A Phase 3, Multi-Site, Open-Label Study Of The Long Term Safety And Tolerability Of 2 Oral Doses Of CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis

Change From Baseline in Hemoglobin Level at Month 3

时间窗: Baseline, Month 3

Change From Baseline in Hemoglobin Level at Month 1

时间窗: Baseline, Month 1

Change From Baseline in Lymphocyte and Neutrophil Count at Month 12

时间窗: 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 3

时间窗: Baseline, Month 3

Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 12

时间窗: Baseline, Month 12

Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 3

时间窗: Baseline, Month 3

Number of Adverse Events (AEs) by Severity

时间窗: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

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.

Change From Baseline in Lymphocyte and Neutrophil Count at Month 1

时间窗: Baseline, Month 1

Change From Baseline in Hemoglobin Level at Month 6

时间窗: Baseline, Month 6

Change From Baseline in Hemoglobin Level at Month 36

时间窗: Baseline, Month 36

Change From Baseline in Heart Rate at Month 24

时间窗: Baseline, Month 24

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

时间窗: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

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.

Change From Baseline in Lymphocyte and Neutrophil Count at Month 6

时间窗: Baseline, Month 6

Change From Baseline in Lymphocyte and Neutrophil Count at Month 36

时间窗: Baseline, Month 36

Change From Baseline in Lymphocyte and Neutrophil Count at Month 48

时间窗: Baseline, Month 48

Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 48

时间窗: Baseline, Month 48

Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 6

时间窗: Baseline, Month 6

Number of Participants With Laboratory Abnormalities

时间窗: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

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).

Change From Baseline in Hemoglobin Level at Month 12

时间窗: Baseline, Month 12

Change From Baseline in Hemoglobin Level at Month 24

时间窗: Baseline, Month 24

Change From Baseline in Hemoglobin Level at Month 48

时间窗: 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

时间窗: Baseline, Month 1

Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 3

时间窗: Baseline, Month 3

Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 6

时间窗: Baseline, Month 6

Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 36

时间窗: Baseline, Month 36

Number of Participants With Clinically Significant Change From Baseline in Physical Examination

时间窗: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

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.

Change From Baseline in Lymphocyte and Neutrophil Count at Month 3

时间窗: Baseline, Month 3

Change From Baseline in Lymphocyte and Neutrophil Count at Month 24

时间窗: 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 24

时间窗: 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

时间窗: Baseline, Month 36

Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 1

时间窗: Baseline, Month 1

Change From Baseline in Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) Levels at Month 24

时间窗: Baseline, Month 24

Change From Baseline in Heart Rate at Month 6

时间窗: Baseline, Month 6

Change From Baseline in Heart Rate at Month 48

时间窗: 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 6

时间窗: 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

时间窗: 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 48

时间窗: Baseline, Month 48

Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 1

时间窗: Baseline, Month 1

Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 24

时间窗: Baseline, Month 24

Change From Baseline in Heart Rate at Month 1

时间窗: Baseline, Month 1

Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 12

时间窗: Baseline, Month 12

Number of Participants With Adjudicated Cardiovascular Events

时间窗: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

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.

Number of Participants With Vital Sign Abnormalities

时间窗: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

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.

Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 36

时间窗: Baseline, Month 36

Change From Baseline in Heart Rate at Month 36

时间窗: Baseline, Month 36

Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 24

时间窗: Baseline, Month 24

Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 36

时间窗: Baseline, Month 36

Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 12

时间窗: Baseline, Month 12

Change From Baseline in Heart Rate at Month 12

时间窗: Baseline, Month 12

Number of Participants With Electrocardiogram (ECG) Abnormalities

时间窗: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

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.

Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 48

时间窗: Baseline, Month 48

Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Month 48

时间窗: Baseline, Month 48

Change From Baseline in Heart Rate at Month 3

时间窗: Baseline, Month 3

Change From Baseline in QRS Complex, PR, QT, QTcB, QTcF and RR Interval at Month 6

时间窗: Baseline, Month 6

Number of Participants With Malignancy Events

时间窗: Baseline up to 4 weeks after last dose of study drug (up to a maximum of 67 months)

Malignancy events included lymphoma, and demyelinating neurologic events. Biopsies collected for malignancy events were submitted to the central laboratory for pathologist over-read.