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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020002-15 | EudraCT Number |
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The main objective of this study is to evaluate the long-term safety of CP-690,550 in patients being treated for moderate to severe chronic plaque psoriasis. This is an open label extension study available to patients who participated in one of the qualifying studies with CP-690,550 providing entry criteria is met.
The study terminated on 08MAR2016 as it met its objectives of characterizing long term safety and tolerability. The study did not terminate due to safety concerns.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment | Experimental | The study is anticipated to continue for up to at least 2 years post First Market Approval (FMA) in a global, major market. All subjects will receive 10 mg BID of CP-690,550 for first 3 months of trial. Study has the option for variable dosing with 5 mg or 10 mg BID after first 3-months of treatment based on PI discretion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CP-690,550 | Drug | 5 mg oral BID |
| |
| CP-690,550 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 4 weeks after last dose (up to 67 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) |
| Number of Adverse Events (AEs) by Severity | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories: a) mild: AEs did not interfere with participant's usual function; b) moderate: AEs interfered to some extent with participant's usual function; c) severe: AEs interfered significantly with participant's usual function. | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) |
| Number of Participants With Laboratory Abnormalities | Abnormality criteria: hematology (hemoglobin, hematocrit, red blood cell <0.8*lower limit of normal [LLN]; reticulocyte<0.5*LLN,>1.5*ULN; platelets<0.5*LLN,>1.75* upper limit of normal [ULN]; WBC<0.6*LLN, >1.5*ULN; lymphocytes, neutrophils, basophils, eosinophils, monocytes<0.8*LLN; >1.2*ULN; coagulation (prothrombin [PT], PT ratio>1.1*ULN) liver function (bilirubin>1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma GT>0.3*ULN, protein, albumin<0.8*LLN; >1.2*ULN, globulin<0.5*LLN; >1.5*ULN); renal function (blood urea nitrogen, creatinine>1.3*ULN); electrolytes(sodium<0.95* LLN; >1.05* ULN, potassium, chloride, calcium, bicarbonate<0.9*LLN; >1.1*ULN), chemistry (glucose<0.6*LLN; >1.5* ULN), urinalysis (pH <4.5;>8, glucose, ketones, protein, blood, urobilinogen, nitrite, bilirubin, leukocyte esterase>=1; RBC, WBC>=20); lipids (cholesterol [C], LDL-C >1.3*ULN, HDL-C<0.8*LLN, triglycerides>1.3* ULN), hormones(T4, T3, T4, TSH<0.8* LLN; >1.2* ULN). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' | The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema (E), induration (I), and scaling (S) across all psoriatic lesions in participants. The severity rating scores (Erythema: 0= no evidence of erythema to 4= dark, deep red; Induration: 0= no evidence of plaque elevation to 4= marked plaque elevation, hard/sharp borders; Scaling: 0= no evidence of scaling to 4= thick, coarse scale predominates) were summed (E + I + S = total) and the average (total/3) was taken. The total average was rounded to the nearest whole number score to determine the PGA. The 5-point scale for PGA was: 0= clear; 1= almost clear; 2= mild; 3= moderate; 4= severe, where higher score indicated more severity of psoriasis. Percentage of participants with response of 'clear' (score of '0') and 'almost clear' (score of '1') were reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research, Inc. | Birmingham | Alabama | 35209 | United States | ||
| UAB Dermatology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38696034 | Derived | Kristensen LE, Deodhar A, Leung YY, Vranic I, Mortezavi M, Fallon L, Yndestad A, Kinch CD, Gladman DD. Risk Stratification of Patients with Psoriatic Arthritis and Ankylosing Spondylitis for Treatment with Tofacitinib: A Review of Current Clinical Data. Rheumatol Ther. 2024 Jun;11(3):487-499. doi: 10.1007/s40744-024-00662-5. Epub 2024 May 2. | |
| 36777695 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Information relating to our policy on data sharing and the process for requesting data can be found at the following link:
http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests
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A total of 2881 participants were enrolled in this study, however 2867 participants received treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tofacitinib 10 mg | Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months). |
| FG001 | Tofacitinib 5 mg or 10 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
10 mg oral BID |
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| Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) |
| Change From Baseline in Hemoglobin Level at Month 1 | Baseline, Month 1 |
| Change From Baseline in Hemoglobin Level at Month 3 | Baseline, Month 3 |
| Change From Baseline in Hemoglobin Level at Month 6 | Baseline, Month 6 |
| Change From Baseline in Hemoglobin Level at Month 12 | Baseline, Month 12 |
| Change From Baseline in Hemoglobin Level at Month 24 | Baseline, Month 24 |
| Change From Baseline in Hemoglobin Level at Month 36 | Baseline, Month 36 |
| Change From Baseline in Hemoglobin Level at Month 48 | Baseline, Month 48 |
| Change From Baseline in Lymphocyte and Neutrophil Count at Month 1 | Baseline, Month 1 |
| Change From Baseline in Lymphocyte and Neutrophil Count at Month 3 | Baseline, Month 3 |
| Change From Baseline in Lymphocyte and Neutrophil Count at Month 6 | Baseline, Month 6 |
| Change From Baseline in Lymphocyte and Neutrophil Count at Month 12 | Baseline, Month 12 |
| Change From Baseline in Lymphocyte and Neutrophil Count at Month 24 | Baseline, Month 24 |
| Change From Baseline in Lymphocyte and Neutrophil Count at Month 36 | Baseline, Month 36 |
| Change From Baseline in Lymphocyte and Neutrophil Count at Month 48 | Baseline, Month 48 |
| Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1 | Baseline, Month 1 |
| Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3 | Baseline, Month 3 |
| Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6 | Baseline, Month 6 |
| Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 12 | Baseline, Month 12 |
| Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 24 | Baseline, Month 24 |
| Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 36 | Baseline, Month 36 |
| Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 48 | Baseline, Month 48 |
| Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1 | Baseline, Month 1 |
| Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3 | Baseline, Month 3 |
| Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6 | Baseline, Month 6 |
| Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12 | Baseline, Month 12 |
| Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24 | Baseline, Month 24 |
| Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36 | Baseline, Month 36 |
| Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48 | Baseline, Month 48 |
| Number of Participants With Clinically Significant Change From Baseline in Physical Examination | Physical examinations included: general appearance; skin, head, eyes, ears, nose and throat; heart; lungs; abdomen; lower extremities (for the presence of peripheral edema) and lymph nodes. Clinical significance of change from baseline values in physical examination was based on investigator's discretion. | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) |
| Number of Participants With Vital Sign Abnormalities | Criteria for abnormalities in vital signs included: Systolic blood pressure (SBP): less than (<) 90 millimeter of mercury (mmHg) and maximum increase from baseline (IFB) of greater than or equal to (>=) 30 mmHg; diastolic blood pressure (DBP): <50 and greater than (>) 120 mmHg and maximum IFB of >=20 mmHg; heart rate: <40 and >120 beats per minute. | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) |
| Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1 | Baseline, Month 1 |
| Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3 | Baseline, Month 3 |
| Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6 | Baseline, Month 6 |
| Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12 | Baseline, Month 12 |
| Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24 | Baseline, Month 24 |
| Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36 | Baseline, Month 36 |
| Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48 | Baseline, Month 48 |
| Change From Baseline in Heart Rate at Month 1 | Baseline, Month 1 |
