Kidney Transplantation
Conditions
Keywords
immunosuppression, JAK3 inhibitor, kidney transplant, tofacitinib, Xeljanz, CP-690, 550, tacromilus, mycophenolate mofetil
Brief summary
A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In study A3921009, kidney transplant patients were given a JAK inhibitor or tacrolimus for 6 months posttransplant. Patients who completed study A3921009 were offered the opportunity to participate in study A3921021 which will extend the evaluation of safety and efficacy of CP-690,550 versus tacrolimus through 8 years posttransplant. In treatment group 1 (control arm), subjects will continue to receive tacrolimus. In treatment groups 2 and 3, subjects will continue to receive CP-690,550. Per Amendment 4, the tacrolimus comparator arm will be discontinued.
Interventions
DRUGTacrolimus
Standard of care
DRUGCP-690,550
CP-690,550 5 mg BID
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Enrollment in Stage 1 of Study A3921009 and have completed 6-months of treatment with trial medications (CP-690,550 or tacrolimus) * Recipient of a first-time kidney transplant
Exclusion criteria
* Subject with any untreated condition that may affect drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy). * Subjects who are on the waiting list for a second kidney transplant or any non-renal organ transplants.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR by MDRD equation = 170 \* (serum creatinine \[in milligrams per deciliter (mg/dL)\])\^(-0.999) \* (age in years)\^(-0.176) \* (0.762 if female) \* (1.18 if black) \* (blood urea nitrogen \[BUN\] concentration \[mg/dL\])\^(-0.170) \* (serum albumin concentration \[in grams per dL (g/dL)\])\^(0.318). A normal GFR is \>90 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \<15 mL/min/1.73 m\^2 indicated kidney failure. |
| Serum Creatinine Levels | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | — |
| Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | Kaplan-Meier analysis of percentage of participants with clinically significant infections by time to first clinically significant infection within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. |
| Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | Kaplan-Meier analysis of time to NODM-1 within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. NODM-1 was defined as an event experienced by participants who were non-diabetic prior to transplantation and required treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin for greater than or equal to (≥)30 days. |
| Percentage of Participants With Hypercholesterolemia | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96, and Follow-Up (Month 98) | Hypercholesterolemia was defined as cholesterol levels \>240 mg/dL or 6.2 mmol/L. |
| Percentage of Participants With Hypertriglyceridemia by Visit | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | Hypertriglyceridemia was defined as triglyceride levels of \>200 mg/dL or 2.3 mmol/L. |
| Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | Kaplan-Meier analysis of percentage of participants with first BPAR by time to first BPAR within 96 months post-transplant. BPAR was defined as acute/active cellular rejection (Category 4 of the Banff Classification), based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. |
| Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | Kaplan-Meier analysis of percentage of participants with treatment failure by time to treatment failure within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Treatment failure was defined as the first occurrence of BPAR, death, graft loss or premature discontinuation of trial medication for any reason. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | — |
| Ratio of Serum LDL Level to HDL Level by Visit | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | — |
| Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | — |
| Serum Triglyceride Levels by Visit | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | — |
| Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | — |
| Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | — |
| Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | — |
| Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | Calculated as number of copies per 500 mg DNA. |
| Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 and Follow-Up (Month 98) | EBV DNA PCR categories included 0, 1-50, 51-100, 101-1000, and \>1000 copies/PCR. |
| BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | Calculated as number of copies per PCR. Per protocol, BKV DNA PCR was performed on tofacitinib-treated participants only. |
| Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | Cutoff categories for BKV DNA were 0-199 and ≥200 copies/PCR. Per protocol, BKV DNA PCR was performed on tofacitinib-treated participants only. |
| Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | Kaplan-Meier analysis of percentage of participants with CMV disease within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. CMV disease was an adverse event associated with the preferred term 'CMV infection'. |
| Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | Kaplan-Meier analysis of percentage of participants with first BPCAN by time to first BPCAN within 96 months post-transplant. BPCAN was defined as chronic allograft nephropathy (Category 5 of the Banff Classification), based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Includes BPCAN diagnosed on biopsies done for cause and ready by the central pathologist. |
| Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Months 12, 18, 24, 36, 48, 60, 72, 84, 96, and Follow-Up (Month 98) | Antibody-mediated rejection is defined as Category 2 and BPAR is defined as Category 4 of the Banff Classification, based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Acute humoral rejection was categorized as Grades I, II, III and acute/active cellular rejection was categorized as Grades IA, IB, IIA, IIB, and III. Only participants with first BPAR were included. |
| Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Months 12, 18, 24, 36, 48, 60, 72, 84, and 96 | Ordered categorical severity of first BPCAN was classified according to the Banff Classification. Grade I: mild, grade II: moderate and grade III: severe interstitial fibrosis and tubular atrophy/loss. (Racusen et al: The Banff classification, 1999). |
| Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | Kaplan-Meier analysis of percentage of participants with efficacy failure by time to first efficacy failure within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Efficacy failure was defined as first occurrence of BPAR, death, or graft loss. |
| Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | Months 12 and 24 | — |
| Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | Kaplan-Meier analysis of percentage of participants with graft survival by time to graft loss within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Graft loss was defined as graft nephrectomy, retransplantation, return to dialysis for ≥6 consecutive weeks, or death. |
| Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | Kaplan-Meier analysis of percentage of participants surviving by time to event (death) within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. |
| Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | Kaplan-Meier analysis of percentage of participants with rejection by time to rejection within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Rejection was defined as first occurrence of BPAR, antibody-mediated rejection or suspicious for acute rejection. This included biopsies read by the central pathologist. |
| Hemoglobin A1c (HbA1c) Levels by Visit | Months 12, 24, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 and Follow-up (Month 98) | — |
| Homeostatic Model Assessment (HOMA)-%B by Visit | Months 12 and 24 | HOMA-%B = (20 times \[\*\] fasting serum insulin) divided by (/) (fasting serum glucose minus \[-\] 3.5). HOMA-%B was only performed in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin prior to the time of measurements. |
| Ratio of Fasting Serum Proinsulin (Pmol/L) to Insulin (Pmol/L) by Visit | Months 12 and 24 | Measured only in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin prior to the time of measurement. |
| Area Under the Curve (AUC) of Serum Glucose (mg*h/dL) Measured During Oral Glucose Tolerance Test (OGTT) by Visit | Months 12 and 24 | Only performed in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin. |
| Calculated GFR Using the Nankivell Equation (mL/Min) | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was estimated by creatinine clearance (CLcr; in mL/min\]) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine \[in millimoles per liter (mmol/L)\]) plus (0.25\*body weight \[in kilograms (kg)\]) minus (0.5\*serum urea \[mmol/dL, where 1 mg/dL BUN=0.36 mmol/L urea\]) minus (100 per height \[in meters\] square) plus (35 for male/25 for female). A normal GFR is \>90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \<15 mL/min indicated kidney failure. |
| HOMA Insulin Resistance (IR) by Visit | Months 12 and 24 | HOMA-IR=fasting serum insulin\*fasting serum glucose/22.5. Measurement only performed in participants who were non-diabetic prior to kidney transplantation and who do not require treatment with oral hypoglycemic agents, anti diabetic agents, and/or insulin prior to the time of measurement. |
| Fasting Serum Glucose Levels (mg/dL) by Visit | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | — |
| Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Months 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-up (Month 98) | — |
| Trough Levels of Tacrolimus (ng/mL) by Visit | Months 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, and 72 and Follow-up (Month 98) | — |
| Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale | Months 12, 18, and 24 | The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). |
| Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale | Baseline, Months 12, 18, and 24 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Negative change from baseline represented improvement. |
| SF-36 v2 Subscale Scores by Visit | Months 12, 18, and 24 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). |
| Change From Baseline in SF-36 v2 Subscale Scores by Visit | Baseline, Months 12, 18, and 24 | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Negative change from baseline represented improvement. |
| End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Months 12, 18, and 24 | ESRD-SCL: 43-item, disease-specific, self-administered questionnaire. Participants' rated question At the moment, how much do you suffer? for each item on 5-point scale, ranged from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: cardiac and renal dysfunction (Range, 0-28), increased growth of gum and hair (Range, 0-20), limited cognitive capacity (Range, 0-32), limited physical capacity (Range, 0-40), side effects (SEs) of corticosteroids (Range, 0-20), transplantation associated psychological distress (TAPD; Range, 0-32); higher scores=greater dysfunction for each subscale. Total score: 0-172, higher scores=greater dysfunction. |
| Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Baseline, Months 12, 18, and 24 | ESRD-SCL: 43-item, disease-specific, self-administered questionnaire. Participants' rated question At the moment, how much do you suffer? for each item on 5-point scale, ranged from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: cardiac and renal dysfunction (Range, 0-28), increased growth of gum and hair (Range, 0-20), limited cognitive capacity (Range, 0-32), limited physical capacity (Range, 0-40), SEs of corticosteroids (Range, 0-20),TAPD (Range, 0-32); higher scores=greater dysfunction for each subscale. Total score: 0-172, higher scores=greater dysfunction. |
| Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Months 12, 18, and 24 | HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any number of events including visits to doctor or other healthcare professionals (HCP), non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported. |
| AUC of Serum Insulin (microU*h/mL) Measured During OGTT by Visit | Months 12 and 24 | The OGTT was performed only in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin. |
| Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight (kg)\*(140 minus age in years) divided by (72\*serum creatinine \[mg/dL\]). For females value obtained was multiplied by 0.85. A normal GFR is \>90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \<15 mL/min indicated kidney failure. |
| Reciprocal of Serum Creatinine | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | — |
| Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 | Kaplan-Meier analysis of percentage of participants with NODM-2 by time to NODM-2 within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. NODM-2 was defined as an event experienced by a transplanted subject who meets any of the following criteria: (a) NODM-1; or (b) Symptoms of diabetes plus 2 casual serum glucose levels ≥200 mg/dL separated by at least approximately 24 hours. Casual was defined as any time of day without regard to time since last meal; or (c) Fasting serum glucose ≥126 mg/dL on 2 different occasions separated by at least approximately 24 hours. Fasting was defined as no caloric intake for at least 8 hours; or (d) 2-hour serum glucose ≥200 mg/dL during an OGTT (Oral Glucose Tolerance Test). |
| Total Cholesterol Levels by Visit | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | — |
| Low-Density Lipoprotein (LDL) Levels by Visit | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | — |
| High-Density Lipoprotein (HDL) Levels by Visit | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | — |
| Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98) | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tofacitinib Participants received tacrolimus BID, administered according to standard institutional practice. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | 18 |
| Tofacitinib 15-10-5 mg BID Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | 14 |
| Tofacitinib 30-15-10 mg BID Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily \[or equivalent\] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion. | 13 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 4 |
| Overall Study | Death | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 | 0 |
| Overall Study | Other | 3 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 0 | 1 |
Baseline characteristics
| Characteristic | Tofacitinib | Tofacitinib 15-10-5 mg BID | Tofacitinib 30-15-10 mg BID | Total |
|---|---|---|---|---|
| Age, Continuous | 39.6 Years STANDARD_DEVIATION 9.3 | 48.1 Years STANDARD_DEVIATION 7.9 | 44.5 Years STANDARD_DEVIATION 12.2 | 43.6 Years STANDARD_DEVIATION 10.3 |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 3 Participants | 17 Participants |
| Sex: Female, Male Male | 11 Participants | 7 Participants | 10 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 17 / 18 | 14 / 14 | 11 / 13 |
| serious Total, serious adverse events | 7 / 18 | 10 / 14 | 8 / 13 |
Outcome results
Primary
Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation
GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using MDRD equation. GFR by MDRD equation = 170 \* (serum creatinine \[in milligrams per deciliter (mg/dL)\])\^(-0.999) \* (age in years)\^(-0.176) \* (0.762 if female) \* (1.18 if black) \* (blood urea nitrogen \[BUN\] concentration \[mg/dL\])\^(-0.170) \* (serum albumin concentration \[in grams per dL (g/dL)\])\^(0.318). A normal GFR is \>90 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2), although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \<15 mL/min/1.73 m\^2 indicated kidney failure.
Time frame: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 66 (n=12,14,10) | 89.80 mL/min/1.73 m^2 | Standard Deviation 36.51 |
| Tacrolimus | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 30 (n=14,14,10) | 79.89 mL/min/1.73 m^2 | Standard Deviation 29.56 |
| Tacrolimus | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 9 (n=18,14,12) | 67.06 mL/min/1.73 m^2 | Standard Deviation 19.79 |
| Tacrolimus | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 36 (n=15,14,9) | 79.87 mL/min/1.73 m^2 | Standard Deviation 30.2 |
| Tacrolimus | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Follow-up (n=6,12,8) | 42.29 mL/min/1.73 m^2 | Standard Deviation 19.87 |
| Tacrolimus | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 42 (n=15,14,9) | 77.95 mL/min/1.73 m^2 | Standard Deviation 29.77 |
| Tacrolimus | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 84 (n=0,12,8) | NA mL/min/1.73 m^2 | — |
| Tacrolimus | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 60 (n=13,13,10) | 82.86 mL/min/1.73 m^2 | Standard Deviation 33.72 |
| Tacrolimus | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 12 (n=16,14,12) | 64.97 mL/min/1.73 m^2 | Standard Deviation 25.1 |
| Tacrolimus | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 54 (n=14,14,10) | 78.10 mL/min/1.73 m^2 | Standard Deviation 32.27 |
| Tacrolimus | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 96 (n=0,11,6) | NA mL/min/1.73 m^2 | — |
| Tacrolimus | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 78 (n=0,13,8) | NA mL/min/1.73 m^2 | — |
| Tacrolimus | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 15 (n=16,14,12) | 66.22 mL/min/1.73 m^2 | Standard Deviation 15.1 |
| Tacrolimus | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 48 (n=15,14,10) | 76.23 mL/min/1.73 m^2 | Standard Deviation 30.34 |
| Tacrolimus | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 18 (n=18,14,12) | 72.81 mL/min/1.73 m^2 | Standard Deviation 23.09 |
| Tacrolimus | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 90 (n=0,12,7) | NA mL/min/1.73 m^2 | — |
| Tacrolimus | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 72 (n=9,13,8) | 76.61 mL/min/1.73 m^2 | Standard Deviation 20.99 |
| Tacrolimus | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 24 (n=17,14,12) | 77.05 mL/min/1.73 m^2 | Standard Deviation 28.23 |
| Tofacitinib 15-10-5 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 78 (n=0,13,8) | 69.95 mL/min/1.73 m^2 | Standard Deviation 14.4 |
| Tofacitinib 15-10-5 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 24 (n=17,14,12) | 68.45 mL/min/1.73 m^2 | Standard Deviation 10.47 |
| Tofacitinib 15-10-5 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 9 (n=18,14,12) | 65.99 mL/min/1.73 m^2 | Standard Deviation 12.46 |
| Tofacitinib 15-10-5 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 12 (n=16,14,12) | 65.16 mL/min/1.73 m^2 | Standard Deviation 11.9 |
| Tofacitinib 15-10-5 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 15 (n=16,14,12) | 67.86 mL/min/1.73 m^2 | Standard Deviation 9.33 |
| Tofacitinib 15-10-5 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 18 (n=18,14,12) | 66.91 mL/min/1.73 m^2 | Standard Deviation 12.19 |
| Tofacitinib 15-10-5 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 30 (n=14,14,10) | 71.55 mL/min/1.73 m^2 | Standard Deviation 7.33 |
| Tofacitinib 15-10-5 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 36 (n=15,14,9) | 70.44 mL/min/1.73 m^2 | Standard Deviation 13.65 |
| Tofacitinib 15-10-5 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 42 (n=15,14,9) | 70.77 mL/min/1.73 m^2 | Standard Deviation 16.05 |
| Tofacitinib 15-10-5 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 48 (n=15,14,10) | 70.36 mL/min/1.73 m^2 | Standard Deviation 14.36 |
| Tofacitinib 15-10-5 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 54 (n=14,14,10) | 69.98 mL/min/1.73 m^2 | Standard Deviation 15.18 |
| Tofacitinib 15-10-5 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 60 (n=13,13,10) | 70.10 mL/min/1.73 m^2 | Standard Deviation 18.01 |
| Tofacitinib 15-10-5 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 66 (n=12,14,10) | 69.69 mL/min/1.73 m^2 | Standard Deviation 18.23 |
| Tofacitinib 15-10-5 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 72 (n=9,13,8) | 67.89 mL/min/1.73 m^2 | Standard Deviation 11.61 |
| Tofacitinib 15-10-5 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 84 (n=0,12,8) | 69.24 mL/min/1.73 m^2 | Standard Deviation 13.8 |
| Tofacitinib 15-10-5 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 90 (n=0,12,7) | 65.28 mL/min/1.73 m^2 | Standard Deviation 14.19 |
| Tofacitinib 15-10-5 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 96 (n=0,11,6) | 64.94 mL/min/1.73 m^2 | Standard Deviation 14.01 |
| Tofacitinib 15-10-5 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Follow-up (n=6,12,8) | 63.25 mL/min/1.73 m^2 | Standard Deviation 14.07 |
| Tofacitinib 30-15-10 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 66 (n=12,14,10) | 64.98 mL/min/1.73 m^2 | Standard Deviation 15.95 |
| Tofacitinib 30-15-10 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 18 (n=18,14,12) | 64.71 mL/min/1.73 m^2 | Standard Deviation 12.1 |
| Tofacitinib 30-15-10 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Follow-up (n=6,12,8) | 60.41 mL/min/1.73 m^2 | Standard Deviation 24.43 |
| Tofacitinib 30-15-10 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 72 (n=9,13,8) | 61.96 mL/min/1.73 m^2 | Standard Deviation 8.15 |
| Tofacitinib 30-15-10 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 12 (n=16,14,12) | 63.50 mL/min/1.73 m^2 | Standard Deviation 12.01 |
| Tofacitinib 30-15-10 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 15 (n=16,14,12) | 65.71 mL/min/1.73 m^2 | Standard Deviation 9.44 |
| Tofacitinib 30-15-10 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 78 (n=0,13,8) | 68.64 mL/min/1.73 m^2 | Standard Deviation 6.15 |
| Tofacitinib 30-15-10 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 9 (n=18,14,12) | 67.05 mL/min/1.73 m^2 | Standard Deviation 13.63 |
| Tofacitinib 30-15-10 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 96 (n=0,11,6) | 70.33 mL/min/1.73 m^2 | Standard Deviation 14.22 |
| Tofacitinib 30-15-10 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 84 (n=0,12,8) | 68.77 mL/min/1.73 m^2 | Standard Deviation 4.9 |
| Tofacitinib 30-15-10 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 48 (n=15,14,10) | 65.50 mL/min/1.73 m^2 | Standard Deviation 10.19 |
| Tofacitinib 30-15-10 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 90 (n=0,12,7) | 69.46 mL/min/1.73 m^2 | Standard Deviation 6.23 |
| Tofacitinib 30-15-10 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 54 (n=14,14,10) | 61.99 mL/min/1.73 m^2 | Standard Deviation 9.54 |
| Tofacitinib 30-15-10 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 42 (n=15,14,9) | 65.25 mL/min/1.73 m^2 | Standard Deviation 8.71 |
| Tofacitinib 30-15-10 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 30 (n=14,14,10) | 64.04 mL/min/1.73 m^2 | Standard Deviation 10.24 |
| Tofacitinib 30-15-10 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 60 (n=13,13,10) | 67.30 mL/min/1.73 m^2 | Standard Deviation 9.37 |
| Tofacitinib 30-15-10 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 24 (n=17,14,12) | 66.29 mL/min/1.73 m^2 | Standard Deviation 8.72 |
| Tofacitinib 30-15-10 mg BID | Calculated Glomerular Filtration Rate (GFR) Using the Modification of Diet in Renal Disease (MDRD) Equation | Month 36 (n=15,14,9) | 61.72 mL/min/1.73 m^2 | Standard Deviation 15.84 |
Primary
Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit
Kaplan-Meier analysis of percentage of participants with clinically significant infections by time to first clinically significant infection within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier.
