Psoriasis
Conditions
Brief summary
This multicenter study is being conducted to provide additional PF-06826647 safety and tolerability data, and to further explore the clinical efficacy of PF-06826647 in the treatment of moderate to severe plaque psoriasis. Additionally, the study is intended to enable selection of oral dose and dosing regimen for the future clinical development of PF-06826647.
Interventions
DRUGPF-06826647 or Placebo
Delivered orally (tablet) once daily (QD) for 16 weeks during the Investigational Treatment Period
DRUGPF-06826647
Delivered orally (tablet) once daily (QD) for 24 weeks during the Extension Period
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female between the ages of 18 and 75 years. * Participants with a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months. * Have a PASI score of 12 or greater AND a Physician Global Assessment score of 3 (moderate) or 4 (severe). * Have plaque-type psoriasis covering at least 10 % of total body surface area (BSA).
Exclusion criteria
* Have non-plaque forms of psoriasis. * Drug-induced psoriasis. * Current active infection. * Infected with Mycobacterium tuberculosis (TB). * Have any history of malignancies. * Require treatment with prohibited concomitant medications(s). * Positive for hepatitis B or C, or human immunodeficiency virus (HIV).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Baseline up to Week 16 | The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. The statistical analysis was for the data at Week 16. |
| Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | From Week 16 to Week 40 | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time. |
| Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | From Week 16 to Week 40 | Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time. Relatedness to investigational product (PF-06826647 or placebo) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. |
| Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | From Week 16 to Week 40 | Following hematology parameters were analyzed for laboratory examination: hemoglobin (HGB), hematocrit, erythrocytes (Ery.), reticulocytes, Ery. mean corpuscular volume, Ery. mean corpuscular HGB, Ery. mean corpuscular HGB concentration, platelets, reticulocytes/erythrocytes, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes, activated partial thromboplastin time, prothrombin time, prothrombin international (Intl.) normalized ratio, neutrophils total count, and lymphocytes total count. LLN=lower limit of normal; ULN=upper limit of normal. |
| Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | From Week 16 to Week 40 | Following clinical chemistry parameters were analyzed for laboratory examination: bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, urea, creatinine, urate, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, and cholesterol. |
| Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | From Week 16 to Week 40 | Following urinalysis parameters were analyzed for laboratory examination: urine pH, urine glucose, urine ketones, urine protein, urine hemoglobin, urine urobilinogen, urine bilirubin, urine nitrite, urine leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline, and urine bacteria. |
| Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | From Week 16 to Week 40 | Criteria for ECG abnormalities: maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) \>=25 percent (%) for baseline value of \>200 milliseconds (msec) and Pctchg\>=50% for baseline value of \<=200 msec for PR interval, a maximum IFB: Pctchg\>=50%, maximum QTcF interval (Fridericia's Correction) of 450 msec to \<=480 msec, 480 msec to \<=500 msec and a maximum change of \<30 change =\<60 or \>60 msec from baseline. |
| Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | From Week 16 to Week 40 | The vital signs were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Criteria for vital signs abnormalities: sitting diastolic blood pressure (BP) \< 50 millimeter of mercury (mmHg), sitting diastolic BP change \>= 20 mmHg increase, sitting diastolic BP change \>= 20 mmHg decrease, sitting systolic BP \< 90 mmHg, sitting systolic BP change \>= 30 mmHg increase, and sitting systolic BP change \>= 30 mmHg decrease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Baseline up to Week 16 | The Psoriasis Symptom Inventory (PSI) is a self administered 8-item questionnaire that measures the severity of psoriasis symptoms over the past 24 hours and the past 7 days. The measure includes concepts of itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Participants were asked to respond to each item using a 5-point Likert response scale: 0: not all severe, 1: mild, 2: moderate, 3: severe and 4: very severe. The statistical analysis was for the data at Week 16. |
| Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Baseline up to Week 16 | The Psoriasis Symptom Inventory (PSI) is a self administered 8-item questionnaire that measures the severity of psoriasis symptoms over the past 24 hours and the past 7 days. The measure includes concepts of itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Participants were asked to respond to each item using a 5-point Likert response scale: 0: not all severe, 1: mild, 2: moderate, 3: severe and 4: very severe. The outcome of PSI is the sum of the scores for the 8 items. The total score range of PSI is 0-32. A negative change from baseline means a better outcome and the bigger score decrease means a better outcome. The statistical analysis was for the data at Week 16. |
| Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Baseline up to Week 16 | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time. |
| Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Baseline up to Week 16 | Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug ((PF-06826647 or placebo). Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time. Relatedness to investigational product (PF-06826647 or placebo) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. |
| Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Baseline up to Week 16 | The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. The statistical analysis was for the data at Week 16. |
| Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Baseline up to Week 16 | The vital signs were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Criteria for vital signs abnormalities: pulse rate \>120 beats per minute (BPM), sitting diastolic blood pressure (BP) change \>=20 millimeter of mercury (mmHg) increase, sitting diastolic BP change \>=20 mmHg decrease, sitting systolic BP \<90 mmHg, sitting systolic BP change \>=30 mmHg increase, and sitting systolic BP change \>=30 mmHg decrease. |
| Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Baseline up to Week 16 | Following hematology parameters were analyzed for laboratory examination: hemoglobin (HGB), hematocrit, erythrocytes (Ery.), reticulocytes, Ery. mean corpuscular volume, Ery. mean corpuscular HGB, Ery. mean corpuscular HGB concentration, platelets, reticulocytes/erythrocytes, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes, activated partial thromboplastin time, prothrombin time, neutrophils total count, and lymphocytes total count. LLN=lower limit of normal; ULN=upper limit of normal. |
| Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Baseline up to Week 16. | Following clinical chemistry parameters were analyzed for laboratory examination: bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, urea, creatinine, urate, high-density lipoprotein (HDL) cholesterol, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, and cholesterol. LLN=lower limit of normal; ULN=upper limit of normal. |
| Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Baseline up to Week 16 | Following urinalysis parameters were analyzed for laboratory examination: urine pH, urine glucose, urine ketones, urine protein, urine hemoglobin, urine urobilinogen, urine bilirubin, urine nitrite, urine leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline, and urine bacteria. |
| Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Baseline up to Week 16 | Criteria for ECG abnormalities: Criteria for ECG abnormalities: maximum PR interval \>=300 milliseconds (msec) and maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) \>=25 percent (%) for baseline value of \>200 msec and Pctchg\>=50% for baseline value of \<=200 msec for PR interval, maximum QRS interval \>=140 msec and a maximum IFB: Pctchg\>=50%, maximum QTcF interval (Fridericia's Correction) of 450 msec to \<=480 msec, 480 msec to \<=500 msec and a maximum change of \<30change\<=60 or \>60 msec from baseline. |
| Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Baseline up to Week 16 | The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). The statistical analysis was for the data at Week 16. |
| Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Baseline up to Week 16 | The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). The statistical analysis was for the data at Week 16. |
| Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Baseline up to Week 16 | The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline. |
| Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Baseline up to Week 16 | The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 100 response was defined as at least a 100 percent (%) reduction in PASI relative to Baseline. |
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Baseline up to Week 16 | Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. The statistical analysis was for the data at Week 16. |
| Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Baseline up to Week 16 | Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. The statistical analysis was for the data at Week 16. |
| Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Baseline up to Week 16 | The intensity of pruritus was assessed by a PP-NRS, an 11-category numeric rating scale from 0 to 10, which was participant reported. Participants were asked to assess their itch over the past 24 hours, anchored by the terms no itch (0) and worst itch imaginable (10) at the ends. The statistical analysis was for the data at Week 16. |
Countries
Canada, Japan, Poland, United States
Participant flow
Recruitment details
This study included 2 treatment periods (16-week investigational treatment period and 24-week extension treatment period) followed by a 4-week follow-up. A total of 179 participants were enrolled and 178 participants were treated in investigational treatment period and 153 participants completed this period and entered the extension treatment period. A total of 130 participants completed the extension treatment period.
Pre-assignment details
This was a Phase 2b, randomized, double blind, placebo controlled, parallel group, and multicenter study in participants with moderate to severe plaque psoriasis.
Participants by arm
| Arm | Count |
|---|---|
| Placebo QD->PF-06826647 200 mg QD Group This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo)once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 187 days in extension treatment period. | 23 |
| Placebo QD->PF-06826647 400 mg QD Group This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received matching placebo (2\*25 mg size placebo and 4\*100 mg size placebo) once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 116 days in investigational treatment period and 176 days in extension treatment period. | 22 |
| PF-06826647 50 mg QD->PF-06826647 200 mg QD Group This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 182 days in extension treatment period. | 11 |
| PF-06826647 50 mg QD->PF-06826647 400 mg QD Group This study includes 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 50 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 183 days in extension treatment period. | 11 |
| PF-06826647 100 mg QD->PF-06826647 200 mg QD Group This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 171 days in extension treatment period. | 12 |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 100 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 115 days in investigational treatment period and 174 days in extension treatment period. | 11 |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 200 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 200 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 120 days in investigational treatment period and 186 days in extension treatment period. | 45 |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group This study included 2 treatment periods: 16-week investigational treatment period and 24-week extension treatment period. The enrolled participants entered the investigational treatment period first and then the participants who completed the investigational treatment period entered the extension treatment period. The participants in this group received PF-06826647 400 mg once a day (QD) in the investigational treatment period (16 weeks) and PF-06826647 400 mg QD in the extension treatment period (24 weeks). The maximum duration of treatment was 119 days in investigational treatment period and 180 days in extension treatment period. | 43 |
| Total | 178 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Extension Treatment Period | Adverse Event | 0 | 1 | 0 | 1 | 0 | 0 | 3 | 3 |
| Extension Treatment Period | Other | 1 | 3 | 0 | 0 | 1 | 0 | 0 | 2 |
| Extension Treatment Period | Pregnancy | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Extension Treatment Period | Withdrawal by Subject | 2 | 1 | 0 | 0 | 1 | 1 | 1 | 1 |
| Investigational Treatment Period | Adverse Event | 1 | 0 | 0 | 0 | 0 | 0 | 4 | 3 |
| Investigational Treatment Period | Lack of Efficacy | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Investigational Treatment Period | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Investigational Treatment Period | Other | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 |
| Investigational Treatment Period | Protocol Violation | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Investigational Treatment Period | Withdrawal by Subject | 2 | 3 | 1 | 1 | 0 | 1 | 3 | 0 |
Baseline characteristics
| Characteristic | Placebo QD->PF-06826647 400 mg QD Group | Placebo QD->PF-06826647 200 mg QD Group | PF-06826647 50 mg QD->PF-06826647 200 mg QD Group | PF-06826647 50 mg QD->PF-06826647 400 mg QD Group | PF-06826647 100 mg QD->PF-06826647 200 mg QD Group | PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized 18-44 Years | 11 Participants | 9 Participants | 7 Participants | 3 Participants | 6 Participants | 6 Participants | 24 Participants | 20 Participants | 86 Participants |
| Age, Customized 45-64 Years | 9 Participants | 12 Participants | 4 Participants | 6 Participants | 6 Participants | 4 Participants | 19 Participants | 20 Participants | 80 Participants |
| Age, Customized >=65 Years | 2 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 2 Participants | 3 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 22 Participants | 10 Participants | 11 Participants | 11 Participants | 11 Participants | 44 Participants | 39 Participants | 169 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 3 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 6 Participants | 2 Participants | 16 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 19 Participants | 20 Participants | 10 Participants | 11 Participants | 10 Participants | 11 Participants | 37 Participants | 40 Participants | 158 Participants |
| Sex: Female, Male Female | 8 Participants | 7 Participants | 2 Participants | 5 Participants | 3 Participants | 4 Participants | 19 Participants | 8 Participants | 56 Participants |
| Sex: Female, Male Male | 14 Participants | 16 Participants | 9 Participants | 6 Participants | 9 Participants | 7 Participants | 26 Participants | 35 Participants | 122 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 | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 22 | 0 / 11 | 0 / 11 | 0 / 12 | 0 / 11 | 0 / 45 | 0 / 43 |
| other Total, other adverse events | 14 / 23 | 11 / 22 | 10 / 11 | 8 / 11 | 9 / 12 | 9 / 11 | 29 / 45 | 32 / 43 |
| serious Total, serious adverse events | 0 / 23 | 1 / 22 | 0 / 11 | 1 / 11 | 0 / 12 | 1 / 11 | 3 / 45 | 0 / 43 |
Outcome results
Primary
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period
Criteria for ECG abnormalities: maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) \>=25 percent (%) for baseline value of \>200 milliseconds (msec) and Pctchg\>=50% for baseline value of \<=200 msec for PR interval, a maximum IFB: Pctchg\>=50%, maximum QTcF interval (Fridericia's Correction) of 450 msec to \<=480 msec, 480 msec to \<=500 msec and a maximum change of \<30 change =\<60 or \>60 msec from baseline.