| Change From Baseline in Heart Rate at Month 3 | Baseline, Month 3 |
| Change From Baseline in Heart Rate at Month 6 | Baseline, Month 6 |
| Change From Baseline in Heart Rate at Month 12 | Baseline, Month 12 |
| Change From Baseline in Heart Rate at Month 24 | Baseline, Month 24 |
| Change From Baseline in Heart Rate at Month 36 | Baseline, Month 36 |
| Change From Baseline in Heart Rate at Month 48 | Baseline, Month 48 |
| Number of Participants With Electrocardiogram (ECG) Abnormalities | Criteria for ECG abnormality: PR interval >=300 milliseconds (msec); QT interval >=500 msec; QTcB (Bazett's Correction) and QTcF (Fridericia's Correction) 450 to <480 msec, 480 to <500 msec and >=500 msec. | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) |
| Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Baseline, Month 6 |
| Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 | Baseline, Month 12 |
| Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 | Baseline, Month 24 |
| Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 | Baseline, Month 36 |
| Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 | Baseline, Month 48 |
| Number of Participants With Adjudicated Cardiovascular Events | Adjudicated cardiovascular events were assessed by adjudication committee as independent reviewers based on event documentation including: hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic enzymes, results of other diagnostic tests, autopsy reports and death certificate information; as applicable. | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) |
| Number of Participants With Malignancy Events | Malignancy events included lymphoma, and demyelinating neurologic events. Biopsies collected for malignancy events were submitted to the central laboratory for pathologist over-read. | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) |
| Month 1, 3, 6, 12, 24, 36, 48 |
| Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=75 percent (%) reduction from baseline in PASI scores were reported. | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
| Psoriasis Area and Severity Index (PASI) Scores | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
| Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Erythema was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
| Psoriasis Area and Severity Index (PASI) Component Scores: Induration | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Induration was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
| Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Scaling was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Erythema was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Induration was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Scaling was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
| Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=50% reduction from baseline in PASI scores were reported. | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
| Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=90% reduction from baseline in PASI scores were reported. | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
| Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=125% increase from baseline in PASI scores were reported. | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
| Itch Severity Item (ISI) Scores | ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Participants were asked to rate their 'severity of itching' due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms '0=no itching' and '10=worst possible itching' at the ends. Higher scores indicated greater severity of itching. | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
| Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Participants were asked to rate their 'severity of itching' due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms '0=no itching' and '10=worst possible itching' at the ends. Higher scores indicated greater severity of itching. | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
| Dermatology Life Quality Index (DLQI) Scores | The DLQI was a validated, self-administered, 10-item quality-of-life questionnaire that consisted of 10 items that assessed the impact of skin disease on quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each question was scored on a scale of 0=not at all/not relevant to 3=very much. Response from all of the 10 questions were added to derive the DLQI total scores. Total DLQI scores ranges from 0=not at all to 30=very much, with higher scores indicating greater impairment in quality of life. | Baseline, Month 1, 6, 12, 24, 36, 48 |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48 | The DLQI was a validated, self-administered, 10-item quality-of-life questionnaire that consisted of 10 items that assessed the impact of skin disease on quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each question was scored on a scale of 0=not at all/not relevant to 3=very much. Response from all of the 10 questions were added to derive the DLQI total scores. Total DLQI scores ranges from 0=not at all to 30=very much, with higher scores indicating greater impairment in quality of life. | Baseline, Month 1, 6, 12, 24, 36, 48 |
| 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores | The SF-36 questionnaire, version 2, acute was a 36-item generic health status measure. SF-36 evaluated 8 health-related aspects of an individual: physical functioning, role-physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. Two summary scale scores were computed from the 8 health aspect scores: physical component summary score and mental component summary score. Score range for both summary scales ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. | Baseline, Month 6, 12, 24, 36, 48 |
| 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores | The SF-36 questionnaire, version 2 was a 36-item generic health status measure. SF-36 evaluated 8 health-related aspects of an individual: physical functioning, role-physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. Two summary scale scores were computed from the 8 health aspect scores: the Physical Component Summary and the Mental Component Summary. Score range for both summary scale ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. | Baseline, Month 6, 12, 24, 36, 48 |
| Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" | The PtGA evaluated the overall skin disease of participants at that point in time on a single-item. Participants provided their response on a 5-point scale ranges from: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe. Higher score indicated greater severity of disease. Participants who provided their response as "clear (score of 0)" or "almost clear (score of 1)" in PtGA at each specified visit were reported in this outcome measure. | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
| Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores | EQ-5D: participant rated 5-dimension (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) questionnaire to assess health-related quality of life in terms of a single utility score. Each dimension was assessed on a 3-point scale (1=no problems, 2=some problems, 3=extreme problems, where higher scores=worse health condition). The responses from the 5 dimensions were used to calculate a single utility index value. Scoring formula developed by EuroQol Group assigned a utility value for each dimension in the profile. Score was transformed and results in a total score range -0.594 to 1.000; higher score indicated a better health state. | Baseline, Month 6, 12, 24, 36, 48 |
| Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS) | EQ-5D VAS was a participant rated questionnaire to assess health-related quality of life in terms of a single index value. It was a visual analogue scale that ranged from 0 (minimum) to 100 (maximum), with higher scores indicating a better health condition. | Baseline, Month 6, 12, 24, 36, 48 |
| Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) | Ps-HCRU was a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. In the first section, it assessed direct costs associated with healthcare resource use which included participant's interactions with healthcare providers such as general practitioners, dermatologists, cardiologists, gastroenterologists, psychiatrists, surgeons and nurses. When taking the evening dose of tofacitinib, participants were asked to answer the Ps-HCRU questionnaire only if they had an interaction with a healthcare provider or their work was impacted by psoriasis on that specified day. In this outcome measure, number of participants who answered Ps-HCRU at any specified visits were reported. | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
