyping Data Outside the Reference Range | CD16+CD56+;Baseline;n=40,41,43,40,41,40 | 0 Participants |
Secondary
Number of Participants With Reported Tolerability Score of 0 to 4 Over Time
Participants were asked to use a 5-point tolerability scale from 0 (none) to 4 (severe) to assess the presence and degree of burning/stinging and itching at the application sites that has generally been experienced following application of the study treatment. The score represented an 'average' across all application sites. A score of 3 or 4 was reported as an AE. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Week 1, 2, 4, 8, 12, 14, EW (up to Week 14)
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; severe; n= 36, 37, 34, 38, 29, 28 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; slight; n= 36, 37, 34, 38, 29, 28 | 6 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; severe; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; none; n= 3,4,7,3,11,11 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; mild; n= 34,35,32,33,31,29 | 3 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; none; n= 34,35,32,33,31,29 | 26 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; slight; n= 3,4,7,3,11,11 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; severe; n= 3,4,7,3,11,11 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; moderate; n= 3,4,7,3,11,11 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; slight; n= 34,35,32,33,31,29 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; mild; n= 3,4,7,3,11,11 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; slight; n= 38,40,39,37,38,33 | 6 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; moderate; n= 39,37,39,39,33,32 | 4 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; slight; n= 36, 37, 32, 35, 28, 28 | 6 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; mild; n= 39,37,39,39,33,32 | 3 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; none; n= 39,37,39,39,33,32 | 26 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; mild; n= 36, 37, 34, 38, 29, 28 | 3 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; slight;n= 39,37,39,39,33,32 | 5 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; moderate; n= 36, 37, 34, 38, 29, 28 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; severe; n= 39,37,39,39,33,32 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; mild; n= 36, 37, 32, 35, 28, 28 | 5 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; severe; n= 38,40,39,37,38,33 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; none; n= 36, 37, 32, 35, 28, 28 | 24 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; Moderate; n= 38,40,39,37,38,33 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; moderate; n= 36, 37, 32, 35, 28, 28 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; mild; n= 38,40,39,37,38,33 | 9 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; none; n= 38, 39, 38,39,29,32 | 26 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; slight; n= 38, 39, 38,39,29,32 | 7 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; none; n= 38,40,39,37,38,33 | 19 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; mild; n= 38, 39, 38,39,29,32 | 3 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; moderate; n= 38, 39, 38,39,29,32 | 2 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; severe; n= 34,35,32,33,31,29 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; severe; n= 38, 39, 38,39,29,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; moderate; n= 34,35,32,33,31,29 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; none; n= 36, 37, 34, 38, 29, 28 | 25 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; moderate; n= 34,35,32,33,31,29 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; slight; n= 36, 37, 34, 38, 29, 28 | 6 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; slight;n= 39,37,39,39,33,32 | 5 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; mild; n= 36, 37, 34, 38, 29, 28 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; severe; n= 39,37,39,39,33,32 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; severe; n= 36, 37, 32, 35, 28, 28 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; none; n= 3,4,7,3,11,11 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; moderate; n= 36, 37, 34, 38, 29, 28 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; none; n= 39,37,39,39,33,32 | 27 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; severe; n= 36, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; moderate; n= 38, 39, 38,39,29,32 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; none; n= 36, 37, 32, 35, 28, 28 | 27 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; Moderate; n= 38,40,39,37,38,33 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; slight; n= 36, 37, 32, 35, 28, 28 | 8 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; moderate; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; mild; n= 36, 37, 32, 35, 28, 28 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; mild; n= 38,40,39,37,38,33 | 3 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; none; n= 36, 37, 34, 38, 29, 28 | 28 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; slight; n= 38,40,39,37,38,33 | 10 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; severe; n= 3,4,7,3,11,11 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; severe; n= 34,35,32,33,31,29 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; mild; n= 34,35,32,33,31,29 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; none; n= 38, 39, 38,39,29,32 | 26 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; none; n= 34,35,32,33,31,29 | 29 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; severe; n= 38,40,39,37,38,33 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; severe; n= 38, 39, 38,39,29,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; slight; n= 38, 39, 38,39,29,32 | 8 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; slight; n= 34,35,32,33,31,29 | 5 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; mild; n= 3,4,7,3,11,11 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; slight; n= 3,4,7,3,11,11 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; moderate; n= 39,37,39,39,33,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; moderate; n= 3,4,7,3,11,11 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; none; n= 38,40,39,37,38,33 | 25 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; mild; n= 39,37,39,39,33,32 | 4 Participants |
| GSK2894512 1% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; mild; n= 38, 39, 38,39,29,32 | 4 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; slight; n= 38,40,39,37,38,33 | 5 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; mild; n= 34,35,32,33,31,29 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; slight; n= 36, 37, 34, 38, 29, 28 | 8 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; severe; n= 3,4,7,3,11,11 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; mild; n= 38, 39, 38,39,29,32 | 6 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; mild; n= 3,4,7,3,11,11 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; mild; n= 36, 37, 34, 38, 29, 28 | 2 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; none; n= 34,35,32,33,31,29 | 27 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; none; n= 36, 37, 34, 38, 29, 28 | 23 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; none; n= 39,37,39,39,33,32 | 33 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; slight; n= 3,4,7,3,11,11 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; severe; n= 38, 39, 38,39,29,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; severe; n= 34,35,32,33,31,29 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; mild; n= 39,37,39,39,33,32 | 4 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; severe; n= 38,40,39,37,38,33 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; none; n= 38, 39, 38,39,29,32 | 27 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; none; n= 3,4,7,3,11,11 | 4 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; moderate; n= 36, 37, 34, 38, 29, 28 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; Moderate; n= 38,40,39,37,38,33 | 6 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; moderate; n= 38, 39, 38,39,29,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; slight; n= 38, 39, 38,39,29,32 | 5 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; none; n= 36, 37, 32, 35, 28, 28 | 26 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; severe; n= 39,37,39,39,33,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; severe; n= 36, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; severe; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; none; n= 38,40,39,37,38,33 | 25 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; slight; n= 36, 37, 32, 35, 28, 28 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; slight;n= 39,37,39,39,33,32 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; moderate; n= 3,4,7,3,11,11 | 2 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; mild; n= 36, 37, 32, 35, 28, 28 | 3 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; mild; n= 38,40,39,37,38,33 | 2 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; moderate; n= 39,37,39,39,33,32 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; slight; n= 34,35,32,33,31,29 | 4 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; moderate; n= 34,35,32,33,31,29 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; moderate; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; severe; n= 