Ulcerative Colitis
Conditions
Keywords
Mayo score
Brief summary
The purpose of this study is to determine whether PF-06651600 and PF-06700841 are effective in treatment of moderate to severe ulcerative colitis.
Interventions
Delivered orally for 8 weeks.
DRUGPF-06700841 or Placebo
Delivered orally for 8 weeks.
DRUGPF-06700841
Delivered orally for 24 weeks.
DRUGPF-06651600
Delivered orally for 24 weeks.
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
* Diagnosis of ulcerative colitis for greater than/equal to 3 months. * Moderate to severe active ulcerative colitis * Inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC.
Exclusion criteria
* Pregnant or breastfeeding * Clinical findings suggestive of Crohn's Disease * History of bowel surgery within 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Mayo Score at Week 8 (Induction Period) | Week 8 | The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicates more severe disease activity and lower score denotes improvement of disease activity as measured by the total Mayo score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | From Week 8 up to Week 32 | An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes: death, life-threatening experience, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. All AEs mentioned below are treatment-emergent AEs. |
| Number of Participants With Laboratory Test Abnormalities (Chronic Period) | From Week 8 to Week 32 | The number of participants with a laboratory abnormality meeting the pre-specified criteria defined in the study protocol while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. Laboratory data included hematology test, serum chemistry test, C-creative protein and viral surveillance. |
| Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | From Week 8 to Week 32 | The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of hematology test parameters were as follows: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils (absolute, Abs), eosinophils (Abs), monocytes (Abs), basophils (Abs), lymphocytes (Abs), prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT), and reticulocytes (% and Abs). Percentages are displayed for the laboratory tests having a category with greater or equal to 1 evaluable participant. |
| Number of Participants With Abnormal Vital Signs Data (Chronic Period) | From Week 8 to Week 32 | The vital signs data included the single sitting blood pressure, pulse rate and temperature. The criteria of vital sign abnormality are indicated below. |
| Number of Participants With Abnormal ECG Findings (Chronic Period) | Week 8 to Week 32 | The number of participants with abnormal ECG findings during the chronic period (from Week 9 to Week 32) are reported below. |
| Number of Participants With Serious Infections (Chronic Period) | Week 8 to Week 32 | Serious infections was defined as any infection (for example, viral, bacterial, and fungal) requiring hospitalization or parenteral antimicrobials. |
| Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Week 8 to Week 32 | The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of serum chemistry test parameters were as follows: blood urea nitrogen, creatinine, cystatin C, glucose, calcium, sodium, potassium, gamma glutamyl transferase, chloride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, alkaline phosphatase, uric acid, albumin, total protein, creatine kinase (CK), total cholesterol, triglycerides, high-density lipoproteins (HDL), and low-density lipoprotein (LDL). |
| Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Week 8 to Week 32 | The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of urinalysis test parameters were as follows:pH, glucose (qual), protein (qual), blood (qual), ketones, nitrites, leukocyte esterase, microscopy, and spot urine albumin/creatinine ratio. The criteria of laboratory abnormality is defined as one of the following conditions was met: 1)associated with accompanying symptoms;2)Test result requires additional diagnostic testing or medical/surgical intervention;3)Test result leads to a change in study dosing (outside of any protocol specified dose adjustments) or discontinuation from the study, significant additional concomitant drug treatment, or other therapy;4)Test result is considered to be an AE by the investigator or sponsor. |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) | From Day 1 up to Week 8 | An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes: death, life-threatening experience, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. All AEs mentioned below are treatment-emergent AEs. |
| Number of Participants With Laboratory Test Abnormalities (Induction Period) | From Day 1 up to Week 8 | The number of participants with a laboratory abnormality meeting the pre-specified criteria defined in the study protocol while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. Laboratory data included hematology test, serum chemistry test, C-creative protein and viral surveillance. The criteria of laboratory abnormality is defined as one of the following conditions was met: 1)associated with accompanying symptoms;2)Test result requires additional diagnostic testing or medical/surgical intervention;3)Test result leads to a change in study dosing (outside of any protocol specified dose adjustments) or discontinuation from the study, significant additional concomitant drug treatment, or other therapy;4)Test result is considered to be an AE by the investigator or sponsor. |
| Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | From Day 1 up to Week 8 | The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of hematology test parameters were as follows: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils (absolute, Abs), eosinophils (Abs), monocytes (Abs), basophils (Abs), lymphocytes (Abs), prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT), and reticulocytes (% and Abs). Percentages are displayed for the laboratory tests having a category with greater or equal to 1 evaluable participant. |
| Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | From Day 1 up to Week 8 | The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of serum chemistry test parameters were as follows: blood urea nitrogen, creatinine, cystatin C, glucose, calcium, sodium, potassium, gamma glutamyl transferase, chloride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, alkaline phosphatase, uric acid, albumin, total protein, creatine kinase (CK), total cholesterol, triglycerides, high-density lipoproteins (HDL), and low-density lipoprotein (LDL) |
| Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | From Day 1 up to Week 8 | The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of urinalysis test parameters were as follows:pH, glucose (qual), protein (qual), blood (qual), ketones, nitrites, leukocyte esterase, microscopy, and spot urine albumin/creatinine ratio. The criteria of laboratory abnormality is defined as one of the following conditions was met: 1)associated with accompanying symptoms;2)Test result requires additional diagnostic testing or medical/surgical intervention;3)Test result leads to a change in study dosing (outside of any protocol specified dose adjustments) or discontinuation from the study, significant additional concomitant drug treatment, or other therapy;4)Test result is considered to be an AE by the investigator or sponsor. |
| Number of Participants With Abnormal Vital Signs Data (Induction Period) | From screening to Week 8 | The vital signs data included the single sitting blood pressure, pulse rate and temperature. The criteria of vital sign abnormality are indicated below. |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | From screening to Week 8 | The number of participants with abnormal ECG findings during the induction period (from Day 1 to Week 8) are reported below. The criteria of test abnormality is defined as one of the following conditions was met: 1)associated with accompanying symptoms;2)Test result requires additional diagnostic testing or medical/surgical intervention;3)Test result leads to a change in study dosing (outside of any protocol specified dose adjustments) or discontinuation from the study, significant additional concomitant drug treatment, or other therapy;4)Test result is considered to be an AE by the investigator or sponsor. |
| Number of Participants With Serious Infections (Induction Period) | From Day 1 up to Week 8 | Serious infections was defined as any infection (for example, viral, bacterial, and fungal) requiring hospitalization or parenteral antimicrobials including Listeria encephalitis, Pneumonia, Viral infection. |
| Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 8 (Induction Period) | Week 8 | The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Clinical remission was defined as total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. |
| Percentage of Participants Achieving Clinical Response Based on Total Mayo Score at Week 8 (Induction Period) | Week 8 | The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Clinical response was defined as decrease from baseline in total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1. |
| Percentage of Participants Achieving Endoscopic Remission Based on Total Mayo Score at Week 8 (Induction Period) | Week 8 | The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Endoscopic remission was defined as endoscopic subscore of 0. |
| Percentage of Participants Achieving Symptomatic Remission Based on Total Mayo Score at Week 8 (Induction Period) | Week 8 | The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Symptomatic remission was defined as total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and both rectal bleeding and stool frequency subscores of 0. |
| Percentage of Participants Achieving Deep Remission Based on Total Mayo Score at Week 8 (Induction Period) | Week 8 | The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Deep remission was defined as total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a zero on both endoscopic and rectal bleeding subscore. |
| Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period) | Baseline, Weeks 2, 4 and 8 | The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. The partial Mayo score does not incorporate the endoscopy score and the partial Mayo score ranges from 0 to 9. |
| Change From Baseline in Total Mayo Score at Week 8 (Induction Period) | Baseline, Week 8 | The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. |
| Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4 and Week 8 | IBDQ is a psychometrically validated patient reported outcome (PRO) instrument for measuring the disease specific quality of life in participants with inflammatory bowel disease (IBD). The IBDQ is comprised of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35.; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life. |
| Change From Baseline in IBDQ Total Score at Weeks 4 and 8 (Induction Period) | Baseline, Weeks 4 and 8 | IBDQ is a psychometrically validated PRO instrument for measuring the disease specific quality of life in participants with IBD. The IBDQ is comprised of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35.; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life. Baseline value is defined as the last non-missing measurement collected prior to or on Day 1. |
| Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period) | Week 4 and Week 8 | IBDQ is a psychometrically validated PRO instrument for measuring the disease specific quality of life in participants with IBD. The IBDQ is comprised of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35.; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life. |
| Percentage of Participants With Greater Than or Equal to 16 Points Increase in IBDQ Total Score From Baseline at Weeks 4 and 8 (Induction Period) | Baseline, Week 4 and 8 | IBDQ is a psychometrically validated PRO instrument for measuring the disease specific quality of life in participants with IBD. The IBDQ is comprised of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35.; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life. |
| Percentage of Participants With Improvement in IBDQ Bowel Symptom Domain at Weeks 4 and 8 (Induction Period) | Week 4 and Week 8 | IBDQ is a psychometrically validated PRO instrument for measuring the disease specific quality of life in participants with IBD. The IBDQ is comprised of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35.; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life. The improvement in IBDQ bowel symptom domain was defined as an increase of ≥1.2 points from baseline in average score among bowel symptoms domain (items 1, 5, 9, 13, 17, 20, 22, 24, 26, 29). |
| Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 4 and Week 8 | The SF-36 version 2 (Acute version) is a 36-item generic health status measure. It measures 8 general health concepts or domains: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH). These 8 domains can also be summarized as physical and mental component scores. The summary component scores, Physical Component Summary (PCS) and Mental Component Summary (MCS), are based on a normalized sum of the 8 scale scores PF, RP, BP, GH, VT, SF, RE, and MH . All domains and summary components are scored such that a higher score indicates a higher functioning or health level. The minimum and maximum scores of the PCS Score are 6.1 and 79.7, respectively. The minimum and maximum scores of the MCS Score are -3.8 and 78.7, respectively. |
| Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | Week 4 and Week 8 | For EQ-5D 3L, participant rated questionnaire to assess generic health status in two parts: single utility score and visual analog scale. For utility score, participants rated their current health state on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score was transformed and results in a total score range of 0.05 to 1.00; higher scores indicating a better health state. The EQ-5D VAS records the respondent's self rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state). |
| Total Mayo Score at Week 32 (Chronic Period) | Week 32 | The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. |
| Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 32 (Chronic Period) | Week 32 | The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Clinical remission was defined as total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. |
| Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Mayo Score at Week 32 (Chronic Period) | Week 32 | The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Improvement in endoscopic appearance was defined at Mayo endoscopic subscore of ≤1. |
| Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Total Mayo Score at Week 8 (Induction Period) | Week 8 | The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Improvement in endoscopic subscore appearance was defined at Mayo endoscopic subscore of ≤1. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Mayo Score at Week 32 (Chronic Period) | Week 32 | The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. |
Countries
Austria, Bulgaria, Czechia, Denmark, Georgia, Germany, Hungary, Israel, Italy, Poland, Romania, Russia, Serbia, Slovakia, South Korea, Spain, Turkey (Türkiye), Ukraine, United States
Participant flow
Recruitment details
The study consisted of a screening period of up to 6 weeks, an 8-week double-blind induction period, and an additional 24-week open-label active chronic dosing period followed by a 4-week follow up period after the last dose of investigational product.
Pre-assignment details
A total of 319 participants were randomized and 317 participants were treated.
Participants by arm
| Arm | Count |
|---|---|
| Placebo (Induction) The placebo was administered orally once daily (QD) from Day 1 to Week 8. | 25 |
| PF-06651600 20 mg (Induction) PF-06651600 tablet was administered orally at 20 mg QD from Day 1 to Week 8. | 51 |
| PF-06651600 70 mg (Induction) PF-06651600 tablet was administered orally at 70 mg QD from Day 1 to Week 8. | 49 |
| PF-06651600 200 mg (Induction) PF-06651600 tablet was administered orally at 200 mg QD from Day 1 to Week 8. | 50 |
| PF-06700841 10 mg (Induction) PF-06700841 tablet was administered orally at 10 mg QD from Day 1 to Week 8. | 48 |
| PF-06700841 30 mg (Induction) PF-06700841 tablet was administered orally at 30 mg QD from Day 1 to Week 8. | 47 |
| PF-06700841 60 mg (Induction) PF-06700841 tablet was administered orally at 60 mg QD from Day 1 to Week 8. | 47 |
| Total | 317 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Chronic Period (Week 8 to Week 32) | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 2 | 0 | 1 | 4 | 1 | 1 | 5 |
| Chronic Period (Week 8 to Week 32) | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 5 | 0 | 2 | 0 | 8 |
| Chronic Period (Week 8 to Week 32) | No longer meeting eligibility criteria | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Chronic Period (Week 8 to Week 32) | Non-compliance with study drug | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Chronic Period (Week 8 to Week 32) | Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 |
| Chronic Period (Week 8 to Week 32) | Pregnancy | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Chronic Period (Week 8 to Week 32) | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Chronic Period (Week 8 to Week 32) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 6 | 3 | 3 | 2 |
| Induction Period (Day 1 to Week 8) | Adverse Event | 0 | 4 | 0 | 5 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Induction Period (Day 1 to Week 8) | Death | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Induction Period (Day 1 to Week 8) | Lack of Efficacy | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Induction Period (Day 1 to Week 8) | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Induction Period (Day 1 to Week 8) | No longer meeting eligibility criteria | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Induction Period (Day 1 to Week 8) | Other | 0 | 0 | 1 | 2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Induction Period (Day 1 to Week 8) | Physician Decision | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Induction Period (Day 1 to Week 8) | Protocol Violation | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Induction Period (Day 1 to Week 8) | Withdrawal by Subject | 2 | 0 | 3 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Placebo (Induction) | PF-06651600 20 mg (Induction) | PF-06651600 70 mg (Induction) | PF-06651600 200 mg (Induction) | PF-06700841 10 mg (Induction) | PF-06700841 30 mg (Induction) | PF-06700841 60 mg (Induction) |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 40.3 years STANDARD_DEVIATION 13.79 | 42.8 years STANDARD_DEVIATION 15.45 | 41.3 years STANDARD_DEVIATION 14.03 | 40.2 years STANDARD_DEVIATION 13.31 | 37.3 years STANDARD_DEVIATION 15.67 | 40.8 years STANDARD_DEVIATION 13.04 | 40.9 years STANDARD_DEVIATION 13.03 | 40.3 years STANDARD_DEVIATION 12.8 |
| Age, Customized 18-44 years | 196 Participants | 13 Participants | 31 Participants | 30 Participants | 36 Participants | 31 Participants | 25 Participants | 30 Participants |
| Age, Customized 45-64 years | 108 Participants | 10 Participants | 16 Participants | 18 Participants | 10 Participants | 16 Participants | 22 Participants | 16 Participants |
| Age, Customized >=65 years | 13 Participants | 2 Participants | 4 Participants | 1 Participants | 4 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 11 Participants | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 3 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other (not specified) | 5 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 295 Participants | 22 Participants | 46 Participants | 46 Participants | 48 Participants | 44 Participants | 44 Participants | 45 Participants |
| Sex: Female, Male Female | 135 Participants | 11 Participants | 17 Participants | 25 Participants | 18 Participants | 18 Participants | 24 Participants | 22 Participants |
| Sex: Female, Male Male | 182 Participants | 14 Participants | 34 Participants | 24 Participants | 32 Participants | 30 Participants | 23 Participants | 25 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 | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 1 / 51 | 0 / 49 | 0 / 50 | 0 / 48 | 0 / 47 | 0 / 47 | 0 / 35 | 0 / 36 | 0 / 39 | 0 / 10 | 0 / 38 | 0 / 37 | 0 / 39 | 0 / 9 | 0 / 37 |
| other Total, other adverse events | 4 / 25 | 8 / 51 | 6 / 49 | 5 / 50 | 2 / 48 | 11 / 47 | 9 / 47 | 9 / 35 | 21 / 36 | 11 / 39 | 8 / 10 | 15 / 38 | 15 / 37 | 20 / 39 | 4 / 9 | 15 / 37 |
| serious Total, serious adverse events | 0 / 25 | 3 / 51 | 0 / 49 | 3 / 50 | 1 / 48 | 3 / 47 | 1 / 47 | 3 / 35 | 1 / 36 | 1 / 39 | 0 / 10 | 2 / 38 | 4 / 37 | 2 / 39 | 0 / 9 | 0 / 37 |
Outcome results
Primary
Total Mayo Score at Week 8 (Induction Period)
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicates more severe disease activity and lower score denotes improvement of disease activity as measured by the total Mayo score.
Time frame: Week 8
Population: The intent-to-treat (ITT) analysis set which included all randomized participants who received at least 1 dose of investigational product or placebo.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo (Induction) | Total Mayo Score at Week 8 (Induction Period) | 7.88 Units on a scale |
| PF-06651600 20 mg (Induction) | Total Mayo Score at Week 8 (Induction Period) | 5.85 Units on a scale |
| PF-06651600 70 mg (Induction) | Total Mayo Score at Week 8 (Induction Period) | 4.00 Units on a scale |
| PF-06651600 200 mg (Induction) | Total Mayo Score at Week 8 (Induction Period) | 3.27 Units on a scale |
| PF-06700841 10 mg (Induction) | Total Mayo Score at Week 8 (Induction Period) | 6.08 Units on a scale |
| PF-06700841 30 mg (Induction) | Total Mayo Score at Week 8 (Induction Period) | 5.60 Units on a scale |
| PF-06700841 60 mg (Induction) | Total Mayo Score at Week 8 (Induction Period) | 4.67 Units on a scale |
Comparison: The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.p-value: 0.001790% CI: [-3.17, -0.89]Constrained Longitudinal Data Analysis
Comparison: The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.p-value: <0.000190% CI: [-5.01, -2.74]Constrained Longitudinal Data Analysis
Comparison: The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.p-value: <0.000190% CI: [-5.76, -3.46]Constrained Longitudinal Data Analysis
Comparison: The null hypothesis was that the there is no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm is declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect is below zero.p-value: 0.004590% CI: [-2.92, -0.67]Constrained Longitudinal Data Analysis
Comparison: The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.p-value: 0.000590% CI: [-3.41, -1.14]Constrained Longitudinal Data Analysis
Comparison: The null hypothesis was that the there was no difference between the distributions of the total Mayo score at Week 8 between the pooled placebo group and active arm. The treatment arm was declared efficacious if an upper limit of 2-sided 90% confidence interval for the treatment effect was below zero.p-value: <0.000190% CI: [-4.34, -2.08]Constrained Longitudinal Data Analysis
Secondary
Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period)
For EQ-5D 3L, participant rated questionnaire to assess generic health status in two parts: single utility score and visual analog scale. For utility score, participants rated their current health state on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with each dimension having three levels of function: 1 indicates no problem; 2 indicates some problem; 3 indicates extreme problem. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score was transformed and results in a total score range of 0.05 to 1.00; higher scores indicating a better health state. The EQ-5D VAS records the respondent's self rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).