| Birmingham |
| Alabama |
| 35233 |
| United States |
| Horizon Research Group, Inc. | Mobile | Alabama | 36608 | United States |
| Radiant Research, Inc. | Tucson | Arizona | 85712 | United States |
| Burke Pharmaceutical Research | Hot Springs | Arkansas | 71913 | United States |
| Bakersfield Dermatology and Skin Cancer Medical Group | Bakersfield | California | 93309 | United States |
| Associates In Research, Inc. | Fresno | California | 93720 | United States |
| University of California Irvine | Irvine | California | 92697 | United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| Dermatology Specialists, Inc. | Oceanside | California | 92056 | United States |
| MedDerm Associates | San Diego | California | 92103 | United States |
| UCSD Dermatology | San Diego | California | 92122 | United States |
| University of California San Diego | San Diego | California | 92122 | United States |
| University of California San Francisco | San Francisco | California | 94118 | United States |
| Clinical Science Institute | Santa Monica | California | 90404 | United States |
| Healthcare Partners Medical Group | Torrance | California | 90503 | United States |
| Cherry Creek Research, Inc. | Denver | Colorado | 80209 | United States |
| The Savin Center, P.C. | New Haven | Connecticut | 06511 | United States |
| New England Research Associates, LLC | Trumbull | Connecticut | 06611 | United States |
| Florida Academic Dermatology Center | Coral Gables | Florida | 33134 | United States |
| North Florida Dermatology Associates, PA | Jacksonville | Florida | 32204 | United States |
| International Dermatology Research, Inc. | Miami | Florida | 33144 | United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| Park Avenue Dermatology, PA | Orange Park | Florida | 32073 | United States |
| Leavitt Medical Associates of Florida dba Ameriderm Research | Ormond Beach | Florida | 32174 | United States |
| Miami Research Associates, Inc. | South Miami | Florida | 33143 | United States |
| Olympian Clinical Research | Tampa | Florida | 33609 | United States |
| Atlanta Dermatology, Vein & Research Center, P.C. | Alpharetta | Georgia | 30022 | United States |
| Advanced Medical Research, Inc. | Atlanta | Georgia | 30342 | United States |
| MedaPhase Inc. | Newnan | Georgia | 30263 | United States |
| Altman Dermatology Associates | Arlington Heights | Illinois | 60005 | United States |
| Schaumburg Dermatology | Schaumburg | Illinois | 60173 | United States |
| NorthShore University Health System - Division of Dermatology | Skokie | Illinois | 60077 | United States |
| Springfield Clinic | Springfield | Illinois | 62703 | United States |
| Dundee Dermatology | West Dundee | Illinois | 60118 | United States |
| Deaconess Clinic Downtown Research Institute | Evansville | Indiana | 47713 | United States |
| Hudson Dermatology | Evansville | Indiana | 47714 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46256 | United States |
| DermResearch, PLLC | Louisville | Kentucky | 40217 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111-1552 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital - Clinical Unit for Research Trials and Outcomes in Skin | Boston | Massachusetts | 02114 | United States |
| Michigan Center for Research Corporation dba Michigan Center for Skin Care Research | Clinton | Michigan | 48038 | United States |
| Hamzavi Dermatology | Fort Gratiot | Michigan | 48059 | United States |
| Somerset Skin Centre - Dermcenter | Troy | Michigan | 48084 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Saint Louis University - Department of Dermatology | St Louis | Missouri | 63104 | United States |
| Skin Specialists, P.C | Omaha | Nebraska | 68144 | United States |
| Bettencourt Skin Center | Henderson | Nevada | 89074 | United States |
| Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center | Lebanon | New Hampshire | 03756 | United States |
| Centennial Center-Comprehensive Clinical Research | Berlin | New Jersey | 08009 | United States |
| New York University (NYU) School of Medicine - Investigational Pharmacy (IP Shipment, Pharmacy) | New York | New York | 10016 | United States |
| NYU Langone Medical Center, Ambulatory Care Center, Department of Dermatology, Clinical Studies Unit | New York | New York | 10016 | United States |
| The Rockefeller University | New York | New York | 10065 6307 | United States |
| University of North Carolina at Chapel Hill- Hospital | Chapel Hill | North Carolina | 27514 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27516 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Dermatology Consulting Services | High Point | North Carolina | 27262 | United States |
| Wake Dermatology Associates, LLC | Raleigh | North Carolina | 27607 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Dermatology Associates | Wilmington | North Carolina | 28401 | United States |
| PMG Research of Wilmington, LLC | Wilmington | North Carolina | 28401 | United States |
| Piedmont Imaging | Winston-Salem | North Carolina | 27103 | United States |
| PMG Research of Winston-Salem | Winston-Salem | North Carolina | 27103 | United States |
| Triad Dermatology, PA | Winston-Salem | North Carolina | 27103 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27104 | United States |
| Jewish Hospital | Cincinnati | Ohio | 45236 | United States |
| Radiant Research, Inc. | Cincinnati | Ohio | 45249 | United States |
| IP ONLY: University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| University Hospitals Case Medical Center/Dept. of Dermatology | Cleveland | Ohio | 44106 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Central Sooner Research | Norman | Oklahoma | 73071 | United States |
| Baker Allergy Asthma and Dermatology Research Center, LLC | Lake Oswego | Oregon | 97035 | United States |
| Oregon Dermatology and Research Center | Portland | Oregon | 97210 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| University of Pittsburgh Medical Center - Department of Dermatology | Pittsburgh | Pennsylvania | 15213 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Clinical Partners, LLC | Johnston | Rhode Island | 02919 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Office of John Michael Humeniuk, MD | Greer | South Carolina | 29650 | United States |
| Radiant Research, Inc. | Greer | South Carolina | 29650 | United States |
| Health Concepts | Rapid City | South Dakota | 57702 | United States |
| Rivergate Dermatology Clinical Research Center, PLLC | Goodlettsville | Tennessee | 37072 | United States |
| Dermatology Associates of Knoxville PC | Knoxville | Tennessee | 37917 | United States |
| Dermatology Research Associates | Nashville | Tennessee | 37203 | United States |
| Arlington Research Center, Inc. | Arlington | Texas | 76011 | United States |
| Dermatology Treatment & Research Center | Dallas | Texas | 75230 | United States |
| Modern Research Associates, PLLC | Dallas | Texas | 75231 | United States |
| Menter Dermatology Research Institute | Dallas | Texas | 75246 | United States |
| Center for Clinical Studies | Houston | Texas | 77004 | United States |
| Suzanne Bruce and Associates, PA | Houston | Texas | 77056 | United States |
| Office of Mark Lee, MD | San Antonio | Texas | 78229 | United States |
| Progressive Clinical research, P.A. | San Antonio | Texas | 78229 | United States |
| Stephen Miller, MD, PA | San Antonio | Texas | 78249 | United States |
| Center for Clinical Studies | Webster | Texas | 77598 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23502 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23507 | United States |
| Rockwood Research Center | Spokane | Washington | 99202 | United States |
| Wenatchee Valley Hospital & Clinics | Wenatchee | Washington | 98801 | United States |
| Mountain State Clinical Research | Bridgeport | West Virginia | 26330 | United States |
| Madison Skin and Research, Inc. | Madison | Wisconsin | 53719 | United States |
| Centro De Investigaciones Dermatologicas | Caba | C1114AAP | Argentina |
| CENIT Centro de Neurociencias Investigacion y Tratamiento | CABA | C1125ABD | Argentina |
| Dr. Glenn and Partners | Kogarah | New South Wales | 02217 | Australia |
| Premier Dermatology | Kogarah | New South Wales | 02217 | Australia |
| Malvern Diagnostic Imaging | Malvern | Victoria | 3144 | Australia |
| Emeritus Research | Malvern East | Victoria | 3145 | Australia |
| Skin And Cancer Foundation | Melbourne | Victoria | 3053 | Australia |
| LKH Feldkirch | Feldkirch | 6807 | Austria |
| LKH Salzburg, Landesklinik fuer Dermatologie | Salzburg | 5020 | Austria |