Time frame: From Week 16 to Week 40
Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and were treated in the extension treatment period and evaluated against criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | 480< QTcF - Fridericia's correction formula (msec) <=500 | 0 Participants |
| Placebo QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | 30< QTcF - Fridericia's correction formula (msec) change <=60 | 1 Participants |
| Placebo QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | QT interval, single beat (msec) >500 | 0 Participants |
| Placebo QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | PR interval, single beat (msec) Pctchg >=25/50% | 0 Participants |
| Placebo QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | QRS duration, singe beat (msec) Pctchg >=50% | 0 Participants |
| Placebo QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | 450< QTcF - Fridericia's correction formula (msec) <=480 | 0 Participants |
| Placebo QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | QTcF - Fridericia's correction formula (msec) change >60 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | QTcF - Fridericia's correction formula (msec) change >60 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | 480< QTcF - Fridericia's correction formula (msec) <=500 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | QRS duration, singe beat (msec) Pctchg >=50% | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | QT interval, single beat (msec) >500 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | 450< QTcF - Fridericia's correction formula (msec) <=480 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | PR interval, single beat (msec) Pctchg >=25/50% | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | 30< QTcF - Fridericia's correction formula (msec) change <=60 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | 480< QTcF - Fridericia's correction formula (msec) <=500 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | QTcF - Fridericia's correction formula (msec) change >60 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | 450< QTcF - Fridericia's correction formula (msec) <=480 | 1 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | QRS duration, singe beat (msec) Pctchg >=50% | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | PR interval, single beat (msec) Pctchg >=25/50% | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | 30< QTcF - Fridericia's correction formula (msec) change <=60 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | QT interval, single beat (msec) >500 | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | 450< QTcF - Fridericia's correction formula (msec) <=480 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | QTcF - Fridericia's correction formula (msec) change >60 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | QRS duration, singe beat (msec) Pctchg >=50% | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | 30< QTcF - Fridericia's correction formula (msec) change <=60 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | QT interval, single beat (msec) >500 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | PR interval, single beat (msec) Pctchg >=25/50% | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | 480< QTcF - Fridericia's correction formula (msec) <=500 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | 450< QTcF - Fridericia's correction formula (msec) <=480 | 1 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | PR interval, single beat (msec) Pctchg >=25/50% | 1 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | QRS duration, singe beat (msec) Pctchg >=50% | 1 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | QT interval, single beat (msec) >500 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | 480< QTcF - Fridericia's correction formula (msec) <=500 | 1 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | 30< QTcF - Fridericia's correction formula (msec) change <=60 | 2 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | QTcF - Fridericia's correction formula (msec) change >60 | 1 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | 450< QTcF - Fridericia's correction formula (msec) <=480 | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | QTcF - Fridericia's correction formula (msec) change >60 | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | 480< QTcF - Fridericia's correction formula (msec) <=500 | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | QT interval, single beat (msec) >500 | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | 30< QTcF - Fridericia's correction formula (msec) change <=60 | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | QRS duration, singe beat (msec) Pctchg >=50% | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | PR interval, single beat (msec) Pctchg >=25/50% | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | QRS duration, singe beat (msec) Pctchg >=50% | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | PR interval, single beat (msec) Pctchg >=25/50% | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | 30< QTcF - Fridericia's correction formula (msec) change <=60 | 3 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | 480< QTcF - Fridericia's correction formula (msec) <=500 | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | QTcF - Fridericia's correction formula (msec) change >60 | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | QT interval, single beat (msec) >500 | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | 450< QTcF - Fridericia's correction formula (msec) <=480 | 1 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | QTcF - Fridericia's correction formula (msec) change >60 | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | 450< QTcF - Fridericia's correction formula (msec) <=480 | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | 30< QTcF - Fridericia's correction formula (msec) change <=60 | 1 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | PR interval, single beat (msec) Pctchg >=25/50% | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | QT interval, single beat (msec) >500 | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | 480< QTcF - Fridericia's correction formula (msec) <=500 | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | QRS duration, singe beat (msec) Pctchg >=50% | 0 Participants |
Primary
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Following clinical chemistry parameters were analyzed for laboratory examination: bilirubin, direct bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, urea, creatinine, urate, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, and cholesterol.
Time frame: From Week 16 to Week 40
Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who were treated in the extension treatment period, with a normal baseline with at least one observation of the given laboratory test while on study treatment or during lag time from week 16 to week 40.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Alkaline Phosphatase (U/L) > 3.0*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Protein (g/dL) <0.8*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Glucose (mg/dL) >1.5*ULN | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Sodium (Meq/L) >1.05*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Glucose (mg/dL) <0.6*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Indirect Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urea (mg/dL) >1.3*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Gamma Glutamyl Transferase (U/L) > 3.0*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Direct Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Bicarbonate (Meq/L) >1.1*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Triglycerides (mg/dL) >1.3*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Bicarbonate (Meq/L) <0.9*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Albumin (g/dL) >1.2*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Calcium (mg/dL) >1.1*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Creatinine (mg/dL) >1.3*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Alanine Aminotransferase (U/L) > 3.0*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Protein (g/dL) >1.2*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | LDL Cholesterol (mg/dL) >1.2*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Calcium (mg/dL) <0.9*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Chloride (Meq/L) >1.1*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Aspartate Aminotransferase (U/L) > 3.0*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urate (mg/dL) >1.2*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Cholesterol (mg/dL) >1.3*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Albumin (g/dL) <0.8*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Chloride (Meq/L) <0.9*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Creatine Kinase (U/L) >2.0*ULN | 2 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Potassium (Meq/L) >1.1*ULN | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Blood Urea Nitrogen (mg/dL) >1.3*ULN | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Potassium (Meq/L) <0.9*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | HDL Cholesterol (mg/dL) <0.8*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Sodium (Meq/L) <0.95*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | HDL Cholesterol (mg/dL) <0.8*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Sodium (Meq/L) <0.95*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Triglycerides (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | LDL Cholesterol (mg/dL) >1.2*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Protein (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Alanine Aminotransferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Aspartate Aminotransferase (U/L) > 3.0*ULN | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Albumin (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Indirect Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Direct Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Albumin (g/dL) >1.2*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Alkaline Phosphatase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Cholesterol (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Creatine Kinase (U/L) >2.0*ULN | 6 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Blood Urea Nitrogen (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Glucose (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Glucose (mg/dL) <0.6*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Bicarbonate (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urea (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Gamma Glutamyl Transferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Bicarbonate (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Calcium (mg/dL) >1.1*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Creatinine (mg/dL) >1.3*ULN | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Calcium (mg/dL) <0.9*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Chloride (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Chloride (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urate (mg/dL) >1.2*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Protein (g/dL) >1.2*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Potassium (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Potassium (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Sodium (Meq/L) >1.05*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | HDL Cholesterol (mg/dL) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Protein (g/dL) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Albumin (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Albumin (g/dL) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Blood Urea Nitrogen (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urea (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Creatinine (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urate (mg/dL) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | LDL Cholesterol (mg/dL) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Triglycerides (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Sodium (Meq/L) <0.95*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Sodium (Meq/L) >1.05*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Potassium (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Potassium (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Chloride (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Chloride (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Calcium (mg/dL) <0.9*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Calcium (mg/dL) >1.1*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Bicarbonate (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Bicarbonate (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Glucose (mg/dL) <0.6*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Glucose (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Creatine Kinase (U/L) >2.0*ULN | 2 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Cholesterol (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Direct Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Indirect Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Aspartate Aminotransferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Alanine Aminotransferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Gamma Glutamyl Transferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Alkaline Phosphatase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Protein (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Potassium (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | HDL Cholesterol (mg/dL) <0.8*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Cholesterol (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Protein (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Glucose (mg/dL) <0.6*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Protein (g/dL) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Creatine Kinase (U/L) >2.0*ULN | 5 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Blood Urea Nitrogen (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Glucose (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Bicarbonate (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | LDL Cholesterol (mg/dL) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urate (mg/dL) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Alanine Aminotransferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Chloride (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Sodium (Meq/L) <0.95*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Aspartate Aminotransferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Chloride (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Indirect Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Sodium (Meq/L) >1.05*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Creatinine (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Gamma Glutamyl Transferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Calcium (mg/dL) <0.9*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Potassium (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Albumin (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Direct Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Calcium (mg/dL) >1.1*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Triglycerides (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Bicarbonate (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Alkaline Phosphatase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urea (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Albumin (g/dL) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Bicarbonate (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Bicarbonate (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Chloride (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Triglycerides (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Calcium (mg/dL) >1.1*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Albumin (g/dL) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urate (mg/dL) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Creatine Kinase (U/L) >2.0*ULN | 2 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Potassium (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Glucose (mg/dL) <0.6*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Creatinine (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Alkaline Phosphatase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Glucose (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Blood Urea Nitrogen (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Sodium (Meq/L) >1.05*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Calcium (mg/dL) <0.9*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Potassium (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Sodium (Meq/L) <0.95*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | LDL Cholesterol (mg/dL) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urea (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Alanine Aminotransferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Albumin (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Protein (g/dL) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Direct Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Chloride (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Cholesterol (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Aspartate Aminotransferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Gamma Glutamyl Transferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Indirect Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | HDL Cholesterol (mg/dL) <0.8*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Protein (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Alkaline Phosphatase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Sodium (Meq/L) >1.05*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Potassium (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urate (mg/dL) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Potassium (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Chloride (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Creatinine (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Chloride (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Calcium (mg/dL) <0.9*LLN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Calcium (mg/dL) >1.1*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urea (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Gamma Glutamyl Transferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Bicarbonate (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Bicarbonate (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Blood Urea Nitrogen (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Glucose (mg/dL) <0.6*LLN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Glucose (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Protein (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Creatine Kinase (U/L) >2.0*ULN | 3 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Albumin (g/dL) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Cholesterol (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Albumin (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Direct Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Indirect Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Aspartate Aminotransferase (U/L) > 3.0*ULN | 1 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Protein (g/dL) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | LDL Cholesterol (mg/dL) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Triglycerides (mg/dL) >1.3*ULN | 1 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | HDL Cholesterol (mg/dL) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Alanine Aminotransferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Sodium (Meq/L) <0.95*LLN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urea (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Gamma Glutamyl Transferase (U/L) > 3.0*ULN | 2 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Triglycerides (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Cholesterol (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Bicarbonate (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Bilirubin (mg/dL) >1.5*ULN | 1 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Albumin (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Sodium (Meq/L) >1.05*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Calcium (mg/dL) >1.1*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Bicarbonate (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urate (mg/dL) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Direct Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Calcium (mg/dL) <0.9*LLN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Chloride (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Creatinine (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Sodium (Meq/L) <0.95*LLN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Indirect Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Protein (g/dL) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Alkaline Phosphatase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Chloride (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Aspartate Aminotransferase (U/L) > 3.0*ULN | 1 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Potassium (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Alanine Aminotransferase (U/L) > 3.0*ULN | 2 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | LDL Cholesterol (mg/dL) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | HDL Cholesterol (mg/dL) <0.8*LLN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Protein (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Glucose (mg/dL) >1.5*ULN | 3 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Albumin (g/dL) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Potassium (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Glucose (mg/dL) <0.6*LLN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Creatine Kinase (U/L) >2.0*ULN | 5 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Blood Urea Nitrogen (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Chloride (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Alanine Aminotransferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urate (mg/dL) >1.2*ULN | 1 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Glucose (mg/dL) >1.5*ULN | 2 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Cholesterol (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Blood Urea Nitrogen (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Albumin (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Bicarbonate (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Aspartate Aminotransferase (U/L) > 3.0*ULN | 2 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Calcium (mg/dL) >1.1*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Triglycerides (mg/dL) >1.3*ULN | 1 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Sodium (Meq/L) >1.05*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Protein (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Alkaline Phosphatase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Creatinine (mg/dL) >1.3*ULN | 1 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Potassium (Meq/L) >1.1*ULN | 1 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urea (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Albumin (g/dL) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Bicarbonate (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Direct Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Calcium (mg/dL) <0.9*LLN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Creatine Kinase (U/L) >2.0*ULN | 12 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Chloride (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | LDL Cholesterol (mg/dL) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | HDL Cholesterol (mg/dL) <0.8*LLN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Sodium (Meq/L) <0.95*LLN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Gamma Glutamyl Transferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Indirect Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Protein (g/dL) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Glucose (mg/dL) <0.6*LLN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Potassium (Meq/L) <0.9*LLN | 0 Participants |
Primary
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Following hematology parameters were analyzed for laboratory examination: hemoglobin (HGB), hematocrit, erythrocytes (Ery.), reticulocytes, Ery. mean corpuscular volume, Ery. mean corpuscular HGB, Ery. mean corpuscular HGB concentration, platelets, reticulocytes/erythrocytes, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes, activated partial thromboplastin time, prothrombin time, prothrombin international (Intl.) normalized ratio, neutrophils total count, and lymphocytes total count. LLN=lower limit of normal; ULN=upper limit of normal.