Time frame: Week 4 and Week 8
Population: Number of Participants Analyzed: ITT analysis set includes all participants who were randomized to the study and received at least one dose of the randomized investigational drug. Number Analyzed: Number of participants with non-missing data in the ITT analysis set at each specified visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D VAS Score (Week 4) | 8.41 Units on a scale |
| Placebo (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D VAS Score (Week 8) | 13.17 Units on a scale |
| Placebo (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D 3L Utility Score (Week 4) | 0.11 Units on a scale |
| Placebo (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D 3L Utility Score (Week 8) | 0.08 Units on a scale |
| PF-06651600 20 mg (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D VAS Score (Week 4) | 13.60 Units on a scale |
| PF-06651600 20 mg (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D 3L Utility Score (Week 8) | 0.08 Units on a scale |
| PF-06651600 20 mg (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D VAS Score (Week 8) | 13.11 Units on a scale |
| PF-06651600 20 mg (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D 3L Utility Score (Week 4) | 0.07 Units on a scale |
| PF-06651600 70 mg (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D VAS Score (Week 4) | 16.35 Units on a scale |
| PF-06651600 70 mg (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D VAS Score (Week 8) | 18.88 Units on a scale |
| PF-06651600 70 mg (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D 3L Utility Score (Week 4) | 0.12 Units on a scale |
| PF-06651600 70 mg (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D 3L Utility Score (Week 8) | 0.15 Units on a scale |
| PF-06651600 200 mg (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D VAS Score (Week 8) | 22.54 Units on a scale |
| PF-06651600 200 mg (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D VAS Score (Week 4) | 17.45 Units on a scale |
| PF-06651600 200 mg (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D 3L Utility Score (Week 8) | 0.15 Units on a scale |
| PF-06651600 200 mg (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D 3L Utility Score (Week 4) | 0.13 Units on a scale |
| PF-06700841 10 mg (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D 3L Utility Score (Week 4) | 0.07 Units on a scale |
| PF-06700841 10 mg (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D 3L Utility Score (Week 8) | 0.09 Units on a scale |
| PF-06700841 10 mg (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D VAS Score (Week 4) | 10.48 Units on a scale |
| PF-06700841 10 mg (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D VAS Score (Week 8) | 10.35 Units on a scale |
| PF-06700841 30 mg (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D VAS Score (Week 8) | 17.11 Units on a scale |
| PF-06700841 30 mg (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D 3L Utility Score (Week 8) | 0.13 Units on a scale |
| PF-06700841 30 mg (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D 3L Utility Score (Week 4) | 0.11 Units on a scale |
| PF-06700841 30 mg (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D VAS Score (Week 4) | 12.24 Units on a scale |
| PF-06700841 60 mg (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D VAS Score (Week 4) | 14.44 Units on a scale |
| PF-06700841 60 mg (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D 3L Utility Score (Week 8) | 0.14 Units on a scale |
| PF-06700841 60 mg (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D 3L Utility Score (Week 4) | 0.12 Units on a scale |
| PF-06700841 60 mg (Induction) | Change From Baseline in Euro Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D 3L) Utility Score and EQ-5D Visual Analog Scale (VAS) at Weeks 4 and 8 (Induction Period) | EQ-5D VAS Score (Week 8) | 20.01 Units on a scale |
Secondary
Change From Baseline in IBDQ Total Score at Weeks 4 and 8 (Induction Period)
IBDQ is a psychometrically validated PRO instrument for measuring the disease specific quality of life in participants with IBD. The IBDQ is comprised of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35.; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life. Baseline value is defined as the last non-missing measurement collected prior to or on Day 1.
Time frame: Baseline, Weeks 4 and 8
Population: Number of Participants Analyzed: ITT analysis set includes all participants who were randomized to the study and received at least one dose of the randomized investigational drug. Number Analyzed: The participants with non-missing data in the intent-to-treat analysis set at each specified visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Induction) | Change From Baseline in IBDQ Total Score at Weeks 4 and 8 (Induction Period) | Week 4 | 30.30 Units on a scale | Standard Error 6.51 |
| Placebo (Induction) | Change From Baseline in IBDQ Total Score at Weeks 4 and 8 (Induction Period) | Week 8 | 24.23 Units on a scale | Standard Error 7.4 |
| PF-06651600 20 mg (Induction) | Change From Baseline in IBDQ Total Score at Weeks 4 and 8 (Induction Period) | Week 4 | 33.71 Units on a scale | Standard Error 4.6 |
| PF-06651600 20 mg (Induction) | Change From Baseline in IBDQ Total Score at Weeks 4 and 8 (Induction Period) | Week 8 | 37.91 Units on a scale | Standard Error 5.15 |
| PF-06651600 70 mg (Induction) | Change From Baseline in IBDQ Total Score at Weeks 4 and 8 (Induction Period) | Week 4 | 51.12 Units on a scale | Standard Error 4.61 |
| PF-06651600 70 mg (Induction) | Change From Baseline in IBDQ Total Score at Weeks 4 and 8 (Induction Period) | Week 8 | 59.20 Units on a scale | Standard Error 5.23 |
| PF-06651600 200 mg (Induction) | Change From Baseline in IBDQ Total Score at Weeks 4 and 8 (Induction Period) | Week 4 | 57.01 Units on a scale | Standard Error 4.78 |
| PF-06651600 200 mg (Induction) | Change From Baseline in IBDQ Total Score at Weeks 4 and 8 (Induction Period) | Week 8 | 62.17 Units on a scale | Standard Error 5.47 |
| PF-06700841 10 mg (Induction) | Change From Baseline in IBDQ Total Score at Weeks 4 and 8 (Induction Period) | Week 4 | 28.45 Units on a scale | Standard Error 4.68 |
| PF-06700841 10 mg (Induction) | Change From Baseline in IBDQ Total Score at Weeks 4 and 8 (Induction Period) | Week 8 | 36.60 Units on a scale | Standard Error 5.29 |
| PF-06700841 30 mg (Induction) | Change From Baseline in IBDQ Total Score at Weeks 4 and 8 (Induction Period) | Week 4 | 37.94 Units on a scale | Standard Error 4.72 |
| PF-06700841 30 mg (Induction) | Change From Baseline in IBDQ Total Score at Weeks 4 and 8 (Induction Period) | Week 8 | 48.81 Units on a scale | Standard Error 5.33 |
| PF-06700841 60 mg (Induction) | Change From Baseline in IBDQ Total Score at Weeks 4 and 8 (Induction Period) | Week 4 | 49.79 Units on a scale | Standard Error 4.73 |
| PF-06700841 60 mg (Induction) | Change From Baseline in IBDQ Total Score at Weeks 4 and 8 (Induction Period) | Week 8 | 56.39 Units on a scale | Standard Error 5.33 |
Secondary
Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period)
The SF-36 version 2 (Acute version) is a 36-item generic health status measure. It measures 8 general health concepts or domains: Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH). These 8 domains can also be summarized as physical and mental component scores. The summary component scores, Physical Component Summary (PCS) and Mental Component Summary (MCS), are based on a normalized sum of the 8 scale scores PF, RP, BP, GH, VT, SF, RE, and MH . All domains and summary components are scored such that a higher score indicates a higher functioning or health level. The minimum and maximum scores of the PCS Score are 6.1 and 79.7, respectively. The minimum and maximum scores of the MCS Score are -3.8 and 78.7, respectively.
Time frame: Week 4 and Week 8
Population: Number of Participants Analyzed: ITT analysis set includes all participants who were randomized to the study and received at least one dose of the randomized investigational drug. Number Analyzed: Number of participants with non-missing data in the ITT analysis set at each specified visit.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Placebo (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 8 (PCS) | 5.37 Units on a scale |
| Placebo (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 4(MCS) | 7.83 Units on a scale |
| Placebo (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 8(MCS) | 4.24 Units on a scale |
| Placebo (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 4 (PCS) | 4.69 Units on a scale |
| PF-06651600 20 mg (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 8(MCS) | 5.18 Units on a scale |
| PF-06651600 20 mg (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 8 (PCS) | 5.85 Units on a scale |
| PF-06651600 20 mg (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 4 (PCS) | 5.90 Units on a scale |
| PF-06651600 20 mg (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 4(MCS) | 4.95 Units on a scale |
| PF-06651600 70 mg (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 4 (PCS) | 6.36 Units on a scale |
| PF-06651600 70 mg (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 4(MCS) | 7.79 Units on a scale |
| PF-06651600 70 mg (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 8 (PCS) | 8.66 Units on a scale |
| PF-06651600 70 mg (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 8(MCS) | 9.72 Units on a scale |
| PF-06651600 200 mg (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 4 (PCS) | 9.21 Units on a scale |
| PF-06651600 200 mg (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 8 (PCS) | 10.86 Units on a scale |
| PF-06651600 200 mg (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 8(MCS) | 9.41 Units on a scale |
| PF-06651600 200 mg (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 4(MCS) | 8.81 Units on a scale |
| PF-06700841 10 mg (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 4 (PCS) | 5.67 Units on a scale |
| PF-06700841 10 mg (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 8(MCS) | 5.22 Units on a scale |
| PF-06700841 10 mg (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 4(MCS) | 2.44 Units on a scale |
| PF-06700841 10 mg (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 8 (PCS) | 6.29 Units on a scale |
| PF-06700841 30 mg (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 8 (PCS) | 8.21 Units on a scale |
| PF-06700841 30 mg (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 4 (PCS) | 5.85 Units on a scale |
| PF-06700841 30 mg (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 4(MCS) | 7.46 Units on a scale |
| PF-06700841 30 mg (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 8(MCS) | 8.04 Units on a scale |
| PF-06700841 60 mg (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 4 (PCS) | 6.40 Units on a scale |
| PF-06700841 60 mg (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 8 (PCS) | 8.55 Units on a scale |
| PF-06700841 60 mg (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 8(MCS) | 10.01 Units on a scale |
| PF-06700841 60 mg (Induction) | Change From Baseline in Short Form 36 Version 2 (SF-36v2) Acute Mental Component Summary (MCS) Score and Physical Component Summary (PCS) Score at Weeks 4 and 8 (Induction Period) | Week 4(MCS) | 9.28 Units on a scale |
Secondary
Change From Baseline in Total Mayo Score at Week 8 (Induction Period)
The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity.
Time frame: Baseline, Week 8
Population: The intent-to-treat (ITT) analysis set which included all randomized participants who received at least 1 dose of investigational product or placebo.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo (Induction) | Change From Baseline in Total Mayo Score at Week 8 (Induction Period) | -1.14 Units on a scale |
| PF-06651600 20 mg (Induction) | Change From Baseline in Total Mayo Score at Week 8 (Induction Period) | -3.17 Units on a scale |
| PF-06651600 70 mg (Induction) | Change From Baseline in Total Mayo Score at Week 8 (Induction Period) | -5.02 Units on a scale |
| PF-06651600 200 mg (Induction) | Change From Baseline in Total Mayo Score at Week 8 (Induction Period) | -5.74 Units on a scale |
| PF-06700841 10 mg (Induction) | Change From Baseline in Total Mayo Score at Week 8 (Induction Period) | -2.93 Units on a scale |
| PF-06700841 30 mg (Induction) | Change From Baseline in Total Mayo Score at Week 8 (Induction Period) | -3.42 Units on a scale |
| PF-06700841 60 mg (Induction) | Change From Baseline in Total Mayo Score at Week 8 (Induction Period) | -4.35 Units on a scale |
Secondary
Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period)
IBDQ is a psychometrically validated patient reported outcome (PRO) instrument for measuring the disease specific quality of life in participants with inflammatory bowel disease (IBD). The IBDQ is comprised of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35.; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life.
Time frame: Week 4 and Week 8
Population: Number of Participants Analyzed: ITT analysis set includes all participants who were randomized to the study and received at least one dose of the randomized investigational drug. Number Analyzed: the participants evaluated for IBDQ at each specified time point.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4 (Bowel Systems Domain score) | 44.87 Units on a scale |
| Placebo (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Total IBDQ score) | 113.00 Units on a scale |
| Placebo (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8 (Bowel Systems Domain score) | 44.68 Units on a scale |
| Placebo (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4(Systemic Systems Domain score) | 20.87 Units on a scale |
| Placebo (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Emotion Health Domain score) | 43.76 Units on a scale |
| Placebo (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Social Function Domain score) | 16.88 Units on a scale |
| Placebo (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8(Emotion Health Domain score) | 52.50 Units on a scale |
| Placebo (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4 (Social Function Domain score) | 22.57 Units on a scale |
| Placebo (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8 (Total IBDQ score) | 139.91 Units on a scale |
| Placebo (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4 (Total IBDQ score) | 143.04 Units on a scale |
| Placebo (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Bowel Systems Domain score) | 35.80 Units on a scale |
| Placebo (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8(Systemic Systems Domain score) | 20.82 Units on a scale |
| Placebo (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4(Emotion Health Domain score) | 54.74 Units on a scale |
| Placebo (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8 (Social Function Domain score) | 21.91 Units on a scale |
| Placebo (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Systemic Systems Domain score) | 16.56 Units on a scale |
| PF-06651600 20 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8(Systemic Systems Domain score) | 21.85 Units on a scale |
| PF-06651600 20 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4 (Bowel Systems Domain score) | 46.98 Units on a scale |
| PF-06651600 20 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8(Emotion Health Domain score) | 54.23 Units on a scale |
| PF-06651600 20 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4 (Social Function Domain score) | 22.41 Units on a scale |
| PF-06651600 20 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Emotion Health Domain score) | 42.76 Units on a scale |
| PF-06651600 20 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4(Emotion Health Domain score) | 53.65 Units on a scale |
| PF-06651600 20 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8 (Bowel Systems Domain score) | 47.96 Units on a scale |
| PF-06651600 20 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4(Systemic Systems Domain score) | 21.70 Units on a scale |
| PF-06651600 20 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Total IBDQ score) | 110.43 Units on a scale |
| PF-06651600 20 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Bowel Systems Domain score) | 34.29 Units on a scale |
| PF-06651600 20 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Systemic Systems Domain score) | 16.12 Units on a scale |
| PF-06651600 20 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8 (Social Function Domain score) | 23.45 Units on a scale |
| PF-06651600 20 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4 (Total IBDQ score) | 144.74 Units on a scale |
| PF-06651600 20 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8 (Total IBDQ score) | 147.49 Units on a scale |
| PF-06651600 20 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Social Function Domain score) | 17.25 Units on a scale |
| PF-06651600 70 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4(Emotion Health Domain score) | 59.89 Units on a scale |
| PF-06651600 70 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8(Systemic Systems Domain score) | 24.40 Units on a scale |
| PF-06651600 70 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4(Systemic Systems Domain score) | 23.74 Units on a scale |
| PF-06651600 70 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8(Emotion Health Domain score) | 62.73 Units on a scale |
| PF-06651600 70 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4 (Total IBDQ score) | 160.85 Units on a scale |
| PF-06651600 70 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Social Function Domain score) | 16.59 Units on a scale |
| PF-06651600 70 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4 (Bowel Systems Domain score) | 51.00 Units on a scale |
| PF-06651600 70 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8 (Total IBDQ score) | 168.42 Units on a scale |
| PF-06651600 70 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Bowel Systems Domain score) | 33.71 Units on a scale |
| PF-06651600 70 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Total IBDQ score) | 109.18 Units on a scale |
| PF-06651600 70 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8 (Bowel Systems Domain score) | 54.27 Units on a scale |
| PF-06651600 70 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8 (Social Function Domain score) | 27.02 Units on a scale |
| PF-06651600 70 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Emotion Health Domain score) | 42.90 Units on a scale |
| PF-06651600 70 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4 (Social Function Domain score) | 26.21 Units on a scale |
| PF-06651600 70 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Systemic Systems Domain score) | 15.98 Units on a scale |
| PF-06651600 200 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Emotion Health Domain score) | 41.39 Units on a scale |
| PF-06651600 200 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4 (Bowel Systems Domain score) | 53.80 Units on a scale |
| PF-06651600 200 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Systemic Systems Domain score) | 15.41 Units on a scale |
| PF-06651600 200 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Bowel Systems Domain score) | 34.84 Units on a scale |
| PF-06651600 200 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Total IBDQ score) | 108.94 Units on a scale |
| PF-06651600 200 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4(Emotion Health Domain score) | 61.11 Units on a scale |
| PF-06651600 200 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8 (Total IBDQ score) | 174.39 Units on a scale |
| PF-06651600 200 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4 (Total IBDQ score) | 166.77 Units on a scale |
| PF-06651600 200 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8(Emotion Health Domain score) | 63.12 Units on a scale |
| PF-06651600 200 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4 (Social Function Domain score) | 28.20 Units on a scale |
| PF-06651600 200 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Social Function Domain score) | 17.31 Units on a scale |
| PF-06651600 200 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4(Systemic Systems Domain score) | 23.66 Units on a scale |
| PF-06651600 200 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8 (Bowel Systems Domain score) | 55.95 Units on a scale |
| PF-06651600 200 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8 (Social Function Domain score) | 29.80 Units on a scale |
| PF-06651600 200 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8(Systemic Systems Domain score) | 25.51 Units on a scale |
| PF-06700841 10 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8 (Bowel Systems Domain score) | 46.87 Units on a scale |
| PF-06700841 10 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8 (Total IBDQ score) | 147.07 Units on a scale |
| PF-06700841 10 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Bowel Systems Domain score) | 34.17 Units on a scale |
| PF-06700841 10 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4 (Bowel Systems Domain score) | 44.93 Units on a scale |
| PF-06700841 10 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Emotion Health Domain score) | 42.40 Units on a scale |
| PF-06700841 10 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4(Emotion Health Domain score) | 52.43 Units on a scale |
| PF-06700841 10 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8(Emotion Health Domain score) | 54.44 Units on a scale |
| PF-06700841 10 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Systemic Systems Domain score) | 16.30 Units on a scale |
| PF-06700841 10 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4(Systemic Systems Domain score) | 20.70 Units on a scale |
| PF-06700841 10 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8(Systemic Systems Domain score) | 21.40 Units on a scale |
| PF-06700841 10 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Social Function Domain score) | 17.30 Units on a scale |
| PF-06700841 10 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4 (Social Function Domain score) | 22.83 Units on a scale |
| PF-06700841 10 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8 (Social Function Domain score) | 24.36 Units on a scale |
| PF-06700841 10 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Total IBDQ score) | 110.17 Units on a scale |
| PF-06700841 10 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4 (Total IBDQ score) | 140.89 Units on a scale |
| PF-06700841 30 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8(Emotion Health Domain score) | 56.86 Units on a scale |
| PF-06700841 30 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Social Function Domain score) | 14.91 Units on a scale |
| PF-06700841 30 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4(Emotion Health Domain score) | 52.77 Units on a scale |
| PF-06700841 30 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8(Systemic Systems Domain score) | 23.07 Units on a scale |
| PF-06700841 30 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4 (Social Function Domain score) | 23.02 Units on a scale |
| PF-06700841 30 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Emotion Health Domain score) | 38.74 Units on a scale |
| PF-06700841 30 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8 (Bowel Systems Domain score) | 50.12 Units on a scale |
| PF-06700841 30 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8 (Social Function Domain score) | 25.12 Units on a scale |
| PF-06700841 30 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4 (Bowel Systems Domain score) | 46.84 Units on a scale |
| PF-06700841 30 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Bowel Systems Domain score) | 32.38 Units on a scale |
| PF-06700841 30 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4 (Total IBDQ score) | 143.41 Units on a scale |
| PF-06700841 30 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Total IBDQ score) | 101.26 Units on a scale |
| PF-06700841 30 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4(Systemic Systems Domain score) | 20.77 Units on a scale |
| PF-06700841 30 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Systemic Systems Domain score) | 15.21 Units on a scale |
| PF-06700841 30 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8 (Total IBDQ score) | 155.16 Units on a scale |
| PF-06700841 60 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Systemic Systems Domain score) | 16.72 Units on a scale |
| PF-06700841 60 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8(Systemic Systems Domain score) | 24.48 Units on a scale |
| PF-06700841 60 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8 (Social Function Domain score) | 26.57 Units on a scale |
| PF-06700841 60 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Social Function Domain score) | 16.64 Units on a scale |
| PF-06700841 60 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4(Emotion Health Domain score) | 57.86 Units on a scale |
| PF-06700841 60 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Total IBDQ score) | 108.17 Units on a scale |
| PF-06700841 60 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Emotion Health Domain score) | 41.43 Units on a scale |
| PF-06700841 60 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Baseline (Bowel Systems Domain score) | 33.38 Units on a scale |
| PF-06700841 60 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4(Systemic Systems Domain score) | 23.61 Units on a scale |
| PF-06700841 60 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4 (Social Function Domain score) | 24.86 Units on a scale |
| PF-06700841 60 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8 (Total IBDQ score) | 165.39 Units on a scale |
| PF-06700841 60 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8 (Bowel Systems Domain score) | 53.45 Units on a scale |
| PF-06700841 60 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 8(Emotion Health Domain score) | 60.89 Units on a scale |
| PF-06700841 60 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4 (Bowel Systems Domain score) | 50.64 Units on a scale |
| PF-06700841 60 mg (Induction) | Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score and Total Score at Weeks 4 and 8 (Induction Period) | Week 4 (Total IBDQ score) | 156.98 Units on a scale |
Secondary
Number of Participants With Abnormal ECG Findings (Chronic Period)
The number of participants with abnormal ECG findings during the chronic period (from Week 9 to Week 32) are reported below.