| Cliniques Universitaires Saint-Luc | Brussels | 1200 | Belgium |
| UHC Sarajevo | Sarajevo | 71000 | Bosnia and Herzegovina |
| Hospital da Clinicas da Faculdade de Medicina da Universidade de Sao Paulo | São Paulo | São Paulo | 05403-900 | Brazil |
| Instituto de Dermatologia e Estetica do Brasil LTDA - IDERJ | Rio de Janeiro | 22470-220 | Brazil |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo | São Paulo | 05403-000 | Brazil |
| UMHAT "Dr Georgi Stranski" | Pleven | 5800 | Bulgaria |
| UMHAT "Dr. Georgi Stranski" - II clinical base | Pleven | 5800 | Bulgaria |
| Tsentar za kozhno venericheski zaboliavania EOOD | Sofia | 1404 | Bulgaria |
| Mnogoprofilna Bolnitsa Za Aktivno Lechenie- Tokuda Bolnitsa | Sofia | 1407 | Bulgaria |
| UMBAL-Alexandrovska- Sofia Klinika po dermatologia i venerologia | Sofia | 1431 | Bulgaria |
| MBAL na Voennomeditsinska Akademia | Sofia | 1606 | Bulgaria |
| Kirk Barber Research | Calgary | Alberta | T2G 1B1 | Canada |
| Northwest Dermatology & Laser Centre | Calgary | Alberta | T3G 0B4 | Canada |
| Stratica Medical | Edmonton | Alberta | T5K 1X3 | Canada |
| Enverus Medical Research | Surrey | British Columbia | V3V 0C6 | Canada |
| Derm Research @888 Inc | Vancouver | British Columbia | V5Z 3Y1 | Canada |
| The Skin Centre | Vancouver | British Columbia | V5Z 4E8 | Canada |
| Percuro Clinical Research Limited | Victoria | British Columbia | V8V 3P9 | Canada |
| Dermadvances Research | Winnipeg | Manitoba | R3C 1R4 | Canada |
| Wiseman Dermatology Research Inc. | Winnipeg | Manitoba | R3M 3Z4 | Canada |
| Nexus Clinical Research | St. John's | Newfoundland and Labrador | A1A 5E8 | Canada |
| Dr. Zohair Tomi PMC Inc. Paton Medical Centre | St. John's | Newfoundland and Labrador | A1B 4S8 | Canada |
| NewLab Clinical Research Inc. | St. John's | Newfoundland and Labrador | A1C 2H5 | Canada |
| Eastern Canada Cutaneous Research Associates Ltd. | Halifax | Nova Scotia | B3H 1Z2 | Canada |
| CCA Medical Research | Ajax | Ontario | L1S 7K8 | Canada |
| The Waterside Clinic | Barrie | Ontario | L4M 6L2 | Canada |
| Ultranova Skincare | Barrie | Ontario | L4M 6L2 | Canada |
| Co-Medica Research Network Inc. | Courtice | Ontario | L1E 3C3 | Canada |
| Dermatrials Research, Inc. | Hamilton | Ontario | L8N 1V6 | Canada |
| The Guenther Dermatology Research Centre | London | Ontario | N6A 3H7 | Canada |
| Lynderm Research Inc. | Markham | Ontario | L3P 1X2 | Canada |
| North Bay Dermatology Centre | North Bay | Ontario | P1B 3Z7 | Canada |
| Oakville Dermatology Laser Centre | Oakville | Ontario | L6J 7W5 | Canada |
| Dr. Tuppal's Privat Practice, Oshawa Clinic | Oshawa | Ontario | L1H 1B9 | Canada |
| Office of Dr. Michael Robern | Ottawa | Ontario | K2G 6E2 | Canada |
| SKiN Centre for Dermatology | Peterborough | Ontario | K9J 5K2 | Canada |
| Office of Dr. Paul Adam (back-up location) | Scarborough Village | Ontario | MlB 4Z8 | Canada |
| K. Papp Clinical Research | Waterloo | Ontario | N2J 1C4 | Canada |
| XLR8 Medical Research | Windsor | Ontario | N8W 1E6 | Canada |
| Windsor Clinical Research | Windsor | Ontario | N8W 5L7 | Canada |
| Innovaderm Research Inc | Montreal | Quebec | H2K 4L5 | Canada |
| Siena Medical Research | Montreal | Quebec | H3Z 2S6 | Canada |
| CRCMRGilbert Inc., Centre de Dermatologie Maizerets | Québec | Quebec | G1J 1X7 | Canada |
| Centre de Recherche Dermatologique du Québec Métropolitain | Québec | Quebec | G1V 4X7 | Canada |
| Diex Research Sherbrooke Inc. | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| Clinica Dermacross S.A. | Santiago | Santiago Metropolitan | 7640881 | Chile |
| Hospital Clinico Universidad de Chile | Santiago | Santiago Metropolitan | 8380456 | Chile |
| Centro Internacional de Estudios Clinicos, CIEC | Santiago | Santiago Metropolitan | 8420383 | Chile |
| Reumalab S.A.S. | Medellín | Antioquia | 0 | Colombia |
| Hospital Pablo Tobon Uribe | Medellín | Antioquia | Colombia |
| Centro Integral de Reumatologia del Caribe Cicaribe S.A.S | Barranquilla | Atlántico | 08001000 | Colombia |
| Riesgo De Fractura S.A | Bogota | Cundinamarca | 0000 | Colombia |
| Riesgo De Fractura S.A | Bogota | Cundinamarca | Colombia |
| Colegio Mayor de Nuestra Señora del Rosario | Bogotá | Cundinamarca | 110221 | Colombia |
| Medicity S.A.S | Bucaramanga | Santander Department | 680003 | Colombia |
| University Hospital Center Osijek | Osijek | 31000 | Croatia |
| University hospital center "Sestre milosrdnice" clinic for dermatology and venerology disease | Zagreb | 10000 | Croatia |
| University hospital center zagreb | Zagreb | 10000 | Croatia |
| Nemocnice Ceske Budejovice, a.s. Ustavni lekarna | České Budějovice | Czech Republic | 370 01 | Czechia |
| Ustanvi lekarna | Hradec Králové | Czech Republic | 50005 | Czechia |
| Nemocnice Ceske Budejovice,a.s. | České Budějovice | 37001 | Czechia |
| Klinika nemoci koznich a pohlavnich | Hradec Králové | 500 05 | Czechia |
| Fakultni nemocnice Plzen | Plzen-Bory | 30599 | Czechia |
| Kozni ordinace | Prague | 11000 | Czechia |
| Lekarna U sv. Ignace | Prague | 120 00 | Czechia |
| Krajska zdravotni a.s.,Masarykovy nemocnice o.z. | Ústí nad Labem | 40113 | Czechia |
| Aarhus University Hospital | Aarhus C | 8000 | Denmark |
| Bispebjerg Hospital, University of Copenhagen | Copenhagen NV | 2400 | Denmark |
| Gentofte Hospital | Hellerup | 2900 | Denmark |
| Hudklinikken Herning | Herning | 7400 | Denmark |
| Hudklinikken | Svendborg | 5700 | Denmark |
| Tampere Univeristy Hospital, Department of Dermatology and Venereology | Tampere | 33521 | Finland |
| Chu Morvan | Brest | Cedex | 29609 | France |
| CHU Limoges - Hôpital Dupuytren - Pharmacie | Limoges | Cedex | 87042 | France |
| Hopital Saint Louis | Paris | Lle-de-france | 75010 | France |
| Hôpital Jean Minjoz | Besançon | 25000 | France |
| CHU Jean-Minjoz | Besançon | 25030 | France |
| CHG Le Mans | Le Mans | 72037 | France |
| Hopital Dupuytren | Limoges | 87042 | France |
| CHU de Nantes - Hotel Dieu | Nantes | 44035 | France |
| CHU De Nice Hopital De L'Archet II | Nice | 06202 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69310 | France |
| Centre Hospitalier Lyon Sud - Pharmacie | Pierre-Bénite | 69495 | France |
| C.H.U. de Poitiers la Miletrie | Poitiers | 86000 | France |
| C.H.U de Reims | Reims | 51092 | France |
| Hôpital Robert Debre | Reims | 51100 | France |
| Hopital Nord | Saint-Priest-en-Jarez | 42270 | France |
| Hopital Larrey Departement de Dermatologie | Toulouse | 31000 | France |
| Hopital de Brabois / Batiment Philippe Canton | Vandœuvre-lès-Nancy | 54511 | France |
| Universitaets-Hautklinik Eberhard-Karls-Universitaet Tuebingen | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Universitatsklinikum Schleswig-Holstein | Kiel | Schleswig-Holstein | 24105 | Germany |
| Charité Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| Klinische Forschung Berlin-Mitte GmbH | Berlin | 10117 | Germany |
| Facharzt fuer Dermatologie und Allergologie | Berlin | 10435 | Germany |
| MVZ Reichenberger Str., Aerztehaus "Rudolf Virchow" | Berlin | 13055 | Germany |
| Hautarztpraxis Tegel | Berlin | 13507 | Germany |
| Klinik and Poliklinik fur Dermatologie and Allergologie der Universitaet Bonn | Bonn | 53105 | Germany |
| Klinik und Poliklinik fur Dermatologie und Allergologie der Universitaet Bonn | Bonn | 53105 | Germany |
| Dres. Kirsten Prepeneit und Volker Streit | Buchholz | 21244 | Germany |
| Universitaetsklinikum Koeln | Cologne | 50937 | Germany |
| Universitaetsklinik Carl Gustav Carus | Dresden | 01307 | Germany |
| Universitaetsklinikum Erlangen Hautklinik im Internistischen Zentrum | Erlangen | 91054 | Germany |
| Klinikum der Johann Wolfgang Goethe Universitaet | Frankfurt am Main | 60590 | Germany |
| Universitaetsklinik und Poliklinik fuer Dermatologie und Venerologie | Halle | 06120 | Germany |
| Universitaetsklinikum Hamburg-Eppendorf | Hamburg | 20246 | Germany |
| Klinische Forschung Hamburg GmbH | Hamburg | 20253 | Germany |
| Gemeinschaftspraxis Dres.Michael Ockenfels und Christoph Sauter | Hanau | 63450 | Germany |
| Universitaetsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Universitaetsklinikum Schleswig-Holstein, Campus Kiel | Kiel | 24105 | Germany |
| Universitaetsklinikum Schleswig-Holstein Campus Luebeck | Lübeck | 23538 | Germany |
| Hautarztpraxis Dres. Scholz, Sebastian, Schilling | Mahlow | 15831 | Germany |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KoeR | Mainz | 55131 | Germany |
| Technischen Universitaet Muenchen | München | 80802 | Germany |
| Universitaetsklinikum Muenster | Münster | 48149 | Germany |
| Klinische Forschung Schwerin GmbH | Schwerin | 19055 | Germany |