38,40,39,37,38,33 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; mild; n= 36, 37, 32, 35, 28, 28 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; moderate; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; slight; n= 34,35,32,33,31,29 | 5 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; mild; n= 3,4,7,3,11,11 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; mild; n= 38,40,39,37,38,33 | 8 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; mild; n= 36, 37, 34, 38, 29, 28 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; moderate; n= 36, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; severe; n= 36, 37, 34, 38, 29, 28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; none; n= 36, 37, 32, 35, 28, 28 | 27 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; slight; n= 36, 37, 32, 35, 28, 28 | 6 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; severe; n= 39,37,39,39,33,32 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; none; n= 38, 39, 38,39,29,32 | 27 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; slight; n= 38, 39, 38,39,29,32 | 9 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; mild; n= 38, 39, 38,39,29,32 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; moderate; n= 38, 39, 38,39,29,32 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; severe; n= 38, 39, 38,39,29,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; none; n= 36, 37, 34, 38, 29, 28 | 29 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; severe; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; none; n= 3,4,7,3,11,11 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; none; n= 34,35,32,33,31,29 | 26 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; slight; n= 3,4,7,3,11,11 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; moderate; n= 3,4,7,3,11,11 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; severe; n= 3,4,7,3,11,11 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; mild; n= 34,35,32,33,31,29 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; moderate; n= 34,35,32,33,31,29 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; severe; n= 34,35,32,33,31,29 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; none; n= 38,40,39,37,38,33 | 21 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; slight; n= 38,40,39,37,38,33 | 6 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; Moderate; n= 38,40,39,37,38,33 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; slight; n= 36, 37, 34, 38, 29, 28 | 7 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; none; n= 39,37,39,39,33,32 | 20 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; slight;n= 39,37,39,39,33,32 | 11 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; mild; n= 39,37,39,39,33,32 | 4 Participants |
| GSK2894512 0.5% QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; moderate; n= 39,37,39,39,33,32 | 3 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; moderate; n= 3,4,7,3,11,11 | 1 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; none; n= 36, 37, 32, 35, 28, 28 | 16 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; severe; n= 34,35,32,33,31,29 | 1 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; slight; n= 36, 37, 34, 38, 29, 28 | 5 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; Moderate; n= 38,40,39,37,38,33 | 7 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; slight; n= 36, 37, 32, 35, 28, 28 | 8 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; severe; n= 36, 37, 34, 38, 29, 28 | 1 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; mild; n= 38, 39, 38,39,29,32 | 4 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; moderate; n= 39,37,39,39,33,32 | 2 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; severe; n= 38, 39, 38,39,29,32 | 0 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; moderate; n= 36, 37, 34, 38, 29, 28 | 1 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; slight; n= 38, 39, 38,39,29,32 | 8 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; none; n= 36, 37, 34, 38, 29, 28 | 19 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; none; n= 39,37,39,39,33,32 | 16 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; mild; n= 36, 37, 34, 38, 29, 28 | 3 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; none; n= 38, 39, 38,39,29,32 | 15 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; mild; n= 39,37,39,39,33,32 | 8 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; none; n= 38,40,39,37,38,33 | 15 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; slight;n= 39,37,39,39,33,32 | 6 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; moderate; n= 34,35,32,33,31,29 | 2 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; severe; n= 38,40,39,37,38,33 | 1 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; mild; n= 34,35,32,33,31,29 | 2 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; slight; n= 3,4,7,3,11,11 | 4 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; severe; n= 39,37,39,39,33,32 | 1 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; none; n= 3,4,7,3,11,11 | 3 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; mild; n= 3,4,7,3,11,11 | 0 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; moderate; n= 38, 39, 38,39,29,32 | 2 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; severe; n= 3,4,7,3,11,11 | 3 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; mild; n= 38,40,39,37,38,33 | 6 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; slight; n= 34,35,32,33,31,29 | 4 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; moderate; n= 36, 37, 32, 35, 28, 28 | 1 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; none; n= 34,35,32,33,31,29 | 22 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; slight; n= 38,40,39,37,38,33 | 9 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; mild; n= 36, 37, 32, 35, 28, 28 | 3 Participants |
| Vehicle BID | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; severe; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; none; n= 36, 37, 32, 35, 28, 28 | 23 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; none; n= 36, 37, 34, 38, 29, 28 | 17 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; severe; n= 3,4,7,3,11,11 | 1 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; mild; n= 34,35,32,33,31,29 | 2 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; severe; n= 38, 39, 38,39,29,32 | 1 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; moderate; n= 38, 39, 38,39,29,32 | 3 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; mild; n= 39,37,39,39,33,32 | 5 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; moderate; n= 34,35,32,33,31,29 | 1 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; mild; n= 38, 39, 38,39,29,32 | 5 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; severe; n= 34,35,32,33,31,29 | 0 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; slight; n= 38, 39, 38,39,29,32 | 2 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 4; none; n= 38, 39, 38,39,29,32 | 21 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; slight; n= 3,4,7,3,11,11 | 0 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; none; n= 38,40,39,37,38,33 | 22 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; severe; n= 39,37,39,39,33,32 | 2 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; moderate; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; slight; n= 38,40,39,37,38,33 | 5 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; mild; n= 36, 37, 32, 35, 28, 28 | 0 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; severe; n= 36, 37, 34, 38, 29, 28 | 0 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; Moderate; n= 38,40,39,37,38,33 | 2 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; moderate; n= 36, 37, 34, 38, 29, 28 | 3 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; severe; n= 38,40,39,37,38,33 | 1 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; mild; n= 36, 37, 34, 38, 29, 28 | 3 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; moderate; n= 39,37,39,39,33,32 | 2 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 8; slight; n= 36, 37, 34, 38, 29, 28 | 5 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; none; n= 39,37,39,39,33,32 | 18 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; slight; n= 36, 37, 32, 35, 28, 28 | 3 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 2; slight;n= 39,37,39,39,33,32 | 5 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 1; mild; n= 38,40,39,37,38,33 | 3 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; none; n= 3,4,7,3,11,11 | 7 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; mild; n= 3,4,7,3,11,11 | 1 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; none; n= 34,35,32,33,31,29 | 22 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | EW; moderate; n= 3,4,7,3,11,11 | 2 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 14; slight; n= 34,35,32,33,31,29 | 4 Participants |
| Vehicle QD | Number of Participants With Reported Tolerability Score of 0 to 4 Over Time | Week 12; severe; n= 36, 37, 32, 35, 28, 28 | 2 Participants |
Secondary
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth effect, other situations and is associated with liver injury or impaired liver function. Treatment emergent AEs (TEAE) is defined as AE occurred on or after study treatment start date and on or before last visit. Number of participants with AEs and serious TEAEs were presented. The analysis was performed on Safety population which comprised of all participants who receive at least one dose of study treatment.