Time frame: Week 8 to Week 32
Population: The participants evaluated against the criteria during the chronic period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Induction) | Number of Participants With Abnormal ECG Findings (Chronic Period) | Abnormal, not clinically significant | 3 Participants |
| Placebo (Induction) | Number of Participants With Abnormal ECG Findings (Chronic Period) | Abnormal, clinically significant | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Abnormal ECG Findings (Chronic Period) | Abnormal, not clinically significant | 6 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Abnormal ECG Findings (Chronic Period) | Abnormal, clinically significant | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Abnormal ECG Findings (Chronic Period) | Abnormal, not clinically significant | 2 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Abnormal ECG Findings (Chronic Period) | Abnormal, clinically significant | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Abnormal ECG Findings (Chronic Period) | Abnormal, not clinically significant | 1 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Abnormal ECG Findings (Chronic Period) | Abnormal, clinically significant | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Abnormal ECG Findings (Chronic Period) | Abnormal, not clinically significant | 1 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Abnormal ECG Findings (Chronic Period) | Abnormal, clinically significant | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Abnormal ECG Findings (Chronic Period) | Abnormal, clinically significant | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Abnormal ECG Findings (Chronic Period) | Abnormal, not clinically significant | 2 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Abnormal ECG Findings (Chronic Period) | Abnormal, clinically significant | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Abnormal ECG Findings (Chronic Period) | Abnormal, not clinically significant | 4 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Abnormal ECG Findings (Chronic Period) | Abnormal, not clinically significant | 2 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Abnormal ECG Findings (Chronic Period) | Abnormal, clinically significant | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Abnormal ECG Findings (Chronic Period) | Abnormal, not clinically significant | 4 Participants |
| Pooling Placebo During Chronic | Number of Participants With Abnormal ECG Findings (Chronic Period) | Abnormal, clinically significant | 0 Participants |
Secondary
Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period)
The number of participants with abnormal ECG findings during the induction period (from Day 1 to Week 8) are reported below. The criteria of test abnormality is defined as one of the following conditions was met: 1)associated with accompanying symptoms;2)Test result requires additional diagnostic testing or medical/surgical intervention;3)Test result leads to a change in study dosing (outside of any protocol specified dose adjustments) or discontinuation from the study, significant additional concomitant drug treatment, or other therapy;4)Test result is considered to be an AE by the investigator or sponsor.
Time frame: From screening to Week 8
Population: Number of Participants Analyzed: the participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Number Analyzed: the participants evaluated at the specified time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, not clinical significant (at Week 8) | 2 Participants |
| Placebo (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, not clinical significant (at screening) | 2 Participants |
| Placebo (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, clinical significant (at screening) | 0 Participants |
| Placebo (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, clinical significant (at Week 8) | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, not clinical significant (at Week 8) | 7 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, clinical significant (at screening) | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, clinical significant (at Week 8) | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, not clinical significant (at screening) | 8 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, not clinical significant (at screening) | 6 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, clinical significant (at Week 8) | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, not clinical significant (at Week 8) | 8 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, clinical significant (at screening) | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, clinical significant (at Week 8) | 1 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, not clinical significant (at screening) | 4 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, clinical significant (at screening) | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, not clinical significant (at Week 8) | 4 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, clinical significant (at screening) | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, not clinical significant (at screening) | 9 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, not clinical significant (at Week 8) | 5 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, clinical significant (at Week 8) | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, not clinical significant (at Week 8) | 4 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, clinical significant (at Week 8) | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, not clinical significant (at screening) | 10 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, clinical significant (at screening) | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, clinical significant (at Week 8) | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, not clinical significant (at Week 8) | 3 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, not clinical significant (at screening) | 8 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Abnormal Electrocardiogram (ECG) Findings (Induction Period) | abnormal, clinical significant (at screening) | 0 Participants |
Secondary
Number of Participants With Abnormal Vital Signs Data (Chronic Period)
The vital signs data included the single sitting blood pressure, pulse rate and temperature. The criteria of vital sign abnormality are indicated below.
Time frame: From Week 8 to Week 32
Population: The participants evaluated against the criteria during the chronic period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Decrease | 0 Participants |
| Placebo (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Increase | 0 Participants |
| Placebo (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Value <90 mmHg | 0 Participants |
| Placebo (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Value <50 mmHg | 0 Participants |
| Placebo (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Increase | 0 Participants |
| Placebo (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Decrease | 2 Participants |
| Placebo (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Pulse Rate Value <40 beat per minute (bpm) | 0 Participants |
| Placebo (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Pulse Rate Value >120 bpm | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Value <50 mmHg | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Increase | 3 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Pulse Rate Value <40 beat per minute (bpm) | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Decrease | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Decrease | 4 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Value <90 mmHg | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Pulse Rate Value >120 bpm | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Increase | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Pulse Rate Value >120 bpm | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Value <50 mmHg | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Decrease | 5 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Increase | 4 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Pulse Rate Value <40 beat per minute (bpm) | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Decrease | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Value <90 mmHg | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Increase | 6 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Increase | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Pulse Rate Value <40 beat per minute (bpm) | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Pulse Rate Value >120 bpm | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Decrease | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Value <50 mmHg | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Increase | 1 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Value <90 mmHg | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Decrease | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Increase | 4 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Value <50 mmHg | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Pulse Rate Value >120 bpm | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Decrease | 2 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Increase | 3 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Pulse Rate Value <40 beat per minute (bpm) | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Decrease | 1 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Value <90 mmHg | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Increase | 2 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Pulse Rate Value >120 bpm | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Decrease | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Pulse Rate Value <40 beat per minute (bpm) | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Increase | 2 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Value <50 mmHg | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Decrease | 3 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Value <90 mmHg | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Pulse Rate Value >120 bpm | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Value <90 mmHg | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Decrease | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Decrease | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Increase | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Value <50 mmHg | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Increase | 3 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Pulse Rate Value <40 beat per minute (bpm) | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Value <90 mmHg | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Increase | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Decrease | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Value <50 mmHg | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Increase | 1 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Decrease | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Pulse Rate Value >120 bpm | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Pulse Rate Value <40 beat per minute (bpm) | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Pulse Rate Value >120 bpm | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Pulse Rate Value <40 beat per minute (bpm) | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Decrease | 2 Participants |
| Pooling Placebo During Chronic | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Increase | 1 Participants |
| Pooling Placebo During Chronic | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Diastolic Blood Pressure Value <50 mmHg | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Decrease | 1 Participants |
| Pooling Placebo During Chronic | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Increase | 3 Participants |
| Pooling Placebo During Chronic | Number of Participants With Abnormal Vital Signs Data (Chronic Period) | Sitting Systolic Blood Pressure Value <90 mmHg | 1 Participants |
Secondary
Number of Participants With Abnormal Vital Signs Data (Induction Period)
The vital signs data included the single sitting blood pressure, pulse rate and temperature. The criteria of vital sign abnormality are indicated below.
Time frame: From screening to Week 8
Population: Number of participants evaluated against the criteria during the induction period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Pulse Rate Value >120 bpm | 0 Participants |
| Placebo (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Pulse Rate Value <40 bpm | 0 Participants |
| Placebo (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Increase | 0 Participants |
| Placebo (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Increase | 0 Participants |
| Placebo (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Systolic Blood Pressure Value <90 mmHg | 0 Participants |
| Placebo (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Diastolic Blood Pressure Value <50 mmHg | 0 Participants |
| Placebo (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Decrease | 0 Participants |
| Placebo (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Decrease | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Increase | 2 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Diastolic Blood Pressure Value <50 mmHg | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Systolic Blood Pressure Value <90 mmHg | 1 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Pulse Rate Value <40 bpm | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Increase | 1 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Decrease | 4 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Decrease | 1 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Pulse Rate Value >120 bpm | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Diastolic Blood Pressure Value <50 mmHg | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Pulse Rate Value >120 bpm | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Systolic Blood Pressure Value <90 mmHg | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Increase | 3 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Decrease | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Increase | 3 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Pulse Rate Value <40 bpm | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Decrease | 4 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Increase | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Pulse Rate Value <40 bpm | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Systolic Blood Pressure Value <90 mmHg | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Decrease | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Diastolic Blood Pressure Value <50 mmHg | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Increase | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Decrease | 2 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Pulse Rate Value >120 bpm | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Decrease | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Pulse Rate Value >120 bpm | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Increase | 2 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Increase | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Decrease | 2 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Diastolic Blood Pressure Value <50 mmHg | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Systolic Blood Pressure Value <90 mmHg | 3 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Pulse Rate Value <40 bpm | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Pulse Rate Value >120 bpm | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Decrease | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Systolic Blood Pressure Value <90 mmHg | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Pulse Rate Value <40 bpm | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Decrease | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Increase | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Increase | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Diastolic Blood Pressure Value <50 mmHg | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Pulse Rate Value <40 bpm | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Pulse Rate Value >120 bpm | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Decrease | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Decrease | 2 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Diastolic Blood Pressure Value <50 mmHg | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Systolic Blood Pressure Value <90 mmHg | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Diastolic Blood Pressure Change ≥20 mmHg Increase | 5 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Abnormal Vital Signs Data (Induction Period) | Sitting Systolic Blood Pressure Change ≥30 mmHg Increase | 3 Participants |
Secondary
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period)
An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes: death, life-threatening experience, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. All AEs mentioned below are treatment-emergent AEs.
Time frame: From Day 1 up to Week 8
Population: The participants who received at least one dose of PF-06651600, PF-06700841, or placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Induction) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) | Participants discontinued from study due to AEs | 0 Participants |
| Placebo (Induction) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) | Participants with SAEs | 0 Participants |
| Placebo (Induction) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) | Participants with AEs | 13 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) | Participants with AEs | 23 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) | Participants discontinued from study due to AEs | 5 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) | Participants with SAEs | 3 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) | Participants with SAEs | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) | Participants with AEs | 21 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) | Participants discontinued from study due to AEs | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) | Participants with SAEs | 3 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) | Participants discontinued from study due to AEs | 5 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) | Participants with AEs | 21 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) | Participants with AEs | 19 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) | Participants with SAEs | 1 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) | Participants discontinued from study due to AEs | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) | Participants with AEs | 26 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) | Participants with SAEs | 3 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) | Participants discontinued from study due to AEs | 2 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) | Participants with AEs | 23 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) | Participants with SAEs | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs (All-causalities) (Induction Period) | Participants discontinued from study due to AEs | 1 Participants |
Secondary
Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period)
An AE was an untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes: death, life-threatening experience, initial or prolonged inpatient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or that worsen in severity after the first dose of study medication. All AEs mentioned below are treatment-emergent AEs.
Time frame: From Week 8 up to Week 32
Population: The safety analysis set was defined as those participants who received at least one dose of PF-06651600, PF-06700841, or placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Induction) | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants with AEs | 18 Participants |
| Placebo (Induction) | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants discontinued from study due to AEs | 1 Participants |
| Placebo (Induction) | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants with SAEs | 3 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants discontinued from study due to AEs | 1 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants with SAEs | 1 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants with AEs | 27 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants with SAEs | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants with AEs | 18 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants discontinued from study due to AEs | 3 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants discontinued from study due to AEs | 1 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants with AEs | 8 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants with SAEs | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants with SAEs | 2 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants with AEs | 21 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants discontinued from study due to AEs | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants with SAEs | 4 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants with AEs | 23 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants discontinued from study due to AEs | 4 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants discontinued from study due to AEs | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants with AEs | 26 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants with SAEs | 2 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants with SAEs | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants discontinued from study due to AEs | 1 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants with AEs | 4 Participants |
| Pooling Placebo During Chronic | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants with SAEs | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants discontinued from study due to AEs | 6 Participants |
| Pooling Placebo During Chronic | Number of Participants With AEs, SAEs and Discontinuation Due to AEs (Chronic Period) | Participants with AEs | 18 Participants |
Secondary
Number of Participants With Laboratory Test Abnormalities (Chronic Period)
The number of participants with a laboratory abnormality meeting the pre-specified criteria defined in the study protocol while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. Laboratory data included hematology test, serum chemistry test, C-creative protein and viral surveillance.
Time frame: From Week 8 to Week 32
Population: The participants with at least one observation of the given laboratory test while on study treatment or during lag time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities (Chronic Period) | 27 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities (Chronic Period) | 31 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities (Chronic Period) | 33 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities (Chronic Period) | 8 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities (Chronic Period) | 29 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities (Chronic Period) | 27 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities (Chronic Period) | 28 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities (Chronic Period) | 8 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities (Chronic Period) | 23 Participants |
Secondary
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period)
The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of serum chemistry test parameters were as follows: blood urea nitrogen, creatinine, cystatin C, glucose, calcium, sodium, potassium, gamma glutamyl transferase, chloride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, alkaline phosphatase, uric acid, albumin, total protein, creatine kinase (CK), total cholesterol, triglycerides, high-density lipoproteins (HDL), and low-density lipoprotein (LDL).