Time frame: Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Population: Safety population; n=number of participants remaining at risk for the specified parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 3 (n=16,13,7) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 96 (n=0,8,2) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 48 (n=7,8,2) | 45.68 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 6 (n=14,12,4) | 22.22 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 90 (n=0,8,2) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 42 (n=8,8,2) | 45.68 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 9 (n=13,11,4) | 27.78 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 84 (n=0,8,2) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 30 (n=9,8,3) | 38.89 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 12 (n=12,9,4) | 33.33 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 66 (n=7,8,2) | 45.68 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 24 (n=10,8,3) | 38.89 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 72 (n=4,8,2) | 45.68 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 60 (n=7,8,2) | 45.68 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Day 1 (n=18,14,13) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 36 (n=8,8,3) | 45.68 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 15 (n=11,8,3) | 38.89 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 1 (n=16,14,12) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 18 (n=10,8,3) | 38.89 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 54 (n=7,8,2) | 45.68 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 54 (n=7,8,2) | 42.86 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 15 (n=11,8,3) | 42.86 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 18 (n=10,8,3) | 42.86 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 42 (n=8,8,2) | 42.86 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 48 (n=7,8,2) | 42.86 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 60 (n=7,8,2) | 42.86 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Day 1 (n=18,14,13) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 1 (n=16,14,12) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 3 (n=16,13,7) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 6 (n=14,12,4) | 14.29 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 9 (n=13,11,4) | 21.43 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 12 (n=12,9,4) | 35.71 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 24 (n=10,8,3) | 42.86 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 30 (n=9,8,3) | 42.86 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 36 (n=8,8,3) | 42.86 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 66 (n=7,8,2) | 42.86 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 72 (n=4,8,2) | 42.86 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 84 (n=0,8,2) | 42.86 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 90 (n=0,8,2) | 42.86 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 96 (n=0,8,2) | 42.86 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 6 (n=14,12,4) | 69.23 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 42 (n=8,8,2) | 76.92 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 3 (n=16,13,7) | 46.15 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 48 (n=7,8,2) | 76.92 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 1 (n=16,14,12) | 7.69 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Day 1 (n=18,14,13) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 54 (n=7,8,2) | 76.92 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 96 (n=0,8,2) | 76.92 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 18 (n=10,8,3) | 76.92 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 66 (n=7,8,2) | 76.92 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 84 (n=0,8,2) | 76.92 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 15 (n=11,8,3) | 76.92 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 12 (n=12,9,4) | 69.23 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 72 (n=4,8,2) | 76.92 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 24 (n=10,8,3) | 76.92 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 9 (n=13,11,4) | 69.23 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 60 (n=7,8,2) | 76.92 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 30 (n=9,8,3) | 76.92 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 90 (n=0,8,2) | 76.92 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infections by Visit | Month 36 (n=8,8,3) | 76.92 percentage of participants |
Primary
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit
Kaplan-Meier analysis of percentage of participants with first BPAR by time to first BPAR within 96 months post-transplant. BPAR was defined as acute/active cellular rejection (Category 4 of the Banff Classification), based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier.
Time frame: Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Population: Safety population; n=number of participants remaining at risk for the specified parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 15 (n=16,14,11) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 42 (n=14,14,9) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 1 (n=17,14,13) | 5.56 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 48 (n=13,14,9) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 3 (n=17,14,11) | 5.56 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 54 (n=13,14,9) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 60 (n=12,14,9) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 66 (n=12,14,8) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 6 (n=17,14,11) | 5.56 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 72 (n=5,14,7) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 78 (n=0,14,6) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Day 1 (n=18,14,13) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 9 (n=16,14,11) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 84 (n=0,13,6) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 12 (n=16,14,11) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 18 (n=16,14,11) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 90 (n=0,13,6) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 24 (n=16,14,11) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 30 (n=14,14,10) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 36 (n=14,14,10) | 11.11 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 30 (n=14,14,10) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 1 (n=17,14,13) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 42 (n=14,14,9) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 9 (n=16,14,11) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 24 (n=16,14,11) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 48 (n=13,14,9) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 90 (n=0,13,6) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 12 (n=16,14,11) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 54 (n=13,14,9) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 3 (n=17,14,11) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 84 (n=0,13,6) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 60 (n=12,14,9) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 78 (n=0,14,6) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 15 (n=16,14,11) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 66 (n=12,14,8) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Day 1 (n=18,14,13) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 36 (n=14,14,10) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 72 (n=5,14,7) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 6 (n=17,14,11) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 18 (n=16,14,11) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 30 (n=14,14,10) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Day 1 (n=18,14,13) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 78 (n=0,14,6) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 84 (n=0,13,6) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 90 (n=0,13,6) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 1 (n=17,14,13) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 3 (n=17,14,11) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 6 (n=17,14,11) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 9 (n=16,14,11) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 12 (n=16,14,11) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 15 (n=16,14,11) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 18 (n=16,14,11) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 24 (n=16,14,11) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 36 (n=14,14,10) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 42 (n=14,14,9) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 48 (n=13,14,9) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 54 (n=13,14,9) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 60 (n=12,14,9) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 66 (n=12,14,8) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit | Month 72 (n=5,14,7) | 15.38 percentage of participants |
Primary
Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit
Kaplan-Meier analysis of time to NODM-1 within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. NODM-1 was defined as an event experienced by participants who were non-diabetic prior to transplantation and required treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin for greater than or equal to (≥)30 days.
Time frame: Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Population: Safety population; participants who had a history of diabetes at transplant were not included in the Kaplan-Meier analysis. n=number of participants remaining at risk for the specified parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 78 (n=0,8,6) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 12 (n=17,8,9) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 54 (n=12,8,8) | 6.25 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 90 (n=0,8,6) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 6 (n=17,8,9) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 36 (n=13,8,8) | 6.25 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 9 (n=17,8,9) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 84 (n=0,8,6) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 72 (n=6,8,7) | 6.25 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 18 (n=16,8,9) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 15 (n=17,8,9) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 60 (n=11,8,8) | 6.25 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 66 (n=11,8,7) | 6.25 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 1 (n=17,8,9) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 24 (n=15,8,9) | 6.25 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 30 (n=13,8,8) | 6.25 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 96 (n=0,8,6) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 42 (n=13,8,8) | 6.25 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 3 (n=17,8,9) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 48 (n=12,8,8) | 6.25 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 1 (n=17,8,9) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 48 (n=12,8,8) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 60 (n=11,8,8) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 24 (n=15,8,9) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 66 (n=11,8,7) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 72 (n=6,8,7) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 78 (n=0,8,6) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 84 (n=0,8,6) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 96 (n=0,8,6) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 90 (n=0,8,6) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 54 (n=12,8,8) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 3 (n=17,8,9) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 12 (n=17,8,9) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 9 (n=17,8,9) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 36 (n=13,8,8) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 15 (n=17,8,9) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 6 (n=17,8,9) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 18 (n=16,8,9) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 30 (n=13,8,8) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 42 (n=13,8,8) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 96 (n=0,8,6) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 18 (n=16,8,9) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 24 (n=15,8,9) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 30 (n=13,8,8) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 36 (n=13,8,8) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 42 (n=13,8,8) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 48 (n=12,8,8) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 1 (n=17,8,9) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 3 (n=17,8,9) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 6 (n=17,8,9) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 9 (n=17,8,9) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 12 (n=17,8,9) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 15 (n=17,8,9) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 54 (n=12,8,8) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 60 (n=11,8,8) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 66 (n=11,8,7) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 72 (n=6,8,7) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 78 (n=0,8,6) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 84 (n=0,8,6) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With New Onset Diabetes Mellitus, Definition 1 (NODM-1) by Visit | Month 90 (n=0,8,6) | 0.00 percentage of participants |
Primary
Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit
Kaplan-Meier analysis of percentage of participants with treatment failure by time to treatment failure within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Treatment failure was defined as the first occurrence of BPAR, death, graft loss or premature discontinuation of trial medication for any reason.
Time frame: Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Population: Full Analysis Set (FAS): all participants who received at least 1 dose of study medication. n=number of participants remaining at risk for the specified parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 9 (n=16,14,11) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 96 (n=0,12,6) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 36 (n=14,14,8) | 22.22 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 12 (n=16,14,10) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Day 1 (n=18,14,13) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 30 (n=14,14,9) | 22.22 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 15 (n=16,14,10) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 24 (n=15,14,10) | 16.67 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 18 (n=16,14,10) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 60 (n=12,14,8) | 33.33 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 90 (n=0,12,6) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 1 (n=17,14,13) | 5.56 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 66 (n=11,14,8) | 38.89 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 72 (n=5,13,6) | 50.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 3 (n=17,14,11) | 5.56 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 48 (n=13,14,8) | 27.78 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 54 (n=13,14,8) | 27.78 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 84 (n=0,13,6) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 6 (n=17,14,11) | 5.56 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 78 (n=0,13,6) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 42 (n=14,14,8) | 22.22 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 24 (n=15,14,10) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 66 (n=11,14,8) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Day 1 (n=18,14,13) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 1 (n=17,14,13) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 3 (n=17,14,11) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 15 (n=16,14,10) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 6 (n=17,14,11) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 9 (n=16,14,11) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 12 (n=16,14,10) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 18 (n=16,14,10) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 30 (n=14,14,9) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 36 (n=14,14,8) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 42 (n=14,14,8) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 48 (n=13,14,8) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 72 (n=5,13,6) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 78 (n=0,13,6) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 84 (n=0,13,6) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 90 (n=0,12,6) | 14.29 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 96 (n=0,12,6) | 14.29 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 54 (n=13,14,8) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 60 (n=12,14,8) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 42 (n=14,14,8) | 38.46 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 90 (n=0,12,6) | 53.85 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 48 (n=13,14,8) | 38.46 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 3 (n=17,14,11) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 1 (n=17,14,13) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 96 (n=0,12,6) | 53.85 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 72 (n=5,13,6) | 53.85 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 54 (n=13,14,8) | 38.46 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 78 (n=0,13,6) | 53.85 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 66 (n=11,14,8) | 38.46 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 18 (n=16,14,10) | 23.08 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 15 (n=16,14,10) | 23.08 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 24 (n=15,14,10) | 23.08 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 12 (n=16,14,10) | 23.08 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 84 (n=0,13,6) | 53.85 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 30 (n=14,14,9) | 30.77 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 9 (n=16,14,11) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Day 1 (n=18,14,13) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 36 (n=14,14,8) | 38.46 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 6 (n=17,14,11) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Treatment Failure by Visit | Month 60 (n=12,14,8) | 38.46 percentage of participants |
Primary
Percentage of Participants With Hypercholesterolemia
Hypercholesterolemia was defined as cholesterol levels \>240 mg/dL or 6.2 mmol/L.
Time frame: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96, and Follow-Up (Month 98)
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus | Percentage of Participants With Hypercholesterolemia | Month 66 (n=12,14,10) | 16.7 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypercholesterolemia | Month 18 (n=18,14,12) | 5.6 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypercholesterolemia | Month 78 (n=0,13,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With Hypercholesterolemia | Month 84 (n=0,13,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With Hypercholesterolemia | Month 90 (n=0,12,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With Hypercholesterolemia | Month 24 (n=17,14,12) | 11.8 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypercholesterolemia | Month 96 (n=0,11,6) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With Hypercholesterolemia | Follow-Up (n=7,14,11) | 14.3 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypercholesterolemia | Month 72 (n=9,13,8) | 11.1 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypercholesterolemia | Month 30 (n=15,14,11) | 6.7 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypercholesterolemia | Month 12 (n=18,14,12) | 5.6 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypercholesterolemia | Month 36 (n=15,14,11) | 6.7 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypercholesterolemia | Month 42 (n=15,14,10) | 6.7 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypercholesterolemia | Month 48 (n=15,14,10) | 20.0 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypercholesterolemia | Month 15 (n=18,14,12) | 5.6 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypercholesterolemia | Month 54 (n=14,14,10) | 14.3 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypercholesterolemia | Month 60 (n=13,14,10) | 7.7 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypercholesterolemia | Month 9 (n=18,14,13) | 11.1 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypercholesterolemia | Month 72 (n=9,13,8) | 15.4 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypercholesterolemia | Month 66 (n=12,14,10) | 14.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypercholesterolemia | Month 60 (n=13,14,10) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypercholesterolemia | Month 30 (n=15,14,11) | 7.1 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypercholesterolemia | Month 78 (n=0,13,8) | 7.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypercholesterolemia | Month 18 (n=18,14,12) | 7.1 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypercholesterolemia | Month 15 (n=18,14,12) | 35.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypercholesterolemia | Month 84 (n=0,13,8) | 7.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypercholesterolemia | Month 9 (n=18,14,13) | 35.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypercholesterolemia | Month 48 (n=15,14,10) | 7.1 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypercholesterolemia | Month 90 (n=0,12,8) | 8.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypercholesterolemia | Month 36 (n=15,14,11) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypercholesterolemia | Month 12 (n=18,14,12) | 28.6 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypercholesterolemia | Month 96 (n=0,11,6) | 9.1 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypercholesterolemia | Month 24 (n=17,14,12) | 7.1 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypercholesterolemia | Month 54 (n=14,14,10) | 21.4 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypercholesterolemia | Follow-Up (n=7,14,11) | 7.1 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypercholesterolemia | Month 42 (n=15,14,10) | 21.4 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypercholesterolemia | Follow-Up (n=7,14,11) | 9.1 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypercholesterolemia | Month 72 (n=9,13,8) | 12.5 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypercholesterolemia | Month 9 (n=18,14,13) | 15.4 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypercholesterolemia | Month 12 (n=18,14,12) | 8.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypercholesterolemia | Month 15 (n=18,14,12) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypercholesterolemia | Month 18 (n=18,14,12) | 8.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypercholesterolemia | Month 24 (n=17,14,12) | 16.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypercholesterolemia | Month 30 (n=15,14,11) | 9.1 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypercholesterolemia | Month 36 (n=15,14,11) | 9.1 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypercholesterolemia | Month 42 (n=15,14,10) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypercholesterolemia | Month 48 (n=15,14,10) | 10.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypercholesterolemia | Month 54 (n=14,14,10) | 10.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypercholesterolemia | Month 60 (n=13,14,10) | 20.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypercholesterolemia | Month 66 (n=12,14,10) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypercholesterolemia | Month 78 (n=0,13,8) | 12.5 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypercholesterolemia | Month 84 (n=0,13,8) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypercholesterolemia | Month 90 (n=0,12,8) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypercholesterolemia | Month 96 (n=0,11,6) | 0 percentage of participants |