Time frame: From Week 16 to Week 40
Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who were treated in the extension treatment period, with a normal baseline with at least one observation of the given laboratory test while on study treatment or during lag time from week 16 to week 40.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Monocytes/Leukocytes (%) >1.2*ULN | 2 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Monocytes (10^3/mm^3) >1.2*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils/Leukocytes (%) <0.8*LLN | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Platelets (10^3/mm^3) <0.5*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes/Leukocytes (%) >1.2*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Activated Partial Thromboplastin Time (sec) >1.1 x ULN | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes total count (10^3/mm^3) <0.8*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular Volume (um^3) <0.9*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Eosinophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Basophils (10^3/mm^3) >1.2*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Leukocytes(10^3/mm^3) >1.5*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Prothrombin Time (sec) >1.1*ULN | 3 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Hematocrit (%) <0.8*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Leukocytes(10^3/mm^3) <0.6*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular Volume (um^3) >1.1*ULN | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes (10^3/mm^3) <0.5*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils total count (10^3/mm^3) <0.8*LLN | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes/Erythrocytes (%) >1.5*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Platelets (10^3/mm^3) >1.75*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Eosinophils (10^3/mm^3) >1.2*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB (pg/cell) <0.9*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | HGB (g/dL) <0.8*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes total count (10^3/mm^3) >1.2*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes/Leukocytes (%) <0.8*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes/Erythrocytes (%) <0.5*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Erythrocytes (10^6/mm^3) <0.8*LLN | 2 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils total count (10^3/mm^3) >1.2*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Prothrombin Intl. Normalized Ratio >1.1*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB (pg/cell) >1.1*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Basophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes (10^3/mm^3) >1.5*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular Volume (um^3) <0.9*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Platelets (10^3/mm^3) >1.75*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Hematocrit (%) <0.8*LLN | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Platelets (10^3/mm^3) <0.5*LLN | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils total count (10^3/mm^3) <0.8*LLN | 3 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Eosinophils (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils/Leukocytes (%) <0.8*LLN | 3 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes/Leukocytes (%) >1.2*ULN | 5 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Eosinophils/Leukocytes (%) >1.2*ULN | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes (10^3/mm^3) <0.5*LLN | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Basophils (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Activated Partial Thromboplastin Time (sec) >1.1 x ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes/Leukocytes (%) <0.8*LLN | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes (10^3/mm^3) >1.5*ULN | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Basophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes total count (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Leukocytes(10^3/mm^3) >1.5*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | HGB (g/dL) <0.8*LLN | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes total count (10^3/mm^3) <0.8*LLN | 2 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Prothrombin Intl. Normalized Ratio >1.1*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Leukocytes(10^3/mm^3) <0.6*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Prothrombin Time (sec) >1.1*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular Volume (um^3) >1.1*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Erythrocytes (10^6/mm^3) <0.8*LLN | 2 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes/Erythrocytes (%) >1.5*ULN | 2 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Monocytes/Leukocytes (%) >1.2*ULN | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils total count (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB (pg/cell) <0.9*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes/Erythrocytes (%) <0.5*LLN | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB (pg/cell) >1.1*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Monocytes (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Basophils (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Monocytes (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Basophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Eosinophils (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Eosinophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes (10^3/mm^3) <0.5*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes total count (10^3/mm^3) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes (10^3/mm^3) >1.5*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular Volume (um^3) <0.9*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular Volume (um^3) >1.1*ULN | 1 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils total count (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB (pg/cell) <0.9*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB (pg/cell) >1.1*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils total count (10^3/mm^3) <0.8*LLN | 1 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | HGB (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Platelets (10^3/mm^3) <0.5*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Prothrombin Intl. Normalized Ratio >1.1*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Platelets (10^3/mm^3) >1.75*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Hematocrit (%) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes/Erythrocytes (%) <0.5*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes/Erythrocytes (%) >1.5*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Prothrombin Time (sec) >1.1*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Leukocytes(10^3/mm^3) <0.6*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes total count (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Leukocytes(10^3/mm^3) >1.5*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Activated Partial Thromboplastin Time (sec) >1.1 x ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes/Leukocytes (%) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Erythrocytes (10^6/mm^3) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils/Leukocytes (%) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Monocytes/Leukocytes (%) >1.2*ULN | 1 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular Volume (um^3) >1.1*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB (pg/cell) >1.1*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB (pg/cell) <0.9*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes/Erythrocytes (%) <0.5*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Hematocrit (%) <0.8*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Prothrombin Time (sec) >1.1*ULN | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes/Erythrocytes (%) >1.5*ULN | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils/Leukocytes (%) <0.8*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils total count (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | HGB (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Leukocytes(10^3/mm^3) <0.6*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Basophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular Volume (um^3) <0.9*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Monocytes (10^3/mm^3) >1.2*ULN | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Leukocytes(10^3/mm^3) >1.5*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes (10^3/mm^3) >1.5*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Activated Partial Thromboplastin Time (sec) >1.1 x ULN | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Basophils (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes total count (10^3/mm^3) <0.8*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes/Leukocytes (%) <0.8*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes (10^3/mm^3) <0.5*LLN | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Eosinophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Erythrocytes (10^6/mm^3) <0.8*LLN | 2 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes total count (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Monocytes/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Platelets (10^3/mm^3) <0.5*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils total count (10^3/mm^3) <0.8*LLN | 2 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Prothrombin Intl. Normalized Ratio >1.1*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Eosinophils (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Platelets (10^3/mm^3) >1.75*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB (pg/cell) >1.1*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils total count (10^3/mm^3) <0.8*LLN | 2 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB (pg/cell) <0.9*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes (10^3/mm^3) <0.5*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils/Leukocytes (%) <0.8*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Monocytes (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes/Erythrocytes (%) <0.5*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Prothrombin Intl. Normalized Ratio >1.1*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Prothrombin Time (sec) >1.1*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes/Leukocytes (%) <0.8*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | HGB (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular Volume (um^3) >1.1*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Erythrocytes (10^6/mm^3) <0.8*LLN | 1 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes/Erythrocytes (%) >1.5*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Basophils (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Platelets (10^3/mm^3) >1.75*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils total count (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Eosinophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Basophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes total count (10^3/mm^3) <0.8*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Leukocytes(10^3/mm^3) <0.6*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Hematocrit (%) <0.8*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular Volume (um^3) <0.9*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Activated Partial Thromboplastin Time (sec) >1.1 x ULN | 1 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Eosinophils (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes (10^3/mm^3) >1.5*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes total count (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Leukocytes(10^3/mm^3) >1.5*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Monocytes/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Platelets (10^3/mm^3) <0.5*LLN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Prothrombin Intl. Normalized Ratio >1.1*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | HGB (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Hematocrit (%) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Erythrocytes (10^6/mm^3) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes (10^3/mm^3) <0.5*LLN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes (10^3/mm^3) >1.5*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular Volume (um^3) <0.9*LLN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular Volume (um^3) >1.1*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB (pg/cell) <0.9*LLN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB (pg/cell) >1.1*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Platelets (10^3/mm^3) <0.5*LLN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Platelets (10^3/mm^3) >1.75*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes/Erythrocytes (%) <0.5*LLN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes/Erythrocytes (%) >1.5*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Leukocytes(10^3/mm^3) <0.6*LLN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Leukocytes(10^3/mm^3) >1.5*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes/Leukocytes (%) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils/Leukocytes (%) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Basophils (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Basophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Eosinophils (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Eosinophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Monocytes (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Monocytes/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Activated Partial Thromboplastin Time (sec) >1.1 x ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Prothrombin Time (sec) >1.1*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils total count (10^3/mm^3) <0.8*LLN | 1 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils total count (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes total count (10^3/mm^3) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes total count (10^3/mm^3) >1.2*ULN | 1 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Prothrombin Intl. Normalized Ratio >1.1*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Hematocrit (%) <0.8*LLN | 1 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Activated Partial Thromboplastin Time (sec) >1.1 x ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB (pg/cell) >1.1*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Leukocytes(10^3/mm^3) <0.6*LLN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | HGB (g/dL) <0.8*LLN | 1 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils total count (10^3/mm^3) <0.8*LLN | 7 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Monocytes/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB (pg/cell) <0.9*LLN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes/Erythrocytes (%) >1.5*ULN | 1 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular Volume (um^3) >1.1*ULN | 1 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Monocytes (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular Volume (um^3) <0.9*LLN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes/Erythrocytes (%) <0.5*LLN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils total count (10^3/mm^3) >1.2*ULN | 1 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils/Leukocytes (%) <0.8*LLN | 1 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Prothrombin Time (sec) >1.1*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes (10^3/mm^3) >1.5*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes/Leukocytes (%) <0.8*LLN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes (10^3/mm^3) <0.5*LLN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Erythrocytes (10^6/mm^3) <0.8*LLN | 1 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes total count (10^3/mm^3) >1.2*ULN | 1 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes total count (10^3/mm^3) <0.8*LLN | 1 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Platelets (10^3/mm^3) >1.75*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Eosinophils (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Leukocytes(10^3/mm^3) >1.5*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Eosinophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Platelets (10^3/mm^3) <0.5*LLN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes/Leukocytes (%) >1.2*ULN | 2 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Basophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Basophils (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Eosinophils (10^3/mm^3) >1.2*ULN | 1 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Monocytes (10^3/mm^3) >1.2*ULN | 1 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils/Leukocytes (%) <0.8*LLN | 3 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes/Leukocytes (%) >1.2*ULN | 5 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Hematocrit (%) <0.8*LLN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Monocytes/Leukocytes (%) >1.2*ULN | 3 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes/Leukocytes (%) <0.8*LLN | 1 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Leukocytes(10^3/mm^3) >1.5*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Leukocytes(10^3/mm^3) <0.6*LLN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Activated Partial Thromboplastin Time (sec) >1.1 x ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes/Erythrocytes (%) >1.5*ULN | 2 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes/Erythrocytes (%) <0.5*LLN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | HGB (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Prothrombin Time (sec) >1.1*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Platelets (10^3/mm^3) >1.75*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Platelets (10^3/mm^3) <0.5*LLN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Prothrombin Intl. Normalized Ratio >1.1*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB (pg/cell) >1.1*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular HGB (pg/cell) <0.9*LLN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils total count (10^3/mm^3) <0.8*LLN | 4 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular Volume (um^3) >1.1*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Ery. Mean Corpuscular Volume (um^3) <0.9*LLN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes total count (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils total count (10^3/mm^3) >1.2*ULN | 1 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes (10^3/mm^3) >1.5*ULN | 1 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Reticulocytes (10^3/mm^3) <0.5*LLN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Erythrocytes (10^6/mm^3) <0.8*LLN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Neutrophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Lymphocytes total count (10^3/mm^3) <0.8*LLN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Eosinophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Basophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Basophils (10^3/mm^3) >1.2*ULN | 0 Participants |
Primary
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period
Following urinalysis parameters were analyzed for laboratory examination: urine pH, urine glucose, urine ketones, urine protein, urine hemoglobin, urine urobilinogen, urine bilirubin, urine nitrite, urine leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline, and urine bacteria.
Time frame: From Week 16 to Week 40
Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who were treated in the extension treatment period, with a normal baseline with at least one observation of the given laboratory test while on study treatment or during lag time from week 16 to week 40.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine pH (Scalar) <4.5 | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Hemoglobin (Scalar) >=1 | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Urobilinogen (EU/dL) >=1 | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Leukocyte Esterase (Scalar) >=1 | 2 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Glucose >=1 | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Leukocytes (/HPF) >=20 | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Nitrite (Scalar) >=1 | 2 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Erythrocytes (Scalar) >=20 | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Bacteria (/LPF) >20 | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Ketones (Scalar) >=1 | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine pH (Scalar) >8 | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Protein >=1 | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Bilirubin (Scalar) >=1 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Glucose >=1 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Urobilinogen (EU/dL) >=1 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Ketones (Scalar) >=1 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Hemoglobin (Scalar) >=1 | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Bilirubin (Scalar) >=1 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Nitrite (Scalar) >=1 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Protein >=1 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine pH (Scalar) <4.5 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Erythrocytes (Scalar) >=20 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Leukocytes (/HPF) >=20 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Leukocyte Esterase (Scalar) >=1 | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine pH (Scalar) >8 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Urobilinogen (EU/dL) >=1 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine pH (Scalar) <4.5 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine pH (Scalar) >8 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Leukocytes (/HPF) >=20 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Glucose >=1 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Protein >=1 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Bilirubin (Scalar) >=1 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Erythrocytes (Scalar) >=20 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Nitrite (Scalar) >=1 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Hemoglobin (Scalar) >=1 | 1 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Leukocyte Esterase (Scalar) >=1 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Ketones (Scalar) >=1 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Leukocyte Esterase (Scalar) >=1 | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Erythrocytes (Scalar) >=20 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine pH (Scalar) >8 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Bacteria (/LPF) >20 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Glucose >=1 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine pH (Scalar) <4.5 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Ketones (Scalar) >=1 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Protein >=1 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Hemoglobin (Scalar) >=1 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Urobilinogen (EU/dL) >=1 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Leukocytes (/HPF) >=20 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Bilirubin (Scalar) >=1 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Nitrite (Scalar) >=1 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Ketones (Scalar) >=1 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Hyaline Casts (/LPF) >1 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Glucose >=1 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine pH (Scalar) <4.5 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Leukocyte Esterase (Scalar) >=1 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Nitrite (Scalar) >=1 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Urobilinogen (EU/dL) >=1 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine pH (Scalar) >8 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Bilirubin (Scalar) >=1 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Leukocytes (/HPF) >=20 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Hemoglobin (Scalar) >=1 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Erythrocytes (Scalar) >=20 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Protein >=1 | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Leukocytes (/HPF) >=20 | 1 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Erythrocytes (Scalar) >=20 | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Urobilinogen (EU/dL) >=1 | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Protein >=1 | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Leukocyte Esterase (Scalar) >=1 | 1 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Bilirubin (Scalar) >=1 | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Ketones (Scalar) >=1 | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Glucose >=1 | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine pH (Scalar) >8 | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Nitrite (Scalar) >=1 | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Hemoglobin (Scalar) >=1 | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine pH (Scalar) <4.5 | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Bacteria (/LPF) >20 | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine pH (Scalar) <4.5 | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine pH (Scalar) >8 | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Glucose >=1 | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Ketones (Scalar) >=1 | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Protein >=1 | 1 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Hemoglobin (Scalar) >=1 | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Urobilinogen (EU/dL) >=1 | 2 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Bilirubin (Scalar) >=1 | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Nitrite (Scalar) >=1 | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Leukocyte Esterase (Scalar) >=1 | 2 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Erythrocytes (Scalar) >=20 | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Leukocytes (/HPF) >=20 | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Leukocyte Esterase (Scalar) >=1 | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Nitrite (Scalar) >=1 | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Bilirubin (Scalar) >=1 | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Urobilinogen (EU/dL) >=1 | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Hemoglobin (Scalar) >=1 | 2 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Protein >=1 | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine pH (Scalar) <4.5 | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Leukocytes (/HPF) >=20 | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Ketones (Scalar) >=1 | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Glucose >=1 | 1 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine pH (Scalar) >8 | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Week 16 to Week 40 - Extension Treatment Period | Urine Erythrocytes (Scalar) >=20 | 0 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time.
Time frame: From Week 16 to Week 40
Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who were treated in the extension treatment period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 0 Participants |
| Placebo QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with AEs | 11 Participants |
| Placebo QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with SAEs | 0 Participants |
| Placebo QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with severe AEs | 2 Participants |
| Placebo QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued study drug due to AE and continue study | 0 Participants |
| Placebo QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued from study due to AEs | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with severe AEs | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with AEs | 8 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued from study due to AEs | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with SAEs | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued study drug due to AE and continue study | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued study drug due to AE and continue study | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with severe AEs | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with SAEs | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued from study due to AEs | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 1 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with AEs | 7 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued study drug due to AE and continue study | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with AEs | 6 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with SAEs | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with severe AEs | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued from study due to AEs | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued study drug due to AE and continue study | 1 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with SAEs | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with AEs | 7 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued from study due to AEs | 1 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with severe AEs | 1 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with severe AEs | 2 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued from study due to AEs | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with SAEs | 1 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued study drug due to AE and continue study | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with AEs | 7 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 1 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued from study due to AEs | 3 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued study drug due to AE and continue study | 1 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with AEs | 24 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with severe AEs | 2 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 4 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with SAEs | 2 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued from study due to AEs | 3 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with severe AEs | 3 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 1 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued study drug due to AE and continue study | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with AEs | 26 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Week 16 to Week 40 - Extension Treatment Period | Participants with SAEs | 0 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period
Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time. Relatedness to investigational product (PF-06826647 or placebo) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Time frame: From Week 16 to Week 40
Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who entered the extension treatment period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 0 Participants |
| Placebo QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with AEs | 4 Participants |
| Placebo QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with SAEs | 0 Participants |
| Placebo QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with severe AEs | 0 Participants |
| Placebo QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued study drug due to AE and continue study | 0 Participants |
| Placebo QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued from study due to AEs | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with severe AEs | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with AEs | 3 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued from study due to AEs | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with SAEs | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued study drug due to AE and continue study | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued study drug due to AE and continue study | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with severe AEs | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with SAEs | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued from study due to AEs | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 1 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with AEs | 2 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued study drug due to AE and continue study | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with AEs | 3 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with SAEs | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with severe AEs | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued from study due to AEs | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued study drug due to AE and continue study | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with SAEs | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with AEs | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued from study due to AEs | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with severe AEs | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with severe AEs | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued from study due to AEs | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with SAEs | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued study drug due to AE and continue study | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with AEs | 1 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued from study due to AEs | 2 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued study drug due to AE and continue study | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with AEs | 10 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with severe AEs | 1 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 3 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with SAEs | 2 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued from study due to AEs | 2 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with severe AEs | 1 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants discontinued study drug due to AE and continue study | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with AEs | 5 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Week 16 to Week 40 - Extension Treatment Period | Participants with SAEs | 0 Participants |
Primary
Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period
The vital signs were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Criteria for vital signs abnormalities: sitting diastolic blood pressure (BP) \< 50 millimeter of mercury (mmHg), sitting diastolic BP change \>= 20 mmHg increase, sitting diastolic BP change \>= 20 mmHg decrease, sitting systolic BP \< 90 mmHg, sitting systolic BP change \>= 30 mmHg increase, and sitting systolic BP change \>= 30 mmHg decrease.