Time frame: Week 8 to Week 32
Population: Number of Participants Analyzed: the participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Number Analyzed: the participants with at least one observation of the given laboratory test while on study treatment or during lag time.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Urate (mg/dL) >1.2 x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Glucose (mg/dL) <0.6 x LLN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | HDL Cholesterol (mg/dL) <0.8 x LLN | 1 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Triglycerides (mg/dL) >1.3 x ULN | 3 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Creatinine (mg/dL) >1.3 x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Albumin (g/dL) <0.8 x LLN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | AST (U/L) >3.0 x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Chloride (Meq/L) >1.1 x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Sodium (Meq/L) <0.95 x LLN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | LDL Cholesterol (mg/dL) >1.2 x ULN | 1 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Cholesterol (mg/dl) >1.3 x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Calcium (mg/dL) >1.1 x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Hemoglobin A1C (%) >1.3 x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Direct Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Protein (g/dL) <0.8 x LLN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | ALT (U/L) >3.0 x ULN | 1 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Potassium (Meq/L) >1.1 x ULN | 1 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Glucose (mg/dL) >1.5 x ULN | 1 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Potassium (Meq/L) <0.9 x LLN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Urea Nitrogen (mg/dL) >1.3 x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Chloride (Meq/L) <0.9 x LLN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Indirect Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Protein (g/dL) >1.2 x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Sodium (Meq/L) >1.05 x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Gamma Glutamyl Transferase (U/L) >3.0 x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Alkaline Phosphatase (U/L) >3.0 x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Creatine Kinase (U/L) >2.0 x ULN | 1 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Albumin (g/dL) >1.2 x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Calcium (mg/dL) <0.9 x LLN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Bilirubin (mg/dL) >1.5 x ULN | 1 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | AST (U/L) >3.0 x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Potassium (Meq/L) <0.9 x LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Alkaline Phosphatase (U/L) >3.0 x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Triglycerides (mg/dL) >1.3 x ULN | 2 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Sodium (Meq/L) >1.05 x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Albumin (g/dL) <0.8 x LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Protein (g/dL) <0.8 x LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Hemoglobin A1C (%) >1.3 x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Sodium (Meq/L) <0.95 x LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Creatinine (mg/dL) >1.3 x ULN | 1 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Glucose (mg/dL) >1.5 x ULN | 3 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | HDL Cholesterol (mg/dL) <0.8 x LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Indirect Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Protein (g/dL) >1.2 x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Cholesterol (mg/dl) >1.3 x ULN | 1 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Urea Nitrogen (mg/dL) >1.3 x ULN | 1 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Glucose (mg/dL) <0.6 x LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Urate (mg/dL) >1.2 x ULN | 2 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Calcium (mg/dL) >1.1 x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Direct Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | LDL Cholesterol (mg/dL) >1.2 x ULN | 1 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Chloride (Meq/L) <0.9 x LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | ALT (U/L) >3.0 x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Chloride (Meq/L) >1.1 x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Creatine Kinase (U/L) >2.0 x ULN | 3 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Calcium (mg/dL) <0.9 x LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Potassium (Meq/L) >1.1 x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Albumin (g/dL) >1.2 x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Gamma Glutamyl Transferase (U/L) >3.0 x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Protein (g/dL) >1.2 x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Creatinine (mg/dL) >1.3 x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Albumin (g/dL) <0.8 x LLN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Chloride (Meq/L) >1.1 x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Albumin (g/dL) >1.2 x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Direct Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Cholesterol (mg/dl) >1.3 x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Hemoglobin A1C (%) >1.3 x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Indirect Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Calcium (mg/dL) >1.1 x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | AST (U/L) >3.0 x ULN | 2 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Chloride (Meq/L) <0.9 x LLN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | ALT (U/L) >3.0 x ULN | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Potassium (Meq/L) >1.1 x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Urea Nitrogen (mg/dL) >1.3 x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Gamma Glutamyl Transferase (U/L) >3.0 x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Potassium (Meq/L) <0.9 x LLN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Alkaline Phosphatase (U/L) >3.0 x ULN | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Sodium (Meq/L) >1.05 x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Calcium (mg/dL) <0.9 x LLN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Sodium (Meq/L) <0.95 x LLN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Bilirubin (mg/dL) >1.5 x ULN | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Triglycerides (mg/dL) >1.3 x ULN | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | LDL Cholesterol (mg/dL) >1.2 x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Creatine Kinase (U/L) >2.0 x ULN | 2 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Glucose (mg/dL) <0.6 x LLN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Glucose (mg/dL) >1.5 x ULN | 3 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | HDL Cholesterol (mg/dL) <0.8 x LLN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Protein (g/dL) <0.8 x LLN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Urate (mg/dL) >1.2 x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Sodium (Meq/L) >1.05 x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Potassium (Meq/L) <0.9 x LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | LDL Cholesterol (mg/dL) >1.2 x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Direct Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Gamma Glutamyl Transferase (U/L) >3.0 x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Protein (g/dL) >1.2 x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Urea Nitrogen (mg/dL) >1.3 x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Potassium (Meq/L) >1.1 x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Calcium (mg/dL) <0.9 x LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | ALT (U/L) >3.0 x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Chloride (Meq/L) <0.9 x LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | AST (U/L) >3.0 x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Calcium (mg/dL) >1.1 x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Albumin (g/dL) <0.8 x LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | HDL Cholesterol (mg/dL) <0.8 x LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Chloride (Meq/L) >1.1 x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Albumin (g/dL) >1.2 x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Indirect Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Glucose (mg/dL) <0.6 x LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Glucose (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Creatinine (mg/dL) >1.3 x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Protein (g/dL) <0.8 x LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Sodium (Meq/L) <0.95 x LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Urate (mg/dL) >1.2 x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Cholesterol (mg/dl) >1.3 x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Triglycerides (mg/dL) >1.3 x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Hemoglobin A1C (%) >1.3 x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Creatine Kinase (U/L) >2.0 x ULN | 1 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Alkaline Phosphatase (U/L) >3.0 x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Albumin (g/dL) >1.2 x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Bilirubin (mg/dL) >1.5 x ULN | 1 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Direct Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Indirect Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | AST (U/L) >3.0 x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | ALT (U/L) >3.0 x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Urea Nitrogen (mg/dL) >1.3 x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Gamma Glutamyl Transferase (U/L) >3.0 x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Alkaline Phosphatase (U/L) >3.0 x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Urate (mg/dL) >1.2 x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Sodium (Meq/L) <0.95 x LLN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Chloride (Meq/L) >1.1 x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Calcium (mg/dL) <0.9 x LLN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Protein (g/dL) <0.8 x LLN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Protein (g/dL) >1.2 x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Albumin (g/dL) <0.8 x LLN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Chloride (Meq/L) <0.9 x LLN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Creatinine (mg/dL) >1.3 x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | HDL Cholesterol (mg/dL) <0.8 x LLN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | LDL Cholesterol (mg/dL) >1.2 x ULN | 1 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Triglycerides (mg/dL) >1.3 x ULN | 2 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Sodium (Meq/L) >1.05 x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Potassium (Meq/L) <0.9 x LLN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Potassium (Meq/L) >1.1 x ULN | 2 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Calcium (mg/dL) >1.1 x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Glucose (mg/dL) <0.6 x LLN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Glucose (mg/dL) >1.5 x ULN | 1 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Hemoglobin A1C (%) >1.3 x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Creatine Kinase (U/L) >2.0 x ULN | 3 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Cholesterol (mg/dl) >1.3 x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Glucose (mg/dL) <0.6 x LLN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Chloride (Meq/L) >1.1 x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Potassium (Meq/L) >1.1 x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | ALT (U/L) >3.0 x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Glucose (mg/dL) >1.5 x ULN | 2 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Calcium (mg/dL) <0.9 x LLN | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Urate (mg/dL) >1.2 x ULN | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | AST (U/L) >3.0 x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Chloride (Meq/L) <0.9 x LLN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Calcium (mg/dL) >1.1 x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Albumin (g/dL) >1.2 x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Indirect Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | LDL Cholesterol (mg/dL) >1.2 x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Albumin (g/dL) <0.8 x LLN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Protein (g/dL) <0.8 x LLN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Triglycerides (mg/dL) >1.3 x ULN | 2 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Protein (g/dL) >1.2 x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Creatinine (mg/dL) >1.3 x ULN | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Sodium (Meq/L) <0.95 x LLN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Creatine Kinase (U/L) >2.0 x ULN | 10 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Alkaline Phosphatase (U/L) >3.0 x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Urea Nitrogen (mg/dL) >1.3 x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Hemoglobin A1C (%) >1.3 x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Sodium (Meq/L) >1.05 x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | HDL Cholesterol (mg/dL) <0.8 x LLN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Cholesterol (mg/dl) >1.3 x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Gamma Glutamyl Transferase (U/L) >3.0 x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Direct Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Potassium (Meq/L) <0.9 x LLN | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Chloride (Meq/L) >1.1 x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Protein (g/dL) >1.2 x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | ALT (U/L) >3.0 x ULN | 2 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Urea Nitrogen (mg/dL) >1.3 x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Triglycerides (mg/dL) >1.3 x ULN | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Potassium (Meq/L) >1.1 x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Glucose (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Protein (g/dL) <0.8 x LLN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Chloride (Meq/L) <0.9 x LLN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Calcium (mg/dL) <0.9 x LLN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | AST (U/L) >3.0 x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Hemoglobin A1C (%) >1.3 x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Bilirubin (mg/dL) >1.5 x ULN | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | HDL Cholesterol (mg/dL) <0.8 x LLN | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Direct Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Glucose (mg/dL) <0.6 x LLN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Indirect Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Albumin (g/dL) >1.2 x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Alkaline Phosphatase (U/L) >3.0 x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Calcium (mg/dL) >1.1 x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Creatine Kinase (U/L) >2.0 x ULN | 2 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Gamma Glutamyl Transferase (U/L) >3.0 x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Sodium (Meq/L) <0.95 x LLN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Sodium (Meq/L) >1.05 x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | LDL Cholesterol (mg/dL) >1.2 x ULN | 2 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Urate (mg/dL) >1.2 x ULN | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Cholesterol (mg/dl) >1.3 x ULN | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Potassium (Meq/L) <0.9 x LLN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Creatinine (mg/dL) >1.3 x ULN | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Albumin (g/dL) <0.8 x LLN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Creatinine (mg/dL) >1.3 x ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Protein (g/dL) <0.8 x LLN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Urate (mg/dL) >1.2 x ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Hemoglobin A1C (%) >1.3 x ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | HDL Cholesterol (mg/dL) <0.8 x LLN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Chloride (Meq/L) <0.9 x LLN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | LDL Cholesterol (mg/dL) >1.2 x ULN | 1 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Potassium (Meq/L) >1.1 x ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Creatine Kinase (U/L) >2.0 x ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Triglycerides (mg/dL) >1.3 x ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Alkaline Phosphatase (U/L) >3.0 x ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Urea Nitrogen (mg/dL) >1.3 x ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Sodium (Meq/L) <0.95 x LLN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Sodium (Meq/L) >1.05 x ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Gamma Glutamyl Transferase (U/L) >3.0 x ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Potassium (Meq/L) <0.9 x LLN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | ALT (U/L) >3.0 x ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Albumin (g/dL) >1.2 x ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | AST (U/L) >3.0 x ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Calcium (mg/dL) <0.9 x LLN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Indirect Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Calcium (mg/dL) >1.1 x ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Glucose (mg/dL) <0.6 x LLN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Direct Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Chloride (Meq/L) >1.1 x ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Cholesterol (mg/dl) >1.3 x ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Glucose (mg/dL) >1.5 x ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Albumin (g/dL) <0.8 x LLN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Protein (g/dL) >1.2 x ULN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Creatinine (mg/dL) >1.3 x ULN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | HDL Cholesterol (mg/dL) <0.8 x LLN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | AST (U/L) >3.0 x ULN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Potassium (Meq/L) >1.1 x ULN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Cholesterol (mg/dl) >1.3 x ULN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Glucose (mg/dL) >1.5 x ULN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | ALT (U/L) >3.0 x ULN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Potassium (Meq/L) <0.9 x LLN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Albumin (g/dL) >1.2 x ULN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Bilirubin (mg/dL) >1.5 x ULN | 1 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Sodium (Meq/L) >1.05 x ULN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Creatine Kinase (U/L) >2.0 x ULN | 1 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Gamma Glutamyl Transferase (U/L) >3.0 x ULN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Hemoglobin A1C (%) >1.3 x ULN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Sodium (Meq/L) <0.95 x LLN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Urea Nitrogen (mg/dL) >1.3 x ULN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Albumin (g/dL) <0.8 x LLN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Alkaline Phosphatase (U/L) >3.0 x ULN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Triglycerides (mg/dL) >1.3 x ULN | 1 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Protein (g/dL) <0.8 x LLN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Chloride (Meq/L) <0.9 x LLN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Urate (mg/dL) >1.2 x ULN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | LDL Cholesterol (mg/dL) >1.2 x ULN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Direct Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Calcium (mg/dL) >1.1 x ULN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Indirect Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Protein (g/dL) >1.2 x ULN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Glucose (mg/dL) <0.6 x LLN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Calcium (mg/dL) <0.9 x LLN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Chronic Period) | Chloride (Meq/L) >1.1 x ULN | 0 Participants |
Secondary
Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period)
The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of serum chemistry test parameters were as follows: blood urea nitrogen, creatinine, cystatin C, glucose, calcium, sodium, potassium, gamma glutamyl transferase, chloride, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, direct bilirubin, alkaline phosphatase, uric acid, albumin, total protein, creatine kinase (CK), total cholesterol, triglycerides, high-density lipoproteins (HDL), and low-density lipoprotein (LDL)
Time frame: From Day 1 up to Week 8
Population: Number of Participants Analyzed: the participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Number Analyzed: the participants with at least one observation of the given laboratory test while on study treatment or during lag time.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Calcium (mg/dL) >1.1x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Albumin (g/dL) <0.8x LLN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Urea Nitrogen (mg/dL) >1.3x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Calcium (mg/dL) <0.9x LLN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Hemoglobin A1C (%) >1.3x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Urate (mg/dL) >1.2x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | AST (U/L) >3.0x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | CK (U/L) >2.0x ULN | 2 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Potassium (Meq/L) >1.1x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Chloride (Meq/L) >1.1x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Sodium(Meq/L) >1.05x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Sodium(Meq/L) <0.95x LLN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | ALT (U/L) >3.0x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Protein (g/dL) >1.2x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Direct Bilirubin (mg/dL) >1.5x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Glucose (mg/dL) <0.6x LLN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Protein (g/dL) <0.8x LLN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Glucose (mg/dL) >1.5x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Gamma Glutamyl Transferase (U/L) >3.0x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | HDL Cholesterol (mg/dL) <0.8x LLN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | LDL Cholesterol (mg/dL) >1.2x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Cholesterol (mg/dl) >1.3x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Chloride (Meq/L) <0.9x LLN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Creatinine (mg/dL) >1.3x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Bilirubin (mg/dL) >1.5x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Alkaline Phosphatase (U/L) >3.0x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Albumin (g/dL) >1.2x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Triglycerides (mg/dL) >1.3x ULN | 1 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Indirect Bilirubin (mg/dL) >1.5x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Potassium (Meq/L) <0.9x LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Cholesterol (mg/dl) >1.3x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Glucose (mg/dL) <0.6x LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Protein (g/dL) <0.8x LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Protein (g/dL) >1.2x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Sodium(Meq/L) >1.05x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Albumin (g/dL) >1.2x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Albumin (g/dL) <0.8x LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | CK (U/L) >2.0x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Calcium (mg/dL) <0.9x LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Calcium (mg/dL) >1.1x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | HDL Cholesterol (mg/dL) <0.8x LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Direct Bilirubin (mg/dL) >1.5x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Triglycerides (mg/dL) >1.3x ULN | 1 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Chloride (Meq/L) <0.9x LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Hemoglobin A1C (%) >1.3x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Indirect Bilirubin (mg/dL) >1.5x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | LDL Cholesterol (mg/dL) >1.2x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Urate (mg/dL) >1.2x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Bilirubin (mg/dL) >1.5x ULN | 1 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | AST (U/L) >3.0x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Potassium (Meq/L) <0.9x LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | ALT (U/L) >3.0x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Sodium(Meq/L) <0.95x LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Potassium (Meq/L) >1.1x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Glucose (mg/dL) >1.5x ULN | 1 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Gamma Glutamyl Transferase (U/L) >3.0x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Creatinine (mg/dL) >1.3x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Chloride (Meq/L) >1.1x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Alkaline Phosphatase (U/L) >3.0x ULN | 1 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Urea Nitrogen (mg/dL) >1.3x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | LDL Cholesterol (mg/dL) >1.2x ULN | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Potassium (Meq/L) >1.1x ULN | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Triglycerides (mg/dL) >1.3x ULN | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Sodium(Meq/L) <0.95x LLN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Bilirubin (mg/dL) >1.5x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Direct Bilirubin (mg/dL) >1.5x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Hemoglobin A1C (%) >1.3x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Indirect Bilirubin (mg/dL) >1.5x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Sodium(Meq/L) >1.05x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | AST (U/L) >3.0x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Cholesterol (mg/dl) >1.3x ULN | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Glucose (mg/dL) >1.5x ULN | 2 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | ALT (U/L) >3.0x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Potassium (Meq/L) <0.9x LLN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Gamma Glutamyl Transferase (U/L) >3.0x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Alkaline Phosphatase (U/L) >3.0x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Glucose (mg/dL) <0.6x LLN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Protein (g/dL) <0.8x LLN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Calcium (mg/dL) >1.1x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Protein (g/dL) >1.2x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Albumin (g/dL) <0.8x LLN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Calcium (mg/dL) <0.9x LLN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Albumin (g/dL) >1.2x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Urea Nitrogen (mg/dL) >1.3x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Chloride (Meq/L) >1.1x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Creatinine (mg/dL) >1.3x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Urate (mg/dL) >1.2x ULN | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | CK (U/L) >2.0x ULN | 2 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Chloride (Meq/L) <0.9x LLN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | HDL Cholesterol (mg/dL) <0.8x LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Protein (g/dL) <0.8x LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Alkaline Phosphatase (U/L) >3.0x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | LDL Cholesterol (mg/dL) >1.2x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Urea Nitrogen (mg/dL) >1.3x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | ALT (U/L) >3.0x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | HDL Cholesterol (mg/dL) <0.8x LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Glucose (mg/dL) <0.6x LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Bilirubin (mg/dL) >1.5x ULN | 1 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Potassium (Meq/L) <0.9x LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Sodium(Meq/L) >1.05x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Creatinine (mg/dL) >1.3x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Gamma Glutamyl Transferase (U/L) >3.0x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | AST (U/L) >3.0x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Chloride (Meq/L) <0.9x LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Glucose (mg/dL) >1.5x ULN | 1 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Indirect Bilirubin (mg/dL) >1.5x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Potassium (Meq/L) >1.1x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Urate (mg/dL) >1.2x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Sodium(Meq/L) <0.95x LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Triglycerides (mg/dL) >1.3x ULN | 3 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Cholesterol (mg/dl) >1.3x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Direct Bilirubin (mg/dL) >1.5x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Albumin (g/dL) <0.8x LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Calcium (mg/dL) <0.9x LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Protein (g/dL) >1.2x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Hemoglobin A1C (%) >1.3x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Albumin (g/dL) >1.2x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Calcium (mg/dL) >1.1x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | CK (U/L) >2.0x ULN | 3 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Chloride (Meq/L) >1.1x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Glucose (mg/dL) <0.6x LLN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Bilirubin (mg/dL) >1.5x ULN | 2 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | HDL Cholesterol (mg/dL) <0.8x LLN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | CK (U/L) >2.0x ULN | 2 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Direct Bilirubin (mg/dL) >1.5x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Indirect Bilirubin (mg/dL) >1.5x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | AST (U/L) >3.0x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | ALT (U/L) >3.0x ULN | 2 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Gamma Glutamyl Transferase (U/L) >3.0x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Alkaline Phosphatase (U/L) >3.0x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Protein (g/dL) <0.8x LLN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Protein (g/dL) >1.2x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Albumin (g/dL) <0.8x LLN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Albumin (g/dL) >1.2x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Urea Nitrogen (mg/dL) >1.3x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Creatinine (mg/dL) >1.3x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Urate (mg/dL) >1.2x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | LDL Cholesterol (mg/dL) >1.2x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Triglycerides (mg/dL) >1.3x ULN | 1 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Sodium(Meq/L) <0.95x LLN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Sodium(Meq/L) >1.05x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Potassium (Meq/L) <0.9x LLN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Potassium (Meq/L) >1.1x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Chloride (Meq/L) <0.9x LLN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Chloride (Meq/L) >1.1x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Calcium (mg/dL) <0.9x LLN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Calcium (mg/dL) >1.1x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Glucose (mg/dL) >1.5x ULN | 1 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Hemoglobin A1C (%) >1.3x ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Cholesterol (mg/dl) >1.3x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | LDL Cholesterol (mg/dL) >1.2x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Potassium (Meq/L) >1.1x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | HDL Cholesterol (mg/dL) <0.8x LLN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Urate (mg/dL) >1.2x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | CK (U/L) >2.0x ULN | 3 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Creatinine (mg/dL) >1.3x ULN | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Urea Nitrogen (mg/dL) >1.3x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Chloride (Meq/L) >1.1x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Albumin (g/dL) >1.2x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Albumin (g/dL) <0.8x LLN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Chloride (Meq/L) <0.9x LLN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Calcium (mg/dL) <0.9x LLN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Protein (g/dL) <0.8x LLN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Calcium (mg/dL) >1.1x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Protein (g/dL) >1.2x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Alkaline Phosphatase (U/L) >3.0x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Gamma Glutamyl Transferase (U/L) >3.0x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Glucose (mg/dL) <0.6x LLN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | ALT (U/L) >3.0x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | AST (U/L) >3.0x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Glucose (mg/dL) >1.5x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Indirect Bilirubin (mg/dL) >1.5x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Direct Bilirubin (mg/dL) >1.5x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Hemoglobin A1C (%) >1.3x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Bilirubin (mg/dL) >1.5x ULN | 2 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Sodium(Meq/L) >1.05x ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Sodium(Meq/L) <0.95x LLN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Cholesterol (mg/dl) >1.3x ULN | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Potassium (Meq/L) <0.9x LLN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Triglycerides (mg/dL) >1.3x ULN | 2 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Alkaline Phosphatase (U/L) >3.0x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | HDL Cholesterol (mg/dL) <0.8x LLN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Chloride (Meq/L) <0.9x LLN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Potassium (Meq/L) <0.9x LLN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Potassium (Meq/L) >1.1x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Gamma Glutamyl Transferase (U/L) >3.0x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Urate (mg/dL) >1.2x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Bilirubin (mg/dL) >1.5x ULN | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Creatinine (mg/dL) >1.3x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Cholesterol (mg/dl) >1.3x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Glucose (mg/dL) <0.6x LLN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Urea Nitrogen (mg/dL) >1.3x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | ALT (U/L) >3.0x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Albumin (g/dL) >1.2x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | CK (U/L) >2.0x ULN | 6 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | LDL Cholesterol (mg/dL) >1.2x ULN | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Chloride (Meq/L) >1.1x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Hemoglobin A1C (%) >1.3x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Albumin (g/dL) <0.8x LLN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Indirect Bilirubin (mg/dL) >1.5x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | AST (U/L) >3.0x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Sodium(Meq/L) <0.95x LLN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Calcium (mg/dL) <0.9x LLN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Protein (g/dL) >1.2x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Protein (g/dL) <0.8x LLN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Glucose (mg/dL) >1.5x ULN | 2 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Sodium(Meq/L) >1.05x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Triglycerides (mg/dL) >1.3x ULN | 5 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Calcium (mg/dL) >1.1x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-clinical Chemistry (Induction Period) | Direct Bilirubin (mg/dL) >1.5x ULN | 0 Participants |
Secondary
Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period)
The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of hematology test parameters were as follows: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils (absolute, Abs), eosinophils (Abs), monocytes (Abs), basophils (Abs), lymphocytes (Abs), prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT), and reticulocytes (% and Abs). Percentages are displayed for the laboratory tests having a category with greater or equal to 1 evaluable participant.