Primary
Percentage of Participants With Hypertriglyceridemia by Visit
Hypertriglyceridemia was defined as triglyceride levels of \>200 mg/dL or 2.3 mmol/L.
Time frame: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus | Percentage of Participants With Hypertriglyceridemia by Visit | Month 96 (n=0,11,6) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With Hypertriglyceridemia by Visit | Month 72 (n=9,13,8) | 11.1 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypertriglyceridemia by Visit | Month 36 (n=15,14,11) | 20.0 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypertriglyceridemia by Visit | Month 15 (n=18,14,12) | 5.6 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypertriglyceridemia by Visit | Month 66 (n=12,14,10) | 16.7 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypertriglyceridemia by Visit | Month 42 (n=15,14,10) | 20.0 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypertriglyceridemia by Visit | Month 12 (n=18,14,12) | 5.6 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypertriglyceridemia by Visit | Month 60 (n=13,14,10) | 15.4 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypertriglyceridemia by Visit | Month 48 (n=15,14,10) | 20.0 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypertriglyceridemia by Visit | Month 90 (n=0,12,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With Hypertriglyceridemia by Visit | Month 54 (n=14,14,10) | 7.1 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypertriglyceridemia by Visit | Month 18 (n=18,14,12) | 5.6 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypertriglyceridemia by Visit | Month 9 (n=18,14,13) | 11.1 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypertriglyceridemia by Visit | Month 84 (n=0,13,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With Hypertriglyceridemia by Visit | Month 24 (n=17,14,12) | 17.6 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypertriglyceridemia by Visit | Follow-Up (n=7,14,11) | 14.3 percentage of participants |
| Tacrolimus | Percentage of Participants With Hypertriglyceridemia by Visit | Month 78 (n=0,13,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With Hypertriglyceridemia by Visit | Month 30 (n=15,14,11) | 13.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 60 (n=13,14,10) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 12 (n=18,14,12) | 42.9 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Follow-Up (n=7,14,11) | 14.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 9 (n=18,14,13) | 50.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 15 (n=18,14,12) | 42.9 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 18 (n=18,14,12) | 35.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 24 (n=17,14,12) | 21.4 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 30 (n=15,14,11) | 28.6 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 36 (n=15,14,11) | 14.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 42 (n=15,14,10) | 35.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 48 (n=15,14,10) | 35.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 54 (n=14,14,10) | 35.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 66 (n=12,14,10) | 14.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 72 (n=9,13,8) | 23.1 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 78 (n=0,13,8) | 7.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 84 (n=0,13,8) | 7.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 90 (n=0,12,8) | 8.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 96 (n=0,11,6) | 18.2 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 96 (n=0,11,6) | 33.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 66 (n=12,14,10) | 20.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 30 (n=15,14,11) | 36.4 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 90 (n=0,12,8) | 50.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 72 (n=9,13,8) | 50.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 24 (n=17,14,12) | 33.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 12 (n=18,14,12) | 33.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 78 (n=0,13,8) | 25.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 18 (n=18,14,12) | 33.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Follow-Up (n=7,14,11) | 27.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 84 (n=0,13,8) | 37.5 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 48 (n=15,14,10) | 30.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 15 (n=18,14,12) | 41.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 54 (n=14,14,10) | 40.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 42 (n=15,14,10) | 20.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 9 (n=18,14,13) | 38.5 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 60 (n=13,14,10) | 30.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Hypertriglyceridemia by Visit | Month 36 (n=15,14,11) | 27.3 percentage of participants |
Primary
Serum Creatinine Levels
Time frame: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | Serum Creatinine Levels | Month 9 (n=18,14,12) | 1.26 mg/dL | Standard Deviation 0.3 |
| Tacrolimus | Serum Creatinine Levels | Month 66 (n=12,14,10) | 1.12 mg/dL | Standard Deviation 0.5 |
| Tacrolimus | Serum Creatinine Levels | Month 72 (n=9,13,8) | 1.12 mg/dL | Standard Deviation 0.26 |
| Tacrolimus | Serum Creatinine Levels | Month 78 (n=0,13,8) | NA mg/dL | — |
| Tacrolimus | Serum Creatinine Levels | Month 15 (n=16,14,12) | 1.24 mg/dL | Standard Deviation 0.32 |
| Tacrolimus | Serum Creatinine Levels | Month 12 (n=16,14,12) | 1.34 mg/dL | Standard Deviation 0.3 |
| Tacrolimus | Serum Creatinine Levels | Month 18 (n=18,14,12) | 1.18 mg/dL | Standard Deviation 0.3 |
| Tacrolimus | Serum Creatinine Levels | Month 24 (n=17,14,12) | 1.15 mg/dL | Standard Deviation 0.29 |
| Tacrolimus | Serum Creatinine Levels | Month 30 (n=14,14,10) | 1.14 mg/dL | Standard Deviation 0.36 |
| Tacrolimus | Serum Creatinine Levels | Month 36 (n=15,14,9) | 1.18 mg/dL | Standard Deviation 0.43 |
| Tacrolimus | Serum Creatinine Levels | Month 42 (n=15,14,9) | 1.19 mg/dL | Standard Deviation 0.42 |
| Tacrolimus | Serum Creatinine Levels | Month 48 (n=15,14,10) | 1.23 mg/dL | Standard Deviation 0.47 |
| Tacrolimus | Serum Creatinine Levels | Month 54 (n=14,14,10) | 1.38 mg/dL | Standard Deviation 1.04 |
| Tacrolimus | Serum Creatinine Levels | Month 60 (n=13,13,10) | 1.17 mg/dL | Standard Deviation 0.4 |
| Tacrolimus | Serum Creatinine Levels | Month 84 (n=0,12,8) | NA mg/dL | — |
| Tacrolimus | Serum Creatinine Levels | Month 90 (n=0,12,7) | NA mg/dL | — |
| Tacrolimus | Serum Creatinine Levels | Month 96 (n=0,11,6) | NA mg/dL | — |
| Tacrolimus | Serum Creatinine Levels | Follow-Up (n=6,12,8) | 2.35 mg/dL | Standard Deviation 2.11 |
| Tofacitinib 15-10-5 mg BID | Serum Creatinine Levels | Follow-Up (n=6,12,8) | 1.16 mg/dL | Standard Deviation 0.27 |
| Tofacitinib 15-10-5 mg BID | Serum Creatinine Levels | Month 9 (n=18,14,12) | 1.19 mg/dL | Standard Deviation 0.26 |
| Tofacitinib 15-10-5 mg BID | Serum Creatinine Levels | Month 36 (n=15,14,9) | 1.08 mg/dL | Standard Deviation 0.22 |
| Tofacitinib 15-10-5 mg BID | Serum Creatinine Levels | Month 84 (n=0,12,8) | 1.10 mg/dL | Standard Deviation 0.21 |
| Tofacitinib 15-10-5 mg BID | Serum Creatinine Levels | Month 54 (n=14,14,10) | 1.10 mg/dL | Standard Deviation 0.26 |
| Tofacitinib 15-10-5 mg BID | Serum Creatinine Levels | Month 66 (n=12,14,10) | 1.14 mg/dL | Standard Deviation 0.33 |
| Tofacitinib 15-10-5 mg BID | Serum Creatinine Levels | Month 90 (n=0,12,7) | 1.16 mg/dL | Standard Deviation 0.25 |
| Tofacitinib 15-10-5 mg BID | Serum Creatinine Levels | Month 42 (n=15,14,9) | 1.09 mg/dL | Standard Deviation 0.27 |
| Tofacitinib 15-10-5 mg BID | Serum Creatinine Levels | Month 72 (n=9,13,8) | 1.09 mg/dL | Standard Deviation 0.21 |
| Tofacitinib 15-10-5 mg BID | Serum Creatinine Levels | Month 30 (n=14,14,10) | 1.06 mg/dL | Standard Deviation 0.16 |
| Tofacitinib 15-10-5 mg BID | Serum Creatinine Levels | Month 96 (n=0,11,6) | 1.15 mg/dL | Standard Deviation 0.25 |
| Tofacitinib 15-10-5 mg BID | Serum Creatinine Levels | Month 78 (n=0,13,8) | 1.09 mg/dL | Standard Deviation 0.21 |
| Tofacitinib 15-10-5 mg BID | Serum Creatinine Levels | Month 60 (n=13,13,10) | 1.12 mg/dL | Standard Deviation 0.35 |
| Tofacitinib 15-10-5 mg BID | Serum Creatinine Levels | Month 24 (n=17,14,12) | 1.11 mg/dL | Standard Deviation 0.18 |
| Tofacitinib 15-10-5 mg BID | Serum Creatinine Levels | Month 12 (n=16,14,12) | 1.21 mg/dL | Standard Deviation 0.3 |
| Tofacitinib 15-10-5 mg BID | Serum Creatinine Levels | Month 48 (n=15,14,10) | 1.08 mg/dL | Standard Deviation 0.27 |
| Tofacitinib 15-10-5 mg BID | Serum Creatinine Levels | Month 15 (n=16,14,12) | 1.13 mg/dL | Standard Deviation 0.2 |
| Tofacitinib 15-10-5 mg BID | Serum Creatinine Levels | Month 18 (n=18,14,12) | 1.15 mg/dL | Standard Deviation 0.23 |
| Tofacitinib 30-15-10 mg BID | Serum Creatinine Levels | Month 15 (n=16,14,12) | 1.28 mg/dL | Standard Deviation 0.29 |
| Tofacitinib 30-15-10 mg BID | Serum Creatinine Levels | Month 18 (n=18,14,12) | 1.29 mg/dL | Standard Deviation 0.29 |
| Tofacitinib 30-15-10 mg BID | Serum Creatinine Levels | Month 24 (n=17,14,12) | 1.23 mg/dL | Standard Deviation 0.22 |
| Tofacitinib 30-15-10 mg BID | Serum Creatinine Levels | Month 84 (n=0,12,8) | 1.15 mg/dL | Standard Deviation 0.15 |
| Tofacitinib 30-15-10 mg BID | Serum Creatinine Levels | Month 30 (n=14,14,10) | 1.24 mg/dL | Standard Deviation 0.22 |
| Tofacitinib 30-15-10 mg BID | Serum Creatinine Levels | Follow-Up (n=6,12,8) | 1.50 mg/dL | Standard Deviation 0.84 |
| Tofacitinib 30-15-10 mg BID | Serum Creatinine Levels | Month 36 (n=15,14,9) | 1.33 mg/dL | Standard Deviation 0.3 |
| Tofacitinib 30-15-10 mg BID | Serum Creatinine Levels | Month 42 (n=15,14,9) | 1.17 mg/dL | Standard Deviation 0.12 |
| Tofacitinib 30-15-10 mg BID | Serum Creatinine Levels | Month 90 (n=0,12,7) | 1.16 mg/dL | Standard Deviation 0.19 |
| Tofacitinib 30-15-10 mg BID | Serum Creatinine Levels | Month 48 (n=15,14,10) | 1.20 mg/dL | Standard Deviation 0.11 |
| Tofacitinib 30-15-10 mg BID | Serum Creatinine Levels | Month 9 (n=18,14,12) | 1.28 mg/dL | Standard Deviation 0.31 |
| Tofacitinib 30-15-10 mg BID | Serum Creatinine Levels | Month 60 (n=13,13,10) | 1.16 mg/dL | Standard Deviation 0.13 |
| Tofacitinib 30-15-10 mg BID | Serum Creatinine Levels | Month 66 (n=12,14,10) | 1.24 mg/dL | Standard Deviation 0.27 |
| Tofacitinib 30-15-10 mg BID | Serum Creatinine Levels | Month 54 (n=14,14,10) | 1.25 mg/dL | Standard Deviation 0.14 |
| Tofacitinib 30-15-10 mg BID | Serum Creatinine Levels | Month 72 (n=9,13,8) | 1.29 mg/dL | Standard Deviation 0.21 |
| Tofacitinib 30-15-10 mg BID | Serum Creatinine Levels | Month 78 (n=0,13,8) | 1.16 mg/dL | Standard Deviation 0.14 |
| Tofacitinib 30-15-10 mg BID | Serum Creatinine Levels | Month 12 (n=16,14,12) | 1.33 mg/dL | Standard Deviation 0.32 |
| Tofacitinib 30-15-10 mg BID | Serum Creatinine Levels | Month 96 (n=0,11,6) | 1.10 mg/dL | Standard Deviation 0.14 |
Secondary
Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit
Time frame: Months 12 and 24
Population: Safety population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | CD19+: Month 24 | 144.47 cells/uL | Standard Deviation 116.77 |
| Tacrolimus | Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | CD8+: Month 24 | 318.20 cells/uL | Standard Deviation 183.85 |
| Tacrolimus | Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | CD4+: Month 24 | 599.13 cells/uL | Standard Deviation 216.61 |
| Tacrolimus | Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | CD4+: Month 12 | 612.80 cells/uL | Standard Deviation 339.75 |
| Tacrolimus | Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | CD8+: Month 12 | 284.67 cells/uL | Standard Deviation 218.43 |
| Tacrolimus | Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | CD56+: Month 24 | 135.27 cells/uL | Standard Deviation 145.25 |
| Tacrolimus | Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | CD19+: Month 12 | 197.53 cells/uL | Standard Deviation 209.42 |
| Tacrolimus | Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | CD56+: Month 12 | 152.67 cells/uL | Standard Deviation 198.33 |
| Tofacitinib 15-10-5 mg BID | Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | CD19+: Month 12 | 169.64 cells/uL | Standard Deviation 97.97 |
| Tofacitinib 15-10-5 mg BID | Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | CD8+: Month 12 | 207.43 cells/uL | Standard Deviation 97.19 |
| Tofacitinib 15-10-5 mg BID | Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | CD8+: Month 24 | 224.36 cells/uL | Standard Deviation 194.45 |
| Tofacitinib 15-10-5 mg BID | Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | CD19+: Month 24 | 125.86 cells/uL | Standard Deviation 79.56 |
| Tofacitinib 15-10-5 mg BID | Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | CD4+: Month 12 | 634.86 cells/uL | Standard Deviation 280.75 |
| Tofacitinib 15-10-5 mg BID | Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | CD4+: Month 24 | 462.00 cells/uL | Standard Deviation 295.73 |
| Tofacitinib 15-10-5 mg BID | Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | CD56+: Month 12 | 50.14 cells/uL | Standard Deviation 43.96 |
| Tofacitinib 15-10-5 mg BID | Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | CD56+: Month 24 | 77.86 cells/uL | Standard Deviation 107.37 |
| Tofacitinib 30-15-10 mg BID | Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | CD4+: Month 24 | 457.83 cells/uL | Standard Deviation 202.29 |
| Tofacitinib 30-15-10 mg BID | Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | CD19+: Month 12 | 127.42 cells/uL | Standard Deviation 67.08 |
| Tofacitinib 30-15-10 mg BID | Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | CD56+: Month 24 | 59.17 cells/uL | Standard Deviation 69.31 |
| Tofacitinib 30-15-10 mg BID | Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | CD56+: Month 12 | 35.58 cells/uL | Standard Deviation 30.6 |
| Tofacitinib 30-15-10 mg BID | Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | CD8+: Month 24 | 238.08 cells/uL | Standard Deviation 172.46 |
| Tofacitinib 30-15-10 mg BID | Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | CD4+: Month 12 | 565.00 cells/uL | Standard Deviation 222.61 |
| Tofacitinib 30-15-10 mg BID | Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | CD19+: Month 24 | 85.08 cells/uL | Standard Deviation 51.02 |
| Tofacitinib 30-15-10 mg BID | Absolute Cluster of Differentiation (CD) 8+, CD19+, CD4+, and CD56+ Flouresence Activated Cell Sorting (FACS) Counts (Cells/uL) by Visit | CD8+: Month 12 | 232.33 cells/uL | Standard Deviation 110.61 |
Secondary
Area Under the Curve (AUC) of Serum Glucose (mg*h/dL) Measured During Oral Glucose Tolerance Test (OGTT) by Visit
Only performed in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin.
Time frame: Months 12 and 24
Population: Safety population; n=number of participants eligible for OGTT with data (non-missing) at that particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | Area Under the Curve (AUC) of Serum Glucose (mg*h/dL) Measured During Oral Glucose Tolerance Test (OGTT) by Visit | Month 12 (n=10,6,6) | 234.78 mg*h/dL | Standard Deviation 58.78 |
| Tacrolimus | Area Under the Curve (AUC) of Serum Glucose (mg*h/dL) Measured During Oral Glucose Tolerance Test (OGTT) by Visit | Month 24 (n=12,8,5) | 230.10 mg*h/dL | Standard Deviation 56.41 |
| Tofacitinib 15-10-5 mg BID | Area Under the Curve (AUC) of Serum Glucose (mg*h/dL) Measured During Oral Glucose Tolerance Test (OGTT) by Visit | Month 12 (n=10,6,6) | 254.25 mg*h/dL | Standard Deviation 72.34 |
| Tofacitinib 15-10-5 mg BID | Area Under the Curve (AUC) of Serum Glucose (mg*h/dL) Measured During Oral Glucose Tolerance Test (OGTT) by Visit | Month 24 (n=12,8,5) | 236.94 mg*h/dL | Standard Deviation 92.98 |
| Tofacitinib 30-15-10 mg BID | Area Under the Curve (AUC) of Serum Glucose (mg*h/dL) Measured During Oral Glucose Tolerance Test (OGTT) by Visit | Month 12 (n=10,6,6) | 281.54 mg*h/dL | Standard Deviation 52.39 |
| Tofacitinib 30-15-10 mg BID | Area Under the Curve (AUC) of Serum Glucose (mg*h/dL) Measured During Oral Glucose Tolerance Test (OGTT) by Visit | Month 24 (n=12,8,5) | 281.90 mg*h/dL | Standard Deviation 100.76 |
Secondary
AUC of Serum Insulin (microU*h/mL) Measured During OGTT by Visit
The OGTT was performed only in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin.
Time frame: Months 12 and 24
Population: Safety population: n=number of participants who were eligible for OGTT and had data (non-mising) at that particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | AUC of Serum Insulin (microU*h/mL) Measured During OGTT by Visit | Month 12 (n=10,6,6) | 85.05 microU*h/mL | Standard Deviation 37.57 |
| Tacrolimus | AUC of Serum Insulin (microU*h/mL) Measured During OGTT by Visit | Month 24 (n=8,6,5) | 79.84 microU*h/mL | Standard Deviation 42.65 |
| Tofacitinib 15-10-5 mg BID | AUC of Serum Insulin (microU*h/mL) Measured During OGTT by Visit | Month 12 (n=10,6,6) | 99.96 microU*h/mL | Standard Deviation 54.22 |
| Tofacitinib 15-10-5 mg BID | AUC of Serum Insulin (microU*h/mL) Measured During OGTT by Visit | Month 24 (n=8,6,5) | 130.63 microU*h/mL | Standard Deviation 48.07 |
| Tofacitinib 30-15-10 mg BID | AUC of Serum Insulin (microU*h/mL) Measured During OGTT by Visit | Month 12 (n=10,6,6) | 153.46 microU*h/mL | Standard Deviation 92.11 |
| Tofacitinib 30-15-10 mg BID | AUC of Serum Insulin (microU*h/mL) Measured During OGTT by Visit | Month 24 (n=8,6,5) | 181.70 microU*h/mL | Standard Deviation 155.32 |
Secondary
BK Virus (BKV) DNA Levels Determined Using PCR by Visit
Calculated as number of copies per PCR. Per protocol, BKV DNA PCR was performed on tofacitinib-treated participants only.
Time frame: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 9 (n=14,12) | 1.29 number of copies/PCR | Standard Deviation 4.53 |
| Tacrolimus | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 12 (n=13,10) | 2.23 number of copies/PCR | Standard Deviation 3.81 |
| Tacrolimus | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 18 (n=7,8) | 0.14 number of copies/PCR | Standard Deviation 0.38 |
| Tacrolimus | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 48 (n=9,6) | 8.33 number of copies/PCR | Standard Deviation 23.18 |
| Tacrolimus | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 54 (n=13,10) | 4.54 number of copies/PCR | Standard Deviation 14.66 |
| Tacrolimus | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 60 (n=13,7) | 15.85 number of copies/PCR | Standard Deviation 41.81 |
| Tacrolimus | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 72 (n=10,7) | 1.00 number of copies/PCR | Standard Deviation 2.83 |
| Tacrolimus | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 78 (n=9,7) | 0.56 number of copies/PCR | Standard Deviation 1.13 |
| Tacrolimus | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 96 (n=9,3) | 1.11 number of copies/PCR | Standard Deviation 2.67 |
| Tacrolimus | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 15 (n=13,12) | 2.85 number of copies/PCR | Standard Deviation 7.66 |
| Tacrolimus | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 24 (n=2,1) | 0.00 number of copies/PCR | Standard Deviation 0 |
| Tacrolimus | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 30 (n=0,1) | NA number of copies/PCR | — |
| Tacrolimus | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 36 (n=5,4) | 15.80 number of copies/PCR | Standard Deviation 34.77 |
| Tacrolimus | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 42 (n=11,7) | 0.64 number of copies/PCR | Standard Deviation 2.11 |
| Tacrolimus | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 66 (n=13,8) | 6.15 number of copies/PCR | Standard Deviation 21 |
| Tacrolimus | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 84 (n=10,7) | 0.60 number of copies/PCR | Standard Deviation 1.9 |
| Tacrolimus | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 90 (n=9,4) | 0.56 number of copies/PCR | Standard Deviation 1.67 |
| Tacrolimus | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Follow-up (n=3,2) | 0.00 number of copies/PCR | Standard Deviation 0 |
| Tofacitinib 15-10-5 mg BID | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 12 (n=13,10) | 0.10 number of copies/PCR | Standard Deviation 0.32 |
| Tofacitinib 15-10-5 mg BID | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 9 (n=14,12) | 1.58 number of copies/PCR | Standard Deviation 2.84 |
| Tofacitinib 15-10-5 mg BID | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 42 (n=11,7) | 1.86 number of copies/PCR | Standard Deviation 4.49 |
| Tofacitinib 15-10-5 mg BID | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 15 (n=13,12) | 0.75 number of copies/PCR | Standard Deviation 0.97 |
| Tofacitinib 15-10-5 mg BID | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 84 (n=10,7) | 0.14 number of copies/PCR | Standard Deviation 0.38 |
| Tofacitinib 15-10-5 mg BID | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 18 (n=7,8) | 0.38 number of copies/PCR | Standard Deviation 0.74 |
| Tofacitinib 15-10-5 mg BID | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 24 (n=2,1) | 0.00 number of copies/PCR | — |
| Tofacitinib 15-10-5 mg BID | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 48 (n=9,6) | 3.33 number of copies/PCR | Standard Deviation 8.16 |
| Tofacitinib 15-10-5 mg BID | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 66 (n=13,8) | 0.00 number of copies/PCR | Standard Deviation 0 |
| Tofacitinib 15-10-5 mg BID | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 54 (n=13,10) | 1.40 number of copies/PCR | Standard Deviation 3.78 |
| Tofacitinib 15-10-5 mg BID | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 30 (n=0,1) | 0.00 number of copies/PCR | — |
| Tofacitinib 15-10-5 mg BID | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 60 (n=13,7) | 0.86 number of copies/PCR | Standard Deviation 2.27 |
| Tofacitinib 15-10-5 mg BID | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 78 (n=9,7) | 0.14 number of copies/PCR | Standard Deviation 0.38 |
| Tofacitinib 15-10-5 mg BID | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 72 (n=10,7) | 0.14 number of copies/PCR | Standard Deviation 0.38 |
| Tofacitinib 15-10-5 mg BID | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 36 (n=5,4) | 6.75 number of copies/PCR | Standard Deviation 13.5 |
| Tofacitinib 15-10-5 mg BID | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Follow-up (n=3,2) | 0.50 number of copies/PCR | Standard Deviation 0.71 |
| Tofacitinib 15-10-5 mg BID | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 90 (n=9,4) | 0.00 number of copies/PCR | Standard Deviation 0 |
| Tofacitinib 15-10-5 mg BID | BK Virus (BKV) DNA Levels Determined Using PCR by Visit | Month 96 (n=9,3) | 0.00 number of copies/PCR | Standard Deviation 0 |
Secondary
Calculated GFR Using Cockcroft-Gault Equation (mL/Min)
GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was calculated using Cockcroft-Gault equation. GFR by Cockcroft-Gault equation= body weight (kg)\*(140 minus age in years) divided by (72\*serum creatinine \[mg/dL\]). For females value obtained was multiplied by 0.85. A normal GFR is \>90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \<15 mL/min indicated kidney failure.