Time frame: From Week 16 to Week 40
Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who entered the extension treatment period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting diastolic BP (mmHg) change >= 20 decrease | 1 Participants |
| Placebo QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting diastolic BP (mmHg) <50 | 0 Participants |
| Placebo QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting systolic BP (mmHg) change >= 30 increase | 0 Participants |
| Placebo QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting diastolic BP (mmHg) change >= 20 increase | 0 Participants |
| Placebo QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting systolic BP (mmHg) change >= 30 decrease | 0 Participants |
| Placebo QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting systolic BP (mmHg) <90 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting diastolic BP (mmHg) change >= 20 decrease | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting diastolic BP (mmHg) change >= 20 increase | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting diastolic BP (mmHg) <50 | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting systolic BP (mmHg) change >= 30 decrease | 2 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting systolic BP (mmHg) change >= 30 increase | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting systolic BP (mmHg) <90 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting systolic BP (mmHg) change >= 30 increase | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting systolic BP (mmHg) change >= 30 decrease | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting diastolic BP (mmHg) change >= 20 increase | 1 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting systolic BP (mmHg) <90 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting diastolic BP (mmHg) change >= 20 decrease | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting diastolic BP (mmHg) <50 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting diastolic BP (mmHg) change >= 20 increase | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting diastolic BP (mmHg) <50 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting systolic BP (mmHg) change >= 30 decrease | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting systolic BP (mmHg) <90 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting systolic BP (mmHg) change >= 30 increase | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting diastolic BP (mmHg) change >= 20 decrease | 2 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting systolic BP (mmHg) change >= 30 decrease | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting diastolic BP (mmHg) <50 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting diastolic BP (mmHg) change >= 20 increase | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting diastolic BP (mmHg) change >= 20 decrease | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting systolic BP (mmHg) <90 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting systolic BP (mmHg) change >= 30 increase | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting systolic BP (mmHg) <90 | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting diastolic BP (mmHg) <50 | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting systolic BP (mmHg) change >= 30 increase | 2 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting diastolic BP (mmHg) change >= 20 decrease | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting diastolic BP (mmHg) change >= 20 increase | 0 Participants |
| PF-06826647 100 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting systolic BP (mmHg) change >= 30 decrease | 0 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting systolic BP (mmHg) change >= 30 decrease | 1 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting systolic BP (mmHg) <90 | 1 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting diastolic BP (mmHg) change >= 20 decrease | 3 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting diastolic BP (mmHg) change >= 20 increase | 4 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting systolic BP (mmHg) change >= 30 increase | 4 Participants |
| PF-06826647 200 mg QD->PF-06826647 200 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting diastolic BP (mmHg) <50 | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting diastolic BP (mmHg) <50 | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting systolic BP (mmHg) <90 | 0 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting systolic BP (mmHg) change >= 30 decrease | 1 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting diastolic BP (mmHg) change >= 20 increase | 4 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting diastolic BP (mmHg) change >= 20 decrease | 4 Participants |
| PF-06826647 400 mg QD->PF-06826647 400 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Week 16 to Week 40 - Extension Treatment Period | Sitting systolic BP (mmHg) change >= 30 increase | 5 Participants |
Primary
Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period
The PASI quantifies the severity of a participant's psoriasis based on both lesion severity and the percentage of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to baseline. The statistical analysis was for the data at Week 16.
Time frame: Baseline up to Week 16
Population: The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 1 | 0 Percentage of participants |
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 16 | 4.8 Percentage of participants |
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 12 | 2.4 Percentage of participants |
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 4 | 0 Percentage of participants |
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 2 | 0 Percentage of participants |
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 6 | 0 Percentage of participants |
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 8 | 2.4 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 8 | 4.5 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 6 | 4.5 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 2 | 0 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 1 | 0 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 12 | 13.6 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 4 | 0 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 16 | 13.6 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 6 | 4.8 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 1 | 0 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 2 | 0 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 4 | 0 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 8 | 4.8 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 12 | 9.5 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 16 | 9.5 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 4 | 11.1 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 8 | 24.4 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 2 | 2.2 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 16 | 37.8 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 12 | 37.8 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 1 | 0 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 6 | 20.0 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 4 | 7.3 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 16 | 51.2 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 12 | 48.8 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 8 | 34.1 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 2 | 0 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 1 | 0 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response Up to Week 16 - Investigational Treatment Period | Week 6 | 26.8 Percentage of participants |
Comparison: The analysis was based on the data at Week 16.p-value: 0.262190% CI: [-4.5, 26.26]Chan and Zhang method
Comparison: The analysis was based on the data at Week 16.p-value: 0.262190% CI: [-7.07, 21.48]Chan and Zhang method
Comparison: The analysis was based on the data at Week 16.p-value: 0.000490% CI: [18.01, 47.11]Chan and Zhang method
Comparison: The analysis was based on the data at Week 16.p-value: <0.000190% CI: [30.62, 60.56]Chan and Zhang method
Secondary
Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period
The intensity of pruritus was assessed by a PP-NRS, an 11-category numeric rating scale from 0 to 10, which was participant reported. Participants were asked to assess their itch over the past 24 hours, anchored by the terms no itch (0) and worst itch imaginable (10) at the ends. The statistical analysis was for the data at Week 16.
Time frame: Baseline up to Week 16
Population: The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed) and who had observed data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Week 4 | -0.54 Units on a scale | Standard Error 0.354 |
| Placebo QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 6, Week 1 | -0.82 Units on a scale | Standard Error 0.246 |
| Placebo QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 2, Week 1 | -0.60 Units on a scale | Standard Error 0.238 |
| Placebo QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 3, Week 1 | -0.71 Units on a scale | Standard Error 0.239 |
| Placebo QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 4, Week 1 | -0.76 Units on a scale | Standard Error 0.234 |
| Placebo QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 16, Week 2 | -0.73 Units on a scale | Standard Error 0.314 |
| Placebo QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 7, Week 1 | -0.72 Units on a scale | Standard Error 0.272 |
| Placebo QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Week 12 | -0.84 Units on a scale | Standard Error 0.455 |
| Placebo QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 10, Week 1 | -0.85 Units on a scale | Standard Error 0.284 |
| Placebo QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 12, Week 2 | -0.63 Units on a scale | Standard Error 0.289 |
| Placebo QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 15, Week 2 | -0.75 Units on a scale | Standard Error 0.308 |
| Placebo QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 8, Week 1 | -0.83 Units on a scale | Standard Error 0.274 |
| Placebo QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Week 8 | -1.24 Units on a scale | Standard Error 0.391 |
| Placebo QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 5, Week 1 | -0.63 Units on a scale | Standard Error 0.233 |
| Placebo QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 11, Week 1 | -0.70 Units on a scale | Standard Error 0.291 |
| Placebo QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 14, Week 2 | -0.82 Units on a scale | Standard Error 0.317 |
| Placebo QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 9, Week 1 | -0.79 Units on a scale | Standard Error 0.289 |
| Placebo QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Week 16 | -0.93 Units on a scale | Standard Error 0.453 |
| Placebo QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 13, Week 2 | -0.78 Units on a scale | Standard Error 0.294 |
| PF-06826647 50 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Week 12 | -1.66 Units on a scale | Standard Error 0.651 |
| PF-06826647 50 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 10, Week 1 | -1.48 Units on a scale | Standard Error 0.42 |
| PF-06826647 50 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 12, Week 2 | -1.67 Units on a scale | Standard Error 0.424 |
| PF-06826647 50 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 11, Week 1 | -1.55 Units on a scale | Standard Error 0.429 |
| PF-06826647 50 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 4, Week 1 | -0.83 Units on a scale | Standard Error 0.348 |
| PF-06826647 50 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Week 16 | -2.15 Units on a scale | Standard Error 0.645 |
| PF-06826647 50 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Week 8 | -1.10 Units on a scale | Standard Error 0.561 |
| PF-06826647 50 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 5, Week 1 | -0.91 Units on a scale | Standard Error 0.348 |
| PF-06826647 50 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Week 4 | -1.74 Units on a scale | Standard Error 0.517 |
| PF-06826647 50 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 6, Week 1 | -0.94 Units on a scale | Standard Error 0.362 |
| PF-06826647 50 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 16, Week 2 | -1.52 Units on a scale | Standard Error 0.462 |
| PF-06826647 50 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 7, Week 1 | -1.11 Units on a scale | Standard Error 0.399 |
| PF-06826647 50 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 3, Week 1 | -0.65 Units on a scale | Standard Error 0.354 |
| PF-06826647 50 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 15, Week 2 | -1.48 Units on a scale | Standard Error 0.454 |
| PF-06826647 50 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 8, Week 1 | -1.26 Units on a scale | Standard Error 0.403 |
| PF-06826647 50 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 2, Week 1 | 0.05 Units on a scale | Standard Error 0.355 |
| PF-06826647 50 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 14, Week 2 | -1.66 Units on a scale | Standard Error 0.464 |
| PF-06826647 50 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 9, Week 1 | -1.32 Units on a scale | Standard Error 0.425 |
| PF-06826647 50 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 13, Week 2 | -1.49 Units on a scale | Standard Error 0.433 |
| PF-06826647 100 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 11, Week 1 | -1.11 Units on a scale | Standard Error 0.392 |
| PF-06826647 100 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 2, Week 1 | -0.64 Units on a scale | Standard Error 0.331 |
| PF-06826647 100 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 3, Week 1 | -0.90 Units on a scale | Standard Error 0.325 |
| PF-06826647 100 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 4, Week 1 | -0.89 Units on a scale | Standard Error 0.323 |
| PF-06826647 100 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 5, Week 1 | -1.12 Units on a scale | Standard Error 0.324 |
| PF-06826647 100 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 6, Week 1 | -0.81 Units on a scale | Standard Error 0.336 |
| PF-06826647 100 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 7, Week 1 | -0.86 Units on a scale | Standard Error 0.372 |
| PF-06826647 100 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 8, Week 1 | -0.92 Units on a scale | Standard Error 0.371 |
| PF-06826647 100 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 9, Week 1 | -1.08 Units on a scale | Standard Error 0.394 |
| PF-06826647 100 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 10, Week 1 | -1.01 Units on a scale | Standard Error 0.384 |
| PF-06826647 100 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 12, Week 2 | -0.92 Units on a scale | Standard Error 0.39 |
| PF-06826647 100 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 13, Week 2 | -1.15 Units on a scale | Standard Error 0.397 |
| PF-06826647 100 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 14, Week 2 | -1.21 Units on a scale | Standard Error 0.426 |
| PF-06826647 100 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 15, Week 2 | -1.18 Units on a scale | Standard Error 0.417 |
| PF-06826647 100 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 16, Week 2 | -1.13 Units on a scale | Standard Error 0.426 |
| PF-06826647 100 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Week 4 | -1.64 Units on a scale | Standard Error 0.477 |
| PF-06826647 100 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Week 8 | -1.93 Units on a scale | Standard Error 0.517 |
| PF-06826647 100 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Week 12 | -2.18 Units on a scale | Standard Error 0.599 |
| PF-06826647 100 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Week 16 | -2.14 Units on a scale | Standard Error 0.604 |
| PF-06826647 200 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 9, Week 1 | -1.50 Units on a scale | Standard Error 0.278 |
| PF-06826647 200 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 13, Week 2 | -2.18 Units on a scale | Standard Error 0.28 |
| PF-06826647 200 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 8, Week 1 | -1.65 Units on a scale | Standard Error 0.261 |
| PF-06826647 200 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Week 12 | -3.92 Units on a scale | Standard Error 0.433 |
| PF-06826647 200 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 14, Week 2 | -2.15 Units on a scale | Standard Error 0.302 |
| PF-06826647 200 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 7, Week 1 | -1.75 Units on a scale | Standard Error 0.261 |
| PF-06826647 200 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 15, Week 2 | -2.20 Units on a scale | Standard Error 0.294 |
| PF-06826647 200 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 6, Week 1 | -1.49 Units on a scale | Standard Error 0.235 |
| PF-06826647 200 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 16, Week 2 | -2.29 Units on a scale | Standard Error 0.301 |
| PF-06826647 200 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 5, Week 1 | -1.26 Units on a scale | Standard Error 0.223 |
| PF-06826647 200 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 2, Week 1 | -0.76 Units on a scale | Standard Error 0.229 |
| PF-06826647 200 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Week 4 | -2.90 Units on a scale | Standard Error 0.337 |
| PF-06826647 200 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 4, Week 1 | -1.24 Units on a scale | Standard Error 0.224 |
| PF-06826647 200 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Week 8 | -4.10 Units on a scale | Standard Error 0.374 |
| PF-06826647 200 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 11, Week 1 | -1.67 Units on a scale | Standard Error 0.278 |
| PF-06826647 200 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 10, Week 1 | -1.63 Units on a scale | Standard Error 0.272 |
| PF-06826647 200 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 3, Week 1 | -0.83 Units on a scale | Standard Error 0.23 |
| PF-06826647 200 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 12, Week 2 | -1.93 Units on a scale | Standard Error 0.275 |
| PF-06826647 200 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Week 16 | -4.40 Units on a scale | Standard Error 0.435 |
| PF-06826647 400 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 3, Week 1 | -0.88 Units on a scale | Standard Error 0.239 |
| PF-06826647 400 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 12, Week 2 | -1.39 Units on a scale | Standard Error 0.289 |
| PF-06826647 400 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 13, Week 2 | -1.61 Units on a scale | Standard Error 0.296 |
| PF-06826647 400 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 8, Week 1 | -1.21 Units on a scale | Standard Error 0.276 |
| PF-06826647 400 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 11, Week 1 | -1.27 Units on a scale | Standard Error 0.291 |
| PF-06826647 400 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Week 4 | -2.57 Units on a scale | Standard Error 0.354 |
| PF-06826647 400 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 4, Week 1 | -1.04 Units on a scale | Standard Error 0.236 |
| PF-06826647 400 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 14, Week 2 | -1.81 Units on a scale | Standard Error 0.317 |
| PF-06826647 400 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 7, Week 1 | -1.11 Units on a scale | Standard Error 0.273 |
| PF-06826647 400 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 10, Week 1 | -1.46 Units on a scale | Standard Error 0.286 |
| PF-06826647 400 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Week 12 | -4.27 Units on a scale | Standard Error 0.442 |
| PF-06826647 400 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Week 16 | -4.59 Units on a scale | Standard Error 0.44 |
| PF-06826647 400 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 15, Week 2 | -1.83 Units on a scale | Standard Error 0.309 |
| PF-06826647 400 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 6, Week 1 | -1.34 Units on a scale | Standard Error 0.25 |
| PF-06826647 400 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 9, Week 1 | -1.43 Units on a scale | Standard Error 0.292 |
| PF-06826647 400 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 2, Week 1 | -0.41 Units on a scale | Standard Error 0.241 |
| PF-06826647 400 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Week 8 | -4.12 Units on a scale | Standard Error 0.381 |
| PF-06826647 400 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 16, Week 2 | -1.80 Units on a scale | Standard Error 0.314 |
| PF-06826647 400 mg QD Group | Change From Baseline in Peak-Pruritus Numerical Rating Scale (PP-NRS) Scores, Up to Week 16 - Investigational Treatment Period | Study Day 5, Week 1 | -1.08 Units on a scale | Standard Error 0.237 |
Comparison: The analysis was based on the data at Week 16.90% CI: [-2.52, 0.09]
Comparison: The analysis was based on the data at Week 16.90% CI: [-2.46, 0.05]
Comparison: The analysis was based on the data at Week 16.90% CI: [-4.51, -2.43]
Comparison: The analysis was based on the data at Week 16.90% CI: [-4.71, -2.61]
Secondary
Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. The statistical analysis was for the data at Week 16.