Time frame: From Week 8 to Week 32
Population: Number of Participants Analyzed: the participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Number Analyzed: the participants with at least one observation of the given laboratory test while on study treatment or during lag time.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Reticulocytes/Erythrocytes (%) >1.5× ULN | 1 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | PT (second) >1.1× ULN | 2 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Leukocytes (10^3/mm^3) >1.5× ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Prothrombin INR >1.1× ULN | 2 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Lymphocytes (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Hemoglobin (g/dL) <0.8× LLN | 2 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Neutrophils (Abs) (10^3/mm^3) <0.8× LLN | 1 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Platelets (10^3/mm^3) >1.75× ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Neutrophils (Abs) (10^3/mm^3) >1.2× ULN | 3 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Lymphocytes (Abs) (10^3/mm^3) <0.8× LLN | 7 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Erythrocytes Mean Corpuscular Volume (10^-15L) <0.9× LLN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Basophils (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Reticulocytes (Abs) (10^3/mm^3) >1.5× ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Eosinophils (Abs) (10^3/mm^3) >1.2x ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Erythrocytes (10^6/mm^3) <0.8× LLN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Monocytes (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Hematocrit (%) <0.8× LLN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Activated PTT (second) >1.1× ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Monocytes (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Platelets (10^3/mm^3) >1.75× ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Neutrophils (Abs) (10^3/mm^3) <0.8× LLN | 2 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Leukocytes (10^3/mm^3) >1.5× ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Erythrocytes Mean Corpuscular Volume (10^-15L) <0.9× LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Neutrophils (Abs) (10^3/mm^3) >1.2× ULN | 8 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Reticulocytes (Abs) (10^3/mm^3) >1.5× ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Basophils (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Lymphocytes (Abs) (10^3/mm^3) <0.8× LLN | 6 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Hemoglobin (g/dL) <0.8× LLN | 2 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Erythrocytes (10^6/mm^3) <0.8× LLN | 1 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Eosinophils (Abs) (10^3/mm^3) >1.2x ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Activated PTT (second) >1.1× ULN | 3 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Prothrombin INR >1.1× ULN | 3 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | PT (second) >1.1× ULN | 3 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Hematocrit (%) <0.8× LLN | 2 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Reticulocytes/Erythrocytes (%) >1.5× ULN | 1 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Lymphocytes (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Hematocrit (%) <0.8× LLN | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Lymphocytes (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Platelets (10^3/mm^3) >1.75× ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Hemoglobin (g/dL) <0.8× LLN | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Monocytes (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Prothrombin INR >1.1× ULN | 2 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Neutrophils (Abs) (10^3/mm^3) <0.8× LLN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Erythrocytes (10^6/mm^3) <0.8× LLN | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Activated PTT (second) >1.1× ULN | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Reticulocytes (Abs) (10^3/mm^3) >1.5× ULN | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Basophils (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Erythrocytes Mean Corpuscular Volume (10^-15L) <0.9× LLN | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Reticulocytes/Erythrocytes (%) >1.5× ULN | 2 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Eosinophils (Abs) (10^3/mm^3) >1.2x ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Leukocytes (10^3/mm^3) >1.5× ULN | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Neutrophils (Abs) (10^3/mm^3) >1.2× ULN | 11 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | PT (second) >1.1× ULN | 2 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Lymphocytes (Abs) (10^3/mm^3) <0.8× LLN | 6 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Activated PTT (second) >1.1× ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Reticulocytes (Abs) (10^3/mm^3) >1.5× ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | PT (second) >1.1× ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Basophils (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Erythrocytes (10^6/mm^3) <0.8× LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Reticulocytes/Erythrocytes (%) >1.5× ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Leukocytes (10^3/mm^3) >1.5× ULN | 1 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Eosinophils (Abs) (10^3/mm^3) >1.2x ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Lymphocytes (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Platelets (10^3/mm^3) >1.75× ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Prothrombin INR >1.1× ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Neutrophils (Abs) (10^3/mm^3) <0.8× LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Monocytes (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Erythrocytes Mean Corpuscular Volume (10^-15L) <0.9× LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Hematocrit (%) <0.8× LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Lymphocytes (Abs) (10^3/mm^3) <0.8× LLN | 1 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Neutrophils (Abs) (10^3/mm^3) >1.2× ULN | 1 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Hemoglobin (g/dL) <0.8× LLN | 1 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Leukocytes (10^3/mm^3) >1.5× ULN | 1 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Lymphocytes (Abs) (10^3/mm^3) <0.8× LLN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Lymphocytes (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Neutrophils (Abs) (10^3/mm^3) <0.8× LLN | 3 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Neutrophils (Abs) (10^3/mm^3) >1.2× ULN | 8 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Basophils (Abs) (10^3/mm^3) >1.2× ULN | 2 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Eosinophils (Abs) (10^3/mm^3) >1.2x ULN | 2 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Monocytes (Abs) (10^3/mm^3) >1.2× ULN | 2 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Activated PTT (second) >1.1× ULN | 2 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | PT (second) >1.1× ULN | 2 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Prothrombin INR >1.1× ULN | 2 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Reticulocytes (Abs) (10^3/mm^3) >1.5× ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Hemoglobin (g/dL) <0.8× LLN | 3 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Hematocrit (%) <0.8× LLN | 1 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Erythrocytes (10^6/mm^3) <0.8× LLN | 1 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Erythrocytes Mean Corpuscular Volume (10^-15L) <0.9× LLN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Platelets (10^3/mm^3) >1.75× ULN | 3 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Reticulocytes/Erythrocytes (%) >1.5× ULN | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Erythrocytes (10^6/mm^3) <0.8× LLN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Reticulocytes/Erythrocytes (%) >1.5× ULN | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Lymphocytes (Abs) (10^3/mm^3) <0.8× LLN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Hematocrit (%) <0.8× LLN | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Leukocytes (10^3/mm^3) >1.5× ULN | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Eosinophils (Abs) (10^3/mm^3) >1.2x ULN | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Erythrocytes Mean Corpuscular Volume (10^-15L) <0.9× LLN | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Activated PTT (second) >1.1× ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Lymphocytes (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Platelets (10^3/mm^3) >1.75× ULN | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Prothrombin INR >1.1× ULN | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Neutrophils (Abs) (10^3/mm^3) <0.8× LLN | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Hemoglobin (g/dL) <0.8× LLN | 3 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | PT (second) >1.1× ULN | 2 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Neutrophils (Abs) (10^3/mm^3) >1.2× ULN | 6 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Reticulocytes (Abs) (10^3/mm^3) >1.5× ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Monocytes (Abs) (10^3/mm^3) >1.2× ULN | 2 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Basophils (Abs) (10^3/mm^3) >1.2× ULN | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Reticulocytes/Erythrocytes (%) >1.5× ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Prothrombin INR >1.1× ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Monocytes (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Hemoglobin (g/dL) <0.8× LLN | 6 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Eosinophils (Abs) (10^3/mm^3) >1.2x ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Hematocrit (%) <0.8× LLN | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Basophils (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Erythrocytes (10^6/mm^3) <0.8× LLN | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Neutrophils (Abs) (10^3/mm^3) >1.2× ULN | 6 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Reticulocytes (Abs) (10^3/mm^3) >1.5× ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Neutrophils (Abs) (10^3/mm^3) <0.8× LLN | 2 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Erythrocytes Mean Corpuscular Volume (10^-15L) <0.9× LLN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Lymphocytes (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Leukocytes (10^3/mm^3) >1.5× ULN | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Platelets (10^3/mm^3) >1.75× ULN | 2 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Lymphocytes (Abs) (10^3/mm^3) <0.8× LLN | 3 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | PT (second) >1.1× ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Activated PTT (second) >1.1× ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Neutrophils (Abs) (10^3/mm^3) >1.2× ULN | 3 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Hematocrit (%) <0.8× LLN | 1 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Reticulocytes (Abs) (10^3/mm^3) >1.5× ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Hemoglobin (g/dL) <0.8× LLN | 2 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Neutrophils (Abs) (10^3/mm^3) <0.8× LLN | 1 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Prothrombin INR >1.1× ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Leukocytes (10^3/mm^3) >1.5× ULN | 1 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | PT (second) >1.1× ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Erythrocytes Mean Corpuscular Volume (10^-15L) <0.9× LLN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Lymphocytes (Abs) (10^3/mm^3) >1.2× ULN | 1 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Monocytes (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Platelets (10^3/mm^3) >1.75× ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Basophils (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Lymphocytes (Abs) (10^3/mm^3) <0.8× LLN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Eosinophils (Abs) (10^3/mm^3) >1.2x ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Activated PTT (second) >1.1× ULN | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Erythrocytes (10^6/mm^3) <0.8× LLN | 1 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Reticulocytes/Erythrocytes (%) >1.5× ULN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Leukocytes (10^3/mm^3) >1.5× ULN | 1 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Hemoglobin (g/dL) <0.8× LLN | 3 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Activated PTT (second) >1.1× ULN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Erythrocytes (10^6/mm^3) <0.8× LLN | 1 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Reticulocytes (Abs) (10^3/mm^3) >1.5× ULN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Platelets (10^3/mm^3) >1.75× ULN | 2 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Neutrophils (Abs) (10^3/mm^3) <0.8× LLN | 1 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Monocytes (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Lymphocytes (Abs) (10^3/mm^3) <0.8× LLN | 3 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Hematocrit (%) <0.8× LLN | 2 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Basophils (Abs) (10^3/mm^3) >1.2× ULN | 1 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Eosinophils (Abs) (10^3/mm^3) >1.2x ULN | 2 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Erythrocytes Mean Corpuscular Volume (10^-15L) <0.9× LLN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Reticulocytes/Erythrocytes (%) >1.5× ULN | 1 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Lymphocytes (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Neutrophils (Abs) (10^3/mm^3) >1.2× ULN | 6 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | PT (second) >1.1× ULN | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-hematology (Chronic Period) | Prothrombin INR >1.1× ULN | 0 Participants |
Secondary
Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period)
The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of hematology test parameters were as follows: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils (absolute, Abs), eosinophils (Abs), monocytes (Abs), basophils (Abs), lymphocytes (Abs), prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT), and reticulocytes (% and Abs). Percentages are displayed for the laboratory tests having a category with greater or equal to 1 evaluable participant.