Time frame: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 90 (n=0,12,7) | NA mL/min | — |
| Tacrolimus | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 96 (n=0,11,6) | NA mL/min | — |
| Tacrolimus | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 66 (n=12,14,10) | 118.60 mL/min | Standard Deviation 42.38 |
| Tacrolimus | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Follow-Up (n=6,12,8) | 63.95 mL/min | Standard Deviation 35.17 |
| Tacrolimus | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 42 (n=15,14,9) | 102.79 mL/min | Standard Deviation 27.15 |
| Tacrolimus | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 9 (n=18,14,12) | 92.82 mL/min | Standard Deviation 19.95 |
| Tacrolimus | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 12 (n=16,14,12) | 87.05 mL/min | Standard Deviation 19.95 |
| Tacrolimus | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 24 (n=17,14,12) | 100.46 mL/min | Standard Deviation 21.65 |
| Tacrolimus | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 15 (n=16,14,12) | 98.39 mL/min | Standard Deviation 22.67 |
| Tacrolimus | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 36 (n=15,14,9) | 101.92 mL/min | Standard Deviation 33.77 |
| Tacrolimus | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 48 (n=15,14,10) | 100.77 mL/min | Standard Deviation 27.37 |
| Tacrolimus | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 54 (n=14,14,10) | 106.65 mL/min | Standard Deviation 33.5 |
| Tacrolimus | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 60 (n=13,13,10) | 113.73 mL/min | Standard Deviation 31.33 |
| Tacrolimus | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 18 (n=18,14,12) | 98.68 mL/min | Standard Deviation 24.03 |
| Tacrolimus | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 72 (n=9,13,8) | 113.23 mL/min | Standard Deviation 30.03 |
| Tacrolimus | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 30 (n=14,14,10) | 102.29 mL/min | Standard Deviation 21.29 |
| Tacrolimus | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 78 (n=0,13,8) | NA mL/min | — |
| Tacrolimus | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 84 (n=0,12,8) | NA mL/min | — |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 72 (n=9,13,8) | 86.00 mL/min | Standard Deviation 17.77 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 90 (n=0,12,7) | 80.73 mL/min | Standard Deviation 19.03 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 36 (n=15,14,9) | 94.67 mL/min | Standard Deviation 23.12 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 48 (n=15,14,10) | 92.78 mL/min | Standard Deviation 23.6 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 96 (n=0,11,6) | 79.02 mL/min | Standard Deviation 18.97 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 18 (n=18,14,12) | 90.61 mL/min | Standard Deviation 16.53 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 54 (n=14,14,10) | 89.96 mL/min | Standard Deviation 19.19 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Follow-Up (n=6,12,8) | 82.26 mL/min | Standard Deviation 17.32 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 84 (n=0,12,8) | 85.54 mL/min | Standard Deviation 19.31 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 60 (n=13,13,10) | 87.89 mL/min | Standard Deviation 21.2 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 9 (n=18,14,12) | 86.74 mL/min | Standard Deviation 15.7 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 42 (n=15,14,9) | 92.13 mL/min | Standard Deviation 19.39 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 24 (n=17,14,12) | 89.62 mL/min | Standard Deviation 24.06 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 12 (n=16,14,12) | 87.29 mL/min | Standard Deviation 17.83 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 66 (n=12,14,10) | 86.74 mL/min | Standard Deviation 20.14 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 78 (n=0,13,8) | 85.10 mL/min | Standard Deviation 16.99 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 15 (n=16,14,12) | 92.69 mL/min | Standard Deviation 15.97 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 30 (n=14,14,10) | 95.79 mL/min | Standard Deviation 20.38 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 15 (n=16,14,12) | 92.79 mL/min | Standard Deviation 15.98 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 54 (n=14,14,10) | 91.90 mL/min | Standard Deviation 21.03 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 48 (n=15,14,10) | 93.23 mL/min | Standard Deviation 19.62 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 18 (n=18,14,12) | 91.31 mL/min | Standard Deviation 18.19 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 24 (n=17,14,12) | 94.67 mL/min | Standard Deviation 16.46 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 30 (n=14,14,10) | 88.19 mL/min | Standard Deviation 13.32 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 36 (n=15,14,9) | 86.32 mL/min | Standard Deviation 22.76 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 42 (n=15,14,9) | 91.96 mL/min | Standard Deviation 14.62 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 60 (n=13,13,10) | 98.94 mL/min | Standard Deviation 21.29 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 66 (n=12,14,10) | 94.80 mL/min | Standard Deviation 32.99 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 72 (n=9,13,8) | 93.33 mL/min | Standard Deviation 18.12 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 78 (n=0,13,8) | 100.93 mL/min | Standard Deviation 20.4 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 84 (n=0,12,8) | 102.36 mL/min | Standard Deviation 14.46 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 90 (n=0,12,7) | 103.59 mL/min | Standard Deviation 16.99 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 96 (n=0,11,6) | 100.89 mL/min | Standard Deviation 14.55 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Follow-Up (n=6,12,8) | 89.79 mL/min | Standard Deviation 40.28 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 9 (n=18,14,12) | 92.35 mL/min | Standard Deviation 10.45 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using Cockcroft-Gault Equation (mL/Min) | Month 12 (n=16,14,12) | 90.36 mL/min | Standard Deviation 18.79 |
Secondary
Calculated GFR Using the Nankivell Equation (mL/Min)
GFR: an index of kidney function. GFR described the flow rate of filtered fluid through the kidney. GFR was measured directly or estimated using established formulas. GFR was estimated by creatinine clearance (CLcr; in mL/min\]) using Nankivell equation. CLcr by Nankivell equation= (6.7 per serum creatinine \[in millimoles per liter (mmol/L)\]) plus (0.25\*body weight \[in kilograms (kg)\]) minus (0.5\*serum urea \[mmol/dL, where 1 mg/dL BUN=0.36 mmol/L urea\]) minus (100 per height \[in meters\] square) plus (35 for male/25 for female). A normal GFR is \>90 mL/min, although children and older people usually have a lower GFR. Lower values indicated poor kidney function. A GFR \<15 mL/min indicated kidney failure.
Time frame: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 30 (n=14,14,10) | 88.61 mL/min | Standard Deviation 16.59 |
| Tacrolimus | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 96 (n=0,11,6) | NA mL/min | — |
| Tacrolimus | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 78 (n=0,13,8) | NA mL/min | — |
| Tacrolimus | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 24 (n=17,14,12) | 84.93 mL/min | Standard Deviation 14.36 |
| Tacrolimus | Calculated GFR Using the Nankivell Equation (mL/Min) | Follow-Up (n=6,12,8) | 52.35 mL/min | Standard Deviation 28.37 |
| Tacrolimus | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 60 (n=13,13,10) | 93.01 mL/min | Standard Deviation 19.88 |
| Tacrolimus | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 18 (n=18,14,12) | 82.77 mL/min | Standard Deviation 14.14 |
| Tacrolimus | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 84 (n=0,12,8) | NA mL/min | — |
| Tacrolimus | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 15 (n=16,14,12) | 80.92 mL/min | Standard Deviation 12.79 |
| Tacrolimus | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 12 (n=16,14,12) | 73.64 mL/min | Standard Deviation 15.23 |
| Tacrolimus | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 48 (n=15,14,10) | 85.59 mL/min | Standard Deviation 21.32 |
| Tacrolimus | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 9 (n=18,14,12) | 77.98 mL/min | Standard Deviation 11.29 |
| Tacrolimus | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 54 (n=14,14,10) | 88.08 mL/min | Standard Deviation 27.63 |
| Tacrolimus | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 72 (n=9,13,8) | 90.60 mL/min | Standard Deviation 17.58 |
| Tacrolimus | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 66 (n=12,14,10) | 98.72 mL/min | Standard Deviation 33.7 |
| Tacrolimus | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 42 (n=15,14,9) | 86.95 mL/min | Standard Deviation 17.96 |
| Tacrolimus | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 90 (n=0,12,7) | NA mL/min | — |
| Tacrolimus | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 36 (n=15,14,9) | 89.08 mL/min | Standard Deviation 24.53 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 54 (n=14,14,10) | 85.35 mL/min | Standard Deviation 12.99 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 60 (n=13,13,10) | 85.75 mL/min | Standard Deviation 15.79 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 72 (n=9,13,8) | 83.80 mL/min | Standard Deviation 10.92 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 84 (n=0,12,8) | 84.21 mL/min | Standard Deviation 12.5 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 66 (n=12,14,10) | 84.26 mL/min | Standard Deviation 16.14 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 78 (n=0,13,8) | 83.94 mL/min | Standard Deviation 10.95 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 90 (n=0,12,7) | 81.09 mL/min | Standard Deviation 12.75 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 96 (n=0,11,6) | 79.46 mL/min | Standard Deviation 12.35 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Follow-Up (n=6,12,8) | 81.06 mL/min | Standard Deviation 12.76 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 9 (n=18,14,12) | 80.15 mL/min | Standard Deviation 9.74 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 12 (n=16,14,12) | 80.02 mL/min | Standard Deviation 9.39 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 15 (n=16,14,12) | 83.06 mL/min | Standard Deviation 6.99 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 18 (n=18,14,12) | 81.72 mL/min | Standard Deviation 10.35 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 24 (n=17,14,12) | 82.62 mL/min | Standard Deviation 10.15 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 30 (n=14,14,10) | 86.35 mL/min | Standard Deviation 7.12 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 42 (n=15,14,9) | 86.07 mL/min | Standard Deviation 13.13 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 48 (n=15,14,10) | 86.47 mL/min | Standard Deviation 13.32 |
| Tofacitinib 15-10-5 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 36 (n=15,14,9) | 86.05 mL/min | Standard Deviation 12.76 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 96 (n=0,11,6) | 88.20 mL/min | Standard Deviation 8.93 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 30 (n=14,14,10) | 79.87 mL/min | Standard Deviation 9.74 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 24 (n=17,14,12) | 81.66 mL/min | Standard Deviation 8.2 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 90 (n=0,12,7) | 88.91 mL/min | Standard Deviation 6.31 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 72 (n=9,13,8) | 81.46 mL/min | Standard Deviation 7.94 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 36 (n=15,14,9) | 76.38 mL/min | Standard Deviation 15.14 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 84 (n=0,12,8) | 88.53 mL/min | Standard Deviation 5.4 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 42 (n=15,14,9) | 81.89 mL/min | Standard Deviation 7.03 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 66 (n=12,14,10) | 82.21 mL/min | Standard Deviation 17.48 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 48 (n=15,14,10) | 82.06 mL/min | Standard Deviation 8.68 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 60 (n=13,13,10) | 85.36 mL/min | Standard Deviation 10.01 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 12 (n=16,14,12) | 79.31 mL/min | Standard Deviation 11.71 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 9 (n=18,14,12) | 81.39 mL/min | Standard Deviation 9.77 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 78 (n=0,13,8) | 87.44 mL/min | Standard Deviation 8.72 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 15 (n=16,14,12) | 81.18 mL/min | Standard Deviation 10.61 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Follow-Up (n=6,12,8) | 76.41 mL/min | Standard Deviation 29.81 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 54 (n=14,14,10) | 79.98 mL/min | Standard Deviation 10.36 |
| Tofacitinib 30-15-10 mg BID | Calculated GFR Using the Nankivell Equation (mL/Min) | Month 18 (n=18,14,12) | 80.03 mL/min | Standard Deviation 10.82 |
Secondary
Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale
ESRD-SCL: 43-item, disease-specific, self-administered questionnaire. Participants' rated question At the moment, how much do you suffer? for each item on 5-point scale, ranged from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: cardiac and renal dysfunction (Range, 0-28), increased growth of gum and hair (Range, 0-20), limited cognitive capacity (Range, 0-32), limited physical capacity (Range, 0-40), SEs of corticosteroids (Range, 0-20),TAPD (Range, 0-32); higher scores=greater dysfunction for each subscale. Total score: 0-172, higher scores=greater dysfunction.
Time frame: Baseline, Months 12, 18, and 24
Population: Safety population; n=number of participants in Safety Population per visit with non-missing value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Transplant-assoc psychodistress: Mnth24(n=13,10,9) | -0.30 scores on a scale | Standard Deviation 0.51 |
| Tacrolimus | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Increased growth gum/hair: Month 12 (n=13,10,8) | 0.06 scores on a scale | Standard Deviation 0.28 |
| Tacrolimus | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Limited Cognitive: Month 12 (n = 13, 10, 8) | -0.37 scores on a scale | Standard Deviation 0.59 |
| Tacrolimus | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Global Score: Month 12 (n = 13, 10, 8) | -0.34 scores on a scale | Standard Deviation 0.37 |
| Tacrolimus | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Increased growth gum/hair: Month 18 (n=13,9,8) | 0.04 scores on a scale | Standard Deviation 0.27 |
| Tacrolimus | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Limited Physical: Month 24 (n = 13, 10, 9) | -0.16 scores on a scale | Standard Deviation 0.63 |
| Tacrolimus | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Global Score: Month 18 (n = 13, 9, 8) | -0.21 scores on a scale | Standard Deviation 0.57 |
| Tacrolimus | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Side effects Corticosteroids: Month 24 (n=13,10,9) | -0.25 scores on a scale | Standard Deviation 0.68 |
| Tacrolimus | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Limited Physical: Month 18 (n = 13, 9, 8) | -0.20 scores on a scale | Standard Deviation 0.54 |
| Tacrolimus | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Global Score: Month 24 (n = 13, 10, 9) | -0.21 scores on a scale | Standard Deviation 0.52 |
| Tacrolimus | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Cardiac / Renal Dysfunc: Month 18 (n = 12, 8, 7) | -0.49 scores on a scale | Standard Deviation 0.78 |
| Tacrolimus | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Limited Physical: Month 12 (n = 13, 10, 8) | -0.34 scores on a scale | Standard Deviation 0.45 |
| Tacrolimus | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Increased growth gum/hair: Month 24 (n=13,10,9) | 0.29 scores on a scale | Standard Deviation 0.59 |
| Tacrolimus | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Side effects Corticosteroids: Month 18 (n=12,8,8) | -0.40 scores on a scale | Standard Deviation 0.72 |
| Tacrolimus | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Cardiac / Renal Dysfunc: Month 12 (n = 13, 9, 8) | -0.48 scores on a scale | Standard Deviation 0.68 |
| Tacrolimus | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Transplant-assoc psychodistress: Mnth12(n=13,10,8) | -0.49 scores on a scale | Standard Deviation 0.56 |
| Tacrolimus | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Cardiac / Renal Dysfunc: Month 24 (n = 13, 9, 9) | -0.46 scores on a scale | Standard Deviation 0.61 |
| Tacrolimus | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Limited Cognitive: Month 24 (n = 13, 10, 9) | -0.25 scores on a scale | Standard Deviation 0.89 |
| Tacrolimus | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Transplant-assoc psychodistress: Mnth18(n=13,9,8) | -0.28 scores on a scale | Standard Deviation 0.46 |
| Tacrolimus | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Side effects Corticosteroids: Month 12(n=13, 9, 8) | -0.25 scores on a scale | Standard Deviation 0.55 |
| Tacrolimus | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Limited Cognitive: Month 18 (n = 13, 9, 8) | -0.22 scores on a scale | Standard Deviation 0.8 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Cardiac / Renal Dysfunc: Month 18 (n = 12, 8, 7) | -0.50 scores on a scale | Standard Deviation 0.41 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Side effects Corticosteroids: Month 18 (n=12,8,8) | -0.23 scores on a scale | Standard Deviation 0.43 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Side effects Corticosteroids: Month 24 (n=13,10,9) | -0.31 scores on a scale | Standard Deviation 0.55 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Increased growth gum/hair: Month 12 (n=13,10,8) | -0.06 scores on a scale | Standard Deviation 0.4 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Increased growth gum/hair: Month 18 (n=13,9,8) | -0.04 scores on a scale | Standard Deviation 0.46 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Increased growth gum/hair: Month 24 (n=13,10,9) | 0.10 scores on a scale | Standard Deviation 0.63 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Transplant-assoc psychodistress: Mnth12(n=13,10,8) | -0.57 scores on a scale | Standard Deviation 0.58 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Transplant-assoc psychodistress: Mnth18(n=13,9,8) | -0.57 scores on a scale | Standard Deviation 0.55 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Transplant-assoc psychodistress: Mnth24(n=13,10,9) | -0.62 scores on a scale | Standard Deviation 0.67 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Global Score: Month 12 (n = 13, 10, 8) | -0.36 scores on a scale | Standard Deviation 0.24 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Global Score: Month 18 (n = 13, 9, 8) | -0.40 scores on a scale | Standard Deviation 0.31 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Global Score: Month 24 (n = 13, 10, 9) | -0.30 scores on a scale | Standard Deviation 0.31 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Limited Physical: Month 12 (n = 13, 10, 8) | -0.34 scores on a scale | Standard Deviation 0.25 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Limited Physical: Month 18 (n = 13, 9, 8) | -0.36 scores on a scale | Standard Deviation 0.32 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Limited Physical: Month 24 (n = 13, 10, 9) | -0.23 scores on a scale | Standard Deviation 0.28 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Limited Cognitive: Month 12 (n = 13, 10, 8) | -0.37 scores on a scale | Standard Deviation 0.24 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Limited Cognitive: Month 18 (n = 13, 9, 8) | -0.39 scores on a scale | Standard Deviation 0.45 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Limited Cognitive: Month 24 (n = 13, 10, 9) | -0.21 scores on a scale | Standard Deviation 0.56 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Cardiac / Renal Dysfunc: Month 12 (n = 13, 9, 8) | -0.51 scores on a scale | Standard Deviation 0.43 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Cardiac / Renal Dysfunc: Month 24 (n = 13, 9, 9) | -0.41 scores on a scale | Standard Deviation 0.39 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Side effects Corticosteroids: Month 12(n=13, 9, 8) | -0.02 scores on a scale | Standard Deviation 0.66 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Transplant-assoc psychodistress: Mnth24(n=13,10,9) | -0.61 scores on a scale | Standard Deviation 0.7 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Side effects Corticosteroids: Month 24 (n=13,10,9) | 0.13 scores on a scale | Standard Deviation 0.53 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Limited Cognitive: Month 12 (n = 13, 10, 8) | -0.36 scores on a scale | Standard Deviation 0.65 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Transplant-assoc psychodistress: Mnth18(n=13,9,8) | -0.48 scores on a scale | Standard Deviation 0.58 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Side effects Corticosteroids: Month 12(n=13, 9, 8) | 0.18 scores on a scale | Standard Deviation 0.61 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Limited Cognitive: Month 18 (n = 13, 9, 8) | -0.39 scores on a scale | Standard Deviation 0.54 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Transplant-assoc psychodistress: Mnth12(n=13,10,8) | -0.61 scores on a scale | Standard Deviation 0.42 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Cardiac / Renal Dysfunc: Month 24 (n = 13, 9, 9) | -0.33 scores on a scale | Standard Deviation 0.44 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Limited Cognitive: Month 24 (n = 13, 10, 9) | -0.26 scores on a scale | Standard Deviation 0.72 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Increased growth gum/hair: Month 24 (n=13,10,9) | -0.07 scores on a scale | Standard Deviation 0.17 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Side effects Corticosteroids: Month 18 (n=12,8,8) | 0.03 scores on a scale | Standard Deviation 0.52 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Cardiac / Renal Dysfunc: Month 12 (n = 13, 9, 8) | -0.52 scores on a scale | Standard Deviation 0.49 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Global Score: Month 24 (n = 13, 10, 9) | -0.28 scores on a scale | Standard Deviation 0.35 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Increased growth gum/hair: Month 18 (n=13,9,8) | -0.03 scores on a scale | Standard Deviation 0.23 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Limited Physical: Month 12 (n = 13, 10, 8) | -0.53 scores on a scale | Standard Deviation 0.38 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Global Score: Month 18 (n = 13, 9, 8) | -0.31 scores on a scale | Standard Deviation 0.36 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Increased growth gum/hair: Month 12 (n=13,10,8) | -0.08 scores on a scale | Standard Deviation 0.24 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Limited Physical: Month 18 (n = 13, 9, 8) | -0.30 scores on a scale | Standard Deviation 0.63 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Global Score: Month 12 (n = 13, 10, 8) | -0.37 scores on a scale | Standard Deviation 0.29 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Cardiac / Renal Dysfunc: Month 18 (n = 12, 8, 7) | -0.45 scores on a scale | Standard Deviation 0.6 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in ESRD-SCL Transplantation Module Scores by Visit and Scale | Limited Physical: Month 24 (n = 13, 10, 9) | -0.32 scores on a scale | Standard Deviation 0.39 |
Secondary
Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Negative change from baseline represented improvement.
Time frame: Baseline, Months 12, 18, and 24
Population: Safety population; n=number of participants in Safety population per visit with non-missing value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale | PCS: Month 12 (n=12,11,9) | 9.61 scores on a scale | Standard Deviation 6.21 |
| Tacrolimus | Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale | PCS: Month 18 (n=13,9,8) | 10.82 scores on a scale | Standard Deviation 6.29 |
| Tacrolimus | Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale | PCS: Month 24 (n=13,10,10) | 9.67 scores on a scale | Standard Deviation 5.55 |
| Tacrolimus | Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale | MCS: Month 12 (n=12,11,9) | 6.86 scores on a scale | Standard Deviation 7.35 |
| Tacrolimus | Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale | MCS: Month 18 (n=13,9,8) | 1.91 scores on a scale | Standard Deviation 14.71 |
| Tacrolimus | Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale | MCS: Month 24 (n=13,10,10) | 2.99 scores on a scale | Standard Deviation 11.63 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale | MCS: Month 24 (n=13,10,10) | 10.05 scores on a scale | Standard Deviation 12.55 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale | PCS: Month 12 (n=12,11,9) | 6.23 scores on a scale | Standard Deviation 8.75 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale | MCS: Month 12 (n=12,11,9) | 5.03 scores on a scale | Standard Deviation 13.29 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale | MCS: Month 18 (n=13,9,8) | 9.54 scores on a scale | Standard Deviation 9.53 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale | PCS: Month 18 (n=13,9,8) | 5.65 scores on a scale | Standard Deviation 7.84 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale | PCS: Month 24 (n=13,10,10) | 7.09 scores on a scale | Standard Deviation 7.25 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale | PCS: Month 18 (n=13,9,8) | 2.76 scores on a scale | Standard Deviation 10.26 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale | PCS: Month 24 (n=13,10,10) | 4.36 scores on a scale | Standard Deviation 8.6 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale | MCS: Month 24 (n=13,10,10) | 9.59 scores on a scale | Standard Deviation 15.22 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale | MCS: Month 12 (n=12,11,9) | 13.70 scores on a scale | Standard Deviation 12.32 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale | PCS: Month 12 (n=12,11,9) | 3.20 scores on a scale | Standard Deviation 10.71 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 MCS and PCS Scores by Visit and Scale | MCS: Month 18 (n=13,9,8) | 8.57 scores on a scale | Standard Deviation 13.96 |
Secondary
Change From Baseline in SF-36 v2 Subscale Scores by Visit
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Negative change from baseline represented improvement.