Time frame: Baseline up to Week 16
Population: The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed) and who had observed data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 1 | -1.88 Units on a scale | Standard Error 0.697 |
| Placebo QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 16 | -7.88 Units on a scale | Standard Error 1.417 |
| Placebo QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 12 | -8.09 Units on a scale | Standard Error 1.364 |
| Placebo QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 4 | -5.08 Units on a scale | Standard Error 1.108 |
| Placebo QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 2 | -3.44 Units on a scale | Standard Error 0.959 |
| Placebo QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 6 | -6.02 Units on a scale | Standard Error 1.268 |
| Placebo QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 8 | -7.43 Units on a scale | Standard Error 1.333 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 8 | -7.55 Units on a scale | Standard Error 1.827 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 6 | -6.96 Units on a scale | Standard Error 1.737 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 2 | -3.83 Units on a scale | Standard Error 1.33 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 1 | -2.82 Units on a scale | Standard Error 0.969 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 12 | -8.58 Units on a scale | Standard Error 1.863 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 4 | -5.16 Units on a scale | Standard Error 1.528 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 16 | -9.34 Units on a scale | Standard Error 1.932 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 6 | -7.53 Units on a scale | Standard Error 1.769 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 1 | -1.96 Units on a scale | Standard Error 0.984 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 2 | -3.24 Units on a scale | Standard Error 1.356 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 4 | -4.68 Units on a scale | Standard Error 1.553 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 8 | -9.29 Units on a scale | Standard Error 1.847 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 12 | -10.02 Units on a scale | Standard Error 1.861 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 16 | -11.42 Units on a scale | Standard Error 1.928 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 4 | -12.25 Units on a scale | Standard Error 1.065 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 8 | -15.74 Units on a scale | Standard Error 1.274 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 2 | -0.804 Units on a scale | Standard Error 0.926 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 16 | -17.68 Units on a scale | Standard Error 1.354 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 12 | -16.79 Units on a scale | Standard Error 1.3 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 1 | -4.32 Units on a scale | Standard Error 0.676 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 6 | -14.45 Units on a scale | Standard Error 1.212 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 4 | -12.16 Units on a scale | Standard Error 1.114 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 16 | -20.21 Units on a scale | Standard Error 1.387 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 12 | -19.69 Units on a scale | Standard Error 1.34 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 8 | -17.12 Units on a scale | Standard Error 1.324 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 2 | -7.40 Units on a scale | Standard Error 0.97 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 1 | -3.00 Units on a scale | Standard Error 0.708 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 6 | -14.78 Units on a scale | Standard Error 1.268 |
Comparison: The analysis was based on the data at Week 16.90% CI: [-5.42, 2.51]
Comparison: The analysis was based on the data at Week 16.90% CI: [-7.5, 0.42]
Comparison: The analysis was based on the data at Week 16.90% CI: [-13.05, -6.56]
Comparison: The analysis was based on the data at Week 16.90% CI: [-15.61, -9.04]
Secondary
Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period
The Psoriasis Symptom Inventory (PSI) is a self administered 8-item questionnaire that measures the severity of psoriasis symptoms over the past 24 hours and the past 7 days. The measure includes concepts of itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Participants were asked to respond to each item using a 5-point Likert response scale: 0: not all severe, 1: mild, 2: moderate, 3: severe and 4: very severe. The outcome of PSI is the sum of the scores for the 8 items. The total score range of PSI is 0-32. A negative change from baseline means a better outcome and the bigger score decrease means a better outcome. The statistical analysis was for the data at Week 16.
Time frame: Baseline up to Week 16
Population: The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed) and who had observed data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 12, Week 2 | -3.04 Unit on a scale | Standard Error 0.763 |
| Placebo QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 6, Week 1 | -3.01 Unit on a scale | Standard Error 0.716 |
| Placebo QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 13, Week 2 | -2.94 Unit on a scale | Standard Error 0.781 |
| Placebo QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 3, Week 1 | -2.70 Unit on a scale | Standard Error 0.653 |
| Placebo QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 16, Week 2 | -3.27 Unit on a scale | Standard Error 0.847 |
| Placebo QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Week 8 | -3.45 Unit on a scale | Standard Error 1.069 |
| Placebo QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 7, Week 1 | -3.23 Unit on a scale | Standard Error 0.77 |
| Placebo QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 10, Week 1 | -3.29 Unit on a scale | Standard Error 0.781 |
| Placebo QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 11, Week 1 | -2.89 Unit on a scale | Standard Error 0.825 |
| Placebo QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Week 12 | -2.27 Unit on a scale | Standard Error 1.208 |
| Placebo QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 15, Week 2 | -2.71 Unit on a scale | Standard Error 0.83 |
| Placebo QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 8, Week 1 | -3.27 Unit on a scale | Standard Error 0.768 |
| Placebo QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 5, Week 1 | -2.55 Unit on a scale | Standard Error 0.692 |
| Placebo QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 4, Week 1 | -2.88 Unit on a scale | Standard Error 0.666 |
| Placebo QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Week 16 | -1.87 Unit on a scale | Standard Error 1.26 |
| Placebo QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 14, Week 2 | -3.25 Unit on a scale | Standard Error 0.793 |
| Placebo QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 9, Week 1 | -3.11 Unit on a scale | Standard Error 0.788 |
| Placebo QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Week 4 | -2.53 Unit on a scale | Standard Error 0.99 |
| Placebo QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 2, Week 1 | -1.51 Unit on a scale | Standard Error 0.636 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Week 12 | -5.65 Unit on a scale | Standard Error 1.722 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 13, Week 2 | -5.61 Unit on a scale | Standard Error 1.149 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 10, Week 1 | -4.24 Unit on a scale | Standard Error 1.15 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 12, Week 2 | -4.54 Unit on a scale | Standard Error 1.118 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 11, Week 1 | -4.72 Unit on a scale | Standard Error 1.216 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 4, Week 1 | -3.05 Unit on a scale | Standard Error 0.985 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Week 16 | -6.07 Unit on a scale | Standard Error 1.782 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Week 8 | -4.09 Unit on a scale | Standard Error 1.536 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Week 4 | -4.83 Unit on a scale | Standard Error 1.449 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 5, Week 1 | -3.18 Unit on a scale | Standard Error 1.032 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 16, Week 2 | -5.03 Unit on a scale | Standard Error 1.25 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 6, Week 1 | -3.98 Unit on a scale | Standard Error 1.058 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 7, Week 1 | -4.34 Unit on a scale | Standard Error 1.134 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 3, Week 1 | -1.95 Unit on a scale | Standard Error 0.952 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 15, Week 2 | -4.98 Unit on a scale | Standard Error 1.227 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 8, Week 1 | -4.38 Unit on a scale | Standard Error 1.137 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 2, Week 1 | -0.89 Unit on a scale | Standard Error 0.927 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 14, Week 2 | -5.84 Unit on a scale | Standard Error 1.162 |
| PF-06826647 50 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 9, Week 1 | -3.95 Unit on a scale | Standard Error 1.159 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 13, Week 2 | -4.79 Unit on a scale | Standard Error 1.055 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 2, Week 1 | -1.98 Unit on a scale | Standard Error 0.88 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 3, Week 1 | -3.65 Unit on a scale | Standard Error 0.879 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 4, Week 1 | -3.95 Unit on a scale | Standard Error 0.915 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 5, Week 1 | -3.87 Unit on a scale | Standard Error 0.959 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 6, Week 1 | -3.94 Unit on a scale | Standard Error 0.981 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 7, Week 1 | -4.08 Unit on a scale | Standard Error 1.059 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 8, Week 1 | -4.65 Unit on a scale | Standard Error 1.042 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 9, Week 1 | -4.54 Unit on a scale | Standard Error 1.078 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 10, Week 1 | -4.15 Unit on a scale | Standard Error 1.055 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 11, Week 1 | -4.41 Unit on a scale | Standard Error 1.111 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 12, Week 2 | -4.65 Unit on a scale | Standard Error 1.027 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 14, Week 2 | -5.22 Unit on a scale | Standard Error 1.065 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 15, Week 2 | -5.23 Unit on a scale | Standard Error 1.123 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 16, Week 2 | -4.83 Unit on a scale | Standard Error 1.15 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Week 4 | -6.58 Unit on a scale | Standard Error 1.338 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Week 8 | -7.30 Unit on a scale | Standard Error 1.407 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Week 12 | -7.35 Unit on a scale | Standard Error 1.572 |
| PF-06826647 100 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Week 16 | -8.31 Unit on a scale | Standard Error 1.661 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 7, Week 1 | -6.42 Unit on a scale | Standard Error 0.74 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 5, Week 1 | -5.40 Unit on a scale | Standard Error 0.661 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 8, Week 1 | -6.23 Unit on a scale | Standard Error 0.731 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 2, Week 1 | -2.54 Unit on a scale | Standard Error 0.605 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Week 4 | -9.14 Unit on a scale | Standard Error 0.943 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 4, Week 1 | -4.61 Unit on a scale | Standard Error 0.637 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Week 12 | -11.50 Unit on a scale | Standard Error 1.146 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Week 8 | -11.63 Unit on a scale | Standard Error 1.022 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 15, Week 2 | -7.84 Unit on a scale | Standard Error 0.793 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 14, Week 2 | -8.12 Unit on a scale | Standard Error 0.757 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 3, Week 1 | -3.45 Unit on a scale | Standard Error 0.624 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 6, Week 1 | -5.43 Unit on a scale | Standard Error 0.684 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 9, Week 1 | -5.71 Unit on a scale | Standard Error 0.756 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 11, Week 1 | -7.06 Unit on a scale | Standard Error 0.787 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 13, Week 2 | -7.94 Unit on a scale | Standard Error 0.742 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Week 16 | -12.38 Unit on a scale | Standard Error 1.205 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 12, Week 2 | -7.10 Unit on a scale | Standard Error 0.726 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 16, Week 2 | -8.12 Unit on a scale | Standard Error 0.81 |
| PF-06826647 200 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 10, Week 1 | -6.22 Unit on a scale | Standard Error 0.747 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 16, Week 2 | -7.45 Unit on a scale | Standard Error 0.836 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 13, Week 2 | -7.16 Unit on a scale | Standard Error 0.776 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 8, Week 1 | -5.67 Unit on a scale | Standard Error 0.762 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 14, Week 2 | -7.09 Unit on a scale | Standard Error 0.784 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 7, Week 1 | -4.90 Unit on a scale | Standard Error 0.763 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 6, Week 1 | -4.77 Unit on a scale | Standard Error 0.717 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Week 12 | -13.42 Unit on a scale | Standard Error 1.145 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 15, Week 2 | -7.47 Unit on a scale | Standard Error 0.821 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 5, Week 1 | -3.93 Unit on a scale | Standard Error 0.696 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 2, Week 1 | -1.25 Unit on a scale | Standard Error 0.639 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 9, Week 1 | -5.70 Unit on a scale | Standard Error 0.782 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 4, Week 1 | -4.28 Unit on a scale | Standard Error 0.665 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Week 16 | -12.68 Unit on a scale | Standard Error 1.191 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Week 8 | -12.19 Unit on a scale | Standard Error 1.026 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 3, Week 1 | -2.79 Unit on a scale | Standard Error 0.65 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Week 4 | -9.02 Unit on a scale | Standard Error 0.978 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 11, Week 1 | -6.03 Unit on a scale | Standard Error 0.812 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 10, Week 1 | -6.02 Unit on a scale | Standard Error 0.776 |
| PF-06826647 400 mg QD Group | Change From Baseline in Psoriasis Symptom Inventory (PSI) Up to Week 16 - Investigational Treatment Period | Study Day 12, Week 2 | -6.62 Unit on a scale | Standard Error 0.753 |
Comparison: The analysis was based on the data at Week 16.90% CI: [-7.82, -0.59]
Comparison: The analysis was based on the data at Week 16.90% CI: [-9.89, -2.99]
Comparison: The analysis was based on the data at Week 16.90% CI: [-13.4, -7.62]
Comparison: The analysis was based on the data at Week 16.90% CI: [-13.68, -7.94]
Secondary
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period
Criteria for ECG abnormalities: Criteria for ECG abnormalities: maximum PR interval \>=300 milliseconds (msec) and maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) \>=25 percent (%) for baseline value of \>200 msec and Pctchg\>=50% for baseline value of \<=200 msec for PR interval, maximum QRS interval \>=140 msec and a maximum IFB: Pctchg\>=50%, maximum QTcF interval (Fridericia's Correction) of 450 msec to \<=480 msec, 480 msec to \<=500 msec and a maximum change of \<30change\<=60 or \>60 msec from baseline.