Time frame: From Day 1 up to Week 8
Population: Number of Participants Analyzed: the participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Number Analyzed: the participants with at least one observation of the given laboratory test while on study treatment or during lag time.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Monocytes (Abs) (10^3/mm^3) >1.2× ULN | 2 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Leukocytes (10^3/mm^3) >1.5× ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Prothrombin INR >1.1× ULN | 1 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Erythrocytes Mean Corpuscular Volume (10^-15L) <0.9× LLN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Eosinophils (Abs) (10^3/mm^3) >1.2x ULN | 2 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Erythrocytes (10^6/mm^3) <0.8× LLN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Lymphocytes (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Neutrophils (Abs) (10^3/mm^3) >1.2× ULN | 7 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes/Erythrocytes (%) >1.5× ULN | 1 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Hematocrit (%) <0.8× LLN | 2 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Basophils (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | PT (second) >1.1× ULN | 1 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Neutrophils (Abs) (10^3/mm^3) <0.8× LLN | 1 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Hemoglobin (g/dL) <0.8× lower limit of normal (LLN) | 3 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes/Erythrocytes (%) <0.5× LLN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Platelets (10^3/mm^3) <0.5× LLN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Leukocytes (10^3/mm^3) <0.6× LLN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Activated PTT (second) >1.1× ULN | 1 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Erythrocytes Mean Corpuscular Volume (10^-15L) >1.1× ULN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes (Abs) (10^3/mm^3) >1.5× upper limit of normal (ULN) | 1 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes (Abs) (10^3/mm^3) <0.5× LLN | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Platelets (10^3/mm^3) >1.75× ULN | 1 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Lymphocytes (Abs) (10^3/mm^3) <0.8× LLN | 3 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes (Abs) (10^3/mm^3) <0.5× LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Erythrocytes Mean Corpuscular Volume (10^-15L) >1.1× ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Erythrocytes Mean Corpuscular Volume (10^-15L) <0.9× LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Platelets (10^3/mm^3) >1.75× ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Platelets (10^3/mm^3) <0.5× LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | PT (second) >1.1× ULN | 2 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes/Erythrocytes (%) <0.5× LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Activated PTT (second) >1.1× ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Leukocytes (10^3/mm^3) <0.6× LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Monocytes (Abs) (10^3/mm^3) >1.2× ULN | 2 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Lymphocytes (Abs) (10^3/mm^3) >1.2× ULN | 1 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Eosinophils (Abs) (10^3/mm^3) >1.2x ULN | 3 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Prothrombin INR >1.1× ULN | 2 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Basophils (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Hemoglobin (g/dL) <0.8× lower limit of normal (LLN) | 2 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Neutrophils (Abs) (10^3/mm^3) >1.2× ULN | 13 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Neutrophils (Abs) (10^3/mm^3) <0.8× LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Hematocrit (%) <0.8× LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Erythrocytes (10^6/mm^3) <0.8× LLN | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Lymphocytes (Abs) (10^3/mm^3) <0.8× LLN | 2 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Leukocytes (10^3/mm^3) >1.5× ULN | 3 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes (Abs) (10^3/mm^3) >1.5× upper limit of normal (ULN) | 1 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes/Erythrocytes (%) >1.5× ULN | 2 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Lymphocytes (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Erythrocytes (10^6/mm^3) <0.8× LLN | 4 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Neutrophils (Abs) (10^3/mm^3) <0.8× LLN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Platelets (10^3/mm^3) >1.75× ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Eosinophils (Abs) (10^3/mm^3) >1.2x ULN | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Lymphocytes (Abs) (10^3/mm^3) <0.8× LLN | 4 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes/Erythrocytes (%) <0.5× LLN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes (Abs) (10^3/mm^3) <0.5× LLN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Monocytes (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Erythrocytes Mean Corpuscular Volume (10^-15L) <0.9× LLN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Leukocytes (10^3/mm^3) >1.5× ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Prothrombin INR >1.1× ULN | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Leukocytes (10^3/mm^3) <0.6× LLN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Erythrocytes Mean Corpuscular Volume (10^-15L) >1.1× ULN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Neutrophils (Abs) (10^3/mm^3) >1.2× ULN | 7 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes (Abs) (10^3/mm^3) >1.5× upper limit of normal (ULN) | 2 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Hemoglobin (g/dL) <0.8× lower limit of normal (LLN) | 5 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Hematocrit (%) <0.8× LLN | 3 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | PT (second) >1.1× ULN | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Platelets (10^3/mm^3) <0.5× LLN | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Activated PTT (second) >1.1× ULN | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Basophils (Abs) (10^3/mm^3) >1.2× ULN | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes/Erythrocytes (%) >1.5× ULN | 3 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Hemoglobin (g/dL) <0.8× lower limit of normal (LLN) | 9 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Hematocrit (%) <0.8× LLN | 4 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes (Abs) (10^3/mm^3) >1.5× upper limit of normal (ULN) | 2 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Neutrophils (Abs) (10^3/mm^3) <0.8× LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Neutrophils (Abs) (10^3/mm^3) >1.2× ULN | 9 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Erythrocytes (10^6/mm^3) <0.8× LLN | 3 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes (Abs) (10^3/mm^3) <0.5× LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Erythrocytes Mean Corpuscular Volume (10^-15L) <0.9× LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Erythrocytes Mean Corpuscular Volume (10^-15L) >1.1× ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Platelets (10^3/mm^3) <0.5× LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Platelets (10^3/mm^3) >1.75× ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes/Erythrocytes (%) <0.5× LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes/Erythrocytes (%) >1.5× ULN | 3 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Leukocytes (10^3/mm^3) <0.6× LLN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Leukocytes (10^3/mm^3) >1.5× ULN | 3 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Lymphocytes (Abs) (10^3/mm^3) <0.8× LLN | 11 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Lymphocytes (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | PT (second) >1.1× ULN | 1 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Basophils (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Eosinophils (Abs) (10^3/mm^3) >1.2x ULN | 1 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Monocytes (Abs) (10^3/mm^3) >1.2× ULN | 2 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Activated PTT (second) >1.1× ULN | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Prothrombin INR >1.1× ULN | 1 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes/Erythrocytes (%) <0.5× LLN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Neutrophils (Abs) (10^3/mm^3) <0.8× LLN | 2 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes/Erythrocytes (%) >1.5× ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Leukocytes (10^3/mm^3) <0.6× LLN | 1 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Hemoglobin (g/dL) <0.8× lower limit of normal (LLN) | 4 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Eosinophils (Abs) (10^3/mm^3) >1.2x ULN | 1 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Neutrophils (Abs) (10^3/mm^3) >1.2× ULN | 7 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Lymphocytes (Abs) (10^3/mm^3) >1.2× ULN | 1 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | PT (second) >1.1× ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Erythrocytes (10^6/mm^3) <0.8× LLN | 1 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Leukocytes (10^3/mm^3) >1.5× ULN | 2 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Basophils (Abs) (10^3/mm^3) >1.2× ULN | 1 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Erythrocytes Mean Corpuscular Volume (10^-15L) >1.1× ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Platelets (10^3/mm^3) >1.75× ULN | 2 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes (Abs) (10^3/mm^3) <0.5× LLN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Platelets (10^3/mm^3) <0.5× LLN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Erythrocytes Mean Corpuscular Volume (10^-15L) <0.9× LLN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Lymphocytes (Abs) (10^3/mm^3) <0.8× LLN | 2 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Activated PTT (second) >1.1× ULN | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Monocytes (Abs) (10^3/mm^3) >1.2× ULN | 1 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Hematocrit (%) <0.8× LLN | 1 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes (Abs) (10^3/mm^3) >1.5× upper limit of normal (ULN) | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Prothrombin INR >1.1× ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Eosinophils (Abs) (10^3/mm^3) >1.2x ULN | 3 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Platelets (10^3/mm^3) <0.5× LLN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes/Erythrocytes (%) >1.5× ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes (Abs) (10^3/mm^3) >1.5× upper limit of normal (ULN) | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes (Abs) (10^3/mm^3) <0.5× LLN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Leukocytes (10^3/mm^3) >1.5× ULN | 2 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | PT (second) >1.1× ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Erythrocytes (10^6/mm^3) <0.8× LLN | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Hemoglobin (g/dL) <0.8× lower limit of normal (LLN) | 4 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Neutrophils (Abs) (10^3/mm^3) <0.8× LLN | 3 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Neutrophils (Abs) (10^3/mm^3) >1.2× ULN | 7 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Hematocrit (%) <0.8× LLN | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Basophils (Abs) (10^3/mm^3) >1.2× ULN | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Lymphocytes (Abs) (10^3/mm^3) >1.2× ULN | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Lymphocytes (Abs) (10^3/mm^3) <0.8× LLN | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Leukocytes (10^3/mm^3) <0.6× LLN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Monocytes (Abs) (10^3/mm^3) >1.2× ULN | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Prothrombin INR >1.1× ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Activated PTT (second) >1.1× ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Erythrocytes Mean Corpuscular Volume (10^-15L) >1.1× ULN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Platelets (10^3/mm^3) >1.75× ULN | 2 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes/Erythrocytes (%) <0.5× LLN | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Erythrocytes Mean Corpuscular Volume (10^-15L) <0.9× LLN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Neutrophils (Abs) (10^3/mm^3) <0.8× LLN | 2 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Hemoglobin (g/dL) <0.8× lower limit of normal (LLN) | 5 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Hematocrit (%) <0.8× LLN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Platelets (10^3/mm^3) >1.75× ULN | 5 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Monocytes (Abs) (10^3/mm^3) >1.2× ULN | 2 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes/Erythrocytes (%) >1.5× ULN | 2 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes/Erythrocytes (%) <0.5× LLN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Erythrocytes Mean Corpuscular Volume (10^-15L) <0.9× LLN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Lymphocytes (Abs) (10^3/mm^3) <0.8× LLN | 2 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Platelets (10^3/mm^3) <0.5× LLN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Erythrocytes (10^6/mm^3) <0.8× LLN | 2 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Erythrocytes Mean Corpuscular Volume (10^-15L) >1.1× ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes (Abs) (10^3/mm^3) <0.5× LLN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Basophils (Abs) (10^3/mm^3) >1.2× ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Lymphocytes (Abs) (10^3/mm^3) >1.2× ULN | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Activated PTT (second) >1.1× ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Neutrophils (Abs) (10^3/mm^3) >1.2× ULN | 11 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Prothrombin INR >1.1× ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | PT (second) >1.1× ULN | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Reticulocytes (Abs) (10^3/mm^3) >1.5× upper limit of normal (ULN) | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Eosinophils (Abs) (10^3/mm^3) >1.2x ULN | 2 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Leukocytes (10^3/mm^3) >1.5× ULN | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-hematology (Induction Period) | Leukocytes (10^3/mm^3) <0.6× LLN | 0 Participants |
Secondary
Number of Participants With Laboratory Test Abnormalities (Induction Period)
The number of participants with a laboratory abnormality meeting the pre-specified criteria defined in the study protocol while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. Laboratory data included hematology test, serum chemistry test, C-creative protein and viral surveillance. The criteria of laboratory abnormality is defined as one of the following conditions was met: 1)associated with accompanying symptoms;2)Test result requires additional diagnostic testing or medical/surgical intervention;3)Test result leads to a change in study dosing (outside of any protocol specified dose adjustments) or discontinuation from the study, significant additional concomitant drug treatment, or other therapy;4)Test result is considered to be an AE by the investigator or sponsor.
Time frame: From Day 1 up to Week 8
Population: The participants with at least one observation of the given laboratory test while on study treatment or during lag time.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities (Induction Period) | 17 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities (Induction Period) | 29 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities (Induction Period) | 28 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities (Induction Period) | 34 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities (Induction Period) | 32 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities (Induction Period) | 31 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities (Induction Period) | 36 Participants |
Secondary
Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period)
The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of urinalysis test parameters were as follows:pH, glucose (qual), protein (qual), blood (qual), ketones, nitrites, leukocyte esterase, microscopy, and spot urine albumin/creatinine ratio. The criteria of laboratory abnormality is defined as one of the following conditions was met: 1)associated with accompanying symptoms;2)Test result requires additional diagnostic testing or medical/surgical intervention;3)Test result leads to a change in study dosing (outside of any protocol specified dose adjustments) or discontinuation from the study, significant additional concomitant drug treatment, or other therapy;4)Test result is considered to be an AE by the investigator or sponsor.
Time frame: Week 8 to Week 32
Population: Number of Participants Analyzed: the participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Number Analyzed: the participants with at least one observation of the given laboratory test while on study treatment or during lag time.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Hyaline Casts (/LPF) >1 | 5 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | pH (scalar) <4.5 | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Bacteria (No Unit) >20 | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Leukocytes (/HPF) >=20 | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Leukocyte Esterase (No Unit) >=1 | 8 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | WBC Casts (/LPF) >1 | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Nitrite (No Unit) >=1 | 2 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Erythrocytes (/HPF) >=20 | 1 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Hemoglobin (No Unit) >=1 | 7 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Ketones (No Unit) >=1 | 4 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Protein (No Unit) >=1 | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | pH (scalar) >8 | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Glucose (No Unit) >=1 | 1 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | pH (scalar) >8 | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | WBC Casts (/LPF) >1 | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Hyaline Casts (/LPF) >1 | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Leukocytes (/HPF) >=20 | 2 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Erythrocytes (/HPF) >=20 | 1 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Leukocyte Esterase (No Unit) >=1 | 13 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Glucose (No Unit) >=1 | 2 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | pH (scalar) <4.5 | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Bacteria (No Unit) >20 | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Nitrite (No Unit) >=1 | 2 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Hemoglobin (No Unit) >=1 | 4 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Protein (No Unit) >=1 | 1 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Ketones (No Unit) >=1 | 3 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | pH (scalar) >8 | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | pH (scalar) <4.5 | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Glucose (No Unit) >=1 | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Ketones (No Unit) >=1 | 8 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Protein (No Unit) >=1 | 3 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Hemoglobin (No Unit) >=1 | 5 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Nitrite (No Unit) >=1 | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Leukocyte Esterase (No Unit) >=1 | 11 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Erythrocytes (/HPF) >=20 | 4 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Leukocytes (/HPF) >=20 | 3 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Hyaline Casts (/LPF) >1 | 6 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | WBC Casts (/LPF) >1 | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Bacteria (No Unit) >20 | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Bacteria (No Unit) >20 | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Hemoglobin (No Unit) >=1 | 1 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Leukocyte Esterase (No Unit) >=1 | 1 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | pH (scalar) <4.5 | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | WBC Casts (/LPF) >1 | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Leukocytes (/HPF) >=20 | 1 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Protein (No Unit) >=1 | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Glucose (No Unit) >=1 | 1 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Ketones (No Unit) >=1 | 2 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | pH (scalar) >8 | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Nitrite (No Unit) >=1 | 2 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Erythrocytes (/HPF) >=20 | 1 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Hyaline Casts (/LPF) >1 | 2 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | pH (scalar) >8 | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | WBC Casts (/LPF) >1 | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Leukocytes (/HPF) >=20 | 3 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Leukocyte Esterase (No Unit) >=1 | 14 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Erythrocytes (/HPF) >=20 | 2 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Protein (No Unit) >=1 | 1 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Hemoglobin (No Unit) >=1 | 7 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Hyaline Casts (/LPF) >1 | 4 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Bacteria (No Unit) >20 | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Ketones (No Unit) >=1 | 4 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | pH (scalar) <4.5 | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Glucose (No Unit) >=1 | 1 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Nitrite (No Unit) >=1 | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Protein (No Unit) >=1 | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Hyaline Casts (/LPF) >1 | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Ketones (No Unit) >=1 | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Hemoglobin (No Unit) >=1 | 9 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | pH (scalar) >8 | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | pH (scalar) <4.5 | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Nitrite (No Unit) >=1 | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Glucose (No Unit) >=1 | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Leukocyte Esterase (No Unit) >=1 | 7 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Erythrocytes (/HPF) >=20 | 3 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Leukocytes (/HPF) >=20 | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | WBC Casts (/LPF) >1 | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Bacteria (No Unit) >20 | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | WBC Casts (/LPF) >1 | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Hemoglobin (No Unit) >=1 | 9 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | pH (scalar) <4.5 | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Ketones (No Unit) >=1 | 3 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Bacteria (No Unit) >20 | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Erythrocytes (/HPF) >=20 | 5 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Leukocytes (/HPF) >=20 | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Hyaline Casts (/LPF) >1 | 2 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Protein (No Unit) >=1 | 2 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Leukocyte Esterase (No Unit) >=1 | 8 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Glucose (No Unit) >=1 | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | pH (scalar) >8 | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Nitrite (No Unit) >=1 | 1 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Hemoglobin (No Unit) >=1 | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | pH (scalar) >8 | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Protein (No Unit) >=1 | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Ketones (No Unit) >=1 | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Nitrite (No Unit) >=1 | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Leukocyte Esterase (No Unit) >=1 | 1 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | pH (scalar) <4.5 | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Erythrocytes (/HPF) >=20 | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Leukocytes (/HPF) >=20 | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Hyaline Casts (/LPF) >1 | 1 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Bacteria (No Unit) >20 | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | WBC Casts (/LPF) >1 | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Glucose (No Unit) >=1 | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Erythrocytes (/HPF) >=20 | 1 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Leukocyte Esterase (No Unit) >=1 | 9 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Protein (No Unit) >=1 | 1 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | pH (scalar) <4.5 | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Nitrite (No Unit) >=1 | 1 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Ketones (No Unit) >=1 | 2 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Glucose (No Unit) >=1 | 1 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Bacteria (No Unit) >20 | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | pH (scalar) >8 | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | WBC Casts (/LPF) >1 | 1 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Leukocytes (/HPF) >=20 | 4 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Hyaline Casts (/LPF) >1 | 2 Participants |
| Pooling Placebo During Chronic | Number of Participants With Laboratory Test Abnormalities-urinalysis (Chronic Period) | Urine Hemoglobin (No Unit) >=1 | 9 Participants |
Secondary
Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period)
The number of participants with a laboratory abnormality meeting specified criteria while on study treatment or during lag time are reported here. Baseline is defined as the last measurement prior to receiving study treatment. The list of urinalysis test parameters were as follows:pH, glucose (qual), protein (qual), blood (qual), ketones, nitrites, leukocyte esterase, microscopy, and spot urine albumin/creatinine ratio. The criteria of laboratory abnormality is defined as one of the following conditions was met: 1)associated with accompanying symptoms;2)Test result requires additional diagnostic testing or medical/surgical intervention;3)Test result leads to a change in study dosing (outside of any protocol specified dose adjustments) or discontinuation from the study, significant additional concomitant drug treatment, or other therapy;4)Test result is considered to be an AE by the investigator or sponsor.
Time frame: From Day 1 up to Week 8
Population: Number of Participants Analyzed: the participants who received at least one dose of PF-06651600, PF-06700841, or placebo. Number Analyzed: the participants with at least one observation of the given laboratory test while on study treatment or during lag time.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | pH (scalar) <4.5 | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Leukocyte esterase (no unit) ≥1 | 3 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Ketones (no unit) ≥1 | 1 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine glucose (no unit) ≥1 | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | WBC casts (/LPF) >1 | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine leukocytes (/HPF) ≥20 | 1 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine erythrocytes (/HPF) ≥20 | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | pH (scalar) >8 | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Granular casts (/LPF) >1 | 1 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine hemoglobin(no unit) ≥1 | 2 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Bacteria (no unit) >20 | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine protein(no unit) ≥1 | 0 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Hyaline casts (/LPF) >1 | 3 Participants |
| Placebo (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Nitrite (no unit) ≥1 | 1 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine erythrocytes (/HPF) ≥20 | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine leukocytes (/HPF) ≥20 | 2 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Leukocyte esterase (no unit) ≥1 | 11 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Bacteria (no unit) >20 | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | pH (scalar) <4.5 | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | WBC casts (/LPF) >1 | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | pH (scalar) >8 | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine glucose (no unit) ≥1 | 1 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Ketones (no unit) ≥1 | 4 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Hyaline casts (/LPF) >1 | 2 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine protein(no unit) ≥1 | 2 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine hemoglobin(no unit) ≥1 | 4 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Granular casts (/LPF) >1 | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Nitrite (no unit) ≥1 | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine glucose (no unit) ≥1 | 4 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Nitrite (no unit) ≥1 | 2 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Hyaline casts (/LPF) >1 | 2 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | pH (scalar) <4.5 | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Ketones (no unit) ≥1 | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | pH (scalar) >8 | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine protein(no unit) ≥1 | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Granular casts (/LPF) >1 | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine hemoglobin(no unit) ≥1 | 4 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine leukocytes (/HPF) ≥20 | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine erythrocytes (/HPF) ≥20 | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | WBC casts (/LPF) >1 | 1 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Bacteria (no unit) >20 | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Leukocyte esterase (no unit) ≥1 | 4 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | pH (scalar) >8 | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine erythrocytes (/HPF) ≥20 | 1 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine glucose (no unit) ≥1 | 1 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine hemoglobin(no unit) ≥1 | 4 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Ketones (no unit) ≥1 | 1 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | WBC casts (/LPF) >1 | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Nitrite (no unit) ≥1 | 1 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Hyaline casts (/LPF) >1 | 4 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Bacteria (no unit) >20 | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Leukocyte esterase (no unit) ≥1 | 10 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | pH (scalar) <4.5 | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine protein(no unit) ≥1 | 1 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine leukocytes (/HPF) ≥20 | 4 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Granular casts (/LPF) >1 | 1 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | pH (scalar) <4.5 | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine leukocytes (/HPF) ≥20 | 3 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Bacteria (no unit) >20 | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | pH (scalar) >8 | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine glucose (no unit) ≥1 | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Ketones (no unit) ≥1 | 7 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine protein(no unit) ≥1 | 1 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine hemoglobin(no unit) ≥1 | 5 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Nitrite (no unit) ≥1 | 2 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Leukocyte esterase (no unit) ≥1 | 7 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine erythrocytes (/HPF) ≥20 | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Granular casts (/LPF) >1 | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Hyaline casts (/LPF) >1 | 4 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | WBC casts (/LPF) >1 | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Nitrite (no unit) ≥1 | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine protein(no unit) ≥1 | 2 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine glucose (no unit) ≥1 | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Hyaline casts (/LPF) >1 | 2 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Bacteria (no unit) >20 | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | pH (scalar) >8 | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Granular casts (/LPF) >1 | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | pH (scalar) <4.5 | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine leukocytes (/HPF) ≥20 | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | WBC casts (/LPF) >1 | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine hemoglobin(no unit) ≥1 | 8 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine erythrocytes (/HPF) ≥20 | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Ketones (no unit) ≥1 | 4 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Leukocyte esterase (no unit) ≥1 | 8 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Leukocyte esterase (no unit) ≥1 | 14 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Nitrite (no unit) ≥1 | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine leukocytes (/HPF) ≥20 | 3 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine hemoglobin(no unit) ≥1 | 4 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine protein(no unit) ≥1 | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Granular casts (/LPF) >1 | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Ketones (no unit) ≥1 | 4 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine glucose (no unit) ≥1 | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | pH (scalar) >8 | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Hyaline casts (/LPF) >1 | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | pH (scalar) <4.5 | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Bacteria (no unit) >20 | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | WBC casts (/LPF) >1 | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Laboratory Test Abnormalities- Urinalysis (Induction Period) | Urine erythrocytes (/HPF) ≥20 | 0 Participants |
Secondary
Number of Participants With Serious Infections (Chronic Period)
Serious infections was defined as any infection (for example, viral, bacterial, and fungal) requiring hospitalization or parenteral antimicrobials.