| Eberhard-Karls-Universitaet Tuebingen Universitaetshautklinik | Tübingen | 72076 | Germany |
| HSK, Dr. Horst Schmidt Kliniken GmbH | Wiesbaden | 65199 | Germany |
| Hautarztpraxis Centrovital | Witten | 58453 | Germany |
| University Dermatology Clinic "Andreas Syggros" Hospital | Athens | Attica | 16121 | Greece |
| University General Hospital of Ioannina / Dermatology and Venereology Department | Ioannina | 45500 | Greece |
| "Papageorgiou" General Hospital/B' Dermatology and Venereology Clinic of University of Thessaloniki | Thessaloniki | 56403 | Greece |
| The University of Hong Kong (HKU)-Queen Mary Hospital (QMH) | Hong Kong | Hong Kong |
| Synexus Magyarorszag Kft. | Budapest | 1036 | Hungary |
| Debreceni Egyetem Klinikai Kozpont, Borgyogyaszati Klinika | Debrecen | 4032 | Hungary |
| Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem AOK Oktato Korhaza, Borgyogyaszati Osztaly | Kecskemét | 6000 | Hungary |
| Miskolci Semmelweis Korhaz es Egyetemi Oktatokorhaz, Borgyogyaszati Osztaly | Miskolc | 3529 | Hungary |
| Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Klinikai Kutatasi Osztaly | Nyíregyháza | 4400 | Hungary |
| Szabolcs-Szatmar-Bereg Megyei Korjazak es Egyetemi Okatokorhaz, Borgyogyaszati Szakrendeles | Nyíregyháza | 4400 | Hungary |
| Pecsi Tudomanyegyetem Aok Bor- Nemikortani Es Onkodermatologiai Klinika | Pécs | H-7632 | Hungary |
| SZTE Szentgyorgyi Albert Klinikai Kozpont/Borgyogyaszati es Allergologiai Klinika | Szeged | 6720 | Hungary |
| Tolna Megyei Balassa Janos Korhaz, Borgyogyaszati Osztaly | Szekszárd | 7100 | Hungary |
| ALLERGO-DERM BAKOS Kft. | Szolnok | 5000 | Hungary |
| Vas Megyei Markusovszky Korhaz/Borgyogyaszati Osztaly | Szombathely | H-9700 | Hungary |
| Veszprem Megyei Csolnoky Ferenc Korhaz Borgyogyaszat | Veszprém | H-8200 | Hungary |
| Gunma University Hospital | Maebashi | Gunma | 3718511 | Japan |
| JR Sapporo hospital | Sapporo | Hokkaido | 060-0033 | Japan |
| Kobe University | Kobe | Hyōgo | 6500017 | Japan |
| Kumamoto University Hospital | Kumamoto | Kumamoto | 860-8556 | Japan |
| Tokyo Yamate Medical Center | Shinjuku-ku | Tokyo | 169-0073 | Japan |
| Instituto Dermatologico De Jalisco "Dr Jose Barba Rubio" | Zapopan | Jalisco | 45190 | Mexico |
| Mexico Centre for Clinical Research S.A. de C.V. | Mexico City | Mexico City | 03100 | Mexico |
| Centro de Dermatologia de Monterrey | Monterrey | Nuevo León | 64460 | Mexico |
| Centro Medico San Lucas | Monterrey | Nuevo León | 64710 | Mexico |
| Academisch Medisch Centrum Universiteit van Amsterdam | Amsterdam | North Holland | 1105 AZ | Netherlands |
| PT&R | Beek | 6191 JW | Netherlands |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Pomeranian Voivodeship | 80-952 | Poland |
| NZOZ Zdrowie Osteo-Medic | Bialystok | 15-351 | Poland |
| Klinika Dermatologii, Wenerologii i Alergologii Uniwersyteckiego Centrum Klinicznego | Gdansk | 80-402 | Poland |
| Krakowskie Centrum Medyczne NZOZ | Krakow | 31-501 | Poland |
| Specjalistyczne Gabinety Lekarskie "Dermed" | Lodz | 90-265 | Poland |
| Novum Instytut Dermatologii Leczniczej i Estetycznej | Opole | 45-080 | Poland |
| Solumed Centrum Medyczne | Poznan | 60-529 | Poland |
| Centrum Badan Klinicznych s.c. Wieslawa Porawska, Lukasz Porawski | Poznan | 60773 | Poland |
| Katedra i Klinika Chorob Skornych i Wenerycznych, Pomorski Uniwersytet Medyczny | Szczecin | 70-111 | Poland |
| Spolka Cywilna Andrzej Krolicki, Tomasz Kochanowski "Laser Clinic" | Szczecin | 70-332 | Poland |
| MTZ Clinical Research Sp. z o.o. | Warsaw | 02-106 | Poland |
| Klinika Dermatologii | Warsaw | 04-141 | Poland |
| Zaklad Radiologii Lekarskiej | Warsaw | 04-141 | Poland |
| Katedra i Klinika Dermatologii, Wenerologii i Alergologii Akademii Medycznej we Wroclawiu | Wroclaw | 50-368 | Poland |
| Oddzial Dermatologiczny | Wroclaw | 51-124 | Poland |
| Poradnia Dermatologiczna | Wroclaw | 51-124 | Poland |
| Grupo Dermatologico De Carolina (Office of Dr. Alma Cruz MD) | Carolina | 00985 | Puerto Rico |
| State Research Center of Dermatovenerology, | Moscow | 107076 | Russia |
| State Research Center of Dermatovenerology | Moscow | 107076 | Russia |
| Dermatovenerological dispensary #7 | Moscow | 121614 | Russia |
| Rostov-on-Don regional dermatovenerologic dispensary | Rostov-on-Don | 344007 | Russia |
| Ryazan regional clinical dermatovenerologic dispensary | Ryazan | 390046 | Russia |
| Dermatovenerologic dispensary #10 of Vyborg region | Saint Petersburg | 194021 | Russia |
| Military Medical Academy N.A. S.M.Kirov | Saint Petersburg | 194044 | Russia |
| North-Western State Medical University I.I. Mechnikov | Saint Petersburg | 195067 | Russia |
| Smolensk State Medical Academy | Smolensk | 214019 | Russia |
| Clinical hospital of emergency care N.V. Soloviev | Yaroslavl | 150003 | Russia |
| Clinical Hospital Center Zvezdara | Belgrade | 11000 | Serbia |
| Military Medical Academy | Belgrade | 11000 | Serbia |
| National Skin Centre | Singapore | 308205 | Singapore |
| Changi General Hospital | Singapore | 529889 | Singapore |
| Dermatovenerologicka klinika SZU, Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica | Banská Bystrica | 975 17 | Slovakia |
| Oddelenie biologickej liecby, Narodny ustav reumatickych chorob | Piešťany | 921 12 | Slovakia |
| DOST-Dermatovenerologicke oddelenie sanatorneho typu, SANARE, spol. s r.o. | Svidník | 089 01 | Slovakia |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Yonsei University College of Medicine, Severance Hospital | Seoul | 120-752 | South Korea |
| Hospital Universitario Puerta de Hierro | Majadahonda | Madrid | 28222 | Spain |
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain |
| Hospital Universitario La Princesa | Madrid | 28006 | Spain |
| Hospital 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario Fundacion Alcorcon | Madrid | 28922 | Spain |
| Consorcio Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Hud kliniken- Skanes Universitetssjukhus i Malmo | Malmö | Sverige | 205 02 | Sweden |
| Hudkliniken | Falun | 791 82 | Sweden |
| Hermelinen Forskning AB | Luleå | 972 33 | Sweden |
| Pharmacy: Sjukhusapoteket Lund | Lund | 222 42 | Sweden |
| Hudkliniken | Stockholm | 118 83 | Sweden |
| Karolinska University Hospital- Solna | Stockholm | 171 76 | Sweden |
| Kantonsspital St. Gallen | Sankt Gallen | 9007 | Switzerland |
| Chung Shan Medical University Hospital | Taichung | Taiwan Roc | 40201 | Taiwan |
| Chang Gung Medical Foundation Kaohsiung Branch | Kaohsiung City | 833 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Taipei Medical University-Shuang Ho Hospital | Taipei | 235 | Taiwan |
| Chang Gung Medical Foundation Linkou Branch | Taoyuan | 333 | Taiwan |
| Dept of Dermatology and Venerology of SI "Crimean State Medical University n.a. S.I.Georgiyevskyy" | Simferopol | Autonomous Republic of Crimea | 95006 | Ukraine |
| Municipal Institution of health Care | Kharkiv | 61038 | Ukraine |
| SI 'Institute for Dermatology and Venerology of AMS of Ukraine' | Kharkiv | 61057 | Ukraine |
| Kyiv Oleksandrivska Clin. Hosp., Dermatology department, NMU n.a. O.O. Bogomolets, | Kyiv | 01601 | Ukraine |
| Dept of Dermatology and Venerology of Lugansk State Medical University, | Luhansk | 91047 | Ukraine |
| Regional Municipal Dermatovenerologic Dispensary | Lviv | 79013 | Ukraine |
| Dept of Dermatology and Venerology of ONMU | Odesa | 65006 | Ukraine |
| Ternopil Regional Municipal Clinical Dermatovenerologic Dispensary | Ternopil | 46006 | Ukraine |
| Salford Royal NHS Foundation Trust | Salford | Manchester | M6 8HD | United Kingdom |
| Department of Dermatology | Nuneaton | Warwickshire | CV10 7DJ | United Kingdom |
| Whipps Cross University Hospital | London | E11 1NR | United Kingdom |
| eRT | Peterborough | PE 2 6UP | United Kingdom |
| Kristensen LE, Strober B, Poddubnyy D, Leung YY, Jo H, Kwok K, Vranic I, Fleishaker DL, Fallon L, Yndestad A, Gladman DD. Association between baseline cardiovascular risk and incidence rates of major adverse cardiovascular events and malignancies in patients with psoriatic arthritis and psoriasis receiving tofacitinib. Ther Adv Musculoskelet Dis. 2023 Feb 7;15:1759720X221149965. doi: 10.1177/1759720X221149965. eCollection 2023. |
| 32816215 | Derived | Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20. |
| 29782642 | Derived | Valenzuela F, Korman NJ, Bissonnette R, Bakos N, Tsai TF, Harper MK, Ports WC, Tan H, Tallman A, Valdez H, Gardner AC. Tofacitinib in patients with moderate-to-severe chronic plaque psoriasis: long-term safety and efficacy in an open-label extension study. Br J Dermatol. 2018 Oct;179(4):853-862. doi: 10.1111/bjd.16798. Epub 2018 Aug 13. |
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator's discretion.
| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set included all participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Tofacitinib 10 mg | Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months). |
| BG001 | Tofacitinib 5 mg or 10 mg | Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator's discretion. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 4 weeks after last dose (up to 67 months) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Number | participants | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) |
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| Primary | Number of Adverse Events (AEs) by Severity | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories: a) mild: AEs did not interfere with participant's usual function; b) moderate: AEs interfered to some extent with participant's usual function; c) severe: AEs interfered significantly with participant's usual function. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Number | adverse events | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) |
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| Primary | Number of Participants With Laboratory Abnormalities | Abnormality criteria: hematology (hemoglobin, hematocrit, red blood cell <0.8*lower limit of normal [LLN]; reticulocyte<0.5*LLN,>1.5*ULN; platelets<0.5*LLN,>1.75* upper limit of normal [ULN]; WBC<0.6*LLN, >1.5*ULN; lymphocytes, neutrophils, basophils, eosinophils, monocytes<0.8*LLN; >1.2*ULN; coagulation (prothrombin [PT], PT ratio>1.1*ULN) liver function (bilirubin>1.5*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma GT>0.3*ULN, protein, albumin<0.8*LLN; >1.2*ULN, globulin<0.5*LLN; >1.5*ULN); renal function (blood urea nitrogen, creatinine>1.3*ULN); electrolytes(sodium<0.95* LLN; >1.05* ULN, potassium, chloride, calcium, bicarbonate<0.9*LLN; >1.1*ULN), chemistry (glucose<0.6*LLN; >1.5* ULN), urinalysis (pH <4.5;>8, glucose, ketones, protein, blood, urobilinogen, nitrite, bilirubin, leukocyte esterase>=1; RBC, WBC>=20); lipids (cholesterol [C], LDL-C >1.3*ULN, HDL-C<0.8*LLN, triglycerides>1.3* ULN), hormones(T4, T3, T4, TSH<0.8* LLN; >1.2* ULN). | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Number | participants | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) |
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| Primary | Change From Baseline in Hemoglobin Level at Month 1 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies participants evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | gram per deciliter (g/dL) | Baseline, Month 1 |
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| Primary | Change From Baseline in Hemoglobin Level at Month 3 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | g/dL | Baseline, Month 3 |
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| Primary | Change From Baseline in Hemoglobin Level at Month 6 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | g/dL | Baseline, Month 6 |
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| Primary | Change From Baseline in Hemoglobin Level at Month 12 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | g/dL | Baseline, Month 12 |
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| Primary | Change From Baseline in Hemoglobin Level at Month 24 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | g/dL | Baseline, Month 24 |
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| Primary | Change From Baseline in Hemoglobin Level at Month 36 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | g/dL | Baseline, Month 36 |
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| Primary | Change From Baseline in Hemoglobin Level at Month 48 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | g/dL | Baseline, Month 48 |
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| Primary | Change From Baseline in Lymphocyte and Neutrophil Count at Month 1 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | 1000 cells/mm^3 | Baseline, Month 1 |
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| Primary | Change From Baseline in Lymphocyte and Neutrophil Count at Month 3 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | 1000 cells/mm^3 | Baseline, Month 3 |
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| Primary | Change From Baseline in Lymphocyte and Neutrophil Count at Month 6 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | 1000 cells/mm^3 | Baseline, Month 6 |
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| Primary | Change From Baseline in Lymphocyte and Neutrophil Count at Month 12 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | 1000 cells/mm^3 | Baseline, Month 12 |
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| Primary | Change From Baseline in Lymphocyte and Neutrophil Count at Month 24 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | 1000 cells/mm^3 | Baseline, Month 24 |
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| Primary | Change From Baseline in Lymphocyte and Neutrophil Count at Month 36 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | 1000 cells/mm^3 | Baseline, Month 36 |
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| Primary | Change From Baseline in Lymphocyte and Neutrophil Count at Month 48 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | 1000 cells/mm^3 | Baseline, Month 48 |
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| Primary | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 1 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | milligram per deciliter (mg/dL) | Baseline, Month 1 |
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| Primary | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 3 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Month 3 |
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| Primary | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 6 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Month 6 |
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| Primary | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 12 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Month 12 |
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| Primary | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 24 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Month 24 |
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| Primary | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 36 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Month 36 |
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| Primary | Change From Baseline in Creatinine, Low Density Lipoprotein Cholesterol (LDL-C), High Density Lipoprotein Cholesterol (HDL-C) and Total Cholesterol (TC) Levels at Month 48 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | mg/dL | Baseline, Month 48 |
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| Primary | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | international unit per liter (IU/L) | Baseline, Month 1 |
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| Primary | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | IU/L | Baseline, Month 3 |
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| Primary | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | IU/L | Baseline, Month 6 |
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| Primary | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | IU/L | Baseline, Month 12 |
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| Primary | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | IU/L | Baseline, Month 24 |
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| Primary | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | IU/L | Baseline, Month 36 |
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| Primary | Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | IU/L | Baseline, Month 48 |
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| Primary | Number of Participants With Clinically Significant Change From Baseline in Physical Examination | Physical examinations included: general appearance; skin, head, eyes, ears, nose and throat; heart; lungs; abdomen; lower extremities (for the presence of peripheral edema) and lymph nodes. Clinical significance of change from baseline values in physical examination was based on investigator's discretion. | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Number | participants | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) |
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| Primary | Number of Participants With Vital Sign Abnormalities | Criteria for abnormalities in vital signs included: Systolic blood pressure (SBP): less than (<) 90 millimeter of mercury (mmHg) and maximum increase from baseline (IFB) of greater than or equal to (>=) 30 mmHg; diastolic blood pressure (DBP): <50 and greater than (>) 120 mmHg and maximum IFB of >=20 mmHg; heart rate: <40 and >120 beats per minute. | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Number | participants | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) |
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| Primary | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | millimeter of mercury (mmHg) | Baseline, Month 1 |
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| Primary | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmHg | Baseline, Month 3 |
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| Primary | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmHg | Baseline, Month 6 |
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| Primary | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmHg | Baseline, Month 12 |
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| Primary | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmHg | Baseline, Month 24 |
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| Primary | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmHg | Baseline, Month 36 |
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| Primary | Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | mmHg | Baseline, Month 48 |
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| Primary | Change From Baseline in Heart Rate at Month 1 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | beats per minute | Baseline, Month 1 |
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| Primary | Change From Baseline in Heart Rate at Month 3 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | beats per minute | Baseline, Month 3 |
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| Primary | Change From Baseline in Heart Rate at Month 6 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | beats per minute | Baseline, Month 6 |
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| Primary | Change From Baseline in Heart Rate at Month 12 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | beats per minute | Baseline, Month 12 |
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| Primary | Change From Baseline in Heart Rate at Month 24 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | beats per minute | Baseline, Month 24 |
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| Primary | Change From Baseline in Heart Rate at Month 36 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | beats per minute | Baseline, Month 36 |
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| Primary | Change From Baseline in Heart Rate at Month 48 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | beats per minute | Baseline, Month 48 |
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| Primary | Number of Participants With Electrocardiogram (ECG) Abnormalities | Criteria for ECG abnormality: PR interval >=300 milliseconds (msec); QT interval >=500 msec; QTcB (Bazett's Correction) and QTcF (Fridericia's Correction) 450 to <480 msec, 480 to <500 msec and >=500 msec. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Number | participants | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) |
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| Primary | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | milliseconds (msec) | Baseline, Month 6 |
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| Primary | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | msec | Baseline, Month 12 |
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| Primary | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | msec | Baseline, Month 24 |
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| Primary | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | msec | Baseline, Month 36 |