Time frame: Baseline, Months 12, 18, and 24
Population: Safety population; n=number of participants in Safety Population per visit with non-missing value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | General Health: Month 12 (n=12,11,9) | 11.73 scores on a scale | Standard Deviation 5.8 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | TR Scale Score: Month 24 (n=13,11,10) | -0.92 scores on a scale | Standard Deviation 1.19 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Emotional: Month 12 (n=13,12,9) | 10.19 scores on a scale | Standard Deviation 13.06 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | General Health: Month 18 (n=13,9,8) | 8.89 scores on a scale | Standard Deviation 9.64 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Phys Func: Month 12 (n=13,12,9) | 8.82 scores on a scale | Standard Deviation 10.58 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Social Function: Month 24 (n=13,11,10) | 7.03 scores on a scale | Standard Deviation 12.68 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | General Health: Month 24 (n=13,10,10) | 8.06 scores on a scale | Standard Deviation 8.96 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Physical: Month 18 (n=13,10,8) | 15.60 scores on a scale | Standard Deviation 6.36 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Social Function: Month 18 (n=13,10,8) | 4.55 scores on a scale | Standard Deviation 14.54 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Vitality: Month 12 (n=13,12,9) | 11.05 scores on a scale | Standard Deviation 9.58 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | TR Scale Score: Month 18 (n=13,10,8) | -1.15 scores on a scale | Standard Deviation 1.28 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Social Function: Month 12 (n=13,12,9) | 4.14 scores on a scale | Standard Deviation 10.79 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Vitality: Month 18 (n=13,10,8) | 7.14 scores on a scale | Standard Deviation 13.36 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Mental Health: Month 24 (n=13,11,10) | 1.70 scores on a scale | Standard Deviation 9.36 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Vitality: Month 24 (n=13,11,8) | 8.90 scores on a scale | Standard Deviation 10.52 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Physical: Month 24 (n=13,11,10) | 12.30 scores on a scale | Standard Deviation 8.76 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Phys Func: Month 24 (n=13,11,10) | 8.48 scores on a scale | Standard Deviation 10.27 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Mental Health: Month 18 (n=13,10,8) | -1.28 scores on a scale | Standard Deviation 13.51 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Bodily Pain: Month 12 (n=13,12,9) | 1.47 scores on a scale | Standard Deviation 15.91 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Phys Func: Month 18 (n=13,10,8) | 9.90 scores on a scale | Standard Deviation 10.46 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Mental Health: Month 12 (n=13,12,9) | 2.98 scores on a scale | Standard Deviation 6.64 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Bodily Pain: Month 18 (n=13,10,8) | 0.83 scores on a scale | Standard Deviation 11.32 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | TR Scale Score: Month 12 (n=13,12,9) | -1.31 scores on a scale | Standard Deviation 1.55 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Emotional: Month 24 (n=13,11,10) | 4.66 scores on a scale | Standard Deviation 17.15 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Bodily Pain: Month 24 (n=13,11,10) | 2.56 scores on a scale | Standard Deviation 10.01 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Physical: Month 12 (n=13,12,9) | 13.77 scores on a scale | Standard Deviation 8.16 |
| Tacrolimus | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Emotional: Month 18 (n=13,10,8) | 9.32 scores on a scale | Standard Deviation 15.35 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Mental Health: Month 24 (n=13,11,10) | 10.58 scores on a scale | Standard Deviation 10.2 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Phys Func: Month 12 (n=13,12,9) | 0.51 scores on a scale | Standard Deviation 12.47 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Phys Func: Month 18 (n=13,10,8) | 4.50 scores on a scale | Standard Deviation 9.92 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Phys Func: Month 24 (n=13,11,10) | 3.91 scores on a scale | Standard Deviation 7.12 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Physical: Month 12 (n=13,12,9) | 12.92 scores on a scale | Standard Deviation 14.51 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Physical: Month 18 (n=13,10,8) | 9.54 scores on a scale | Standard Deviation 9.68 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Physical: Month 24 (n=13,11,10) | 13.23 scores on a scale | Standard Deviation 13.13 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Bodily Pain: Month 12 (n=13,12,9) | 6.87 scores on a scale | Standard Deviation 10.52 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Bodily Pain: Month 18 (n=13,10,8) | 8.08 scores on a scale | Standard Deviation 12.98 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Bodily Pain: Month 24 (n=13,11,10) | 5.57 scores on a scale | Standard Deviation 12.58 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | General Health: Month 12 (n=12,11,9) | 6.75 scores on a scale | Standard Deviation 12.04 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | General Health: Month 18 (n=13,9,8) | 6.94 scores on a scale | Standard Deviation 8.8 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | General Health: Month 24 (n=13,10,10) | 9.11 scores on a scale | Standard Deviation 7.86 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Vitality: Month 12 (n=13,12,9) | 9.23 scores on a scale | Standard Deviation 15.29 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Vitality: Month 18 (n=13,10,8) | 11.67 scores on a scale | Standard Deviation 13.49 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Vitality: Month 24 (n=13,11,8) | 15.51 scores on a scale | Standard Deviation 11.96 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Social Function: Month 12 (n=13,12,9) | 7.62 scores on a scale | Standard Deviation 14.76 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Social Function: Month 18 (n=13,10,8) | 11.83 scores on a scale | Standard Deviation 11.84 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Social Function: Month 24 (n=13,11,10) | 11.73 scores on a scale | Standard Deviation 11.49 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Emotional: Month 12 (n=13,12,9) | 7.26 scores on a scale | Standard Deviation 19.87 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Emotional: Month 18 (n=13,10,8) | 11.74 scores on a scale | Standard Deviation 17.25 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Emotional: Month 24 (n=13,11,10) | 6.54 scores on a scale | Standard Deviation 15.25 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Mental Health: Month 12 (n=13,12,9) | 4.62 scores on a scale | Standard Deviation 8.71 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Mental Health: Month 18 (n=13,10,8) | 8.03 scores on a scale | Standard Deviation 5.76 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | TR Scale Score: Month 12 (n=13,12,9) | -1.83 scores on a scale | Standard Deviation 1.4 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | TR Scale Score: Month 18 (n=13,10,8) | -1.10 scores on a scale | Standard Deviation 1.37 |
| Tofacitinib 15-10-5 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | TR Scale Score: Month 24 (n=13,11,10) | -1.45 scores on a scale | Standard Deviation 1.21 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | General Health: Month 12 (n=12,11,9) | 3.60 scores on a scale | Standard Deviation 7.67 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Phys Func: Month 12 (n=13,12,9) | 5.23 scores on a scale | Standard Deviation 14.94 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Emotional: Month 12 (n=13,12,9) | 15.14 scores on a scale | Standard Deviation 17.45 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Bodily Pain: Month 24 (n=13,11,10) | -1.25 scores on a scale | Standard Deviation 12.99 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | TR Scale Score: Month 12 (n=13,12,9) | -1.78 scores on a scale | Standard Deviation 2.11 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Emotional: Month 18 (n=13,10,8) | 13.25 scores on a scale | Standard Deviation 16.56 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Bodily Pain: Month 18 (n=13,10,8) | -0.31 scores on a scale | Standard Deviation 14.06 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Phys Func: Month 18 (n=13,10,8) | 2.56 scores on a scale | Standard Deviation 15.58 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Emotional: Month 24 (n=13,11,10) | 16.66 scores on a scale | Standard Deviation 18.82 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Bodily Pain: Month 12 (n=13,12,9) | -0.83 scores on a scale | Standard Deviation 14.54 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | TR Scale Score: Month 24 (n=13,11,10) | -0.70 scores on a scale | Standard Deviation 1.25 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Mental Health: Month 12 (n=13,12,9) | 5.54 scores on a scale | Standard Deviation 13.64 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Physical: Month 24 (n=13,11,10) | 17.18 scores on a scale | Standard Deviation 13.81 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | TR Scale Score: Month 18 (n=13,10,8) | -1.13 scores on a scale | Standard Deviation 1.81 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Mental Health: Month 18 (n=13,10,8) | 0.00 scores on a scale | Standard Deviation 14.36 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Vitality: Month 18 (n=13,10,8) | 10.85 scores on a scale | Standard Deviation 6.96 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Physical: Month 18 (n=13,10,8) | 12.53 scores on a scale | Standard Deviation 9.44 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Vitality: Month 24 (n=13,11,8) | 7.18 scores on a scale | Standard Deviation 14.06 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Vitality: Month 12 (n=13,12,9) | 16.30 scores on a scale | Standard Deviation 8.87 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Physical: Month 12 (n=13,12,9) | 11.67 scores on a scale | Standard Deviation 14.14 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Social Function: Month 12 (n=13,12,9) | 11.95 scores on a scale | Standard Deviation 12.55 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | General Health: Month 24 (n=13,10,10) | 1.83 scores on a scale | Standard Deviation 8.55 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Mental Health: Month 24 (n=13,11,10) | 2.22 scores on a scale | Standard Deviation 12.72 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Social Function: Month 18 (n=13,10,8) | 8.74 scores on a scale | Standard Deviation 13.77 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | General Health: Month 18 (n=13,9,8) | -1.29 scores on a scale | Standard Deviation 11.83 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Phys Func: Month 24 (n=13,11,10) | 4.30 scores on a scale | Standard Deviation 9.86 |
| Tofacitinib 30-15-10 mg BID | Change From Baseline in SF-36 v2 Subscale Scores by Visit | Social Function: Month 24 (n=13,11,10) | 9.68 scores on a scale | Standard Deviation 15.38 |
Secondary
Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR
Antibody-mediated rejection is defined as Category 2 and BPAR is defined as Category 4 of the Banff Classification, based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Acute humoral rejection was categorized as Grades I, II, III and acute/active cellular rejection was categorized as Grades IA, IB, IIA, IIB, and III. Only participants with first BPAR were included.
Time frame: Months 12, 18, 24, 36, 48, 60, 72, 84, 96, and Follow-Up (Month 98)
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 36 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 84 BPAR (n=18,14,13) | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 72 BPAR (n=18,14,13) | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 96 BPAR (n=18,14,13) | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Follow-up Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 60 BPAR (n=18,14,13) | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 24 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 18 BPAR (n=18,14,13) | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 48 BPAR (n=18,14,13) | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 60 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 12 BPAR (n=18,14,13) | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 84 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 48 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 18 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 24 BPAR (n=18,14,13) | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 96 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 12 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 36 BPAR (n=18,14,13) | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 72 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Follow-up BPAR (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 18 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 60 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 72 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 84 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 96 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 18 BPAR (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 24 BPAR (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 36 BPAR (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 60 BPAR (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 96 BPAR (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Follow-up BPAR (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 48 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Follow-up Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 12 BPAR (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 48 BPAR (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 72 BPAR (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 84 BPAR (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 12 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 24 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 36 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 96 BPAR (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 84 BPAR (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 24 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 72 BPAR (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 60 BPAR (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 96 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 36 BPAR (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Follow-up BPAR (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 24 BPAR (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 84 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 12 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 18 BPAR (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 72 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 36 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Follow-up Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 60 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 18 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 48 Antibody-mediated rejection (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 12 BPAR (n=18,14,13) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With a First Antibody-Mediated Rejection or First BPAR | Month 48 BPAR (n=18,14,13) | 0 percentage of participants |
Secondary
Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN
Ordered categorical severity of first BPCAN was classified according to the Banff Classification. Grade I: mild, grade II: moderate and grade III: severe interstitial fibrosis and tubular atrophy/loss. (Racusen et al: The Banff classification, 1999).
Time frame: Months 12, 18, 24, 36, 48, 60, 72, 84, and 96
Population: FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 84: Grade III | NA percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 48: Grade III | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 12: Grade II | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 96: Grade II | NA percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 48: Grade I | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 12: Grade III | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 24: Grade III | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 36: Grade II | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 18: Grade II | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 18: Grade I | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 36: Grade I | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 18: Grade III | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 24: Grade I | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 84: Grade II | NA percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 12: Grade I | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 84: Grade I | NA percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 36: Grade III | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 48: Grade II | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 96: Grade III | NA percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 72: Grade III | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 24: Grade II | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 72: Grade II | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 60: Grade II | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 60: Grade III | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 72: Grade I | 0 percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 96: Grade I | NA percentage of participants |
| Tacrolimus | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 60: Grade I | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 60: Grade I | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 12: Grade I | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 18: Grade I | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 18: Grade III | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 24: Grade II | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 24: Grade III | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 36: Grade II | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 48: Grade II | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 72: Grade I | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 96: Grade II | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 12: Grade II | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 12: Grade III | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 18: Grade II | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 24: Grade I | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 36: Grade I | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 36: Grade III | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 48: Grade I | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 48: Grade III | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 60: Grade II | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 60: Grade III | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 72: Grade II | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 72: Grade III | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 84: Grade I | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 84: Grade II | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 84: Grade III | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 96: Grade I | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 96: Grade III | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 72: Grade I | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 12: Grade I | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 60: Grade II | 7.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 60: Grade III | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 84: Grade III | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 60: Grade I | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 18: Grade III | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 72: Grade II | 7.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 48: Grade II | 7.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 96: Grade III | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 72: Grade III | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 36: Grade II | 7.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 96: Grade I | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 84: Grade I | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 24: Grade II | 7.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 18: Grade II | 7.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 24: Grade III | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 36: Grade I | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 18: Grade I | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 12: Grade III | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 36: Grade III | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 12: Grade II | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 84: Grade II | 7.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 48: Grade I | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 96: Grade II | 7.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 24: Grade I | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Cumulative Percentage of Participants With Ordered Categorical Severity of First BPCAN | Month 48: Grade III | 0 percentage of participants |
Secondary
End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale
ESRD-SCL: 43-item, disease-specific, self-administered questionnaire. Participants' rated question At the moment, how much do you suffer? for each item on 5-point scale, ranged from 0 (not at all) to 4 (extremely). Consisted of 6 subscales: cardiac and renal dysfunction (Range, 0-28), increased growth of gum and hair (Range, 0-20), limited cognitive capacity (Range, 0-32), limited physical capacity (Range, 0-40), side effects (SEs) of corticosteroids (Range, 0-20), transplantation associated psychological distress (TAPD; Range, 0-32); higher scores=greater dysfunction for each subscale. Total score: 0-172, higher scores=greater dysfunction.
Time frame: Months 12, 18, and 24
Population: Safety population; n=number of participants in Safety Population per visit with non-missing value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Increased growth gum/hair: Month 12 (n=13,13,4) | 0.17 scores on a scale | Standard Deviation 0.24 |
| Tacrolimus | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Cardiac / Renal Dysfunc: Month 12 (n = 13, 13, 8) | 0.18 scores on a scale | Standard Deviation 0.26 |
| Tacrolimus | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Transplant-assoc psychodistress:Mnth24(n=16,13,11) | 0.77 scores on a scale | Standard Deviation 0.72 |
| Tacrolimus | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Side effects Corticosteroids: Month24 (n=15,13,11) | 0.53 scores on a scale | Standard Deviation 0.64 |
| Tacrolimus | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Cardiac / Renal Dysfunc: Month 18 (n = 14, 12, 9) | 0.25 scores on a scale | Standard Deviation 0.38 |
| Tacrolimus | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Limited Physical: Month 18 (n = 15, 12, 10) | 0.53 scores on a scale | Standard Deviation 0.69 |
| Tacrolimus | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Side effects Corticosteroids: Month18 (n=14,12,10) | 0.39 scores on a scale | Standard Deviation 0.65 |
| Tacrolimus | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Cardiac / Renal Dysfunc: Month 24 (n = 15, 13, 11) | 0.33 scores on a scale | Standard Deviation 0.51 |
| Tacrolimus | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Global Score: Month 24 (n = 16, 13, 11) | 0.57 scores on a scale | Standard Deviation 0.59 |
| Tacrolimus | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Side effects Corticosteroids: Month 12 (n=13,13,8) | 0.29 scores on a scale | Standard Deviation 0.35 |
| Tacrolimus | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Transplant-assoc psychodistress:Mnth18(n=15,12,10) | 0.70 scores on a scale | Standard Deviation 0.81 |
| Tacrolimus | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Limited Physical: Month 24 (n = 16, 13, 11) | 0.60 scores on a scale | Standard Deviation 0.69 |
| Tacrolimus | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Global Score: Month 12 (n = 13, 12, 8) | 0.28 scores on a scale | Standard Deviation 0.26 |
| Tacrolimus | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Transplant-assoc psycho distress:Mnth12(n=13,12,8) | 0.40 scores on a scale | Standard Deviation 0.42 |
| Tacrolimus | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Limited Cognitive: Month 12 (n = 13, 12, 8) | 0.41 scores on a scale | Standard Deviation 0.4 |
| Tacrolimus | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Limited Physical: Month 12 (n = 13, 12, 8) | 0.22 scores on a scale | Standard Deviation 0.25 |
| Tacrolimus | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Increased growth gum/hair: Month 24 (n=16,13,11) | 0.41 scores on a scale | Standard Deviation 0.49 |
| Tacrolimus | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Limited Cognitive: Month 18 (n = 15, 12, 10) | 0.63 scores on a scale | Standard Deviation 0.89 |
| Tacrolimus | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Global Score: Month 18 (n = 15, 12, 10) | 0.50 scores on a scale | Standard Deviation 0.65 |
| Tacrolimus | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Increased growth gum/hair: Month 18 (n=15,12,10) | 0.17 scores on a scale | Standard Deviation 0.28 |
| Tacrolimus | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Limited Cognitive: Month 24 (n = 16, 13, 11) | 0.65 scores on a scale | Standard Deviation 0.85 |
| Tofacitinib 15-10-5 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Limited Cognitive: Month 24 (n = 16, 13, 11) | 0.57 scores on a scale | Standard Deviation 0.67 |
| Tofacitinib 15-10-5 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Global Score: Month 24 (n = 16, 13, 11) | 0.40 scores on a scale | Standard Deviation 0.4 |
| Tofacitinib 15-10-5 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Limited Physical: Month 12 (n = 13, 12, 8) | 0.37 scores on a scale | Standard Deviation 0.4 |
| Tofacitinib 15-10-5 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Limited Physical: Month 18 (n = 15, 12, 10) | 0.41 scores on a scale | Standard Deviation 0.38 |
| Tofacitinib 15-10-5 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Limited Physical: Month 24 (n = 16, 13, 11) | 0.44 scores on a scale | Standard Deviation 0.46 |
| Tofacitinib 15-10-5 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Limited Cognitive: Month 12 (n = 13, 12, 8) | 0.45 scores on a scale | Standard Deviation 0.45 |
| Tofacitinib 15-10-5 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Limited Cognitive: Month 18 (n = 15, 12, 10) | 0.42 scores on a scale | Standard Deviation 0.42 |
| Tofacitinib 15-10-5 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Cardiac / Renal Dysfunc: Month 12 (n = 13, 13, 8) | 0.27 scores on a scale | Standard Deviation 0.31 |
| Tofacitinib 15-10-5 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Cardiac / Renal Dysfunc: Month 18 (n = 14, 12, 9) | 0.30 scores on a scale | Standard Deviation 0.31 |
| Tofacitinib 15-10-5 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Cardiac / Renal Dysfunc: Month 24 (n = 15, 13, 11) | 0.31 scores on a scale | Standard Deviation 0.35 |
| Tofacitinib 15-10-5 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Side effects Corticosteroids: Month 12 (n=13,13,8) | 0.57 scores on a scale | Standard Deviation 0.8 |
| Tofacitinib 15-10-5 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Side effects Corticosteroids: Month18 (n=14,12,10) | 0.45 scores on a scale | Standard Deviation 0.66 |
| Tofacitinib 15-10-5 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Side effects Corticosteroids: Month24 (n=15,13,11) | 0.26 scores on a scale | Standard Deviation 0.35 |
| Tofacitinib 15-10-5 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Increased growth gum/hair: Month 12 (n=13,13,4) | 0.15 scores on a scale | Standard Deviation 0.25 |
| Tofacitinib 15-10-5 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Increased growth gum/hair: Month 18 (n=15,12,10) | 0.23 scores on a scale | Standard Deviation 0.31 |
| Tofacitinib 15-10-5 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Increased growth gum/hair: Month 24 (n=16,13,11) | 0.28 scores on a scale | Standard Deviation 0.48 |
| Tofacitinib 15-10-5 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Transplant-assoc psycho distress:Mnth12(n=13,12,8) | 0.50 scores on a scale | Standard Deviation 0.41 |
| Tofacitinib 15-10-5 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Transplant-assoc psychodistress:Mnth18(n=15,12,10) | 0.42 scores on a scale | Standard Deviation 0.37 |
| Tofacitinib 15-10-5 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Transplant-assoc psychodistress:Mnth24(n=16,13,11) | 0.45 scores on a scale | Standard Deviation 0.4 |
| Tofacitinib 15-10-5 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Global Score: Month 12 (n = 13, 12, 8) | 0.39 scores on a scale | Standard Deviation 0.36 |
| Tofacitinib 15-10-5 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Global Score: Month 18 (n = 15, 12, 10) | 0.38 scores on a scale | Standard Deviation 0.34 |
| Tofacitinib 30-15-10 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Increased growth gum/hair: Month 12 (n=13,13,4) | 0.08 scores on a scale | Standard Deviation 0.15 |
| Tofacitinib 30-15-10 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Limited Cognitive: Month 18 (n = 15, 12, 10) | 0.29 scores on a scale | Standard Deviation 0.43 |
| Tofacitinib 30-15-10 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Global Score: Month 24 (n = 16, 13, 11) | 0.47 scores on a scale | Standard Deviation 0.41 |
| Tofacitinib 30-15-10 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Increased growth gum/hair: Month 18 (n=15,12,10) | 0.14 scores on a scale | Standard Deviation 0.16 |
| Tofacitinib 30-15-10 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Limited Cognitive: Month 12 (n = 13, 12, 8) | 0.30 scores on a scale | Standard Deviation 0.36 |
| Tofacitinib 30-15-10 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Transplant-assoc psychodistress:Mnth24(n=16,13,11) | 0.57 scores on a scale | Standard Deviation 0.74 |
| Tofacitinib 30-15-10 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Increased growth gum/hair: Month 24 (n=16,13,11) | 0.11 scores on a scale | Standard Deviation 0.21 |
| Tofacitinib 30-15-10 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Limited Physical: Month 24 (n = 16, 13, 11) | 0.55 scores on a scale | Standard Deviation 0.46 |
| Tofacitinib 30-15-10 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Global Score: Month 18 (n = 15, 12, 10) | 0.36 scores on a scale | Standard Deviation 0.25 |
| Tofacitinib 30-15-10 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Transplant-assoc psycho distress:Mnth12(n=13,12,8) | 0.48 scores on a scale | Standard Deviation 0.33 |
| Tofacitinib 30-15-10 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Cardiac / Renal Dysfunc: Month 24 (n = 15, 13, 11) | 0.34 scores on a scale | Standard Deviation 0.24 |
| Tofacitinib 30-15-10 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Limited Physical: Month 18 (n = 15, 12, 10) | 0.46 scores on a scale | Standard Deviation 0.55 |
| Tofacitinib 30-15-10 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Side effects Corticosteroids: Month 12 (n=13,13,8) | 0.70 scores on a scale | Standard Deviation 0.83 |
| Tofacitinib 30-15-10 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Cardiac / Renal Dysfunc: Month 18 (n = 14, 12, 9) | 0.22 scores on a scale | Standard Deviation 0.2 |
| Tofacitinib 30-15-10 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Global Score: Month 12 (n = 13, 12, 8) | 0.33 scores on a scale | Standard Deviation 0.25 |
| Tofacitinib 30-15-10 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Side effects Corticosteroids: Month18 (n=14,12,10) | 0.58 scores on a scale | Standard Deviation 0.61 |
| Tofacitinib 30-15-10 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Cardiac / Renal Dysfunc: Month 12 (n = 13, 13, 8) | 0.18 scores on a scale | Standard Deviation 0.18 |
| Tofacitinib 30-15-10 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Transplant-assoc psychodistress:Mnth18(n=15,12,10) | 0.47 scores on a scale | Standard Deviation 0.19 |
| Tofacitinib 30-15-10 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Side effects Corticosteroids: Month24 (n=15,13,11) | 0.69 scores on a scale | Standard Deviation 0.66 |
| Tofacitinib 30-15-10 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Limited Cognitive: Month 24 (n = 16, 13, 11) | 0.48 scores on a scale | Standard Deviation 0.54 |
| Tofacitinib 30-15-10 mg BID | End Stage Renal Disease Symptom Checklist (ESRD-SCL) Transplanation Module Scores by Visit and Scale | Limited Physical: Month 12 (n = 13, 12, 8) | 0.29 scores on a scale | Standard Deviation 0.4 |
Secondary
Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit
Calculated as number of copies per 500 mg DNA.