Time frame: Weeks 1, 2, 4, 8, 12, 14, EW (up to week 14)
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2894512 1% BID | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | TEAEs | 28 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 | 22 Participants |
| GSK2894512 1% QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | Serious TEAEs | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | TEAEs | 20 Participants |
| GSK2894512 0.5% BID | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | Serious TEAEs | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | TEAEs | 23 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 | Serious TEAEs | 0 Participants |
| Vehicle BID | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | TEAEs | 19 Participants |
| Vehicle QD | 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 | 15 Participants |
Secondary
Number of Participants With Vital Signs of Potential Clinical Importance
Blood samples were collected from participants for evaluation of vital signs by Potential Clinical Importance Criteria from Baseline to Week 14, EW and any visit post-screen. The vital signs included SBP, DBP and pulse rate. 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 the category titles).
Time frame: Baseline, Week 2, 4, 8, 12, 14, EW (up to week 14)
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP: Week 14; n= 34,35,32,34,31,29 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 2; n= 39,39,39,39,33,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; EW; n= 3,4,7,3,11,11 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 8; n= 36,37,34,38,29,28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 12; n= 36,37,32,35,28,28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; EW; n= 3,4,7,3,11,11 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 8; n= 36,37,34,38,29,28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 4; n= 38,39,38,39,30,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 12; n= 36,37,32,35,28,28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 14; n= 34,35,32,34,31,29 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 8; n= 36,37,34,38,29,28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate;Week 2; n= 39,39,39,39,33,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 12; n= 36,37,32,35,28,28 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 4; n=38,39,38,39,30,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 2; n=39,39,39,39,33,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 1; n=38,41,39,37,38,33 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 4; n= 38,39,38,39,30,32 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; post-screen; n= 40,41,43,41,42,40 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 14; n= 34,35,32,34,31,29 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; post-screen; n=40,41,43,41,42,40 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 1; n= 38,41,39,37,38,33 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 1; n= 38,41,39,37,38,33 | 0 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; post-screen; n= 40,41,43,41,42,40 | 1 Participants |
| GSK2894512 1% BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; EW; n= 3,4,7,3,11,11 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate;Week 2; n= 39,39,39,39,33,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 8; n= 36,37,34,38,29,28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 1; n= 38,41,39,37,38,33 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 4; n= 38,39,38,39,30,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 1; n= 38,41,39,37,38,33 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 2; n= 39,39,39,39,33,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 4; n= 38,39,38,39,30,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; EW; n= 3,4,7,3,11,11 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 8; n= 36,37,34,38,29,28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 12; n= 36,37,32,35,28,28 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP: Week 14; n= 34,35,32,34,31,29 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 8; n= 36,37,34,38,29,28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; EW; n= 3,4,7,3,11,11 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 14; n= 34,35,32,34,31,29 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; post-screen; n= 40,41,43,41,42,40 | 2 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 1; n=38,41,39,37,38,33 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 2; n=39,39,39,39,33,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; post-screen; n=40,41,43,41,42,40 | 1 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 4; n=38,39,38,39,30,32 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 12; n= 36,37,32,35,28,28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 12; n= 36,37,32,35,28,28 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 14; n= 34,35,32,34,31,29 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; EW; n= 3,4,7,3,11,11 | 0 Participants |
| GSK2894512 1% QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; post-screen; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 1; n= 38,41,39,37,38,33 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 12; n= 36,37,32,35,28,28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 4; n= 38,39,38,39,30,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; EW; n= 3,4,7,3,11,11 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 4; n=38,39,38,39,30,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 14; n= 34,35,32,34,31,29 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate;Week 2; n= 39,39,39,39,33,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 8; n= 36,37,34,38,29,28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; post-screen; n= 40,41,43,41,42,40 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 4; n= 38,39,38,39,30,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 1; n=38,41,39,37,38,33 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 8; n= 36,37,34,38,29,28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; EW; n= 3,4,7,3,11,11 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 14; n= 34,35,32,34,31,29 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 8; n= 36,37,34,38,29,28 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 1; n= 38,41,39,37,38,33 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; post-screen; n=40,41,43,41,42,40 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Baseline; n= 40,41,43,41,42,40 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; EW; n= 3,4,7,3,11,11 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; post-screen; n= 40,41,43,41,42,40 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 12; n= 36,37,32,35,28,28 | 1 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 2; n=39,39,39,39,33,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 2; n= 39,39,39,39,33,32 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP: Week 14; n= 34,35,32,34,31,29 | 0 Participants |
| GSK2894512 0.5% BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 12; n= 36,37,32,35,28,28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; EW; n= 3,4,7,3,11,11 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP: Week 14; n= 34,35,32,34,31,29 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 1; n= 38,41,39,37,38,33 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 1; n= 38,41,39,37,38,33 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; EW; n= 3,4,7,3,11,11 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; post-screen; n= 40,41,43,41,42,40 | 3 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 8; n= 36,37,34,38,29,28 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 4; n= 38,39,38,39,30,32 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; EW; n= 3,4,7,3,11,11 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 1; n=38,41,39,37,38,33 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; post-screen; n=40,41,43,41,42,40 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 12; n= 36,37,32,35,28,28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 12; n= 36,37,32,35,28,28 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 2; n=39,39,39,39,33,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 8; n= 36,37,34,38,29,28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate;Week 2; n= 39,39,39,39,33,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 4; n=38,39,38,39,30,32 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 4; n= 38,39,38,39,30,32 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; post-screen; n= 40,41,43,41,42,40 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 8; n= 36,37,34,38,29,28 | 0 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 2; n= 39,39,39,39,33,32 | 2 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 14; n= 34,35,32,34,31,29 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 12; n= 36,37,32,35,28,28 | 1 Participants |