Time frame: Week 8 to Week 32
Population: The participants who received at least one dose of PF-06651600, PF-06700841, or placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Induction) | Number of Participants With Serious Infections (Chronic Period) | COVID-19 pneumonia | 0 Participants |
| Placebo (Induction) | Number of Participants With Serious Infections (Chronic Period) | Viral infection | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Serious Infections (Chronic Period) | Viral infection | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Serious Infections (Chronic Period) | COVID-19 pneumonia | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Serious Infections (Chronic Period) | COVID-19 pneumonia | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Serious Infections (Chronic Period) | Viral infection | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Serious Infections (Chronic Period) | Viral infection | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Serious Infections (Chronic Period) | COVID-19 pneumonia | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Serious Infections (Chronic Period) | COVID-19 pneumonia | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Serious Infections (Chronic Period) | Viral infection | 1 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Serious Infections (Chronic Period) | Viral infection | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Serious Infections (Chronic Period) | COVID-19 pneumonia | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Serious Infections (Chronic Period) | COVID-19 pneumonia | 1 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Serious Infections (Chronic Period) | Viral infection | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Serious Infections (Chronic Period) | Viral infection | 0 Participants |
| Placebo -> PF-06700841 30 mg | Number of Participants With Serious Infections (Chronic Period) | COVID-19 pneumonia | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Serious Infections (Chronic Period) | Viral infection | 0 Participants |
| Pooling Placebo During Chronic | Number of Participants With Serious Infections (Chronic Period) | COVID-19 pneumonia | 0 Participants |
Secondary
Number of Participants With Serious Infections (Induction Period)
Serious infections was defined as any infection (for example, viral, bacterial, and fungal) requiring hospitalization or parenteral antimicrobials including Listeria encephalitis, Pneumonia, Viral infection.
Time frame: From Day 1 up to Week 8
Population: The participants who received at least one dose of PF-06651600, PF-06700841, or placebo.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo (Induction) | Number of Participants With Serious Infections (Induction Period) | Listeria encephalitis | 0 Participants |
| Placebo (Induction) | Number of Participants With Serious Infections (Induction Period) | Pneumonia | 0 Participants |
| Placebo (Induction) | Number of Participants With Serious Infections (Induction Period) | Viral infection | 0 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Serious Infections (Induction Period) | Viral infection | 1 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Serious Infections (Induction Period) | Pneumonia | 1 Participants |
| PF-06651600 20 mg (Induction) | Number of Participants With Serious Infections (Induction Period) | Listeria encephalitis | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Serious Infections (Induction Period) | Listeria encephalitis | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Serious Infections (Induction Period) | Pneumonia | 0 Participants |
| PF-06651600 70 mg (Induction) | Number of Participants With Serious Infections (Induction Period) | Viral infection | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Serious Infections (Induction Period) | Listeria encephalitis | 1 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Serious Infections (Induction Period) | Viral infection | 0 Participants |
| PF-06651600 200 mg (Induction) | Number of Participants With Serious Infections (Induction Period) | Pneumonia | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Serious Infections (Induction Period) | Listeria encephalitis | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Serious Infections (Induction Period) | Viral infection | 0 Participants |
| PF-06700841 10 mg (Induction) | Number of Participants With Serious Infections (Induction Period) | Pneumonia | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Serious Infections (Induction Period) | Viral infection | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Serious Infections (Induction Period) | Listeria encephalitis | 0 Participants |
| PF-06700841 30 mg (Induction) | Number of Participants With Serious Infections (Induction Period) | Pneumonia | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Serious Infections (Induction Period) | Listeria encephalitis | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Serious Infections (Induction Period) | Viral infection | 0 Participants |
| PF-06700841 60 mg (Induction) | Number of Participants With Serious Infections (Induction Period) | Pneumonia | 0 Participants |
Secondary
Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period)
The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. The partial Mayo score does not incorporate the endoscopy score and the partial Mayo score ranges from 0 to 9.
Time frame: Baseline, Weeks 2, 4 and 8
Population: Number of Participants Analyzed: ITT analysis set which included all participants who were randomized to the study and received at least one dose of the randomized investigational drug. Number Analyzed: the participants in the ITT analysis set who had partial Mayo score at each specified time point.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo (Induction) | Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period) | Week 2 | -0.66 Units on a scale | Standard Error 0.37 |
| Placebo (Induction) | Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period) | Week 8 | -1.15 Units on a scale | Standard Error 0.43 |
| Placebo (Induction) | Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period) | Week 4 | -1.64 Units on a scale | Standard Error 0.42 |
| PF-06651600 20 mg (Induction) | Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period) | Week 4 | -2.24 Units on a scale | Standard Error 0.29 |
| PF-06651600 20 mg (Induction) | Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period) | Week 2 | -1.65 Units on a scale | Standard Error 0.26 |
| PF-06651600 20 mg (Induction) | Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period) | Week 8 | -2.54 Units on a scale | Standard Error 0.3 |
| PF-06651600 70 mg (Induction) | Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period) | Week 8 | -4.06 Units on a scale | Standard Error 0.3 |
| PF-06651600 70 mg (Induction) | Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period) | Week 2 | -2.56 Units on a scale | Standard Error 0.26 |
| PF-06651600 70 mg (Induction) | Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period) | Week 4 | -3.29 Units on a scale | Standard Error 0.3 |
| PF-06651600 200 mg (Induction) | Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period) | Week 8 | -4.69 Units on a scale | Standard Error 0.32 |
| PF-06651600 200 mg (Induction) | Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period) | Week 2 | -3.19 Units on a scale | Standard Error 0.27 |
| PF-06651600 200 mg (Induction) | Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period) | Week 4 | -4.24 Units on a scale | Standard Error 0.31 |
| PF-06700841 10 mg (Induction) | Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period) | Week 4 | -2.31 Units on a scale | Standard Error 0.3 |
| PF-06700841 10 mg (Induction) | Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period) | Week 2 | -1.6 Units on a scale | Standard Error 0.27 |
| PF-06700841 10 mg (Induction) | Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period) | Week 8 | -2.51 Units on a scale | Standard Error 0.3 |
| PF-06700841 30 mg (Induction) | Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period) | Week 4 | -2.06 Units on a scale | Standard Error 0.3 |
| PF-06700841 30 mg (Induction) | Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period) | Week 2 | -1.64 Units on a scale | Standard Error 0.27 |
| PF-06700841 30 mg (Induction) | Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period) | Week 8 | -2.71 Units on a scale | Standard Error 0.31 |
| PF-06700841 60 mg (Induction) | Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period) | Week 8 | -3.47 Units on a scale | Standard Error 0.31 |
| PF-06700841 60 mg (Induction) | Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period) | Week 2 | -2.45 Units on a scale | Standard Error 0.27 |
| PF-06700841 60 mg (Induction) | Partial Mayo Score and Change From Baseline at Weeks 2, 4 and 8 (Induction Period) | Week 4 | -2.95 Units on a scale | Standard Error 0.3 |
Secondary
Percentage of Participants Achieving Clinical Response Based on Total Mayo Score at Week 8 (Induction Period)
The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Clinical response was defined as decrease from baseline in total Mayo score of at least 3 points and at least 30%, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1.
Time frame: Week 8
Population: The ITT analysis set which included all randomized participants who received at least 1 dose of investigational product or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Induction) | Percentage of Participants Achieving Clinical Response Based on Total Mayo Score at Week 8 (Induction Period) | 24.0 Percentage of participants |
| PF-06651600 20 mg (Induction) | Percentage of Participants Achieving Clinical Response Based on Total Mayo Score at Week 8 (Induction Period) | 41.2 Percentage of participants |
| PF-06651600 70 mg (Induction) | Percentage of Participants Achieving Clinical Response Based on Total Mayo Score at Week 8 (Induction Period) | 69.4 Percentage of participants |
| PF-06651600 200 mg (Induction) | Percentage of Participants Achieving Clinical Response Based on Total Mayo Score at Week 8 (Induction Period) | 68.0 Percentage of participants |
| PF-06700841 10 mg (Induction) | Percentage of Participants Achieving Clinical Response Based on Total Mayo Score at Week 8 (Induction Period) | 41.7 Percentage of participants |
| PF-06700841 30 mg (Induction) | Percentage of Participants Achieving Clinical Response Based on Total Mayo Score at Week 8 (Induction Period) | 53.2 Percentage of participants |
| PF-06700841 60 mg (Induction) | Percentage of Participants Achieving Clinical Response Based on Total Mayo Score at Week 8 (Induction Period) | 61.7 Percentage of participants |
p-value: 0.078890% CI: [-3.4, 34.4]Chan and Zhang method
p-value: 0.000290% CI: [23.6, 62.1]Chan and Zhang method
p-value: 0.000390% CI: [23.5, 60.5]Chan and Zhang Method
p-value: 0.077390% CI: [-4, 35.1]Chan and Zhang method
p-value: 0.013690% CI: [5.6, 47]Chan and Zhang method
p-value: 0.001590% CI: [13.9, 54.7]Chan and Zhang method
Secondary
Percentage of Participants Achieving Deep Remission Based on Total Mayo Score at Week 8 (Induction Period)
The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Deep remission was defined as total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a zero on both endoscopic and rectal bleeding subscore.
Time frame: Week 8
Population: The ITT analysis set which included all randomized participants who received at least 1 dose of investigational product or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Induction) | Percentage of Participants Achieving Deep Remission Based on Total Mayo Score at Week 8 (Induction Period) | 0 Percentage of participants |
| PF-06651600 20 mg (Induction) | Percentage of Participants Achieving Deep Remission Based on Total Mayo Score at Week 8 (Induction Period) | 3.9 Percentage of participants |
| PF-06651600 70 mg (Induction) | Percentage of Participants Achieving Deep Remission Based on Total Mayo Score at Week 8 (Induction Period) | 8.2 Percentage of participants |
| PF-06651600 200 mg (Induction) | Percentage of Participants Achieving Deep Remission Based on Total Mayo Score at Week 8 (Induction Period) | 12.0 Percentage of participants |
| PF-06700841 10 mg (Induction) | Percentage of Participants Achieving Deep Remission Based on Total Mayo Score at Week 8 (Induction Period) | 0 Percentage of participants |
| PF-06700841 30 mg (Induction) | Percentage of Participants Achieving Deep Remission Based on Total Mayo Score at Week 8 (Induction Period) | 14.9 Percentage of participants |
| PF-06700841 60 mg (Induction) | Percentage of Participants Achieving Deep Remission Based on Total Mayo Score at Week 8 (Induction Period) | 6.4 Percentage of participants |
p-value: 0.225990% CI: [-6.5, 11.8]Chan and Zhang method
p-value: 0.08290% CI: [-3.8, 17.7]Chan and Zhang method
p-value: 0.064990% CI: [-0.7, 22.3]Chan and Zhang Method
p-value: 190% CI: [-11.3, 6.1]Chan and Zhang method
p-value: 0.028890% CI: [1.7, 26.2]Chan and Zhang method
p-value: 0.159390% CI: [-4.4, 15.7]Chan and Zhang method
Secondary
Percentage of Participants Achieving Endoscopic Remission Based on Total Mayo Score at Week 8 (Induction Period)
The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Endoscopic remission was defined as endoscopic subscore of 0.
Time frame: Week 8
Population: The ITT analysis set which included all randomized participants who received at least 1 dose of investigational product or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Induction) | Percentage of Participants Achieving Endoscopic Remission Based on Total Mayo Score at Week 8 (Induction Period) | 0 Percentage of participants |
| PF-06651600 20 mg (Induction) | Percentage of Participants Achieving Endoscopic Remission Based on Total Mayo Score at Week 8 (Induction Period) | 3.9 Percentage of participants |
| PF-06651600 70 mg (Induction) | Percentage of Participants Achieving Endoscopic Remission Based on Total Mayo Score at Week 8 (Induction Period) | 8.2 Percentage of participants |
| PF-06651600 200 mg (Induction) | Percentage of Participants Achieving Endoscopic Remission Based on Total Mayo Score at Week 8 (Induction Period) | 12.0 Percentage of participants |
| PF-06700841 10 mg (Induction) | Percentage of Participants Achieving Endoscopic Remission Based on Total Mayo Score at Week 8 (Induction Period) | 2.1 Percentage of participants |
| PF-06700841 30 mg (Induction) | Percentage of Participants Achieving Endoscopic Remission Based on Total Mayo Score at Week 8 (Induction Period) | 17.0 Percentage of participants |
| PF-06700841 60 mg (Induction) | Percentage of Participants Achieving Endoscopic Remission Based on Total Mayo Score at Week 8 (Induction Period) | 8.5 Percentage of participants |
p-value: 0.225990% CI: [-6.5, 11.8]Chan and Zhang method
p-value: 0.08290% CI: [-3.8, 17.7]Chan and Zhang method
p-value: 0.064990% CI: [-0.7, 22.3]Chan and Zhang Method
p-value: 0.377790% CI: [-8.6, 9.7]Chan and Zhang method
p-value: 0.021290% CI: [2.9, 28.6]Chan and Zhang method
p-value: 0.074290% CI: [-4.2, 18.4]Chan and Zhang method
Secondary
Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Mayo Score at Week 32 (Chronic Period)
The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Improvement in endoscopic appearance was defined at Mayo endoscopic subscore of ≤1.
Time frame: Week 32
Population: MITT analysis set that included all participants who were randomized to the study and received at least one dose of the randomized investigational drug, but were not randomized to placebo treatment during chronic period, with treating the missing data as non-responders.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Induction) | Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Mayo Score at Week 32 (Chronic Period) | 33.3 Percentage of participants |
| PF-06651600 20 mg (Induction) | Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Mayo Score at Week 32 (Chronic Period) | 26.1 Percentage of participants |
| PF-06651600 70 mg (Induction) | Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Mayo Score at Week 32 (Chronic Period) | 40.5 Percentage of participants |
| PF-06651600 200 mg (Induction) | Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Mayo Score at Week 32 (Chronic Period) | 34.1 Percentage of participants |
| PF-06700841 10 mg (Induction) | Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Mayo Score at Week 32 (Chronic Period) | 18.2 Percentage of participants |
| PF-06700841 30 mg (Induction) | Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Mayo Score at Week 32 (Chronic Period) | 31.0 Percentage of participants |
| PF-06700841 60 mg (Induction) | Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Mayo Score at Week 32 (Chronic Period) | 34.1 Percentage of participants |
| Placebo -> PF-06700841 30 mg | Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Mayo Score at Week 32 (Chronic Period) | 36.6 Percentage of participants |
Secondary
Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Total Mayo Score at Week 8 (Induction Period)
The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Improvement in endoscopic subscore appearance was defined at Mayo endoscopic subscore of ≤1.
Time frame: Week 8
Population: The ITT analysis set which included all randomized participants who received at least 1 dose of investigational product or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Induction) | Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Total Mayo Score at Week 8 (Induction Period) | 0 Percentage of participants |
| PF-06651600 20 mg (Induction) | Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Total Mayo Score at Week 8 (Induction Period) | 21.6 Percentage of participants |
| PF-06651600 70 mg (Induction) | Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Total Mayo Score at Week 8 (Induction Period) | 34.7 Percentage of participants |
| PF-06651600 200 mg (Induction) | Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Total Mayo Score at Week 8 (Induction Period) | 42.0 Percentage of participants |
| PF-06700841 10 mg (Induction) | Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Total Mayo Score at Week 8 (Induction Period) | 20.8 Percentage of participants |
| PF-06700841 30 mg (Induction) | Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Total Mayo Score at Week 8 (Induction Period) | 31.9 Percentage of participants |
| PF-06700841 60 mg (Induction) | Percentage of Participants Achieving Improvement in Endoscopic Appearance Based on Total Mayo Score at Week 8 (Induction Period) | 29.8 Percentage of participants |
p-value: 0.011190% CI: [5.6, 33.2]Chan and Zhang method
p-value: 0.000690% CI: [20.2, 47.4]Chan and Zhang method
p-value: 0.000190% CI: [29.5, 54.6]Chan and Zhang Method
p-value: 0.010190% CI: [5.6, 33]Chan and Zhang method
p-value: 0.001490% CI: [17, 44.8]Chan and Zhang method
p-value: 0.001590% CI: [17, 42.6]Chan and Zhang method
Secondary
Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 32 (Chronic Period)
The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Clinical remission was defined as total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0.