Time frame: Baseline up to Week 16
Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and who had at least 1 ECG assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | PR interval, single beat (msec) >=300 | 1 Participants |
| Placebo QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | PR interval, single beat (msec) Pctchg >=25/50% | 0 Participants |
| Placebo QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | QRS duration, single beat (msec) >=140 | 1 Participants |
| Placebo QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | QRS duration, single beat (msec) Pctchg >=50% | 1 Participants |
| Placebo QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | 450< QTcF- Fridericia's correction formula (msec) <=480 | 1 Participants |
| Placebo QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | 480< QTcF- Fridericia's correction formula (msec) <=500 | 1 Participants |
| Placebo QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | 30< QTcF- Fridericia's correction formula (msec) change <=60 | 0 Participants |
| Placebo QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | QTcF- Fridericia's correction formula (msec) change >60 | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | QRS duration, single beat (msec) >=140 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | 480< QTcF- Fridericia's correction formula (msec) <=500 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | PR interval, single beat (msec) >=300 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | QRS duration, single beat (msec) Pctchg >=50% | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | PR interval, single beat (msec) Pctchg >=25/50% | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | QTcF- Fridericia's correction formula (msec) change >60 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | 450< QTcF- Fridericia's correction formula (msec) <=480 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | 30< QTcF- Fridericia's correction formula (msec) change <=60 | 1 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | 30< QTcF- Fridericia's correction formula (msec) change <=60 | 1 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | QTcF- Fridericia's correction formula (msec) change >60 | 1 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | QRS duration, single beat (msec) Pctchg >=50% | 1 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | 480< QTcF- Fridericia's correction formula (msec) <=500 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | QRS duration, single beat (msec) >=140 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | PR interval, single beat (msec) Pctchg >=25/50% | 2 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | PR interval, single beat (msec) >=300 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | 450< QTcF- Fridericia's correction formula (msec) <=480 | 2 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | PR interval, single beat (msec) Pctchg >=25/50% | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | QRS duration, single beat (msec) >=140 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | QRS duration, single beat (msec) Pctchg >=50% | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | 450< QTcF- Fridericia's correction formula (msec) <=480 | 2 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | 480< QTcF- Fridericia's correction formula (msec) <=500 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | QTcF- Fridericia's correction formula (msec) change >60 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | PR interval, single beat (msec) >=300 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | 30< QTcF- Fridericia's correction formula (msec) change <=60 | 1 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | QRS duration, single beat (msec) Pctchg >=50% | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | QTcF- Fridericia's correction formula (msec) change >60 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | QRS duration, single beat (msec) >=140 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | 30< QTcF- Fridericia's correction formula (msec) change <=60 | 2 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | PR interval, single beat (msec) >=300 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | 480< QTcF- Fridericia's correction formula (msec) <=500 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | PR interval, single beat (msec) Pctchg >=25/50% | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | 450< QTcF- Fridericia's correction formula (msec) <=480 | 0 Participants |
Secondary
Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Following clinical chemistry parameters were analyzed for laboratory examination: bilirubin, indirect bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, alkaline phosphatase, protein, albumin, blood urea nitrogen, urea, creatinine, urate, high-density lipoprotein (HDL) cholesterol, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, and cholesterol. LLN=lower limit of normal; ULN=upper limit of normal.
Time frame: Baseline up to Week 16.
Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo), with a normal baseline with at least one observation of the given laboratory test while on study treatment or during lag time up to week 16.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Bicarbonate (Meq/L) <0.9*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Protein (g/dL) <0.8*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urate (mg/dL) >1.2*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Sodium (Meq/L) >1.05*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Calcium (mg/dL) >1.1*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Protein (g/dL) >1.2*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Cholesterol (mg/dL) >1.3*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | HDL Cholesterol (mg/dL) <0.8*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Glucose (mg/dL) <0.6*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Calcium (mg/dL) <0.9*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Albumin (g/dL) <0.8*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Gamma Glutamyl Transferase (U/L) > 3.0*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Creatine Kinase (U/L) >2.0*ULN | 3 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Potassium (Meq/L) <0.9*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Chloride (Meq/L) >1.1*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Albumin (g/dL) >1.2*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Indirect Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Aspartate Aminotransferase (U/L) > 3.0*ULN | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Alanine Aminotransferase (U/L) > 3.0*ULN | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Chloride (Meq/L) <0.9*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Blood Urea Nitrogen (mg/dL) >1.3*ULN | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Bicarbonate (Meq/L) >1.1*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Alkaline Phosphatase (U/L) > 3.0*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Glucose (mg/dL) >1.5*ULN | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Potassium (Meq/L) >1.1*ULN | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Sodium (Meq/L) <0.95*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Creatinine (mg/dL) >1.3*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Triglycerides (mg/dL) >1.3*ULN | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Creatinine (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Potassium (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urate (mg/dL) >1.2*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Sodium (Meq/L) >1.05*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | HDL Cholesterol (mg/dL) <0.8*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Sodium (Meq/L) <0.95*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Triglycerides (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Alanine Aminotransferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Glucose (mg/dL) <0.6*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Gamma Glutamyl Transferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Bicarbonate (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Alkaline Phosphatase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Indirect Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Bicarbonate (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Protein (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Calcium (mg/dL) >1.1*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Protein (g/dL) >1.2*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Creatine Kinase (U/L) >2.0*ULN | 3 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Calcium (mg/dL) <0.9*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Albumin (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Chloride (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Albumin (g/dL) >1.2*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Chloride (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Blood Urea Nitrogen (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Aspartate Aminotransferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Potassium (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Cholesterol (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Glucose (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Triglycerides (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Indirect Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Aspartate Aminotransferase (U/L) > 3.0*ULN | 1 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Alanine Aminotransferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Gamma Glutamyl Transferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Alkaline Phosphatase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Protein (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Protein (g/dL) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Albumin (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Albumin (g/dL) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Blood Urea Nitrogen (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urea (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Creatinine (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urate (mg/dL) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | HDL Cholesterol (mg/dL) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Sodium (Meq/L) <0.95*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Sodium (Meq/L) >1.05*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Potassium (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Potassium (Meq/L) >1.1*ULN | 1 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Chloride (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Chloride (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Calcium (mg/dL) <0.9*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Calcium (mg/dL) >1.1*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Bicarbonate (Meq/L) <0.9*LLN | 1 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Bicarbonate (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Glucose (mg/dL) <0.6*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Glucose (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Creatine Kinase (U/L) >2.0*ULN | 2 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Cholesterol (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Glucose (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Potassium (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Blood Urea Nitrogen (mg/dL) >1.3*ULN | 2 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Potassium (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Albumin (g/dL) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Chloride (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Albumin (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Indirect Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Chloride (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Protein (g/dL) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Cholesterol (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Calcium (mg/dL) <0.9*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Protein (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Creatine Kinase (U/L) >2.0*ULN | 9 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Calcium (mg/dL) >1.1*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Alkaline Phosphatase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Bicarbonate (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Gamma Glutamyl Transferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Bicarbonate (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Alanine Aminotransferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Glucose (mg/dL) <0.6*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Triglycerides (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | HDL Cholesterol (mg/dL) <0.8*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Aspartate Aminotransferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Sodium (Meq/L) <0.95*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urate (mg/dL) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Sodium (Meq/L) >1.05*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Creatinine (mg/dL) >1.3*ULN | 1 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urate (mg/dL) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Creatine Kinase (U/L) >2.0*ULN | 15 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Potassium (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Blood Urea Nitrogen (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Triglycerides (mg/dL) >1.3*ULN | 3 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Glucose (mg/dL) >1.5*ULN | 1 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Bicarbonate (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Potassium (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Albumin (g/dL) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Gamma Glutamyl Transferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Indirect Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | HDL Cholesterol (mg/dL) <0.8*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Chloride (Meq/L) <0.9*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Albumin (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Bilirubin (mg/dL) >1.5*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Sodium (Meq/L) >1.05*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Bicarbonate (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Chloride (Meq/L) >1.1*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Protein (g/dL) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Alanine Aminotransferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Cholesterol (mg/dL) >1.3*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Creatinine (mg/dL) >1.3*ULN | 1 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Calcium (mg/dL) <0.9*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Protein (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Sodium (Meq/L) <0.95*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Glucose (mg/dL) <0.6*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Aspartate Aminotransferase (U/L) > 3.0*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Calcium (mg/dL) >1.1*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Chemistry (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Alkaline Phosphatase (U/L) > 3.0*ULN | 0 Participants |
Secondary
Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Following hematology parameters were analyzed for laboratory examination: hemoglobin (HGB), hematocrit, erythrocytes (Ery.), reticulocytes, Ery. mean corpuscular volume, Ery. mean corpuscular HGB, Ery. mean corpuscular HGB concentration, platelets, reticulocytes/erythrocytes, leukocytes, lymphocytes/leukocytes, neutrophils/leukocytes, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes, activated partial thromboplastin time, prothrombin time, neutrophils total count, and lymphocytes total count. LLN=lower limit of normal; ULN=upper limit of normal.
Time frame: Baseline up to Week 16
Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo), with a normal baseline with at least one observation of the given laboratory test while on study treatment or during lag time up to week 16.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Lymphocytes total count (10^3/mm^3) >1.2*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Monocytes/Leukocytes (%) >1.2*ULN | 2 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular HGB (pg/cell) <0.9*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Lymphocytes/Leukocytes (%) <0.8*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Neutrophils total count (10^3/mm^3) >1.2*ULN | 3 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Neutrophils total count (10^3/mm^3) <0.8*LLN | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Monocytes (10^3/mm^3) >1.2*ULN | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Reticulocytes (10^3/mm^3) >1.5*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Lymphocytes total count (10^3/mm^3) <0.8*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Leukocytes(10^3/mm^3) <0.6*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Eosinophils/Leukocytes (%) >1.2*ULN | 2 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Hematocrit (%) <0.8*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Erythrocytes (10^6/mm^3) <0.8*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Reticulocytes/Erythrocytes (%) >1.5*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Eosinophils (10^3/mm^3) >1.2*ULN | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Prothrombin Time (sec) >1.1*ULN | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular Volume (um^3) <0.9*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Neutrophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Basophils/Leukocytes (%) >1.2*ULN | 2 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Platelets (10^3/mm^3) <0.5*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Lymphocytes/Leukocytes (%) >1.2*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Reticulocytes (10^3/mm^3) <0.5*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Activated Partial Thromboplastin Time (sec) >1.1*ULN | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Basophils (10^3/mm^3) >1.2*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Platelets (10^3/mm^3) >1.75*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular Volume (um^3) >1.1*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Leukocytes(10^3/mm^3) >1.5*ULN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | HGB (g/dL) <0.8*LLN | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Neutrophils/Leukocytes (%) <0.8*LLN | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Reticulocytes/Erythrocytes (%) <0.5*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Neutrophils/Leukocytes (%) <0.8*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Reticulocytes/Erythrocytes (%) >1.5*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Lymphocytes/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Leukocytes(10^3/mm^3) <0.6*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Reticulocytes (10^3/mm^3) <0.5*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Lymphocytes/Leukocytes (%) <0.8*LLN | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Leukocytes(10^3/mm^3) >1.5*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Neutrophils total count (10^3/mm^3) <0.8*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Reticulocytes (10^3/mm^3) >1.5*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Prothrombin Time (sec) >1.1*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular Volume (um^3) <0.9*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Hematocrit (%) <0.8*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Activated Partial Thromboplastin Time (sec) >1.1*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular Volume (um^3) >1.1*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | HGB (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Monocytes/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular HGB (pg/cell) <0.9*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Lymphocytes total count (10^3/mm^3) <0.8*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Monocytes (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Reticulocytes/Erythrocytes (%) <0.5*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Eosinophils/Leukocytes (%) >1.2*ULN | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Eosinophils (10^3/mm^3) >1.2*ULN | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Erythrocytes (10^6/mm^3) <0.8*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Basophils/Leukocytes (%) >1.2*ULN | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Platelets (10^3/mm^3) <0.5*LLN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Lymphocytes total count (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Basophils (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Platelets (10^3/mm^3) >1.75*ULN | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Neutrophils total count (10^3/mm^3) >1.2*ULN | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Neutrophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Neutrophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | HGB (g/dL) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Hematocrit (%) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Erythrocytes (10^6/mm^3) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Reticulocytes (10^3/mm^3) <0.5*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Reticulocytes (10^3/mm^3) >1.5*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular Volume (um^3) <0.9*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular Volume (um^3) >1.1*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular HGB (pg/cell) <0.9*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Platelets (10^3/mm^3) <0.5*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Platelets (10^3/mm^3) >1.75*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Reticulocytes/Erythrocytes (%) <0.5*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Reticulocytes/Erythrocytes (%) >1.5*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Leukocytes(10^3/mm^3) <0.6*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Leukocytes(10^3/mm^3) >1.5*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Lymphocytes/Leukocytes (%) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Lymphocytes/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Neutrophils/Leukocytes (%) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Basophils (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Basophils/Leukocytes (%) >1.2*ULN | 1 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Eosinophils (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Eosinophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Monocytes (10^3/mm^3) >1.2*ULN | 1 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Monocytes/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Activated Partial Thromboplastin Time (sec) >1.1*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Prothrombin Time (sec) >1.1*ULN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Neutrophils total count (10^3/mm^3) <0.8*LLN | 2 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Neutrophils total count (10^3/mm^3) >1.2*ULN | 1 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Lymphocytes total count (10^3/mm^3) <0.8*LLN | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Lymphocytes total count (10^3/mm^3) >1.2*ULN | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Lymphocytes total count (10^3/mm^3) <0.8*LLN | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Monocytes/Leukocytes (%) >1.2*ULN | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Neutrophils total count (10^3/mm^3) >1.2*ULN | 2 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular Volume (um^3) <0.9*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Basophils (10^3/mm^3) >1.2*ULN | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Activated Partial Thromboplastin Time (sec) >1.1*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Eosinophils (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Neutrophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Reticulocytes (10^3/mm^3) >1.5*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Reticulocytes/Erythrocytes (%) <0.5*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Prothrombin Time (sec) >1.1*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Hematocrit (%) <0.8*LLN | 2 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Reticulocytes (10^3/mm^3) <0.5*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | HGB (g/dL) <0.8*LLN | 2 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Neutrophils total count (10^3/mm^3) <0.8*LLN | 3 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Eosinophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Leukocytes(10^3/mm^3) >1.5*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Platelets (10^3/mm^3) >1.75*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular HGB (pg/cell) <0.9*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Lymphocytes/Leukocytes (%) <0.8*LLN | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Lymphocytes total count (10^3/mm^3) >1.2*ULN | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Leukocytes(10^3/mm^3) <0.6*LLN | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Monocytes (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Erythrocytes (10^6/mm^3) <0.8*LLN | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Lymphocytes/Leukocytes (%) >1.2*ULN | 3 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Basophils/Leukocytes (%) >1.2*ULN | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Reticulocytes/Erythrocytes (%) >1.5*ULN | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Platelets (10^3/mm^3) <0.5*LLN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular Volume (um^3) >1.1*ULN | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Neutrophils/Leukocytes (%) <0.8*LLN | 2 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Reticulocytes (10^3/mm^3) >1.5*ULN | 2 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Platelets (10^3/mm^3) >1.75*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Neutrophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Platelets (10^3/mm^3) <0.5*LLN | 1 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Basophils (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) >1.1*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Neutrophils total count (10^3/mm^3) >1.2*ULN | 2 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Basophils/Leukocytes (%) >1.2*ULN | 1 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular HGB Concentration (g/dL) <0.9*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Hematocrit (%) <0.8*LLN | 3 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Eosinophils (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular Hemoglobin (pg/cell) >1.1*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Eosinophils/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular HGB (pg/cell) <0.9*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Monocytes (10^3/mm^3) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular Volume (um^3) >1.1*ULN | 1 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Monocytes/Leukocytes (%) >1.2*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Ery. Mean Corpuscular Volume (um^3) <0.9*LLN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Lymphocytes total count (10^3/mm^3) <0.8*LLN | 1 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Activated Partial Thromboplastin Time (sec) >1.1*ULN | 1 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Neutrophils/Leukocytes (%) <0.8*LLN | 2 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | HGB (g/dL) <0.8*LLN | 3 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Prothrombin Time (sec) >1.1*ULN | 3 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Reticulocytes (10^3/mm^3) <0.5*LLN | 2 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Neutrophils total count (10^3/mm^3) <0.8*LLN | 4 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Leukocytes(10^3/mm^3) >1.5*ULN | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Leukocytes(10^3/mm^3) <0.6*LLN | 1 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Erythrocytes (10^6/mm^3) <0.8*LLN | 4 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Lymphocytes/Leukocytes (%) <0.8*LLN | 3 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Reticulocytes/Erythrocytes (%) >1.5*ULN | 2 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Lymphocytes/Leukocytes (%) >1.2*ULN | 4 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Reticulocytes/Erythrocytes (%) <0.5*LLN | 2 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Hematology (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Lymphocytes total count (10^3/mm^3) >1.2*ULN | 1 Participants |
Secondary
Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period
Following urinalysis parameters were analyzed for laboratory examination: urine pH, urine glucose, urine ketones, urine protein, urine hemoglobin, urine urobilinogen, urine bilirubin, urine nitrite, urine leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline, and urine bacteria.