| GSK2894512 0.5% QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 14; n= 34,35,32,34,31,29 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 2; n=39,39,39,39,33,32 | 1 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 8; n= 36,37,34,38,29,28 | 1 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 1; n= 38,41,39,37,38,33 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 2; n= 39,39,39,39,33,32 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 4; n= 38,39,38,39,30,32 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 8; n= 36,37,34,38,29,28 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 12; n= 36,37,32,35,28,28 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP: Week 14; n= 34,35,32,34,31,29 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; EW; n= 3,4,7,3,11,11 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 1; n=38,41,39,37,38,33 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; post-screen; n= 40,41,43,41,42,40 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 4; n=38,39,38,39,30,32 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 12; n= 36,37,32,35,28,28 | 1 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 14; n= 34,35,32,34,31,29 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; EW; n= 3,4,7,3,11,11 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; post-screen; n= 40,41,43,41,42,40 | 1 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 1; n= 38,41,39,37,38,33 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate;Week 2; n= 39,39,39,39,33,32 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 4; n= 38,39,38,39,30,32 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 8; n= 36,37,34,38,29,28 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 12; n= 36,37,32,35,28,28 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 14; n= 34,35,32,34,31,29 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; EW; n= 3,4,7,3,11,11 | 0 Participants |
| Vehicle BID | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; post-screen; n=40,41,43,41,42,40 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; EW; n= 3,4,7,3,11,11 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 8; n= 36,37,34,38,29,28 | 1 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 8; n= 36,37,34,38,29,28 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 14; n= 34,35,32,34,31,29 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 12; n= 36,37,32,35,28,28 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 2; n=39,39,39,39,33,32 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 1; n=38,41,39,37,38,33 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Week 4; n=38,39,38,39,30,32 | 1 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 12; n= 36,37,32,35,28,28 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; EW; n= 3,4,7,3,11,11 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP: Week 14; n= 34,35,32,34,31,29 | 1 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 12; n= 36,37,32,35,28,28 | 1 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; post-screen; n= 40,41,43,41,42,40 | 3 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 14; n= 34,35,32,34,31,29 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 8; n= 36,37,34,38,29,28 | 2 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 4; n= 38,39,38,39,30,32 | 1 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 2; n= 39,39,39,39,33,32 | 1 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Week 1; n= 38,41,39,37,38,33 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; post-screen; n=40,41,43,41,42,40 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; EW; n= 3,4,7,3,11,11 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate;Week 2; n= 39,39,39,39,33,32 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | SBP; Baseline; n= 40,41,43,41,42,40 | 1 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 4; n= 38,39,38,39,30,32 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Week 1; n= 38,41,39,37,38,33 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | Pulse rate; Baseline; n= 40,41,43,41,42,40 | 0 Participants |
| Vehicle QD | Number of Participants With Vital Signs of Potential Clinical Importance | DBP; post-screen; n= 40,41,43,41,42,40 | 2 Participants |
Secondary
Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit
NRS is a 11-point tool ranging from 0 (absent) to 10 (worst imaginable) to assess the severity of 11 disease-related signs and symptoms including itching, discoloration, bleeding, oozing, cracking, scaling, flaking, dry/rough, painful, burning, and stinging. Participants were asked to complete the self-administered sign and symptom severity diary containing NRS using a recall period of the past 24 hours. Question 1 of the diary was used to assess itch. Percentage of participants who achieved a minimum 3-point improvement in itch/pruritus (NRS) from Baseline to each study visit were measured. Baseline was defined as the latest assessment prior to first dose. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles).
Time frame: Week 1, 2, 4, 8, 12, 14, 16, early withdrawal (EW) (up to Week 16)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2894512 1% BID | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 12; n= 22,25,23,23,14,16 | 55 Percentage of Participants |
| GSK2894512 1% BID | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 4; n= 31,31,29,31,20,25 | 42 Percentage of Participants |
| GSK2894512 1% BID | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 1; n= 29,35,33,31,24,25 | 24 Percentage of Participants |
| GSK2894512 1% BID | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 8; n= 26,26,29,30,21,23 | 46 Percentage of Participants |
| GSK2894512 1% BID | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 14; n= 21,20,19,20,17,14 | 38 Percentage of Participants |
| GSK2894512 1% BID | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 16; n= 15,14,22,17,12,13 | 33 Percentage of Participants |
| GSK2894512 1% BID | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 2; n= 28,30,36,30,26,23 | 36 Percentage of Participants |
| GSK2894512 1% QD | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 14; n= 21,20,19,20,17,14 | 40 Percentage of Participants |
| GSK2894512 1% QD | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 16; n= 15,14,22,17,12,13 | 21 Percentage of Participants |
| GSK2894512 1% QD | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 2; n= 28,30,36,30,26,23 | 33 Percentage of Participants |
| GSK2894512 1% QD | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 4; n= 31,31,29,31,20,25 | 48 Percentage of Participants |
| GSK2894512 1% QD | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | EW; n= 0,3,2,2,5,6 | 0 Percentage of Participants |
| GSK2894512 1% QD | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 8; n= 26,26,29,30,21,23 | 50 Percentage of Participants |
| GSK2894512 1% QD | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 12; n= 22,25,23,23,14,16 | 52 Percentage of Participants |
| GSK2894512 1% QD | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 1; n= 29,35,33,31,24,25 | 9 Percentage of Participants |
| GSK2894512 0.5% BID | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 8; n= 26,26,29,30,21,23 | 48 Percentage of Participants |
| GSK2894512 0.5% BID | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 1; n= 29,35,33,31,24,25 | 9 Percentage of Participants |
| GSK2894512 0.5% BID | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 16; n= 15,14,22,17,12,13 | 41 Percentage of Participants |