Time frame: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 66 (n=10,13,9) | 0.40 number of copies/500 mg DNA | Standard Deviation 0.97 |
| Tacrolimus | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 15 (n=17,14,12) | 5.47 number of copies/500 mg DNA | Standard Deviation 22.05 |
| Tacrolimus | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 24 (n=15,13,12) | 0.00 number of copies/500 mg DNA | Standard Deviation 0 |
| Tacrolimus | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 60 (n=13,13,10) | 0.31 number of copies/500 mg DNA | Standard Deviation 0.63 |
| Tacrolimus | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 30 (n=13,14,10) | 2.15 number of copies/500 mg DNA | Standard Deviation 7.19 |
| Tacrolimus | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 90 (n=0,12,7) | NA number of copies/500 mg DNA | — |
| Tacrolimus | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 54 (n=14,14,10) | 0.64 number of copies/500 mg DNA | Standard Deviation 1.08 |
| Tacrolimus | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 36 (n=15,14,8) | 1.20 number of copies/500 mg DNA | Standard Deviation 3.19 |
| Tacrolimus | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 84 (n=0,12,8) | NA number of copies/500 mg DNA | — |
| Tacrolimus | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 42 (n=14,12,9) | 0.57 number of copies/500 mg DNA | Standard Deviation 2.14 |
| Tacrolimus | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 18 (n=17,13,12) | 0.59 number of copies/500 mg DNA | Standard Deviation 2.18 |
| Tacrolimus | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 78 (n=0,12,8) | NA number of copies/500 mg DNA | — |
| Tacrolimus | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 9 (n=17,14,12) | 0.41 number of copies/500 mg DNA | Standard Deviation 1.46 |
| Tacrolimus | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 96 (n=0,9,6) | NA number of copies/500 mg DNA | — |
| Tacrolimus | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 72 (n=9,12,8) | 1.11 number of copies/500 mg DNA | Standard Deviation 3.33 |
| Tacrolimus | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 12 (n=17,14,12) | 0.12 number of copies/500 mg DNA | Standard Deviation 0.49 |
| Tacrolimus | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 48 (n=15,9,6) | 0.07 number of copies/500 mg DNA | Standard Deviation 0.26 |
| Tofacitinib 15-10-5 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 54 (n=14,14,10) | 13.86 number of copies/500 mg DNA | Standard Deviation 26.4 |
| Tofacitinib 15-10-5 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 18 (n=17,13,12) | 21.92 number of copies/500 mg DNA | Standard Deviation 56.56 |
| Tofacitinib 15-10-5 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 24 (n=15,13,12) | 10.38 number of copies/500 mg DNA | Standard Deviation 24.22 |
| Tofacitinib 15-10-5 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 48 (n=15,9,6) | 17.00 number of copies/500 mg DNA | Standard Deviation 32.6 |
| Tofacitinib 15-10-5 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 84 (n=0,12,8) | 1.08 number of copies/500 mg DNA | Standard Deviation 1.51 |
| Tofacitinib 15-10-5 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 9 (n=17,14,12) | 1.00 number of copies/500 mg DNA | Standard Deviation 2.18 |
| Tofacitinib 15-10-5 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 12 (n=17,14,12) | 4.07 number of copies/500 mg DNA | Standard Deviation 11.89 |
| Tofacitinib 15-10-5 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 15 (n=17,14,12) | 6.71 number of copies/500 mg DNA | Standard Deviation 20.36 |
| Tofacitinib 15-10-5 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 30 (n=13,14,10) | 13.57 number of copies/500 mg DNA | Standard Deviation 31.74 |
| Tofacitinib 15-10-5 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 36 (n=15,14,8) | 8.64 number of copies/500 mg DNA | Standard Deviation 25.37 |
| Tofacitinib 15-10-5 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 42 (n=14,12,9) | 15.50 number of copies/500 mg DNA | Standard Deviation 19.1 |
| Tofacitinib 15-10-5 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 60 (n=13,13,10) | 11.46 number of copies/500 mg DNA | Standard Deviation 27.2 |
| Tofacitinib 15-10-5 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 66 (n=10,13,9) | 17.38 number of copies/500 mg DNA | Standard Deviation 26.83 |
| Tofacitinib 15-10-5 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 72 (n=9,12,8) | 11.08 number of copies/500 mg DNA | Standard Deviation 27.22 |
| Tofacitinib 15-10-5 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 78 (n=0,12,8) | 10.08 number of copies/500 mg DNA | Standard Deviation 16.1 |
| Tofacitinib 15-10-5 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 90 (n=0,12,7) | 2.92 number of copies/500 mg DNA | Standard Deviation 5.18 |
| Tofacitinib 15-10-5 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 96 (n=0,9,6) | 5.67 number of copies/500 mg DNA | Standard Deviation 6.69 |
| Tofacitinib 30-15-10 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 48 (n=15,9,6) | 11.50 number of copies/500 mg DNA | Standard Deviation 21.42 |
| Tofacitinib 30-15-10 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 60 (n=13,13,10) | 10.20 number of copies/500 mg DNA | Standard Deviation 20.86 |
| Tofacitinib 30-15-10 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 12 (n=17,14,12) | 8.42 number of copies/500 mg DNA | Standard Deviation 18.46 |
| Tofacitinib 30-15-10 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 96 (n=0,9,6) | 17.67 number of copies/500 mg DNA | Standard Deviation 23.11 |
| Tofacitinib 30-15-10 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 66 (n=10,13,9) | 31.11 number of copies/500 mg DNA | Standard Deviation 32.92 |
| Tofacitinib 30-15-10 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 9 (n=17,14,12) | 3.17 number of copies/500 mg DNA | Standard Deviation 3.3 |
| Tofacitinib 30-15-10 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 90 (n=0,12,7) | 9.29 number of copies/500 mg DNA | Standard Deviation 20.69 |
| Tofacitinib 30-15-10 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 72 (n=9,12,8) | 19.25 number of copies/500 mg DNA | Standard Deviation 41.8 |
| Tofacitinib 30-15-10 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 84 (n=0,12,8) | 10.88 number of copies/500 mg DNA | Standard Deviation 21.24 |
| Tofacitinib 30-15-10 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 24 (n=15,13,12) | 10.83 number of copies/500 mg DNA | Standard Deviation 25.9 |
| Tofacitinib 30-15-10 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 36 (n=15,14,8) | 42.63 number of copies/500 mg DNA | Standard Deviation 110.49 |
| Tofacitinib 30-15-10 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 78 (n=0,12,8) | 17.63 number of copies/500 mg DNA | Standard Deviation 42.28 |
| Tofacitinib 30-15-10 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 42 (n=14,12,9) | 17.00 number of copies/500 mg DNA | Standard Deviation 26.98 |
| Tofacitinib 30-15-10 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 30 (n=13,14,10) | 23.80 number of copies/500 mg DNA | Standard Deviation 39.6 |
| Tofacitinib 30-15-10 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 15 (n=17,14,12) | 18.42 number of copies/500 mg DNA | Standard Deviation 24.27 |
| Tofacitinib 30-15-10 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 54 (n=14,14,10) | 6.30 number of copies/500 mg DNA | Standard Deviation 12.1 |
| Tofacitinib 30-15-10 mg BID | Epstein Barr Virus (EBV) Deooxyribonucleic Acid (DNA) Levels Determined Using Polymerase Chain Reaction (PCR) by Visit | Month 18 (n=17,13,12) | 21.50 number of copies/500 mg DNA | Standard Deviation 32.52 |
Secondary
Fasting Serum Glucose Levels (mg/dL) by Visit
Time frame: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 72 (n=9,13,7) | 100.44 mg/dL | Standard Deviation 39.41 |
| Tacrolimus | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 36 (n=15,14,9) | 108.20 mg/dL | Standard Deviation 39.01 |
| Tacrolimus | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 24 (n=17,14,12) | 113.71 mg/dL | Standard Deviation 32.54 |
| Tacrolimus | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 15 (n=17,13,11) | 95.41 mg/dL | Standard Deviation 20.99 |
| Tacrolimus | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 42 (n=15,14,9) | 104.47 mg/dL | Standard Deviation 30.92 |
| Tacrolimus | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 96 (n=0,11,6) | NA mg/dL | — |
| Tacrolimus | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 84 (n=0,12,6) | NA mg/dL | — |
| Tacrolimus | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 48 (n=15,14,10) | 112.93 mg/dL | Standard Deviation 49.35 |
| Tacrolimus | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 30 (n=14,14,10) | 102.50 mg/dL | Standard Deviation 29.02 |
| Tacrolimus | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 9 (n=18,14,10) | 96.89 mg/dL | Standard Deviation 18.78 |
| Tacrolimus | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 54 (n=12,14,10) | 126.58 mg/dL | Standard Deviation 81.04 |
| Tacrolimus | Fasting Serum Glucose Levels (mg/dL) by Visit | Follow-up (n=6,10,7) | 112.17 mg/dL | Standard Deviation 42.96 |
| Tacrolimus | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 18 (n=18,14,12) | 94.72 mg/dL | Standard Deviation 21.38 |
| Tacrolimus | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 60 (n=12,12,10) | 107.08 mg/dL | Standard Deviation 22.95 |
| Tacrolimus | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 78 (n=0,12,8) | NA mg/dL | — |
| Tacrolimus | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 90 (n=0,11,7) | NA mg/dL | — |
| Tacrolimus | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 66 (n=10,13,10) | 111.90 mg/dL | Standard Deviation 36.39 |
| Tacrolimus | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 12 (n=17,14,12) | 103.00 mg/dL | Standard Deviation 26.25 |
| Tofacitinib 15-10-5 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 66 (n=10,13,10) | 143.77 mg/dL | Standard Deviation 103.15 |
| Tofacitinib 15-10-5 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 72 (n=9,13,7) | 117.69 mg/dL | Standard Deviation 61.22 |
| Tofacitinib 15-10-5 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 78 (n=0,12,8) | 131.67 mg/dL | Standard Deviation 66.25 |
| Tofacitinib 15-10-5 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 24 (n=17,14,12) | 115.64 mg/dL | Standard Deviation 45.68 |
| Tofacitinib 15-10-5 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 84 (n=0,12,6) | 139.50 mg/dL | Standard Deviation 86.88 |
| Tofacitinib 15-10-5 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 90 (n=0,11,7) | 114.55 mg/dL | Standard Deviation 33.39 |
| Tofacitinib 15-10-5 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 12 (n=17,14,12) | 133.79 mg/dL | Standard Deviation 51.07 |
| Tofacitinib 15-10-5 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 96 (n=0,11,6) | 154.64 mg/dL | Standard Deviation 115.73 |
| Tofacitinib 15-10-5 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Follow-up (n=6,10,7) | 126.30 mg/dL | Standard Deviation 75.84 |
| Tofacitinib 15-10-5 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 30 (n=14,14,10) | 137.86 mg/dL | Standard Deviation 77.07 |
| Tofacitinib 15-10-5 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 9 (n=18,14,10) | 115.14 mg/dL | Standard Deviation 42.16 |
| Tofacitinib 15-10-5 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 36 (n=15,14,9) | 128.00 mg/dL | Standard Deviation 54.34 |
| Tofacitinib 15-10-5 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 42 (n=15,14,9) | 113.71 mg/dL | Standard Deviation 47.34 |
| Tofacitinib 15-10-5 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 15 (n=17,13,11) | 128.08 mg/dL | Standard Deviation 85.36 |
| Tofacitinib 15-10-5 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 48 (n=15,14,10) | 123.29 mg/dL | Standard Deviation 77.74 |
| Tofacitinib 15-10-5 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 54 (n=12,14,10) | 119.21 mg/dL | Standard Deviation 50.14 |
| Tofacitinib 15-10-5 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 60 (n=12,12,10) | 136.17 mg/dL | Standard Deviation 68.68 |
| Tofacitinib 15-10-5 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 18 (n=18,14,12) | 117.93 mg/dL | Standard Deviation 51.81 |
| Tofacitinib 30-15-10 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Follow-up (n=6,10,7) | 98.86 mg/dL | Standard Deviation 31.73 |
| Tofacitinib 30-15-10 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 9 (n=18,14,10) | 97.90 mg/dL | Standard Deviation 19.44 |
| Tofacitinib 30-15-10 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 12 (n=17,14,12) | 102.75 mg/dL | Standard Deviation 35.7 |
| Tofacitinib 30-15-10 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 15 (n=17,13,11) | 99.18 mg/dL | Standard Deviation 33.34 |
| Tofacitinib 30-15-10 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 18 (n=18,14,12) | 112.50 mg/dL | Standard Deviation 48.45 |
| Tofacitinib 30-15-10 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 24 (n=17,14,12) | 122.25 mg/dL | Standard Deviation 33.94 |
| Tofacitinib 30-15-10 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 30 (n=14,14,10) | 140.00 mg/dL | Standard Deviation 79.88 |
| Tofacitinib 30-15-10 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 36 (n=15,14,9) | 143.33 mg/dL | Standard Deviation 76.69 |
| Tofacitinib 30-15-10 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 42 (n=15,14,9) | 109.56 mg/dL | Standard Deviation 34.93 |
| Tofacitinib 30-15-10 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 48 (n=15,14,10) | 98.00 mg/dL | Standard Deviation 13.8 |
| Tofacitinib 30-15-10 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 54 (n=12,14,10) | 116.30 mg/dL | Standard Deviation 69.12 |
| Tofacitinib 30-15-10 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 60 (n=12,12,10) | 111.70 mg/dL | Standard Deviation 34.86 |
| Tofacitinib 30-15-10 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 66 (n=10,13,10) | 112.90 mg/dL | Standard Deviation 48.43 |
| Tofacitinib 30-15-10 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 72 (n=9,13,7) | 127.43 mg/dL | Standard Deviation 74.82 |
| Tofacitinib 30-15-10 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 78 (n=0,12,8) | 98.50 mg/dL | Standard Deviation 30.07 |
| Tofacitinib 30-15-10 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 90 (n=0,11,7) | 96.43 mg/dL | Standard Deviation 16.83 |
| Tofacitinib 30-15-10 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 96 (n=0,11,6) | 100.33 mg/dL | Standard Deviation 15.65 |
| Tofacitinib 30-15-10 mg BID | Fasting Serum Glucose Levels (mg/dL) by Visit | Month 84 (n=0,12,6) | 112.50 mg/dL | Standard Deviation 50.12 |
Secondary
Hemoglobin A1c (HbA1c) Levels by Visit
Time frame: Months 12, 24, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 and Follow-up (Month 98)
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | Hemoglobin A1c (HbA1c) Levels by Visit | Month 96 (n=11,6) | NA % HbA1c | — |
| Tacrolimus | Hemoglobin A1c (HbA1c) Levels by Visit | Month 66 (n=12,14,10) | 6.13 % HbA1c | Standard Deviation 1.29 |
| Tacrolimus | Hemoglobin A1c (HbA1c) Levels by Visit | Month 42 (n=15,14,9) | 5.81 % HbA1c | Standard Deviation 1.08 |
| Tacrolimus | Hemoglobin A1c (HbA1c) Levels by Visit | Month 84 (n=12,8) | NA % HbA1c | — |
| Tacrolimus | Hemoglobin A1c (HbA1c) Levels by Visit | Month 60 (n=12,12,10) | 6.18 % HbA1c | Standard Deviation 1.11 |
| Tacrolimus | Hemoglobin A1c (HbA1c) Levels by Visit | Month 48 (n=15,14,10) | 6.03 % HbA1c | Standard Deviation 1.23 |
| Tacrolimus | Hemoglobin A1c (HbA1c) Levels by Visit | Month 12 (n=16,14,12) | 5.65 % HbA1c | Standard Deviation 0.69 |
| Tacrolimus | Hemoglobin A1c (HbA1c) Levels by Visit | Month 54 (n=14,14,10) | 6.39 % HbA1c | Standard Deviation 1.86 |
| Tacrolimus | Hemoglobin A1c (HbA1c) Levels by Visit | Month 90 (n=12,7) | NA % HbA1c | — |
| Tacrolimus | Hemoglobin A1c (HbA1c) Levels by Visit | Month 78 (n=12,8) | NA % HbA1c | — |
| Tacrolimus | Hemoglobin A1c (HbA1c) Levels by Visit | Month 24 (n=16,14,12) | 5.63 % HbA1c | Standard Deviation 0.68 |
| Tacrolimus | Hemoglobin A1c (HbA1c) Levels by Visit | Follow-up (n=3,13,6) | 6.50 % HbA1c | Standard Deviation 2 |
| Tacrolimus | Hemoglobin A1c (HbA1c) Levels by Visit | Month 72 (n=9,12,8) | 6.31 % HbA1c | Standard Deviation 1.72 |
| Tacrolimus | Hemoglobin A1c (HbA1c) Levels by Visit | Month 36 (n=15,14,8) | 5.75 % HbA1c | Standard Deviation 1.21 |
| Tofacitinib 15-10-5 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 90 (n=12,7) | 6.38 % HbA1c | Standard Deviation 1.8 |
| Tofacitinib 15-10-5 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 96 (n=11,6) | 6.32 % HbA1c | Standard Deviation 1.42 |
| Tofacitinib 15-10-5 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Follow-up (n=3,13,6) | 6.65 % HbA1c | Standard Deviation 1.76 |
| Tofacitinib 15-10-5 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 12 (n=16,14,12) | 6.84 % HbA1c | Standard Deviation 2.04 |
| Tofacitinib 15-10-5 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 24 (n=16,14,12) | 7.12 % HbA1c | Standard Deviation 2.2 |
| Tofacitinib 15-10-5 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 36 (n=15,14,8) | 7.19 % HbA1c | Standard Deviation 2.44 |
| Tofacitinib 15-10-5 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 42 (n=15,14,9) | 7.40 % HbA1c | Standard Deviation 2.56 |
| Tofacitinib 15-10-5 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 48 (n=15,14,10) | 7.25 % HbA1c | Standard Deviation 2.37 |
| Tofacitinib 15-10-5 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 54 (n=14,14,10) | 7.25 % HbA1c | Standard Deviation 1.94 |
| Tofacitinib 15-10-5 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 60 (n=12,12,10) | 7.03 % HbA1c | Standard Deviation 1.75 |
| Tofacitinib 15-10-5 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 66 (n=12,14,10) | 6.99 % HbA1c | Standard Deviation 1.82 |
| Tofacitinib 15-10-5 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 72 (n=9,12,8) | 6.93 % HbA1c | Standard Deviation 1.88 |
| Tofacitinib 15-10-5 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 78 (n=12,8) | 7.27 % HbA1c | Standard Deviation 2.52 |
| Tofacitinib 15-10-5 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 84 (n=12,8) | 6.66 % HbA1c | Standard Deviation 1.85 |
| Tofacitinib 30-15-10 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 36 (n=15,14,8) | 6.56 % HbA1c | Standard Deviation 1.35 |
| Tofacitinib 30-15-10 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 90 (n=12,7) | 6.54 % HbA1c | Standard Deviation 2.08 |
| Tofacitinib 30-15-10 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 66 (n=12,14,10) | 6.52 % HbA1c | Standard Deviation 1.59 |
| Tofacitinib 30-15-10 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 24 (n=16,14,12) | 6.28 % HbA1c | Standard Deviation 1.24 |
| Tofacitinib 30-15-10 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 84 (n=12,8) | 5.99 % HbA1c | Standard Deviation 1 |
| Tofacitinib 30-15-10 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 72 (n=9,12,8) | 6.29 % HbA1c | Standard Deviation 1.38 |
| Tofacitinib 30-15-10 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 12 (n=16,14,12) | 6.02 % HbA1c | Standard Deviation 0.82 |
| Tofacitinib 30-15-10 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 96 (n=11,6) | 6.77 % HbA1c | Standard Deviation 2.44 |
| Tofacitinib 30-15-10 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 48 (n=15,14,10) | 6.25 % HbA1c | Standard Deviation 0.82 |
| Tofacitinib 30-15-10 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 78 (n=12,8) | 6.43 % HbA1c | Standard Deviation 1.98 |
| Tofacitinib 30-15-10 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 54 (n=14,14,10) | 6.43 % HbA1c | Standard Deviation 1.28 |
| Tofacitinib 30-15-10 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 42 (n=15,14,9) | 6.68 % HbA1c | Standard Deviation 1.64 |