Time frame: Baseline up to Week 16
Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo), with a normal baseline with at least one observation of the given laboratory test while on study treatment or during lag time up to week 16.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine pH (Scalar) <4.5 | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Urobilinogen (EU/dL) >=1 | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Nitrite (Scalar) >=1 | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Bilirubin (Scalar) >=1 | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Hyaline Casts (/LPF) >1 | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Glucose >=1 | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Leukocytes (/HPF) >=20 | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Ketones (Scalar) >=1 | 2 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Bacteria (/LPF) >20 | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Erythrocytes (Scalar) >=20 | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Protein >=1 | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine pH (Scalar) >8 | 0 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Leukocyte Esterase (Scalar) >=1 | 1 Participants |
| Placebo QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Hemoglobin (Scalar) >=1 | 3 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Hemoglobin (Scalar) >=1 | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Nitrite (Scalar) >=1 | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Protein >=1 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Urobilinogen (EU/dL) >=1 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine pH (Scalar) <4.5 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Ketones (Scalar) >=1 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Bilirubin (Scalar) >=1 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine pH (Scalar) >8 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Hyaline Casts (/LPF) >1 | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Erythrocytes (Scalar) >=20 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Leukocyte Esterase (Scalar) >=1 | 2 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Glucose >=1 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Bacteria (/LPF) >20 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Leukocytes (/HPF) >=20 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Nitrite (Scalar) >=1 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine pH (Scalar) <4.5 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine pH (Scalar) >8 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Glucose >=1 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Ketones (Scalar) >=1 | 1 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Protein >=1 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Hemoglobin (Scalar) >=1 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Urobilinogen (EU/dL) >=1 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Bilirubin (Scalar) >=1 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Leukocyte Esterase (Scalar) >=1 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Erythrocytes (Scalar) >=20 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Leukocytes (/HPF) >=20 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Bacteria (/LPF) >20 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Leukocyte Esterase (Scalar) >=1 | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Glucose >=1 | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Bacteria (/LPF) >20 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Leukocytes (/HPF) >=20 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Nitrite (Scalar) >=1 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Protein >=1 | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine pH (Scalar) >8 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Hyaline Casts (/LPF) >1 | 3 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Ketones (Scalar) >=1 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine pH (Scalar) <4.5 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Bilirubin (Scalar) >=1 | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Erythrocytes (Scalar) >=20 | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Urobilinogen (EU/dL) >=1 | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Hemoglobin (Scalar) >=1 | 4 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Erythrocytes (Scalar) >=20 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Nitrite (Scalar) >=1 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Protein >=1 | 2 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine pH (Scalar) <4.5 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Leukocyte Esterase (Scalar) >=1 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Ketones (Scalar) >=1 | 2 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Hemoglobin (Scalar) >=1 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Glucose >=1 | 1 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Leukocytes (/HPF) >=20 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine pH (Scalar) >8 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Urobilinogen (EU/dL) >=1 | 2 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Hyaline Casts (/LPF) >1 | 1 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Laboratory Test Abnormality - Urinalysis (Normal Baseline), Up to Week 16 - Investigational Treatment Period | Urine Bilirubin (Scalar) >=1 | 0 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time.
Time frame: Baseline up to Week 16
Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants with AEs | 23 Participants |
| Placebo QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants with SAEs | 0 Participants |
| Placebo QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants with severe AEs | 1 Participants |
| Placebo QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants discontinued from study due to AEs | 1 Participants |
| Placebo QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants discontinued study drug due to AE and continue study | 0 Participants |
| Placebo QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants discontinued study drug due to AE and continue study | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants with AEs | 13 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants with severe AEs | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants discontinued from study due to AEs | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants with SAEs | 1 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants discontinued from study due to AEs | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants discontinued study drug due to AE and continue study | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants with AEs | 16 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants with severe AEs | 1 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants with SAEs | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 2 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants discontinued from study due to AEs | 5 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants with SAEs | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants with severe AEs | 2 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 3 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants discontinued study drug due to AE and continue study | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants with AEs | 28 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants discontinued study drug due to AE and continue study | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants with severe AEs | 3 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants with SAEs | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 3 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants discontinued from study due to AEs | 3 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (All-Causality), Up to Week 16 - Investigational Treatment Period | Participants with AEs | 29 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period
Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug ((PF-06826647 or placebo). Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. In this outcome measure, an AE was considered treatment-emergent if the event started on or after the first dosing day and time/start time but before the last dose plus the lag time. Relatedness to investigational product (PF-06826647 or placebo) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Time frame: Baseline up to Week 16
Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants with AEs | 4 Participants |
| Placebo QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants with SAEs | 0 Participants |
| Placebo QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants with severe AEs | 0 Participants |
| Placebo QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants discontinued from study due to AEs | 0 Participants |
| Placebo QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants discontinued study drug due to AE and continue study | 0 Participants |
| Placebo QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants discontinued study drug due to AE and continue study | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants with AEs | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants with severe AEs | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants discontinued from study due to AEs | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants with SAEs | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants discontinued from study due to AEs | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants discontinued study drug due to AE and continue study | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants with AEs | 4 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants with severe AEs | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants with SAEs | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants discontinued from study due to AEs | 4 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants with SAEs | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants with severe AEs | 2 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants discontinued study drug due to AE and continue study | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants with AEs | 11 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants discontinued study drug due to AE and continue study | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants with severe AEs | 1 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants with SAEs | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants with dose reduced or temporary discontinuation due to AEs | 1 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants discontinued from study due to AEs | 3 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Treatment-Emergent Adverse Events (Treatment Related), Up to Week 16 - Investigational Treatment Period | Participants with AEs | 8 Participants |
Secondary
Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period
The vital signs were obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Criteria for vital signs abnormalities: pulse rate \>120 beats per minute (BPM), sitting diastolic blood pressure (BP) change \>=20 millimeter of mercury (mmHg) increase, sitting diastolic BP change \>=20 mmHg decrease, sitting systolic BP \<90 mmHg, sitting systolic BP change \>=30 mmHg increase, and sitting systolic BP change \>=30 mmHg decrease.
Time frame: Baseline up to Week 16
Population: The analysis population included all participants who received at least 1 dose of investigational product (PF-06826647 or placebo) and were evaluated against the criteria.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Pulse rate (BMP) >120 | 0 Participants |
| Placebo QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Sitting diastolic BP (mmHg) change >=20 increase | 4 Participants |
| Placebo QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Sitting diastolic BP (mmHg) change >=20 decrease | 4 Participants |
| Placebo QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Sitting systolic BP (mmHg) <90 increase | 0 Participants |
| Placebo QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Sitting systolic BP (mmHg) change >=30 increase | 0 Participants |
| Placebo QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Sitting systolic BP (mmHg) change >=30 decrease | 4 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Sitting systolic BP (mmHg) change >=30 increase | 1 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Sitting systolic BP (mmHg) change >=30 decrease | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Pulse rate (BMP) >120 | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Sitting diastolic BP (mmHg) change >=20 decrease | 2 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Sitting systolic BP (mmHg) <90 increase | 0 Participants |
| PF-06826647 50 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Sitting diastolic BP (mmHg) change >=20 increase | 3 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Sitting systolic BP (mmHg) <90 increase | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Sitting systolic BP (mmHg) change >=30 increase | 2 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Pulse rate (BMP) >120 | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Sitting diastolic BP (mmHg) change >=20 decrease | 0 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Sitting diastolic BP (mmHg) change >=20 increase | 1 Participants |
| PF-06826647 100 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Sitting systolic BP (mmHg) change >=30 decrease | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Sitting systolic BP (mmHg) <90 increase | 0 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Sitting diastolic BP (mmHg) change >=20 increase | 4 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Sitting diastolic BP (mmHg) change >=20 decrease | 2 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Sitting systolic BP (mmHg) change >=30 decrease | 1 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Sitting systolic BP (mmHg) change >=30 increase | 2 Participants |
| PF-06826647 200 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Pulse rate (BMP) >120 | 0 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Sitting systolic BP (mmHg) change >=30 increase | 2 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Sitting diastolic BP (mmHg) change >=20 decrease | 4 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Sitting diastolic BP (mmHg) change >=20 increase | 4 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Sitting systolic BP (mmHg) change >=30 decrease | 2 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Sitting systolic BP (mmHg) <90 increase | 1 Participants |
| PF-06826647 400 mg QD Group | Number of Participants With Vital Sign Data Meeting Pre-defined Criteria, Up to Week 16 - Investigational Treatment Period | Pulse rate (BMP) >120 | 1 Participants |
Secondary
Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period
The Psoriasis Symptom Inventory (PSI) is a self administered 8-item questionnaire that measures the severity of psoriasis symptoms over the past 24 hours and the past 7 days. The measure includes concepts of itch, pain, burning, stinging, cracking, scaling, flaking, and redness. Participants were asked to respond to each item using a 5-point Likert response scale: 0: not all severe, 1: mild, 2: moderate, 3: severe and 4: very severe. The statistical analysis was for the data at Week 16.