Time frame: Week 32
Population: MITT analysis set that included all participants who were randomized to the study and received at least one dose of the randomized investigational drug, but were not randomized to placebo treatment during chronic period, with treating the missing data as non-responders.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Induction) | Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 32 (Chronic Period) | 16.7 Percentage of participants |
| PF-06651600 20 mg (Induction) | Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 32 (Chronic Period) | 23.9 Percentage of participants |
| PF-06651600 70 mg (Induction) | Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 32 (Chronic Period) | 28.6 Percentage of participants |
| PF-06651600 200 mg (Induction) | Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 32 (Chronic Period) | 34.1 Percentage of participants |
| PF-06700841 10 mg (Induction) | Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 32 (Chronic Period) | 18.2 Percentage of participants |
| PF-06700841 30 mg (Induction) | Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 32 (Chronic Period) | 21.4 Percentage of participants |
| PF-06700841 60 mg (Induction) | Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 32 (Chronic Period) | 26.8 Percentage of participants |
| Placebo -> PF-06700841 30 mg | Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 32 (Chronic Period) | 26.8 Percentage of participants |
Secondary
Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 8 (Induction Period)
The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Clinical remission was defined as total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0.
Time frame: Week 8
Population: The ITT analysis set which included all randomized participants who received at least 1 dose of investigational product or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Induction) | Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 8 (Induction Period) | 0 Percentage of participants |
| PF-06651600 20 mg (Induction) | Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 8 (Induction Period) | 9.8 Percentage of participants |
| PF-06651600 70 mg (Induction) | Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 8 (Induction Period) | 28.6 Percentage of participants |
| PF-06651600 200 mg (Induction) | Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 8 (Induction Period) | 34.0 Percentage of participants |
| PF-06700841 10 mg (Induction) | Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 8 (Induction Period) | 8.3 Percentage of participants |
| PF-06700841 30 mg (Induction) | Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 8 (Induction Period) | 23.4 Percentage of participants |
| PF-06700841 60 mg (Induction) | Percentage of Participants Achieving Remission Based on Total Mayo Score at Week 8 (Induction Period) | 23.4 Percentage of participants |
p-value: 0.062690% CI: [-1, 19.5]Chan and Zhang method
p-value: 0.002790% CI: [13.9, 41]Chan and Zhang method
p-value: 0.00190% CI: [20.2, 46.5]Chan and Zhang Method
p-value: 0.077490% CI: [-4, 18.1]Chan and Zhang method
p-value: 0.005590% CI: [8.2, 35.8]Chan and Zhang method
p-value: 0.005590% CI: [8.2, 35.8]Chan and Zhang method
Secondary
Percentage of Participants Achieving Symptomatic Remission Based on Total Mayo Score at Week 8 (Induction Period)
The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity. Symptomatic remission was defined as total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point, and both rectal bleeding and stool frequency subscores of 0.
Time frame: Week 8
Population: The ITT analysis set which included all randomized participants who received at least 1 dose of investigational product or placebo.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo (Induction) | Percentage of Participants Achieving Symptomatic Remission Based on Total Mayo Score at Week 8 (Induction Period) | 0 Percentage of participants |
| PF-06651600 20 mg (Induction) | Percentage of Participants Achieving Symptomatic Remission Based on Total Mayo Score at Week 8 (Induction Period) | 7.8 Percentage of participants |
| PF-06651600 70 mg (Induction) | Percentage of Participants Achieving Symptomatic Remission Based on Total Mayo Score at Week 8 (Induction Period) | 16.3 Percentage of participants |
| PF-06651600 200 mg (Induction) | Percentage of Participants Achieving Symptomatic Remission Based on Total Mayo Score at Week 8 (Induction Period) | 26.0 Percentage of participants |
| PF-06700841 10 mg (Induction) | Percentage of Participants Achieving Symptomatic Remission Based on Total Mayo Score at Week 8 (Induction Period) | 6.3 Percentage of participants |
| PF-06700841 30 mg (Induction) | Percentage of Participants Achieving Symptomatic Remission Based on Total Mayo Score at Week 8 (Induction Period) | 14.9 Percentage of participants |
| PF-06700841 60 mg (Induction) | Percentage of Participants Achieving Symptomatic Remission Based on Total Mayo Score at Week 8 (Induction Period) | 14.9 Percentage of participants |
p-value: 0.087290% CI: [-3.4, 17.1]Chan and Zhang method
p-value: 0.025490% CI: [3, 27.5]Chan and Zhang method
p-value: 0.003490% CI: [11, 38.1]Chan and Zhang Method
p-value: 0.156590% CI: [-4.5, 15.4]Chan and Zhang method
p-value: 0.028890% CI: [1.7, 26.2]Chan and Zhang method
p-value: 0.028890% CI: [1.7, 26.2]Chan and Zhang method
Secondary
Percentage of Participants With Greater Than or Equal to 16 Points Increase in IBDQ Total Score From Baseline at Weeks 4 and 8 (Induction Period)
IBDQ is a psychometrically validated PRO instrument for measuring the disease specific quality of life in participants with IBD. The IBDQ is comprised of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35.; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life.
Time frame: Baseline, Week 4 and 8
Population: Number of Participants Analyzed: ITT analysis set includes all participants who were randomized to the study and received at least one dose of the randomized investigational drug. Number Analyzed: ITT analysis set which included all participants who were randomized to the study and received at least one dose of the randomized investigational drug, with non-responder imputation of missing data (treating the missing data as non-responders).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (Induction) | Percentage of Participants With Greater Than or Equal to 16 Points Increase in IBDQ Total Score From Baseline at Weeks 4 and 8 (Induction Period) | Week 4 | 48.0 Percentage of participants |
| Placebo (Induction) | Percentage of Participants With Greater Than or Equal to 16 Points Increase in IBDQ Total Score From Baseline at Weeks 4 and 8 (Induction Period) | Week 8 | 56.0 Percentage of participants |
| PF-06651600 20 mg (Induction) | Percentage of Participants With Greater Than or Equal to 16 Points Increase in IBDQ Total Score From Baseline at Weeks 4 and 8 (Induction Period) | Week 4 | 60.8 Percentage of participants |
| PF-06651600 20 mg (Induction) | Percentage of Participants With Greater Than or Equal to 16 Points Increase in IBDQ Total Score From Baseline at Weeks 4 and 8 (Induction Period) | Week 8 | 54.9 Percentage of participants |
| PF-06651600 70 mg (Induction) | Percentage of Participants With Greater Than or Equal to 16 Points Increase in IBDQ Total Score From Baseline at Weeks 4 and 8 (Induction Period) | Week 4 | 83.7 Percentage of participants |
| PF-06651600 70 mg (Induction) | Percentage of Participants With Greater Than or Equal to 16 Points Increase in IBDQ Total Score From Baseline at Weeks 4 and 8 (Induction Period) | Week 8 | 79.6 Percentage of participants |
| PF-06651600 200 mg (Induction) | Percentage of Participants With Greater Than or Equal to 16 Points Increase in IBDQ Total Score From Baseline at Weeks 4 and 8 (Induction Period) | Week 4 | 80.0 Percentage of participants |
| PF-06651600 200 mg (Induction) | Percentage of Participants With Greater Than or Equal to 16 Points Increase in IBDQ Total Score From Baseline at Weeks 4 and 8 (Induction Period) | Week 8 | 70.0 Percentage of participants |
| PF-06700841 10 mg (Induction) | Percentage of Participants With Greater Than or Equal to 16 Points Increase in IBDQ Total Score From Baseline at Weeks 4 and 8 (Induction Period) | Week 4 | 64.6 Percentage of participants |
| PF-06700841 10 mg (Induction) | Percentage of Participants With Greater Than or Equal to 16 Points Increase in IBDQ Total Score From Baseline at Weeks 4 and 8 (Induction Period) | Week 8 | 62.5 Percentage of participants |
| PF-06700841 30 mg (Induction) | Percentage of Participants With Greater Than or Equal to 16 Points Increase in IBDQ Total Score From Baseline at Weeks 4 and 8 (Induction Period) | Week 4 | 78.7 Percentage of participants |
| PF-06700841 30 mg (Induction) | Percentage of Participants With Greater Than or Equal to 16 Points Increase in IBDQ Total Score From Baseline at Weeks 4 and 8 (Induction Period) | Week 8 | 80.9 Percentage of participants |
| PF-06700841 60 mg (Induction) | Percentage of Participants With Greater Than or Equal to 16 Points Increase in IBDQ Total Score From Baseline at Weeks 4 and 8 (Induction Period) | Week 4 | 72.3 Percentage of participants |
| PF-06700841 60 mg (Induction) | Percentage of Participants With Greater Than or Equal to 16 Points Increase in IBDQ Total Score From Baseline at Weeks 4 and 8 (Induction Period) | Week 8 | 78.7 Percentage of participants |
Secondary
Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period)
IBDQ is a psychometrically validated PRO instrument for measuring the disease specific quality of life in participants with IBD. The IBDQ is comprised of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35.; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life.
Time frame: Week 4 and Week 8
Population: Number of Participants Analyzed: ITT analysis set includes all participants who were randomized to the study and received at least one dose of the randomized investigational drug. Number Analyzed: ITT analysis set which included all participants who were randomized to the study and received at least one dose of the randomized investigational drug, with non-responder imputation of missing data (treating the missing data as non-responders).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (Induction) | Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period) | Week 8 | 20.0 Percentage of participants |
| Placebo (Induction) | Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period) | Week 4 | 24.0 Percentage of participants |
| PF-06651600 20 mg (Induction) | Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period) | Week 4 | 21.6 Percentage of participants |
| PF-06651600 20 mg (Induction) | Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period) | Week 8 | 29.4 Percentage of participants |
| PF-06651600 70 mg (Induction) | Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period) | Week 4 | 40.8 Percentage of participants |
| PF-06651600 70 mg (Induction) | Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period) | Week 8 | 57.1 Percentage of participants |
| PF-06651600 200 mg (Induction) | Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period) | Week 8 | 44.0 Percentage of participants |
| PF-06651600 200 mg (Induction) | Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period) | Week 4 | 46.0 Percentage of participants |
| PF-06700841 10 mg (Induction) | Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period) | Week 4 | 27.1 Percentage of participants |
| PF-06700841 10 mg (Induction) | Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period) | Week 8 | 31.3 Percentage of participants |
| PF-06700841 30 mg (Induction) | Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period) | Week 4 | 27.7 Percentage of participants |
| PF-06700841 30 mg (Induction) | Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period) | Week 8 | 40.4 Percentage of participants |
| PF-06700841 60 mg (Induction) | Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period) | Week 8 | 51.1 Percentage of participants |
| PF-06700841 60 mg (Induction) | Percentage of Participants With IBDQ Total Score Greater Than or Equal to 170 at Weeks 4 and 8 (Induction Period) | Week 4 | 38.3 Percentage of participants |
Secondary
Percentage of Participants With Improvement in IBDQ Bowel Symptom Domain at Weeks 4 and 8 (Induction Period)
IBDQ is a psychometrically validated PRO instrument for measuring the disease specific quality of life in participants with IBD. The IBDQ is comprised of 32 items, which are grouped into 4 dimensions: bowel function, emotional status, systemic symptoms and social function. The 4 domains are scored as follows: Bowel symptoms: 10 to 70; Systemic symptoms: 5 to 35.; Emotional function: 12 to 84; Social function: 5 to 35. The total IBDQ score ranges from 32 to 224. For the total score and each domain, a higher score indicates better quality of life. The improvement in IBDQ bowel symptom domain was defined as an increase of ≥1.2 points from baseline in average score among bowel symptoms domain (items 1, 5, 9, 13, 17, 20, 22, 24, 26, 29).
Time frame: Week 4 and Week 8
Population: Number of Participants Analyzed: ITT analysis set includes all participants who were randomized to the study and received at least one dose of the randomized investigational drug. Number Analyzed: ITT analysis set which included all participants who were randomized to the study and received at least one dose of the randomized investigational drug, with non-responder imputation of missing data (treating the missing data as non-responders).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo (Induction) | Percentage of Participants With Improvement in IBDQ Bowel Symptom Domain at Weeks 4 and 8 (Induction Period) | Week 4 | 20.0 Percentage of participants |
| Placebo (Induction) | Percentage of Participants With Improvement in IBDQ Bowel Symptom Domain at Weeks 4 and 8 (Induction Period) | Week 8 | 24.0 Percentage of participants |
| PF-06651600 20 mg (Induction) | Percentage of Participants With Improvement in IBDQ Bowel Symptom Domain at Weeks 4 and 8 (Induction Period) | Week 4 | 51.0 Percentage of participants |
| PF-06651600 20 mg (Induction) | Percentage of Participants With Improvement in IBDQ Bowel Symptom Domain at Weeks 4 and 8 (Induction Period) | Week 8 | 47.1 Percentage of participants |
| PF-06651600 70 mg (Induction) | Percentage of Participants With Improvement in IBDQ Bowel Symptom Domain at Weeks 4 and 8 (Induction Period) | Week 8 | 69.4 Percentage of participants |
| PF-06651600 70 mg (Induction) | Percentage of Participants With Improvement in IBDQ Bowel Symptom Domain at Weeks 4 and 8 (Induction Period) | Week 4 | 65.3 Percentage of participants |
| PF-06651600 200 mg (Induction) | Percentage of Participants With Improvement in IBDQ Bowel Symptom Domain at Weeks 4 and 8 (Induction Period) | Week 8 | 62.0 Percentage of participants |
| PF-06651600 200 mg (Induction) | Percentage of Participants With Improvement in IBDQ Bowel Symptom Domain at Weeks 4 and 8 (Induction Period) | Week 4 | 64.0 Percentage of participants |
| PF-06700841 10 mg (Induction) | Percentage of Participants With Improvement in IBDQ Bowel Symptom Domain at Weeks 4 and 8 (Induction Period) | Week 8 | 50.0 Percentage of participants |
| PF-06700841 10 mg (Induction) | Percentage of Participants With Improvement in IBDQ Bowel Symptom Domain at Weeks 4 and 8 (Induction Period) | Week 4 | 37.5 Percentage of participants |
| PF-06700841 30 mg (Induction) | Percentage of Participants With Improvement in IBDQ Bowel Symptom Domain at Weeks 4 and 8 (Induction Period) | Week 4 | 53.2 Percentage of participants |
| PF-06700841 30 mg (Induction) | Percentage of Participants With Improvement in IBDQ Bowel Symptom Domain at Weeks 4 and 8 (Induction Period) | Week 8 | 63.8 Percentage of participants |
| PF-06700841 60 mg (Induction) | Percentage of Participants With Improvement in IBDQ Bowel Symptom Domain at Weeks 4 and 8 (Induction Period) | Week 8 | 66.0 Percentage of participants |
| PF-06700841 60 mg (Induction) | Percentage of Participants With Improvement in IBDQ Bowel Symptom Domain at Weeks 4 and 8 (Induction Period) | Week 4 | 57.5 Percentage of participants |
Secondary
Total Mayo Score at Week 32 (Chronic Period)
The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity.
Time frame: Week 32
Population: The participants with non-missing data at Week 32 in the modified intent-to-treat (MITT) analysis set which included all participants who were randomized to the study and received at least one dose of the randomized investigational drug, but were not randomized to placebo treatment during chronic period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo (Induction) | Total Mayo Score at Week 32 (Chronic Period) | 4.13 Units on a scale |
| PF-06651600 20 mg (Induction) | Total Mayo Score at Week 32 (Chronic Period) | 3.47 Units on a scale |
| PF-06651600 70 mg (Induction) | Total Mayo Score at Week 32 (Chronic Period) | 3.46 Units on a scale |
| PF-06651600 200 mg (Induction) | Total Mayo Score at Week 32 (Chronic Period) | 2.89 Units on a scale |
| PF-06700841 10 mg (Induction) | Total Mayo Score at Week 32 (Chronic Period) | 4.62 Units on a scale |
| PF-06700841 30 mg (Induction) | Total Mayo Score at Week 32 (Chronic Period) | 3.81 Units on a scale |
| PF-06700841 60 mg (Induction) | Total Mayo Score at Week 32 (Chronic Period) | 3.63 Units on a scale |
| Placebo -> PF-06700841 30 mg | Total Mayo Score at Week 32 (Chronic Period) | 3.86 Units on a scale |
Other Pre-specified
Change From Baseline in Total Mayo Score at Week 32 (Chronic Period)
The Mayo Score is a tool designed to measure disease activity for ulcerative colitis. The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores, which are stool frequency, rectal bleeding, findings on endoscopy and physician's global assessment. Each subscore graded 0 to 3 with the higher score indicating more severe disease activity.
Time frame: Week 32
Population: The participants with non-missing data in the MITT analysis set at Week 32. MITT analysis set that included all participants who were randomized to the study and received at least one dose of the randomized investigational drug, but were not randomized to placebo treatment during chronic period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo (Induction) | Change From Baseline in Total Mayo Score at Week 32 (Chronic Period) | -4.88 Units on a scale |
| PF-06651600 20 mg (Induction) | Change From Baseline in Total Mayo Score at Week 32 (Chronic Period) | -5.54 Units on a scale |
| PF-06651600 70 mg (Induction) | Change From Baseline in Total Mayo Score at Week 32 (Chronic Period) | -5.55 Units on a scale |
| PF-06651600 200 mg (Induction) | Change From Baseline in Total Mayo Score at Week 32 (Chronic Period) | -6.12 Units on a scale |
| PF-06700841 10 mg (Induction) | Change From Baseline in Total Mayo Score at Week 32 (Chronic Period) | -4.45 Units on a scale |
| PF-06700841 30 mg (Induction) | Change From Baseline in Total Mayo Score at Week 32 (Chronic Period) | -5.26 Units on a scale |
| PF-06700841 60 mg (Induction) | Change From Baseline in Total Mayo Score at Week 32 (Chronic Period) | -5.21 Units on a scale |
| Placebo -> PF-06700841 30 mg | Change From Baseline in Total Mayo Score at Week 32 (Chronic Period) | -5.44 Units on a scale |