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| Primary | Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48 | Safety analysis set included all participants who received at least 1 dose of study drug. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | msec | Baseline, Month 48 |
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| Primary | Number of Participants With Adjudicated Cardiovascular Events | Adjudicated cardiovascular events were assessed by adjudication committee as independent reviewers based on event documentation including: hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic enzymes, results of other diagnostic tests, autopsy reports and death certificate information; as applicable. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Number | participants | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) |
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| Primary | Number of Participants With Malignancy Events | Malignancy events included lymphoma, and demyelinating neurologic events. Biopsies collected for malignancy events were submitted to the central laboratory for pathologist over-read. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Number | participants | Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months) |
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| Secondary | Percentage of Participants Achieving Physician Global Assessment (PGA) Response of 'Clear' or 'Almost Clear' | The PGA of psoriasis was scored on a 5-point scale, reflecting a global consideration of the erythema (E), induration (I), and scaling (S) across all psoriatic lesions in participants. The severity rating scores (Erythema: 0= no evidence of erythema to 4= dark, deep red; Induration: 0= no evidence of plaque elevation to 4= marked plaque elevation, hard/sharp borders; Scaling: 0= no evidence of scaling to 4= thick, coarse scale predominates) were summed (E + I + S = total) and the average (total/3) was taken. The total average was rounded to the nearest whole number score to determine the PGA. The 5-point scale for PGA was: 0= clear; 1= almost clear; 2= mild; 3= moderate; 4= severe, where higher score indicated more severity of psoriasis. Percentage of participants with response of 'clear' (score of '0') and 'almost clear' (score of '1') were reported. | Full analysis set (FAS) included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies participants evaluable for this outcome measure and 'n' signifies participants who were evaluable at specified time points for each arm, respectively. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 1, 3, 6, 12, 24, 36, 48 |
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| Secondary | Percentage of Participants Achieving Greater Than or Equal to (>=) 75 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=75 percent (%) reduction from baseline in PASI scores were reported. | FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
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| Secondary | Psoriasis Area and Severity Index (PASI) Scores | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. | FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
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| Secondary | Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. | FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
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| Secondary | Psoriasis Area and Severity Index (PASI) Component Scores: Erythema | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Erythema was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. | FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
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| Secondary | Psoriasis Area and Severity Index (PASI) Component Scores: Induration | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Induration was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. | FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
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| Secondary | Psoriasis Area and Severity Index (PASI) Component Scores: Scaling | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Scaling was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. | FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
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| Secondary | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Erythema at Month 1, 3, 6, 12, 24, 36 and 48 | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Erythema was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. | FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
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| Secondary | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Induration at Month 1, 3, 6, 12, 24, 36 and 48 | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Induration was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. | FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
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| Secondary | Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Scores: Scaling at Month 1, 3, 6, 12, 24, 36 and 48 | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Scaling was assessed separately for four body areas (head and neck, upper limbs, trunk and lower limbs) on a 5-point scale ranges from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. | FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
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| Secondary | Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=50% reduction from baseline in PASI scores were reported. | FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
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| Secondary | Percentage of Participants Achieving Greater Than or Equal to (>=) 90 Percent Reduction From Baseline in Psoriasis Area and Severity Index (PASI) Scores | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=90% reduction from baseline in PASI scores were reported. | FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
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| Secondary | Percentage of Participants Achieving Greater Than or Equal to (>=) 125 Percent Increase From Baseline in Psoriasis Area and Severity Index (PASI) Scores | PASI score is the combined assessment of lesion severity (estimated by 3 components: of erythema, induration and scaling) and area affected into single score range: 0 (no disease) to 72 (maximal disease), with higher scores representing greater severity of psoriasis. Each component of severity, that is, erythema, induration and scaling was assessed separately for four body areas (head and neck [h], upper limbs [u], trunk [t] and lower limbs [l]) on a 5-point scale ranging from 0=no involvement, 1=slight, 2=moderate, 3=marked, 4=very marked. Higher score indicates greater severity. Final PASI score = 0.1Ah (Eh + Ih + Sh) + 0.2Au (Eu + Iu + Su) + 0.3At (Et + It + St) + 0.4Al (El + Il + Sl), where head and neck: 0.1; upper limbs: 0.2; trunk: 0.3; lower limbs: 0.4. Percentage of participants with >=125% increase from baseline in PASI scores were reported. | FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
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| Secondary | Itch Severity Item (ISI) Scores | ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Participants were asked to rate their 'severity of itching' due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms '0=no itching' and '10=worst possible itching' at the ends. Higher scores indicated greater severity of itching. | FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
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| Secondary | Change From Baseline in Itch Severity Item (ISI) Scores at Month 1, 3, 6, 12, 24, 36 and 48 | ISI assessed severity of itching due to psoriasis. ISI was a single item, horizontal numeric rating scale. Participants were asked to rate their 'severity of itching' due to psoriasis over the past 24 hours on a numeric rating scale anchored by the terms '0=no itching' and '10=worst possible itching' at the ends. Higher scores indicated greater severity of itching. | FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
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| Secondary | Dermatology Life Quality Index (DLQI) Scores | The DLQI was a validated, self-administered, 10-item quality-of-life questionnaire that consisted of 10 items that assessed the impact of skin disease on quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each question was scored on a scale of 0=not at all/not relevant to 3=very much. Response from all of the 10 questions were added to derive the DLQI total scores. Total DLQI scores ranges from 0=not at all to 30=very much, with higher scores indicating greater impairment in quality of life. | FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 1, 6, 12, 24, 36, 48 |
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| Secondary | Change From Baseline in Dermatology Life Quality Index (DLQI) Scores at Month 1, 6, 12, 24, 36 and 48 | The DLQI was a validated, self-administered, 10-item quality-of-life questionnaire that consisted of 10 items that assessed the impact of skin disease on quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). Each question was scored on a scale of 0=not at all/not relevant to 3=very much. Response from all of the 10 questions were added to derive the DLQI total scores. Total DLQI scores ranges from 0=not at all to 30=very much, with higher scores indicating greater impairment in quality of life. | FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 1, 6, 12, 24, 36, 48 |
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| Secondary | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Physical Component Summary Scores | The SF-36 questionnaire, version 2, acute was a 36-item generic health status measure. SF-36 evaluated 8 health-related aspects of an individual: physical functioning, role-physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. Two summary scale scores were computed from the 8 health aspect scores: physical component summary score and mental component summary score. Score range for both summary scales ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. | FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 6, 12, 24, 36, 48 |
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| Secondary | 36-Item Short-Form (SF-36) Health Survey Version 2, Acute: Mental Component Summary Scores | The SF-36 questionnaire, version 2 was a 36-item generic health status measure. SF-36 evaluated 8 health-related aspects of an individual: physical functioning, role-physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health. The score range for each of the 8 health aspects ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. Two summary scale scores were computed from the 8 health aspect scores: the Physical Component Summary and the Mental Component Summary. Score range for both summary scale ranged from 0 (worst) to 100 (best), with higher scores indicating good health condition. | FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 6, 12, 24, 36, 48 |
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| Secondary | Number of Participants With Patient Global Assessment (PtGA) Response of "Clear" or "Almost Clear" | The PtGA evaluated the overall skin disease of participants at that point in time on a single-item. Participants provided their response on a 5-point scale ranges from: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe. Higher score indicated greater severity of disease. Participants who provided their response as "clear (score of 0)" or "almost clear (score of 1)" in PtGA at each specified visit were reported in this outcome measure. | FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Number | participants | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
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| Secondary | Euro Quality of Life- 5-Dimensions (EQ-5D)-Utility Scores | EQ-5D: participant rated 5-dimension (mobility, self-care, usual activities, pain and discomfort, and anxiety and depression) questionnaire to assess health-related quality of life in terms of a single utility score. Each dimension was assessed on a 3-point scale (1=no problems, 2=some problems, 3=extreme problems, where higher scores=worse health condition). The responses from the 5 dimensions were used to calculate a single utility index value. Scoring formula developed by EuroQol Group assigned a utility value for each dimension in the profile. Score was transformed and results in a total score range -0.594 to 1.000; higher score indicated a better health state. | FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 6, 12, 24, 36, 48 |