| Tofacitinib 30-15-10 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Follow-up (n=3,13,6) | 7.22 % HbA1c | Standard Deviation 2.71 |
| Tofacitinib 30-15-10 mg BID | Hemoglobin A1c (HbA1c) Levels by Visit | Month 60 (n=12,12,10) | 6.48 % HbA1c | Standard Deviation 1.47 |
Secondary
High-Density Lipoprotein (HDL) Levels by Visit
Time frame: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | High-Density Lipoprotein (HDL) Levels by Visit | Month 24 (n=17,14,12) | 53.76 mg/dL | Standard Deviation 18.6 |
| Tacrolimus | High-Density Lipoprotein (HDL) Levels by Visit | Month 12 (n=16,14,12) | 51.81 mg/dL | Standard Deviation 18.82 |
| Tacrolimus | High-Density Lipoprotein (HDL) Levels by Visit | Month 15 (n=16,14,12) | 51.31 mg/dL | Standard Deviation 16.08 |
| Tacrolimus | High-Density Lipoprotein (HDL) Levels by Visit | Month 18 (n=18,14,12) | 52.67 mg/dL | Standard Deviation 17.07 |
| Tacrolimus | High-Density Lipoprotein (HDL) Levels by Visit | Month 9 (n=18,14,12) | 54.83 mg/dL | Standard Deviation 14.92 |
| Tacrolimus | High-Density Lipoprotein (HDL) Levels by Visit | Month 30 (n=14,14,10) | 51.21 mg/dL | Standard Deviation 16.83 |
| Tacrolimus | High-Density Lipoprotein (HDL) Levels by Visit | Month 36 (n=15,14,9) | 53.13 mg/dL | Standard Deviation 16.92 |
| Tacrolimus | High-Density Lipoprotein (HDL) Levels by Visit | Month 42 (n=15,14,9) | 52.27 mg/dL | Standard Deviation 14.4 |
| Tacrolimus | High-Density Lipoprotein (HDL) Levels by Visit | Month 48 (n=15,14,10) | 49.67 mg/dL | Standard Deviation 16.56 |
| Tacrolimus | High-Density Lipoprotein (HDL) Levels by Visit | Month 54 (n=14,14,10) | 46.64 mg/dL | Standard Deviation 13.28 |
| Tacrolimus | High-Density Lipoprotein (HDL) Levels by Visit | Month 60 (n=13,13,10) | 45.23 mg/dL | Standard Deviation 11.89 |
| Tacrolimus | High-Density Lipoprotein (HDL) Levels by Visit | Month 66 (n=12,14,10) | 49.75 mg/dL | Standard Deviation 15.72 |
| Tacrolimus | High-Density Lipoprotein (HDL) Levels by Visit | Month 72 (n=9,12,8) | 46.67 mg/dL | Standard Deviation 12.4 |
| Tacrolimus | High-Density Lipoprotein (HDL) Levels by Visit | Month 78 (n=0,12,8) | NA mg/dL | — |
| Tacrolimus | High-Density Lipoprotein (HDL) Levels by Visit | Month 84 (n=0,12,8) | NA mg/dL | — |
| Tacrolimus | High-Density Lipoprotein (HDL) Levels by Visit | Month 90 (n=0,12,7) | NA mg/dL | — |
| Tacrolimus | High-Density Lipoprotein (HDL) Levels by Visit | Month 96 (n=0,11,6) | NA mg/dL | — |
| Tacrolimus | High-Density Lipoprotein (HDL) Levels by Visit | Follow-Up (n=6,12,8) | 55.67 mg/dL | Standard Deviation 10.95 |
| Tofacitinib 15-10-5 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Follow-Up (n=6,12,8) | 56.25 mg/dL | Standard Deviation 15.78 |
| Tofacitinib 15-10-5 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 9 (n=18,14,12) | 59.93 mg/dL | Standard Deviation 14.38 |
| Tofacitinib 15-10-5 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 54 (n=14,14,10) | 60.07 mg/dL | Standard Deviation 16.36 |
| Tofacitinib 15-10-5 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 72 (n=9,12,8) | 62.67 mg/dL | Standard Deviation 15.25 |
| Tofacitinib 15-10-5 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 12 (n=16,14,12) | 62.07 mg/dL | Standard Deviation 17.68 |
| Tofacitinib 15-10-5 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 84 (n=0,12,8) | 63.00 mg/dL | Standard Deviation 17.79 |
| Tofacitinib 15-10-5 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 90 (n=0,12,7) | 61.17 mg/dL | Standard Deviation 14.94 |
| Tofacitinib 15-10-5 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 15 (n=16,14,12) | 59.79 mg/dL | Standard Deviation 16.37 |
| Tofacitinib 15-10-5 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 60 (n=13,13,10) | 58.23 mg/dL | Standard Deviation 15.69 |
| Tofacitinib 15-10-5 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 96 (n=0,11,6) | 65.36 mg/dL | Standard Deviation 18.78 |
| Tofacitinib 15-10-5 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 18 (n=18,14,12) | 59.29 mg/dL | Standard Deviation 17.03 |
| Tofacitinib 15-10-5 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 48 (n=15,14,10) | 57.71 mg/dL | Standard Deviation 17.73 |
| Tofacitinib 15-10-5 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 78 (n=0,12,8) | 65.58 mg/dL | Standard Deviation 18.75 |
| Tofacitinib 15-10-5 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 24 (n=17,14,12) | 60.07 mg/dL | Standard Deviation 17.09 |
| Tofacitinib 15-10-5 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 42 (n=15,14,9) | 56.57 mg/dL | Standard Deviation 12.69 |
| Tofacitinib 15-10-5 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 66 (n=12,14,10) | 56.57 mg/dL | Standard Deviation 19.03 |
| Tofacitinib 15-10-5 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 30 (n=14,14,10) | 59.29 mg/dL | Standard Deviation 15.03 |
| Tofacitinib 15-10-5 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 36 (n=15,14,9) | 55.14 mg/dL | Standard Deviation 15.42 |
| Tofacitinib 30-15-10 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 30 (n=14,14,10) | 50.40 mg/dL | Standard Deviation 9.29 |
| Tofacitinib 30-15-10 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 36 (n=15,14,9) | 56.44 mg/dL | Standard Deviation 13.51 |
| Tofacitinib 30-15-10 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 42 (n=15,14,9) | 57.33 mg/dL | Standard Deviation 12.23 |
| Tofacitinib 30-15-10 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 84 (n=0,12,8) | 46.38 mg/dL | Standard Deviation 10.16 |
| Tofacitinib 30-15-10 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 48 (n=15,14,10) | 50.10 mg/dL | Standard Deviation 10.63 |
| Tofacitinib 30-15-10 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Follow-Up (n=6,12,8) | 45.38 mg/dL | Standard Deviation 12.64 |
| Tofacitinib 30-15-10 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 54 (n=14,14,10) | 52.80 mg/dL | Standard Deviation 12.27 |
| Tofacitinib 30-15-10 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 60 (n=13,13,10) | 58.30 mg/dL | Standard Deviation 28.33 |
| Tofacitinib 30-15-10 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 90 (n=0,12,7) | 49.57 mg/dL | Standard Deviation 9.43 |
| Tofacitinib 30-15-10 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 66 (n=12,14,10) | 51.40 mg/dL | Standard Deviation 13.92 |
| Tofacitinib 30-15-10 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 9 (n=18,14,12) | 52.58 mg/dL | Standard Deviation 16.32 |
| Tofacitinib 30-15-10 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 12 (n=16,14,12) | 56.00 mg/dL | Standard Deviation 16.99 |
| Tofacitinib 30-15-10 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 72 (n=9,12,8) | 48.38 mg/dL | Standard Deviation 14.06 |
| Tofacitinib 30-15-10 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 15 (n=16,14,12) | 53.08 mg/dL | Standard Deviation 16.72 |
| Tofacitinib 30-15-10 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 18 (n=18,14,12) | 52.92 mg/dL | Standard Deviation 15.17 |
| Tofacitinib 30-15-10 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 24 (n=17,14,12) | 55.17 mg/dL | Standard Deviation 17.78 |
| Tofacitinib 30-15-10 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 78 (n=0,12,8) | 49.38 mg/dL | Standard Deviation 14.79 |
| Tofacitinib 30-15-10 mg BID | High-Density Lipoprotein (HDL) Levels by Visit | Month 96 (n=0,11,6) | 52.00 mg/dL | Standard Deviation 10.97 |
Secondary
HOMA Insulin Resistance (IR) by Visit
HOMA-IR=fasting serum insulin\*fasting serum glucose/22.5. Measurement only performed in participants who were non-diabetic prior to kidney transplantation and who do not require treatment with oral hypoglycemic agents, anti diabetic agents, and/or insulin prior to the time of measurement.
Time frame: Months 12 and 24
Population: Safety population; n=number of participants who were eligible for OGTT and had data (non-mising) at that particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | HOMA Insulin Resistance (IR) by Visit | Month 12 (n=8,6,5) | 2.55 HOMA-IR | Standard Deviation 1.49 |
| Tacrolimus | HOMA Insulin Resistance (IR) by Visit | Month 24 (n=9,6,5) | 2.67 HOMA-IR | Standard Deviation 2.76 |
| Tofacitinib 15-10-5 mg BID | HOMA Insulin Resistance (IR) by Visit | Month 12 (n=8,6,5) | 2.24 HOMA-IR | Standard Deviation 1.85 |
| Tofacitinib 15-10-5 mg BID | HOMA Insulin Resistance (IR) by Visit | Month 24 (n=9,6,5) | 9.01 HOMA-IR | Standard Deviation 18.37 |
| Tofacitinib 30-15-10 mg BID | HOMA Insulin Resistance (IR) by Visit | Month 12 (n=8,6,5) | 2.54 HOMA-IR | Standard Deviation 1.51 |
| Tofacitinib 30-15-10 mg BID | HOMA Insulin Resistance (IR) by Visit | Month 24 (n=9,6,5) | 2.68 HOMA-IR | Standard Deviation 1.19 |
Secondary
Homeostatic Model Assessment (HOMA)-%B by Visit
HOMA-%B = (20 times \[\*\] fasting serum insulin) divided by (/) (fasting serum glucose minus \[-\] 3.5). HOMA-%B was only performed in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin prior to the time of measurements.
Time frame: Months 12 and 24
Population: Safety population; n=number of participants who were eligible for OGTT and had data (non-missing) at that particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | Homeostatic Model Assessment (HOMA)-%B by Visit | Month 12 (n=8,6,5) | 204.67 %B | Standard Deviation 195.58 |
| Tacrolimus | Homeostatic Model Assessment (HOMA)-%B by Visit | Month 24 (n=9,6,5) | 224.75 %B | Standard Deviation 333.49 |
| Tofacitinib 15-10-5 mg BID | Homeostatic Model Assessment (HOMA)-%B by Visit | Month 12 (n=8,6,5) | 142.23 %B | Standard Deviation 95.06 |
| Tofacitinib 15-10-5 mg BID | Homeostatic Model Assessment (HOMA)-%B by Visit | Month 24 (n=9,6,5) | 138.10 %B | Standard Deviation 89.84 |
| Tofacitinib 30-15-10 mg BID | Homeostatic Model Assessment (HOMA)-%B by Visit | Month 12 (n=8,6,5) | 194.65 %B | Standard Deviation 131.16 |
| Tofacitinib 30-15-10 mg BID | Homeostatic Model Assessment (HOMA)-%B by Visit | Month 24 (n=9,6,5) | 165.38 %B | Standard Deviation 68.73 |
Secondary
Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit
Kaplan-Meier analysis of percentage of participants surviving by time to event (death) within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier.
Time frame: Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Population: FAS; n=number of participants remaining at risk for the specified parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 1 (n=18,14,13) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 30 (n=15,14,12) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 96 (n=0,12,7) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 90 (n=0,13,8) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 36 (n=15,14,12) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 48 (n=14,14,11) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 78 (n=0,14,8) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 42 (n=15,14,11) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 72 (n=6,14,9) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 54 (n=14,14,11) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 12 (n=18,14,13) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 60 (n=13,14,11) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Day 1 (n=18,14,13) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 18 (n=17,14,13) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 15 (n=18,14,13) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 9 (n=18,14,13) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 66 (n=13,14,10) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 6 (n=18,14,13) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 3 (n=18,14,13) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 24 (n=17,14,13) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 84 (n=0,13,8) | NA percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 15 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 18 (n=17,14,13) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 42 (n=15,14,11) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 60 (n=13,14,11) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 96 (n=0,12,7) | 92.86 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Day 1 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 3 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 48 (n=14,14,11) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 24 (n=17,14,13) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 30 (n=15,14,12) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 36 (n=15,14,12) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 54 (n=14,14,11) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 66 (n=13,14,10) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 72 (n=6,14,9) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 78 (n=0,14,8) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 84 (n=0,13,8) | 92.86 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 90 (n=0,13,8) | 92.86 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 1 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 6 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 9 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 12 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 60 (n=13,14,11) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 84 (n=0,13,8) | 90.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 30 (n=15,14,12) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 9 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 90 (n=0,13,8) | 90.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Day 1 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 24 (n=17,14,13) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 96 (n=0,12,7) | 90.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 1 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 18 (n=17,14,13) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 3 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 15 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 54 (n=14,14,11) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 42 (n=15,14,11) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 66 (n=13,14,10) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 48 (n=14,14,11) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 6 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 72 (n=6,14,9) | 90.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 36 (n=15,14,12) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 12 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit | Month 78 (n=0,14,8) | 90.00 percentage of participants |
Secondary
Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit
Kaplan-Meier analysis of percentage of participants with CMV disease within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. CMV disease was an adverse event associated with the preferred term 'CMV infection'.
Time frame: Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Population: Safety population; n=number of participants remaining at risk for the specified parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 15 (n=17,13,12) | 5.56 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 6 (n=18,14,12) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 60 (n=12,13,10) | 5.56 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 78 (n=0,13,8) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 1 (n=18,14,13) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 72 (n=5,13,8) | 5.56 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 96 (n=0,12,7) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Day 1 (n=18,14,13) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 3 (n=18,14,12) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 24 (n=16,13,12) | 5.56 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 18 (n=16,13,12) | 5.56 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 9 (n=18,13,12) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 84 (n=0,12,8) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 30 (n=14,13,11) | 5.56 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 90 (n=0,12,8) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 66 (n=12,13,9) | 5.56 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 36 (n=14,13,11) | 5.56 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 48 (n=13,13,10) | 5.56 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 12 (n=18,13,12) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 42 (n=14,13,10) | 5.56 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 54 (n=13,13,10) | 5.56 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 66 (n=12,13,9) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 6 (n=18,14,12) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 15 (n=17,13,12) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 18 (n=16,13,12) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 24 (n=16,13,12) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 30 (n=14,13,11) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 48 (n=13,13,10) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 54 (n=13,13,10) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 72 (n=5,13,8) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 78 (n=0,13,8) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 84 (n=0,12,8) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 96 (n=0,12,7) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Day 1 (n=18,14,13) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 3 (n=18,14,12) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 9 (n=18,13,12) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 12 (n=18,13,12) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 36 (n=14,13,11) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 42 (n=14,13,10) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 60 (n=12,13,10) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 1 (n=18,14,13) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 90 (n=0,12,8) | 7.14 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 6 (n=18,14,12) | 7.69 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 66 (n=12,13,9) | 7.69 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 78 (n=0,13,8) | 7.69 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 12 (n=18,13,12) | 7.69 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 15 (n=17,13,12) | 7.69 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 18 (n=16,13,12) | 7.69 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 24 (n=16,13,12) | 7.69 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 48 (n=13,13,10) | 7.69 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 9 (n=18,13,12) | 7.69 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 42 (n=14,13,10) | 7.69 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 36 (n=14,13,11) | 7.69 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 96 (n=0,12,7) | 7.69 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 84 (n=0,12,8) | 7.69 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 3 (n=18,14,12) | 7.69 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 72 (n=5,13,8) | 7.69 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 30 (n=14,13,11) | 7.69 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Day 1 (n=18,14,13) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 60 (n=12,13,10) | 7.69 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 1 (n=18,14,13) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 90 (n=0,12,8) | 7.69 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Cytomegalovirus (CMV) Disease by Visit | Month 54 (n=13,13,10) | 7.69 percentage of participants |
Secondary
Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit
Kaplan-Meier analysis of percentage of participants with efficacy failure by time to first efficacy failure within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Efficacy failure was defined as first occurrence of BPAR, death, or graft loss.