Time frame: Baseline up to Week 16
Population: The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 3, Week 1 | 7.1 Percentage of participants |
| Placebo QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 15, Week 2 | 4.8 Percentage of participants |
| Placebo QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Week 8 | 11.9 Percentage of participants |
| Placebo QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 16, Week 2 | 14.3 Percentage of participants |
| Placebo QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 6, Week 1 | 4.8 Percentage of participants |
| Placebo QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Week 4 | 14.3 Percentage of participants |
| Placebo QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 4, Week 1 | 9.5 Percentage of participants |
| Placebo QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 2, Week 1 | 7.1 Percentage of participants |
| Placebo QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 7, Week 1 | 9.5 Percentage of participants |
| Placebo QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 8, Week 1 | 11.9 Percentage of participants |
| Placebo QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 9, Week 1 | 9.5 Percentage of participants |
| Placebo QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Week 16 | 14.3 Percentage of participants |
| Placebo QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 10, Week 1 | 11.9 Percentage of participants |
| Placebo QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 11, Week 1 | 9.5 Percentage of participants |
| Placebo QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 5, Week 1 | 7.1 Percentage of participants |
| Placebo QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 12, Week 2 | 4.8 Percentage of participants |
| Placebo QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Week 12 | 7.1 Percentage of participants |
| Placebo QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 13, Week 2 | 11.9 Percentage of participants |
| Placebo QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 14, Week 2 | 11.9 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 5, Week 1 | 9.1 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Week 8 | 22.7 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 9, Week 1 | 9.1 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 15, Week 2 | 9.1 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 8, Week 1 | 9.1 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 2, Week 1 | 0 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 11, Week 1 | 4.5 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 4, Week 1 | 4.5 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 16, Week 2 | 13.6 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 14, Week 2 | 22.7 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 13, Week 2 | 18.2 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 3, Week 1 | 0 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Week 12 | 31.8 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Week 4 | 13.6 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 10, Week 1 | 4.5 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 6, Week 1 | 13.6 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 7, Week 1 | 9.1 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Week 16 | 27.3 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 12, Week 2 | 4.5 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Week 12 | 28.6 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 7, Week 1 | 19.0 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Week 16 | 38.1 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 8, Week 1 | 14.3 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 4, Week 1 | 14.3 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 14, Week 2 | 14.3 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 9, Week 1 | 9.5 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 3, Week 1 | 19.0 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 10, Week 1 | 19.0 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 2, Week 1 | 4.8 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 12, Week 2 | 19.0 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 13, Week 2 | 14.3 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 15, Week 2 | 14.3 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 11, Week 1 | 19.0 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 16, Week 2 | 9.5 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 5, Week 1 | 14.3 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Week 4 | 28.6 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 6, Week 1 | 19.0 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Week 8 | 23.8 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Week 4 | 44.4 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 3, Week 1 | 6.7 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 4, Week 1 | 13.3 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 5, Week 1 | 15.6 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 6, Week 1 | 20.0 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 7, Week 1 | 17.8 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 8, Week 1 | 20.0 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 9, Week 1 | 20.0 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 10, Week 1 | 24.4 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 11, Week 1 | 20.0 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 12, Week 2 | 22.2 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 13, Week 2 | 40.0 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 14, Week 2 | 33.3 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 15, Week 2 | 33.3 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 16, Week 2 | 24.4 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Week 8 | 53.3 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Week 12 | 55.6 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Week 16 | 55.6 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 2, Week 1 | 6.7 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 13, Week 2 | 26.8 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 4, Week 1 | 14.6 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Week 8 | 63.4 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 12, Week 2 | 29.3 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 11, Week 1 | 26.8 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 10, Week 1 | 19.5 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 3, Week 1 | 12.2 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Week 12 | 63.4 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 9, Week 1 | 22.0 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 8, Week 1 | 19.5 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 7, Week 1 | 19.5 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 2, Week 1 | 12.2 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Week 16 | 63.4 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 6, Week 1 | 19.5 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 5, Week 1 | 19.5 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 16, Week 2 | 39.0 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Week 4 | 43.9 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 15, Week 2 | 29.3 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants Achieving Psoriasis Symptom Inventory (PSI) Response of Not at All or Mild on Every Item, Up to Week 16 - Investigational Treatment Period | Study Day 14, Week 2 | 34.1 Percentage of participants |
Comparison: The analysis was based on the data at Week 16.90% CI: [-4.52, 32.87]
Comparison: The analysis was based on the data at Week 16.90% CI: [2.62, 44.64]
Comparison: The analysis was based on the data at Week 16.90% CI: [23.47, 56.18]
Comparison: The analysis was based on the data at Week 16.90% CI: [30.62, 63.69]
Secondary
Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period
The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 100 response was defined as at least a 100 percent (%) reduction in PASI relative to Baseline.
Time frame: Baseline up to Week 16
Population: The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed) and who were evaluated against criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 1 | 0 Percentage of participants |
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 16 | 0 Percentage of participants |
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 12 | 0 Percentage of participants |
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 4 | 0 Percentage of participants |
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 2 | 0 Percentage of participants |
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 6 | 0 Percentage of participants |
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 8 | 0 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 8 | 5.0 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 6 | 4.8 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 2 | 0 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 1 | 0 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 12 | 5.0 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 4 | 0 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 16 | 15.0 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 6 | 0 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 1 | 0 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 2 | 0 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 4 | 0 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 8 | 0 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 12 | 4.8 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 16 | 5.0 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 4 | 4.5 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 8 | 17.1 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 2 | 2.2 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 16 | 15.8 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 12 | 12.2 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 1 | 0 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 6 | 9.1 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 4 | 0 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 16 | 20.5 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 12 | 22.5 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 8 | 15.0 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 2 | 0 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 1 | 0 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response Up to Week 16 - Investigational Treatment Period | Week 6 | 7.7 Percentage of participants |
Secondary
Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period
The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and percent of BSA affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least 50% reduction in PASI relative to Baseline.
Time frame: Baseline up to Week 16
Population: The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed) and who were evaluated against criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 1 | 2.4 Percentage of participants |
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 16 | 41.7 Percentage of participants |
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 12 | 38.9 Percentage of participants |
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 4 | 22.5 Percentage of participants |
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 2 | 7.1 Percentage of participants |
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 6 | 28.9 Percentage of participants |
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 8 | 32.4 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 8 | 35.0 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 6 | 33.3 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 2 | 13.6 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 1 | 0 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 12 | 45.0 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 4 | 19.0 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 16 | 45.0 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 6 | 30.0 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 1 | 4.8 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 2 | 4.8 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 4 | 14.3 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 8 | 25.0 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 12 | 38.1 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 16 | 45.0 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 4 | 50.0 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 8 | 70.7 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 2 | 28.9 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 16 | 68.4 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 12 | 73.2 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 1 | 11.4 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 6 | 59.1 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 4 | 65.0 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 16 | 94.9 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 12 | 92.5 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 8 | 75.0 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 2 | 22.0 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 1 | 5.0 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response Up to Week 16 - Investigational Treatment Period | Week 6 | 69.2 Percentage of participants |
Secondary
Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period
The PASI quantifies the severity of a participant's psoriasis based on both, lesion severity and the percent of body surface area (BSA) affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk \[including axillae and groin\], and lower limbs \[including buttocks\]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. The statistical analysis was for the data at Week 16.
Time frame: Baseline up to Week 16
Population: The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 1 | 0 Percentage of participants |
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 16 | 14.3 Percentage of participants |
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 12 | 9.5 Percentage of participants |
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 4 | 7.1 Percentage of participants |
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 2 | 4.8 Percentage of participants |
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 6 | 7.1 Percentage of participants |
| Placebo QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 8 | 4.8 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 8 | 13.6 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 6 | 13.6 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 2 | 0 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 1 | 0 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 12 | 13.6 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 4 | 4.5 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 16 | 18.2 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 6 | 4.8 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 1 | 0 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 2 | 0 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 4 | 0 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 8 | 14.3 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 12 | 9.5 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 16 | 9.5 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 4 | 24.4 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 8 | 40.0 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 2 | 8.9 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 16 | 46.7 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 12 | 51.1 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 1 | 2.2 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 6 | 33.3 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 4 | 31.7 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 16 | 73.2 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 12 | 70.7 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 8 | 61.0 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 2 | 2.4 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 1 | 0 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response Up to Week 16 - Investigational Treatment Period | Week 6 | 43.9 Percentage of participants |
Comparison: The analysis was based on the data at Week 16.90% CI: [-11.82, 23.42]
Comparison: The analysis was based on the data at Week 16.90% CI: [-18.61, 13.29]
Comparison: The analysis was based on the data at Week 16.90% CI: [14.32, 47.52]
Comparison: The analysis was based on the data at Week 16.90% CI: [41.01, 72.41]
Secondary
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). The statistical analysis was for the data at Week 16.
Time frame: Baseline up to Week 16
Population: The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 1 | 2.4 Percentage of participants |
| Placebo QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 16 | 16.7 Percentage of participants |
| Placebo QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 12 | 14.3 Percentage of participants |
| Placebo QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 4 | 9.5 Percentage of participants |
| Placebo QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 2 | 2.4 Percentage of participants |
| Placebo QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 6 | 14.3 Percentage of participants |
| Placebo QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 8 | 14.3 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 8 | 18.2 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 6 | 13.6 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 2 | 0 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 1 | 0 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 12 | 18.2 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 4 | 9.1 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 16 | 18.2 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 6 | 14.3 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 1 | 4.8 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 2 | 4.8 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 4 | 4.8 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 8 | 14.3 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 12 | 19.0 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 16 | 14.3 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 4 | 35.6 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 8 | 44.4 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 2 | 11.1 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 16 | 44.4 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 12 | 46.7 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 1 | 4.4 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 6 | 46.7 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 4 | 36.6 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 16 | 70.7 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 12 | 78.0 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 8 | 63.4 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 2 | 7.3 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 1 | 4.9 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear and >=2 Points Improvement Up to Week 16 - Investigational Treatment Period | Week 6 | 53.7 Percentage of participants |
Comparison: The analysis was based on the data at Week 16.90% CI: [-14.52, 20.77]
Comparison: The analysis was based on the data at Week 16.90% CI: [-17.67, 17.01]
Comparison: The analysis was based on the data at Week 16.90% CI: [8.86, 43.26]
Comparison: The analysis was based on the data at Week 16.90% CI: [36.46, 68.27]
Secondary
Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period
The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 \[no symptom\] to 4 \[severe symptom\]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). The statistical analysis was for the data at Week 16.
Time frame: Baseline up to Week 16
Population: The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 1 | 2.4 Percentage of participants |
| Placebo QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 16 | 16.7 Percentage of participants |
| Placebo QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 12 | 14.3 Percentage of participants |
| Placebo QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 4 | 9.5 Percentage of participants |
| Placebo QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 2 | 2.4 Percentage of participants |
| Placebo QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 6 | 14.3 Percentage of participants |
| Placebo QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 8 | 14.3 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 8 | 18.2 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 6 | 13.6 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 2 | 0 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 1 | 0 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 12 | 18.2 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 4 | 9.1 Percentage of participants |
| PF-06826647 50 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 16 | 18.2 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 6 | 14.3 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 1 | 4.8 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 2 | 4.8 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 4 | 4.8 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 8 | 14.3 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 12 | 19.0 Percentage of participants |
| PF-06826647 100 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 16 | 14.3 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 4 | 35.6 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 8 | 44.4 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 2 | 11.1 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 16 | 44.4 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 12 | 46.7 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 1 | 4.4 Percentage of participants |
| PF-06826647 200 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 6 | 46.7 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 4 | 36.6 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 16 | 70.7 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 12 | 78.0 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 8 | 63.4 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 2 | 7.3 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 1 | 4.9 Percentage of participants |
| PF-06826647 400 mg QD Group | Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of Clear or Almost Clear, Up to Week 16 - Investigational Treatment Period | Week 6 | 53.7 Percentage of participants |
Comparison: The analysis was based on the data at Week 16.90% CI: [-14.52, 20.77]
Comparison: The analysis was based on the data at Week 16.90% CI: [-17.67, 17.01]
Comparison: The analysis was based on the data at Week 16.90% CI: [8.86, 43.26]
Comparison: The analysis was based on the data at Week 16.90% CI: [36.46, 68.27]
Secondary
Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section\*area score\*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease. The statistical analysis was for the data at Week 16.
Time frame: Baseline up to Week 16
Population: The analysis population included all randomized participants who received at least 1 dose of investigational product (PF-06826647 or placebo) after non-responder imputation applied (the participants discontinued due to coronavirus disease 2019 were removed) and who had observed data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 1 | -5.63 Percent change | Standard Error 2.858 |
| Placebo QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 16 | -33.29 Percent change | Standard Error 5.369 |
| Placebo QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 12 | -32.66 Percent change | Standard Error 5.137 |
| Placebo QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 4 | -22.66 Percent change | Standard Error 4.437 |
| Placebo QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 2 | -16.18 Percent change | Standard Error 3.809 |
| Placebo QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 6 | -27.07 Percent change | Standard Error 4.833 |
| Placebo QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 8 | -31.16 Percent change | Standard Error 4.983 |
| PF-06826647 50 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 8 | -33.27 Percent change | Standard Error 6.831 |
| PF-06826647 50 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 6 | -30.25 Percent change | Standard Error 6.619 |
| PF-06826647 50 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 2 | -14.80 Percent change | Standard Error 5.283 |
| PF-06826647 50 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 1 | -9.42 Percent change | Standard Error 3.975 |
| PF-06826647 50 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 12 | -37.24 Percent change | Standard Error 7.01 |
| PF-06826647 50 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 4 | -20.88 Percent change | Standard Error 6.107 |
| PF-06826647 50 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 16 | -41.92 Percent change | Standard Error 7.304 |
| PF-06826647 100 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 6 | -33.79 Percent change | Standard Error 6.739 |
| PF-06826647 100 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 1 | -8.93 Percent change | Standard Error 4.039 |
| PF-06826647 100 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 2 | -14.37 Percent change | Standard Error 5.385 |
| PF-06826647 100 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 4 | -22.70 Percent change | Standard Error 6.205 |
| PF-06826647 100 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 8 | -39.81 Percent change | Standard Error 6.909 |
| PF-06826647 100 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 12 | -42.25 Percent change | Standard Error 6.996 |
| PF-06826647 100 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 16 | -46.31 Percent change | Standard Error 7.271 |
| PF-06826647 200 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 4 | -51.26 Percent change | Standard Error 4.259 |
| PF-06826647 200 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 8 | -66.51 Percent change | Standard Error 4.763 |
| PF-06826647 200 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 2 | -33.65 Percent change | Standard Error 3.677 |
| PF-06826647 200 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 16 | -74.03 Percent change | Standard Error 5.122 |
| PF-06826647 200 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 12 | -70.28 Percent change | Standard Error 4.886 |
| PF-06826647 200 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 1 | -17.41 Percent change | Standard Error 2.774 |
| PF-06826647 200 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 6 | -60.63 Percent change | Standard Error 4.62 |
| PF-06826647 400 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 4 | -53.81 Percent change | Standard Error 4.449 |
| PF-06826647 400 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 16 | -86.33 Percent change | Standard Error 5.236 |
| PF-06826647 400 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 12 | -84.17 Percent change | Standard Error 5.039 |
| PF-06826647 400 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 8 | -72.81 Percent change | Standard Error 4.954 |
| PF-06826647 400 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 2 | -30.58 Percent change | Standard Error 3.851 |
| PF-06826647 400 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 1 | -12.55 Percent change | Standard Error 2.908 |
| PF-06826647 400 mg QD Group | Percent Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores, Up to Week 16 - Investigational Treatment Period | Week 6 | -64.03 Percent change | Standard Error 4.828 |
Comparison: The analysis was based on the data at Week 16.90% CI: [-23.61, 6.35]
Comparison: The analysis was based on the data at Week 16.90% CI: [-27.98, 1.94]
Comparison: The analysis was based on the data at Week 16.90% CI: [-53.02, -28.46]
Comparison: The analysis was based on the data at Week 16.90% CI: [-65.44, -40.63]