| GSK2894512 0.5% BID | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 14; n= 21,20,19,20,17,14 | 58 Percentage of Participants |
| GSK2894512 0.5% BID | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | EW; n= 0,3,2,2,5,6 | 50 Percentage of Participants |
| GSK2894512 0.5% BID | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 2; n= 28,30,36,30,26,23 | 22 Percentage of Participants |
| GSK2894512 0.5% BID | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 12; n= 22,25,23,23,14,16 | 61 Percentage of Participants |
| GSK2894512 0.5% BID | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 4; n= 31,31,29,31,20,25 | 45 Percentage of Participants |
| GSK2894512 0.5% QD | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 16; n= 15,14,22,17,12,13 | 47 Percentage of Participants |
| GSK2894512 0.5% QD | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 12; n= 22,25,23,23,14,16 | 52 Percentage of Participants |
| GSK2894512 0.5% QD | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | EW; n= 0,3,2,2,5,6 | 50 Percentage of Participants |
| GSK2894512 0.5% QD | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 8; n= 26,26,29,30,21,23 | 57 Percentage of Participants |
| GSK2894512 0.5% QD | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 1; n= 29,35,33,31,24,25 | 16 Percentage of Participants |
| GSK2894512 0.5% QD | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 4; n= 31,31,29,31,20,25 | 52 Percentage of Participants |
| GSK2894512 0.5% QD | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 14; n= 21,20,19,20,17,14 | 50 Percentage of Participants |
| GSK2894512 0.5% QD | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 2; n= 28,30,36,30,26,23 | 33 Percentage of Participants |
| Vehicle BID | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 2; n= 28,30,36,30,26,23 | 12 Percentage of Participants |
| Vehicle BID | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 1; n= 29,35,33,31,24,25 | 8 Percentage of Participants |
| Vehicle BID | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 4; n= 31,31,29,31,20,25 | 35 Percentage of Participants |
| Vehicle BID | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 8; n= 26,26,29,30,21,23 | 29 Percentage of Participants |
| Vehicle BID | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 12; n= 22,25,23,23,14,16 | 14 Percentage of Participants |
| Vehicle BID | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 14; n= 21,20,19,20,17,14 | 29 Percentage of Participants |
| Vehicle BID | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 16; n= 15,14,22,17,12,13 | 17 Percentage of Participants |
| Vehicle BID | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | EW; n= 0,3,2,2,5,6 | 0 Percentage of Participants |
| Vehicle QD | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 8; n= 26,26,29,30,21,23 | 30 Percentage of Participants |
| Vehicle QD | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | EW; n= 0,3,2,2,5,6 | 17 Percentage of Participants |
| Vehicle QD | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 16; n= 15,14,22,17,12,13 | 23 Percentage of Participants |
| Vehicle QD | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 4; n= 31,31,29,31,20,25 | 28 Percentage of Participants |
| Vehicle QD | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 2; n= 28,30,36,30,26,23 | 22 Percentage of Participants |
| Vehicle QD | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 1; n= 29,35,33,31,24,25 | 12 Percentage of Participants |
| Vehicle QD | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 14; n= 21,20,19,20,17,14 | 50 Percentage of Participants |
| Vehicle QD | Percentage of Participants Who Achieve a Minimum 3- Point Improvement in Itch/Pruritus (NRS) From Baseline to Each Study Visit | Week 12; n= 22,25,23,23,14,16 | 38 Percentage of Participants |
Secondary
Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit
The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. The percentage of participants who have an IGA score of clear or almost clear and a minimum 2 grade improvement from Baseline to each study visit in IGA score was presented. The statistical analysis was performed using a repeated measures factorial logistic regression model with covariates for dose, frequency of administration, and study day as well as a dose by frequency interaction term. The analysis was performed on ITT Population which comprised of all randomized participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category title).
Time frame: Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to week 16)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2894512 1% BID | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 12; n= 36,37,32,35,28,25 | 58 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 4; n= 38,39,38,39,30,32 | 32 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 14; n= 34,35,31,33,27,25 | 44 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 1; n= 38,41,39,37,38,32 | 5 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 8; n= 36,37,34,38,29,27 | 42 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | EW; n= 3,4,7,3,11,11 | 33 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 16; n= 34,36,31,35,27,25 | 35 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 2; n= 39,39,39,39,33,32 | 18 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 12; n= 36,37,32,35,28,25 | 51 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | EW; n= 3,4,7,3,11,11 | 0 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 4; n= 38,39,38,39,30,32 | 38 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 16; n= 34,36,31,35,27,25 | 36 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 8; n= 36,37,34,38,29,27 | 54 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 1; n= 38,41,39,37,38,32 | 5 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 14; n= 34,35,31,33,27,25 | 43 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 2; n= 39,39,39,39,33,32 | 18 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 1; n= 38,41,39,37,38,32 | 0 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 12; n= 36,37,32,35,28,25 | 50 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 2; n= 39,39,39,39,33,32 | 10 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 8; n= 36,37,34,38,29,27 | 38 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 4; n= 38,39,38,39,30,32 | 26 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | EW; n= 3,4,7,3,11,11 | 14 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 14; n= 34,35,31,33,27,25 | 52 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 16; n= 34,36,31,35,27,25 | 39 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 16; n= 34,36,31,35,27,25 | 40 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | EW; n= 3,4,7,3,11,11 | 33 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 1; n= 38,41,39,37,38,32 | 3 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 2; n= 39,39,39,39,33,32 | 13 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 4; n= 38,39,38,39,30,32 | 23 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 8; n= 36,37,34,38,29,27 | 42 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 12; n= 36,37,32,35,28,25 | 40 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 14; n= 34,35,31,33,27,25 | 36 Percentage of participants |
| Vehicle BID | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 8; n= 36,37,34,38,29,27 | 28 Percentage of participants |
| Vehicle BID | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 4; n= 38,39,38,39,30,32 | 20 Percentage of participants |
| Vehicle BID | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 16; n= 34,36,31,35,27,25 | 30 Percentage of participants |
| Vehicle BID | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 14; n= 34,35,31,33,27,25 | 26 Percentage of participants |
| Vehicle BID | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 2; n= 39,39,39,39,33,32 | 15 Percentage of participants |
| Vehicle BID | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 1; n= 38,41,39,37,38,32 | 3 Percentage of participants |
| Vehicle BID | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | EW; n= 3,4,7,3,11,11 | 0 Percentage of participants |
| Vehicle BID | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 12; n= 36,37,32,35,28,25 | 36 Percentage of participants |