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| Secondary | Euro Quality of Life-5-Dimensions (EQ-5D)-Visual Analogue Scale Scores (VAS) | EQ-5D VAS was a participant rated questionnaire to assess health-related quality of life in terms of a single index value. It was a visual analogue scale that ranged from 0 (minimum) to 100 (maximum), with higher scores indicating a better health condition. | FAS included all participants who received at least 1 dose of study drug, excluding the participants who had compliance issues. Here, 'number of participants analyzed' signifies those participants who were evaluable for this outcome measure and 'n' signifies those participants who were evaluable at specified time points for each arm, respectively. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 6, 12, 24, 36, 48 |
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| Secondary | Number of Participants Who Answered Psoriasis Healthcare Resource Utilization Questionnaire (Ps-HCRU) | Ps-HCRU was a short questionnaire designed to assess healthcare resource use and the impact of psoriasis on work. In the first section, it assessed direct costs associated with healthcare resource use which included participant's interactions with healthcare providers such as general practitioners, dermatologists, cardiologists, gastroenterologists, psychiatrists, surgeons and nurses. When taking the evening dose of tofacitinib, participants were asked to answer the Ps-HCRU questionnaire only if they had an interaction with a healthcare provider or their work was impacted by psoriasis on that specified day. In this outcome measure, number of participants who answered Ps-HCRU at any specified visits were reported. | Safety analysis set included all participants who received at least 1 dose of study drug. | Posted | Number | participants | Baseline, Month 1, 3, 6, 12, 24, 36, 48 |
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Not provided
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tofacitinib 10 mg | Participants received Tofacitinib 10 milligram (mg) tablets orally twice daily from Day 1 until any safety finding requiring study discontinuation (up to a maximum of 66 months). | 304 | 2,281 | 1,415 | 2,281 | ||
| EG001 | Tofacitinib 5 mg or 10 mg | Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator's discretion. | 88 | 586 | 394 | 586 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Abscess limb | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
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| Anal abscess | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
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| Coagulopathy | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Aortic valve disease | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Cardiac valve disease | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Cardiomyopathy | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Congestive cardiomyopathy | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Coronary artery occlusion | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Coronary artery stenosis | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Hypertensive cardiomyopathy | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Myocardial ischaemia | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Tachyarrhythmia | Cardiac disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Hydrocele | Congenital, familial and genetic disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Hypoacusis | Ear and labyrinth disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Thyroid cyst | Endocrine disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Toxic nodular goitre | Endocrine disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Periorbital fat herniation | Eye disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Mesenteric vein thrombosis | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Noninfective sialoadenitis | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Portal hypertensive gastropathy | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Salivary gland disorder | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Bacteriuria | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Bartonellosis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Bronchitis bacterial | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Cellulitis staphylococcal | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Chronic tonsillitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Colonic abscess | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Epididymitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Gallbladder empyema | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Gastric ulcer helicobacter | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Herpes simplex meningitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Listeria encephalitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pancreatitis bacterial | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pertussis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pilonidal cyst | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Purulence | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Retroperitoneal abscess | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Staphylococcal abscess | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Syphilis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection bacterial | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Wound abscess | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Fractured sacrum | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Wound haematoma | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Diabetic metabolic decompensation | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Obesity | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Ligament disorder | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Psoriatic arthropathy | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Sacroiliitis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Spinal disorder | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Spinal instability | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Acoustic neuroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Gallbladder cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Hairy cell leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Hepatic cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Keratoacanthoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Liposarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Lung adenocarcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Lung adenocarcinoma stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Malignant neoplasm papilla of Vater | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Metastases to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Metastases to pleura | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Nasal cavity cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Oligodendroglioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Prostate cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Sarcomatosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Small intestine adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Testicular malignant teratoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Throat cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Hypertonia | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Polyneuropathy | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Thrombotic stroke | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 19.0 | Non-systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA 19.0 | Non-systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Calculus urinary | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Obstructive uropathy | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Renal tubular acidosis | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Bartholin's cyst | Reproductive system and breast disorders | MedDRA 19.0 | Non-systematic Assessment | This is gender specific event. The number of participants evaluable for this event are 640 and 203. |
|
| Breast pain | Reproductive system and breast disorders | MedDRA 19.0 | Non-systematic Assessment | This is gender specific event. The number of participants evaluable for this event are 640 and 203. |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 19.0 | Non-systematic Assessment | This is gender specific event. The number of participants evaluable for this event are 640 and 203. |
|
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 19.0 | Non-systematic Assessment | This is gender specific event. The number of participants evaluable for this event are 640 and 203. |
|
| Pelvic haematoma | Reproductive system and breast disorders | MedDRA 19.0 | Non-systematic Assessment | This is gender specific event. The number of participants evaluable for this event are 640 and 203. |
|
| Prostatism | Reproductive system and breast disorders | MedDRA 19.0 | Non-systematic Assessment | This is gender specific event. The number of participants evaluable for this event are 1641 and 383. |
|
| Uterine polyp | Reproductive system and breast disorders | MedDRA 19.0 | Non-systematic Assessment | This is gender specific event. The number of participants evaluable for this event are 640 and 203. |
|
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pulmonary infarction | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pulmonary thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Vocal cord polyp | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Erythrodermic psoriasis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Severe rebound psoriasis | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Aortic aneurysm rupture | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Aortic dissection | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Arterial stenosis | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Arteriosclerosis | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Peripheral artery occlusion | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Peripheral embolism | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Subgaleal haematoma | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Varicose vein | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Vein disorder | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 19.0 | Non-systematic Assessment |
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| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C479163 | tofacitinib |
Not provided
Not provided
Not provided
| Male |
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| Units | Counts |
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| Participants |
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| OG001 | Tofacitinib 5 mg or 10 mg | Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator's discretion. |
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| Units | Counts |
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| Participants |
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| OG001 |
| Tofacitinib 5 mg or 10 mg |
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator's discretion. |
|
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| OG001 | Tofacitinib 5 mg or 10 mg | Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator's discretion. |
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|
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator's discretion. |
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|
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator's discretion. |
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| OG001 | Tofacitinib 5 mg or 10 mg | Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator's discretion. |
|
|
| OG001 | Tofacitinib 5 mg or 10 mg | Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator's discretion. |
|
|
| OG001 | Tofacitinib 5 mg or 10 mg | Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator's discretion. |
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Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator's discretion.
|
|
Participants received Tofacitinib 10 mg tablets orally twice daily for a period of 3 months. After 3 months of treatment, participants received twice daily dosing of tofacitinib 5 mg or 10 mg tablets until any safety and efficacy finding requiring study discontinuation (up to a maximum of 66 months). Dose adjustment (5 mg or 10 mg) was assessed on every 3 month visit and was based on investigator's discretion.
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