| Vehicle QD | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | EW; n= 3,4,7,3,11,11 | 9 Percentage of participants |
| Vehicle QD | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 1; n= 38,41,39,37,38,32 | 3 Percentage of participants |
| Vehicle QD | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 2; n= 39,39,39,39,33,32 | 9 Percentage of participants |
| Vehicle QD | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 4; n= 38,39,38,39,30,32 | 9 Percentage of participants |
| Vehicle QD | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 8; n= 36,37,34,38,29,27 | 19 Percentage of participants |
| Vehicle QD | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 12; n= 36,37,32,35,28,25 | 44 Percentage of participants |
| Vehicle QD | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 14; n= 34,35,31,33,27,25 | 36 Percentage of participants |
| Vehicle QD | Percentage of Participants Who Have an IGA Score of Clear or Almost Clear (0 or 1) and a Minimum 2 Grade Improvement in IGA Score From Baseline to Each Study Visit | Week 16; n= 34,36,31,35,27,25 | 28 Percentage of participants |
95% CI: [-45.8, 32.5]
95% CI: [-25.7, 52.6]
95% CI: [-46, 32.6]
95% CI: [-32.2, 48.8]
95% CI: [-60.8, 14.8]
95% CI: [-13.7, 63]
95% CI: [-67.4, 6.1]
95% CI: [-40.7, 40.7]
95% CI: [-53.8, 23.5]
95% CI: [2.7, 74.6]
95% CI: [-53.8, 23.5]
95% CI: [-35.6, 51.2]
95% CI: [-25.1, 57.1]
95% CI: [4.8, 78.7]
95% CI: [-51.3, 30.2]
95% CI: [-35.6, 51.2]
95% CI: [-35.4, 48.5]
95% CI: [-35.8, 47.1]
95% CI: [-54, 31.2]
95% CI: [-65.3, 22.4]
95% CI: [-44.5, 42.7]
95% CI: [-37.8, 47.3]
95% CI: [-47.9, 37.6]
95% CI: [-48.3, 41.5]
95% CI: [-44.5, 42.7]
95% CI: [-35, 49.2]
95% CI: [-46, 42.3]
Secondary
Percentage of Participants With >=50 Percent Improvement From Baseline in EASI
The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Percentage of participants with \>=50 percent improvement in EASI score from Baseline to Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW were presented and statistical analysis was performed using a repeated measures factorial logistic regression model. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2894512 1% BID | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 4; n= 38, 39, 38, 39, 30, 32 | 76 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 2; n= 39, 39, 39, 39, 33, 32 | 56 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 1; n= 38, 41, 39, 37, 38, 32 | 32 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 8; n= 36, 37, 34, 38, 29, 27 | 81 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 12; n= 36, 37, 32, 35, 28, 25 | 83 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 14; n= 34, 35, 31, 33, 27, 25 | 85 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 16; n= 34, 36, 31 35, 27, 25 | 76 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | EW; n= 3,4,7,3,11,11 | 33 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 8; n= 36, 37, 34, 38, 29, 27 | 92 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | EW; n= 3,4,7,3,11,11 | 0 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 1; n= 38, 41, 39, 37, 38, 32 | 39 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 16; n= 34, 36, 31 35, 27, 25 | 78 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 14; n= 34, 35, 31, 33, 27, 25 | 74 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 4; n= 38, 39, 38, 39, 30, 32 | 72 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 2; n= 39, 39, 39, 39, 33, 32 | 56 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 12; n= 36, 37, 32, 35, 28, 25 | 84 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 2; n= 39, 39, 39, 39, 33, 32 | 38 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 4; n= 38, 39, 38, 39, 30, 32 | 63 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 8; n= 36, 37, 34, 38, 29, 27 | 85 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | EW; n= 3,4,7,3,11,11 | 29 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 12; n= 36, 37, 32, 35, 28, 25 | 97 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 14; n= 34, 35, 31, 33, 27, 25 | 81 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 16; n= 34, 36, 31 35, 27, 25 | 84 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 1; n= 38, 41, 39, 37, 38, 32 | 13 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 16; n= 34, 36, 31 35, 27, 25 | 71 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 14; n= 34, 35, 31, 33, 27, 25 | 76 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 12; n= 36, 37, 32, 35, 28, 25 | 74 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 1; n= 38, 41, 39, 37, 38, 32 | 22 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 4; n= 38, 39, 38, 39, 30, 32 | 59 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 8; n= 36, 37, 34, 38, 29, 27 | 79 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | EW; n= 3,4,7,3,11,11 | 33 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 2; n= 39, 39, 39, 39, 33, 32 | 36 Percentage of participants |
| Vehicle BID | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | EW; n= 3,4,7,3,11,11 | 0 Percentage of participants |
| Vehicle BID | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 1; n= 38, 41, 39, 37, 38, 32 | 11 Percentage of participants |
| Vehicle BID | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 12; n= 36, 37, 32, 35, 28, 25 | 64 Percentage of participants |
| Vehicle BID | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 14; n= 34, 35, 31, 33, 27, 25 | 63 Percentage of participants |
| Vehicle BID | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 16; n= 34, 36, 31 35, 27, 25 | 67 Percentage of participants |
| Vehicle BID | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 2; n= 39, 39, 39, 39, 33, 32 | 33 Percentage of participants |
| Vehicle BID | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 4; n= 38, 39, 38, 39, 30, 32 | 37 Percentage of participants |
| Vehicle BID | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 8; n= 36, 37, 34, 38, 29, 27 | 59 Percentage of participants |
| Vehicle QD | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | EW; n= 3,4,7,3,11,11 | 9 Percentage of participants |
| Vehicle QD | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 12; n= 36, 37, 32, 35, 28, 25 | 84 Percentage of participants |
| Vehicle QD | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 4; n= 38, 39, 38, 39, 30, 32 | 41 Percentage of participants |
| Vehicle QD | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 8; n= 36, 37, 34, 38, 29, 27 | 56 Percentage of participants |
| Vehicle QD | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 14; n= 34, 35, 31, 33, 27, 25 | 68 Percentage of participants |
| Vehicle QD | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 2; n= 39, 39, 39, 39, 33, 32 | 19 Percentage of participants |
| Vehicle QD | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 16; n= 34, 36, 31 35, 27, 25 | 72 Percentage of participants |
| Vehicle QD | Percentage of Participants With >=50 Percent Improvement From Baseline in EASI | Week 1; n= 38, 41, 39, 37, 38, 32 | 13 Percentage of participants |
95% CI: [2.3, 48.4]
95% CI: [-5.3, 40.5]
95% CI: [-2.3, 44.7]
95% CI: [12.1, 57.6]
95% CI: [-2.7, 43.1]
95% CI: [3.3, 47.5]
95% CI: [-19.5, 24.5]
95% CI: [-14.5, 32]
95% CI: [-0.3, 44.6]
95% CI: [14.7, 57.6]
95% CI: [-18, 27.8]
95% CI: [-6.4, 39]
95% CI: [16, 60]
95% CI: [7.8, 52.1]
95% CI: [1.7, 49]
95% CI: [-1.5, 46.1]
95% CI: [-6, 42.3]
95% CI: [-25, 25]
95% CI: [6.9, 55]
95% CI: [-34.6, 16.1]
95% CI: [-3.1, 45.3]
95% CI: [-19.5, 31.5]
95% CI: [-8.4, 41.9]
95% CI: [-17.8, 33.1]
95% CI: [-15.5, 33.9]
95% CI: [-19.7, 30.5]
95% CI: [-9, 41.4]
95% CI: [-26, 25]
95% CI: [-31.9, 90.6]
95% CI: [-62.4, 47.8]
95% CI: [-19.2, 71]
95% CI: [-40.3, 80.9]
Secondary
Percentage of Participants With >=75 Percent Improvement From Baseline in EASI
The EASI scoring system is a standard clinical tool for assessing the severity of AD that takes into account the overall severity of erythema, infiltration/papulation, excoriation, and lichenification, as well as the extent of BSA affected with AD. These 4 clinical signs were graded on a 4-point scale for each of the 4 specified body regions (head and neck, upper extremities, lower extremities, and trunk). Percentage of participants with \>=75 percent improvement in EASI score from Baseline to Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW were presented and statistical analysis was performed using a repeated measures factorial logistic regression model. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2894512 1% BID | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 12; n= 36, 37, 32, 35, 28, 25 | 67 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 8; n= 36, 37, 34, 38, 29, 27 | 44 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 14; n= 34, 35, 31, 33, 27, 25 | 50 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | EW; n= 3,4,7,3,11,11 | 33 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 16; n= 34, 36, 31 35, 27, 25 | 47 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 4; n= 38, 39, 38, 39, 30, 32 | 37 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 2; n= 39, 39, 39, 39, 33, 32 | 21 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 1; n= 38, 41, 39, 37, 38, 32 | 5 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 2; n= 39, 39, 39, 39, 33, 32 | 33 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 4; n= 38, 39, 38, 39, 30, 32 | 51 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 8; n= 36, 37, 34, 38, 29, 27 | 57 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 12; n= 36, 37, 32, 35, 28, 25 | 57 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 14; n= 34, 35, 31, 33, 27, 25 | 49 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 16; n= 34, 36, 31 35, 27, 25 | 39 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | EW; n= 3,4,7,3,11,11 | 0 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 1; n= 38, 41, 39, 37, 38, 32 | 12 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 4; n= 38, 39, 38, 39, 30, 32 | 29 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 8; n= 36, 37, 34, 38, 29, 27 | 53 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 2; n= 39, 39, 39, 39, 33, 32 | 13 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 1; n= 38, 41, 39, 37, 38, 32 | 0 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 16; n= 34, 36, 31 35, 27, 25 | 61 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 12; n= 36, 37, 32, 35, 28, 25 | 69 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | EW; n= 3,4,7,3,11,11 | 14 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 14; n= 34, 35, 31, 33, 27, 25 | 68 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 8; n= 36, 37, 34, 38, 29, 27 | 37 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 16; n= 34, 36, 31 35, 27, 25 | 43 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 4; n= 38, 39, 38, 39, 30, 32 | 26 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 14; n= 34, 35, 31, 33, 27, 25 | 36 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 2; n= 39, 39, 39, 39, 33, 32 | 21 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | EW; n= 3,4,7,3,11,11 | 33 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 12; n= 36, 37, 32, 35, 28, 25 | 46 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 1; n= 38, 41, 39, 37, 38, 32 | 5 Percentage of participants |
| Vehicle BID | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 8; n= 36, 37, 34, 38, 29, 27 | 31 Percentage of participants |
| Vehicle BID | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 16; n= 34, 36, 31 35, 27, 25 | 44 Percentage of participants |
| Vehicle BID | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | EW; n= 3,4,7,3,11,11 | 0 Percentage of participants |
| Vehicle BID | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 12; n= 36, 37, 32, 35, 28, 25 | 39 Percentage of participants |
| Vehicle BID | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 14; n= 34, 35, 31, 33, 27, 25 | 41 Percentage of participants |
| Vehicle BID | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 1; n= 38, 41, 39, 37, 38, 32 | 0 Percentage of participants |
| Vehicle BID | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 2; n= 39, 39, 39, 39, 33, 32 | 9 Percentage of participants |
| Vehicle BID | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 4; n= 38, 39, 38, 39, 30, 32 | 20 Percentage of participants |
| Vehicle QD | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 1; n= 38, 41, 39, 37, 38, 32 | 6 Percentage of participants |
| Vehicle QD | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 8; n= 36, 37, 34, 38, 29, 27 | 26 Percentage of participants |
| Vehicle QD | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 4; n= 38, 39, 38, 39, 30, 32 | 9 Percentage of participants |
| Vehicle QD | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | EW; n= 3,4,7,3,11,11 | 9 Percentage of participants |
| Vehicle QD | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 16; n= 34, 36, 31 35, 27, 25 | 32 Percentage of participants |
| Vehicle QD | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 14; n= 34, 35, 31, 33, 27, 25 | 36 Percentage of participants |
| Vehicle QD | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 12; n= 36, 37, 32, 35, 28, 25 | 40 Percentage of participants |
| Vehicle QD | Percentage of Participants With >=75 Percent Improvement From Baseline in EASI | Week 2; n= 39, 39, 39, 39, 33, 32 | 3 Percentage of participants |
95% CI: [-18.3, 28.4]
95% CI: [-17.1, 28.4]
95% CI: [-24, 22.7]
95% CI: [-12, 33.9]
95% CI: [6.8, 51]
95% CI: [-19.4, 26.6]
95% CI: [-6, 39.5]
95% CI: [-7.1, 39.4]
95% CI: [19.2, 61.2]
95% CI: [-14.9, 32]
95% CI: [-7.3, 38.3]
95% CI: [-11.3, 36.5]
95% CI: [6.1, 52.8]
95% CI: [-3, 44.9]
95% CI: [-13.5, 34.7]
95% CI: [2.5, 49.9]
95% CI: [-9, 40.7]
95% CI: [3.7, 52.3]
95% CI: [-20.1, 30.9]
95% CI: [-16.2, 33.8]
95% CI: [-13.4, 37.3]
95% CI: [0.7, 50.5]
95% CI: [-25.6, 25.6]
95% CI: [-22.6, 27.6]
95% CI: [-18.7, 31.7]
95% CI: [-9.5, 41.4]
95% CI: [-14.9, 35.8]
95% CI: [-31.9, 90.6]
95% CI: [-62.4, 47.8]
95% CI: [-32.2, 57.9]
95% CI: [-40.3, 80.9]
Secondary
Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit
The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. The percentage of participants with a minimum 2-grade improvement in IGA score from Baseline at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and early withdrawal (EW) visit was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2894512 1% BID | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 4; n= 38,39,38,39,30,32 | 32 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 2; n= 39, 39, 39, 39, 33, 32 | 18 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 1; n= 38,41,39,37,38,32 | 5 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 8; n= 36,37,34,38,29,27 | 44 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 12; n= 36,37,32,35,28,25 | 64 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 14; n= 34,35,31,33,27,25 | 47 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 16; n= 34,36,31,35,27,25 | 35 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | EW; n= 3,4,7,3,11,11 | 33 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 8; n= 36,37,34,38,29,27 | 59 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | EW; n= 3,4,7,3,11,11 | 0 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 1; n= 38,41,39,37,38,32 | 7 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 16; n= 34,36,31,35,27,25 | 36 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 14; n= 34,35,31,33,27,25 | 46 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 4; n= 38,39,38,39,30,32 | 46 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 2; n= 39, 39, 39, 39, 33, 32 | 21 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 12; n= 36,37,32,35,28,25 | 51 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 2; n= 39, 39, 39, 39, 33, 32 | 10 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 4; n= 38,39,38,39,30,32 | 26 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 8; n= 36,37,34,38,29,27 | 38 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | EW; n= 3,4,7,3,11,11 | 14 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 12; n= 36,37,32,35,28,25 | 53 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 14; n= 34,35,31,33,27,25 | 55 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 16; n= 34,36,31,35,27,25 | 39 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 1; n= 38,41,39,37,38,32 | 0 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 16; n= 34,36,31,35,27,25 | 43 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 14; n= 34,35,31,33,27,25 | 42 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 12; n= 36,37,32,35,28,25 | 43 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 1; n= 38,41,39,37,38,32 | 3 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 4; n= 38,39,38,39,30,32 | 28 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 8; n= 36,37,34,38,29,27 | 45 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | EW; n= 3,4,7,3,11,11 | 33 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 2; n= 39, 39, 39, 39, 33, 32 | 15 Percentage of participants |
| Vehicle BID | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | EW; n= 3,4,7,3,11,11 | 0 Percentage of participants |
| Vehicle BID | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 1; n= 38,41,39,37,38,32 | 5 Percentage of participants |
| Vehicle BID | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 12; n= 36,37,32,35,28,25 | 39 Percentage of participants |
| Vehicle BID | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 14; n= 34,35,31,33,27,25 | 26 Percentage of participants |
| Vehicle BID | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 16; n= 34,36,31,35,27,25 | 33 Percentage of participants |
| Vehicle BID | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 2; n= 39, 39, 39, 39, 33, 32 | 15 Percentage of participants |
| Vehicle BID | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 4; n= 38,39,38,39,30,32 | 23 Percentage of participants |
| Vehicle BID | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 8; n= 36,37,34,38,29,27 | 28 Percentage of participants |
| Vehicle QD | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | EW; n= 3,4,7,3,11,11 | 9 Percentage of participants |
| Vehicle QD | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 12; n= 36,37,32,35,28,25 | 44 Percentage of participants |
| Vehicle QD | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 4; n= 38,39,38,39,30,32 | 13 Percentage of participants |
| Vehicle QD | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 8; n= 36,37,34,38,29,27 | 22 Percentage of participants |
| Vehicle QD | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 14; n= 34,35,31,33,27,25 | 36 Percentage of participants |
| Vehicle QD | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 2; n= 39, 39, 39, 39, 33, 32 | 9 Percentage of participants |
| Vehicle QD | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 16; n= 34,36,31,35,27,25 | 32 Percentage of participants |
| Vehicle QD | Percentage of Participants With a Minimum 2-grade Improvement in IGA Score From Baseline to Each Visit | Week 1; n= 38,41,39,37,38,32 | 6 Percentage of participants |
Secondary
Percentage of Participants With an IGA Score of 0 or 1 at Each Visit
The IGA is a clinical tool for assessing the current state/severity of a participant's AD. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines. IGA is made without reference to previous scores. The percentage of participants with an IGA score of 0 or 1 at Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 (follow up 1), Week 16 (follow up 2) and EW visit was presented in the form of mean and SD. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Weeks 1, 2, 4, 8, 12, 14, 16, EW (up to Week 16)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK2894512 1% BID | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 4; n= 38,39,38,39,30,32 | 32 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 2; n= 39,39,39,39,33,32 | 18 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 1; 38,41,39,37,38,32 | 5 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 8; n= 36,37,34,38,29,27 | 42 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 12; n= 36,37,32,35,28,25 | 58 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 14; n= 34,35,31,33,27,25 | 44 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 16; n= 34,36,31,35,27,25 | 35 Percentage of participants |
| GSK2894512 1% BID | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | EW; n= 3,4,7,3,11,11 | 33 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 8; n= 36,37,34,38,29,27 | 54 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | EW; n= 3,4,7,3,11,11 | 0 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 1; 38,41,39,37,38,32 | 5 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 16; n= 34,36,31,35,27,25 | 36 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 14; n= 34,35,31,33,27,25 | 43 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 4; n= 38,39,38,39,30,32 | 38 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 2; n= 39,39,39,39,33,32 | 18 Percentage of participants |
| GSK2894512 1% QD | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 12; n= 36,37,32,35,28,25 | 51 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 2; n= 39,39,39,39,33,32 | 10 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 4; n= 38,39,38,39,30,32 | 26 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 8; n= 36,37,34,38,29,27 | 38 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | EW; n= 3,4,7,3,11,11 | 14 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 12; n= 36,37,32,35,28,25 | 50 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 14; n= 34,35,31,33,27,25 | 52 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 16; n= 34,36,31,35,27,25 | 39 Percentage of participants |
| GSK2894512 0.5% BID | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 1; 38,41,39,37,38,32 | 0 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 16; n= 34,36,31,35,27,25 | 40 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 14; n= 34,35,31,33,27,25 | 36 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 12; n= 36,37,32,35,28,25 | 40 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 1; 38,41,39,37,38,32 | 3 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 4; n= 38,39,38,39,30,32 | 23 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 8; n= 36,37,34,38,29,27 | 42 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | EW; n= 3,4,7,3,11,11 | 33 Percentage of participants |
| GSK2894512 0.5% QD | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 2; n= 39,39,39,39,33,32 | 13 Percentage of participants |
| Vehicle BID | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | EW; n= 3,4,7,3,11,11 | 0 Percentage of participants |
| Vehicle BID | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 1; 38,41,39,37,38,32 | 3 Percentage of participants |
| Vehicle BID | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 12; n= 36,37,32,35,28,25 | 36 Percentage of participants |
| Vehicle BID | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 14; n= 34,35,31,33,27,25 | 26 Percentage of participants |
| Vehicle BID | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 16; n= 34,36,31,35,27,25 | 30 Percentage of participants |
| Vehicle BID | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 2; n= 39,39,39,39,33,32 | 15 Percentage of participants |
| Vehicle BID | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 4; n= 38,39,38,39,30,32 | 20 Percentage of participants |
| Vehicle BID | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 8; n= 36,37,34,38,29,27 | 28 Percentage of participants |
| Vehicle QD | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | EW; n= 3,4,7,3,11,11 | 9 Percentage of participants |
| Vehicle QD | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 12; n= 36,37,32,35,28,25 | 44 Percentage of participants |
| Vehicle QD | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 4; n= 38,39,38,39,30,32 | 9 Percentage of participants |
| Vehicle QD | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 8; n= 36,37,34,38,29,27 | 19 Percentage of participants |
| Vehicle QD | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 14; n= 34,35,31,33,27,25 | 36 Percentage of participants |
| Vehicle QD | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 2; n= 39,39,39,39,33,32 | 9 Percentage of participants |
| Vehicle QD | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 16; n= 34,36,31,35,27,25 | 28 Percentage of participants |
| Vehicle QD | Percentage of Participants With an IGA Score of 0 or 1 at Each Visit | Week 1; 38,41,39,37,38,32 | 3 Percentage of participants |