Time frame: Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Population: FAS; n=number of participants remaining at risk for the specified parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 1 (n=17,14,13) | 5.56 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 78 (n=0,14,6) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 48 (n=13,14,9) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Day 1 (n=18,14,13) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 72 (n=5,14,7) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 54 (n=13,14,9) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 90 (n=0,13,6) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 66 (n=12,14,8) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 60 (n=12,14,9) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 18 (n=16,14,11) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 96 (n=0,12,6) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 12 (n=16,14,11) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 9 (n=16,14,11) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 24 (n=16,14,11) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 42 (n=14,14,9) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 6 (n=17,14,11) | 5.56 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 30 (n=14,14,10) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 15 (n=16,14,11) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 3 (n=17,14,11) | 5.56 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 36 (n=14,14,10) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 84 (n=0,13,6) | NA percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 48 (n=13,14,9) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 1 (n=17,14,13) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 42 (n=14,14,9) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 15 (n=16,14,11) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 18 (n=16,14,11) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 24 (n=16,14,11) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 30 (n=14,14,10) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 36 (n=14,14,10) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 54 (n=13,14,9) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 60 (n=12,14,9) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 66 (n=12,14,8) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 72 (n=5,14,7) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Day 1 (n=18,14,13) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 3 (n=17,14,11) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 6 (n=17,14,11) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 9 (n=16,14,11) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 12 (n=16,14,11) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 78 (n=0,14,6) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 84 (n=0,13,6) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 90 (n=0,13,6) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 96 (n=0,12,6) | 7.14 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 30 (n=14,14,10) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 9 (n=16,14,11) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 3 (n=17,14,11) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 24 (n=16,14,11) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 12 (n=16,14,11) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 6 (n=17,14,11) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 18 (n=16,14,11) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 96 (n=0,12,6) | 25.96 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 84 (n=0,13,6) | 25.96 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 90 (n=0,13,6) | 25.96 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 60 (n=12,14,9) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 54 (n=13,14,9) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 15 (n=16,14,11) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 66 (n=12,14,8) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 48 (n=13,14,9) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Day 1 (n=18,14,13) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 72 (n=5,14,7) | 25.96 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 42 (n=14,14,9) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 78 (n=0,14,6) | 25.96 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 36 (n=14,14,10) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit | Month 1 (n=17,14,13) | 0.00 percentage of participants |
Secondary
Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit
Kaplan-Meier analysis of percentage of participants with first BPCAN by time to first BPCAN within 96 months post-transplant. BPCAN was defined as chronic allograft nephropathy (Category 5 of the Banff Classification), based on the assessment of the renal allograft biopsy by a central, blinded pathologist. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Includes BPCAN diagnosed on biopsies done for cause and ready by the central pathologist.
Time frame: Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Population: FAS; n=number of participants remaining at risk for the specified parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 48 (n=14,14,9) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 1 (n=18,14,13) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 6 (n=18,14,12) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 15 (n=18,14,12) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Moth 36 (n=15,14,10) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 42 (n=15,14,9) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 54 (n=14,14,9) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 66 (n=13,14,8) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 72 (n=6,14,7) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 84 (n=0,13,6) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 96 (n=0,12,6) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 3 (n=18,14,12) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 9 (n=18,14,12) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 12 (n=18,14,12) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 18 (n=17,14,12) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 24 (n=17,14,11) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 30 (n=15,14,10) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 60 (n=13,14,9) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 78 (n=0,14,6) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 90 (n=0,13,6) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Day 1 (n=18,14,13) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 60 (n=13,14,9) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 72 (n=6,14,7) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 78 (n=0,14,6) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 90 (n=0,13,6) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 84 (n=0,13,6) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 54 (n=14,14,9) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 1 (n=18,14,13) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 66 (n=13,14,8) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 3 (n=18,14,12) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 6 (n=18,14,12) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 15 (n=18,14,12) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 96 (n=0,12,6) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 30 (n=15,14,10) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 9 (n=18,14,12) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 12 (n=18,14,12) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Moth 36 (n=15,14,10) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 18 (n=17,14,12) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 24 (n=17,14,11) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 42 (n=15,14,9) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 48 (n=14,14,9) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Day 1 (n=18,14,13) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 96 (n=0,12,6) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 60 (n=13,14,9) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 48 (n=14,14,9) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 66 (n=13,14,8) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 54 (n=14,14,9) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Day 1 (n=18,14,13) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Moth 36 (n=15,14,10) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 1 (n=18,14,13) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 30 (n=15,14,10) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 84 (n=0,13,6) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 6 (n=18,14,12) | 7.69 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 18 (n=17,14,12) | 7.69 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 9 (n=18,14,12) | 7.69 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 42 (n=15,14,9) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 3 (n=18,14,12) | 7.69 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 12 (n=18,14,12) | 7.69 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 72 (n=6,14,7) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 90 (n=0,13,6) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 24 (n=17,14,11) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 78 (n=0,14,6) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With First Biopsy-Proven Chronic Allograft Nephropathy (BPCAN) by Visit | Month 15 (n=18,14,12) | 7.69 percentage of participants |
Secondary
Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit
Kaplan-Meier analysis of percentage of participants with graft survival by time to graft loss within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Graft loss was defined as graft nephrectomy, retransplantation, return to dialysis for ≥6 consecutive weeks, or death.
Time frame: Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Population: FAS; n=number of participants remaining at risk for the specified parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 48 (n=14,14,11) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 12 (n=18,14,13) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 90 (n=0,13,8) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 42 (n=15,14,11) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 15 (n=18,14,13) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 84 (n=0,13,8) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 36 (n=15,14,12) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 18 (n=17,14,13) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 1 (n=18,14,13) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 30 (n=15,14,12) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 24 (n=17,14,13) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 96 (n=0,12,7) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 78 (n=0,14,8) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 3 (n=18,14,13) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 66 (n=13,14,10) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 60 (n=13,14,11) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 6 (n=18,14,13) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Day 1 (n=18,14,13) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 54 (n=14,14,11) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 9 (n=18,14,13) | 100.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 72 (n=6,14,9) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 3 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 72 (n=6,14,9) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 78 (n=0,14,8) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 96 (n=0,12,7) | 92.86 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Day 1 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 1 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 6 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 9 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 12 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 15 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 18 (n=17,14,13) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 24 (n=17,14,13) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 30 (n=15,14,12) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 36 (n=15,14,12) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 42 (n=15,14,11) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 48 (n=14,14,11) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 54 (n=14,14,11) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 60 (n=13,14,11) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 66 (n=13,14,10) | 100.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 84 (n=0,13,8) | 92.86 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 90 (n=0,13,8) | 92.86 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 42 (n=15,14,11) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 9 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 96 (n=0,12,7) | 90.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 48 (n=14,14,11) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 6 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 90 (n=0,13,8) | 90.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 54 (n=14,14,11) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 3 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 84 (n=0,13,8) | 90.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 60 (n=13,14,11) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Day 1 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 66 (n=13,14,10) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 24 (n=17,14,13) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 18 (n=17,14,13) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 72 (n=6,14,9) | 90.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 30 (n=15,14,12) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 15 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 1 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 36 (n=15,14,12) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 12 (n=18,14,13) | 100.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Graft Survival by Visit | Month 78 (n=0,14,8) | 90.00 percentage of participants |
Secondary
Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit
Kaplan-Meier analysis of percentage of participants with NODM-2 by time to NODM-2 within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. NODM-2 was defined as an event experienced by a transplanted subject who meets any of the following criteria: (a) NODM-1; or (b) Symptoms of diabetes plus 2 casual serum glucose levels ≥200 mg/dL separated by at least approximately 24 hours. Casual was defined as any time of day without regard to time since last meal; or (c) Fasting serum glucose ≥126 mg/dL on 2 different occasions separated by at least approximately 24 hours. Fasting was defined as no caloric intake for at least 8 hours; or (d) 2-hour serum glucose ≥200 mg/dL during an OGTT (Oral Glucose Tolerance Test).
Time frame: Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Population: Safety population; n=number of participants remaining at risk for the specified parameter at a given visit. Participants who had a history of diabetes at transplant were not included in the Kaplan-Meier analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 24 (n=15,7,9) | 5.88 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 1 (n=17,8,9) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 30 (n=13,7,7) | 5.88 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 54 (n=12,7,7) | 5.88 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 84 (n=0,7,5) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 6 (n=17,8,9) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 3 (n=17,8,9) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 72 (n=6,7,6) | 14.44 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 15 (n=16,7,9) | 5.88 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 90 (n=0,7,5) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 66 (n=11,7,6) | 5.88 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 36 (n=13,7,7) | 5.88 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 78 (n=0,7,5) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 9 (n=16,7,9) | 5.88 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 42 (n=13,7,7) | 5.88 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 96 (n=0,7,5) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 60 (n=11,7,7) | 5.88 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 48 (n=12,7,7) | 5.88 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 18 (n=15,7,9) | 5.88 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Day 1 (n=17,8,9) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 12 (n=16,7,9) | 5.88 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 54 (n=12,7,7) | 12.50 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 60 (n=11,7,7) | 12.50 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 66 (n=11,7,6) | 12.50 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 12 (n=16,7,9) | 12.50 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 72 (n=6,7,6) | 12.50 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 78 (n=0,7,5) | 12.50 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Day 1 (n=17,8,9) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 84 (n=0,7,5) | 12.50 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 90 (n=0,7,5) | 12.50 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 15 (n=16,7,9) | 12.50 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 96 (n=0,7,5) | 12.50 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 18 (n=15,7,9) | 12.50 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 1 (n=17,8,9) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 3 (n=17,8,9) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 6 (n=17,8,9) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 30 (n=13,7,7) | 12.50 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 24 (n=15,7,9) | 12.50 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 36 (n=13,7,7) | 12.50 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 42 (n=13,7,7) | 12.50 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 9 (n=16,7,9) | 12.50 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 48 (n=12,7,7) | 12.50 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 96 (n=0,7,5) | 12.50 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 24 (n=15,7,9) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 72 (n=6,7,6) | 12.50 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Day 1 (n=17,8,9) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 6 (n=17,8,9) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 9 (n=16,7,9) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 12 (n=16,7,9) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 18 (n=15,7,9) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 1 (n=17,8,9) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 3 (n=17,8,9) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 30 (n=13,7,7) | 12.50 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 36 (n=13,7,7) | 12.50 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 42 (n=13,7,7) | 12.50 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 48 (n=12,7,7) | 12.50 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 54 (n=12,7,7) | 12.50 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 60 (n=11,7,7) | 12.50 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 66 (n=11,7,6) | 12.50 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 78 (n=0,7,5) | 12.50 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 84 (n=0,7,5) | 12.50 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 90 (n=0,7,5) | 12.50 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With NODM, Definition 2 (NODM-2) by Visit | Month 15 (n=16,7,9) | 0.00 percentage of participants |
Secondary
Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit
Kaplan-Meier analysis of percentage of participants with rejection by time to rejection within 96 months post-transplant. Time was defined from the date of first dose of study drug in Study A3921009 to the date of first occurrence of the event, censored at the day of the last visit or Day 2980 (the maximum scheduled day for follow-up 98 month), whichever comes earlier. Rejection was defined as first occurrence of BPAR, antibody-mediated rejection or suspicious for acute rejection. This included biopsies read by the central pathologist.
Time frame: Day 1 and Months 1, 3, 6, 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Population: FAS; n=number of participants remaining at risk for the specified parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 6 (n=17,13,11) | 5.56 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 96 (n=0,11,6) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 24 (n=16,13,11) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 90 (n=0,12,6) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 30 (n=14,13,10) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 60 (n=12,13,9) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 54 (n=13,13,9) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 36 (n=14,13,10) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 84 (n=0,12,6) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 48 (n=13,13,9) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 42 (n=14,13,9) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 9 (n=16,13,11) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 3 (n=17,13,11) | 5.56 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 78 (n=0,13,6) | NA percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 12 (n=16,13,11) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 66 (n=12,13,8) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 72 (n=5,13,6) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 15 (n=16,13,11) | 11.11 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Day 1 (n=18,14,13) | 0.00 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 1 (n=17,13,13) | 5.56 percentage of participants |
| Tacrolimus | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 18 (n=16,13,11) | 11.11 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 96 (n=0,11,6) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Day 1 (n=18,14,13) | 0.00 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 1 (n=17,13,13) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 3 (n=17,13,11) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 6 (n=17,13,11) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 9 (n=16,13,11) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 12 (n=16,13,11) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 15 (n=16,13,11) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 18 (n=16,13,11) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 30 (n=14,13,10) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 36 (n=14,13,10) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 48 (n=13,13,9) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 54 (n=13,13,9) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 66 (n=12,13,8) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 78 (n=0,13,6) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 84 (n=0,12,6) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 90 (n=0,12,6) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 72 (n=5,13,6) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 24 (n=16,13,11) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 42 (n=14,13,9) | 7.14 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 60 (n=12,13,9) | 7.14 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 24 (n=16,13,11) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 1 (n=17,13,13) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 90 (n=0,12,6) | 27.47 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 18 (n=16,13,11) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 96 (n=0,11,6) | 27.47 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 15 (n=16,13,11) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 12 (n=16,13,11) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 66 (n=12,13,8) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 72 (n=5,13,6) | 27.47 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 9 (n=16,13,11) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 6 (n=17,13,11) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 42 (n=14,13,9) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 36 (n=14,13,10) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 84 (n=0,12,6) | 27.47 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 48 (n=13,13,9) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 30 (n=14,13,10) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 60 (n=12,13,9) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 3 (n=17,13,11) | 15.38 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Day 1 (n=18,14,13) | 0.00 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 78 (n=0,13,6) | 27.47 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Kaplan-Meier Analysis of Percentage of Participants With Rejection by Visit | Month 54 (n=13,13,9) | 15.38 percentage of participants |
Secondary
Low-Density Lipoprotein (LDL) Levels by Visit
Time frame: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | Low-Density Lipoprotein (LDL) Levels by Visit | Month 18 (n=18,14,12) | 95.94 mg/dL | Standard Deviation 34.55 |
| Tacrolimus | Low-Density Lipoprotein (LDL) Levels by Visit | Month 30 (n=14,14,10) | 97.93 mg/dL | Standard Deviation 37.96 |
| Tacrolimus | Low-Density Lipoprotein (LDL) Levels by Visit | Month 78 (n=0,12,8) | NA mg/dL | — |
| Tacrolimus | Low-Density Lipoprotein (LDL) Levels by Visit | Month 12 (n=16,14,12) | 102.75 mg/dL | Standard Deviation 32.98 |
| Tacrolimus | Low-Density Lipoprotein (LDL) Levels by Visit | Month 36 (n=15,14,9) | 94.20 mg/dL | Standard Deviation 34.49 |
| Tacrolimus | Low-Density Lipoprotein (LDL) Levels by Visit | Month 96 (n=0,11,6) | NA mg/dL | — |
| Tacrolimus | Low-Density Lipoprotein (LDL) Levels by Visit | Month 42 (n=15,13,9) | 100.27 mg/dL | Standard Deviation 34.56 |
| Tacrolimus | Low-Density Lipoprotein (LDL) Levels by Visit | Month 72 (n=9,12,8) | 102.89 mg/dL | Standard Deviation 43.96 |
| Tacrolimus | Low-Density Lipoprotein (LDL) Levels by Visit | Month 24 (n=17,14,12) | 101.82 mg/dL | Standard Deviation 48.27 |
| Tacrolimus | Low-Density Lipoprotein (LDL) Levels by Visit | Month 48 (n=15,14,10) | 110.13 mg/dL | Standard Deviation 55.46 |
| Tacrolimus | Low-Density Lipoprotein (LDL) Levels by Visit | Follow-Up (n=6,12,8) | 110.00 mg/dL | Standard Deviation 49.37 |
| Tacrolimus | Low-Density Lipoprotein (LDL) Levels by Visit | Month 84 (n=0,12,8) | NA mg/dL | — |
| Tacrolimus | Low-Density Lipoprotein (LDL) Levels by Visit | Month 54 (n=14,13,10) | 108.36 mg/dL | Standard Deviation 40.27 |
| Tacrolimus | Low-Density Lipoprotein (LDL) Levels by Visit | Month 9 (n=18,12,11) | 107.11 mg/dL | Standard Deviation 37.14 |
| Tacrolimus | Low-Density Lipoprotein (LDL) Levels by Visit | Month 15 (n=16,14,11) | 95.13 mg/dL | Standard Deviation 28.34 |
| Tacrolimus | Low-Density Lipoprotein (LDL) Levels by Visit | Month 60 (n=13,13,10) | 105.62 mg/dL | Standard Deviation 42.86 |
| Tacrolimus | Low-Density Lipoprotein (LDL) Levels by Visit | Month 90 (n=0,12,7) | NA mg/dL | — |
| Tacrolimus | Low-Density Lipoprotein (LDL) Levels by Visit | Month 66 (n=12,13,10) | 109.83 mg/dL | Standard Deviation 44.59 |
| Tofacitinib 15-10-5 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 15 (n=16,14,11) | 117.29 mg/dL | Standard Deviation 39.8 |
| Tofacitinib 15-10-5 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 66 (n=12,13,10) | 100.92 mg/dL | Standard Deviation 33.67 |
| Tofacitinib 15-10-5 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 72 (n=9,12,8) | 100.00 mg/dL | Standard Deviation 28.63 |
| Tofacitinib 15-10-5 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 78 (n=0,12,8) | 103.25 mg/dL | Standard Deviation 31.13 |
| Tofacitinib 15-10-5 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 18 (n=18,14,12) | 95.14 mg/dL | Standard Deviation 37.28 |
| Tofacitinib 15-10-5 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 90 (n=0,12,7) | 101.92 mg/dL | Standard Deviation 41.67 |
| Tofacitinib 15-10-5 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 9 (n=18,12,11) | 138.83 mg/dL | Standard Deviation 65.33 |
| Tofacitinib 15-10-5 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 96 (n=0,11,6) | 93.82 mg/dL | Standard Deviation 28.22 |
| Tofacitinib 15-10-5 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Follow-Up (n=6,12,8) | 102.42 mg/dL | Standard Deviation 46.08 |
| Tofacitinib 15-10-5 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 24 (n=17,14,12) | 99.29 mg/dL | Standard Deviation 26.75 |
| Tofacitinib 15-10-5 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 84 (n=0,12,8) | 103.92 mg/dL | Standard Deviation 37.55 |
| Tofacitinib 15-10-5 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 30 (n=14,14,10) | 96.86 mg/dL | Standard Deviation 26.09 |
| Tofacitinib 15-10-5 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 36 (n=15,14,9) | 90.29 mg/dL | Standard Deviation 26.07 |
| Tofacitinib 15-10-5 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 42 (n=15,13,9) | 99.69 mg/dL | Standard Deviation 36.08 |
| Tofacitinib 15-10-5 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 12 (n=16,14,12) | 130.21 mg/dL | Standard Deviation 50.51 |
| Tofacitinib 15-10-5 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 48 (n=15,14,10) | 107.07 mg/dL | Standard Deviation 29.03 |
| Tofacitinib 15-10-5 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 54 (n=14,13,10) | 109.08 mg/dL | Standard Deviation 32.78 |
| Tofacitinib 15-10-5 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 60 (n=13,13,10) | 101.00 mg/dL | Standard Deviation 24.15 |
| Tofacitinib 30-15-10 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Follow-Up (n=6,12,8) | 129.38 mg/dL | Standard Deviation 39.71 |
| Tofacitinib 30-15-10 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 84 (n=0,12,8) | 117.88 mg/dL | Standard Deviation 32.73 |
| Tofacitinib 30-15-10 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 9 (n=18,12,11) | 109.82 mg/dL | Standard Deviation 32.6 |
| Tofacitinib 30-15-10 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 12 (n=16,14,12) | 119.42 mg/dL | Standard Deviation 39.38 |
| Tofacitinib 30-15-10 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 15 (n=16,14,11) | 106.64 mg/dL | Standard Deviation 26.98 |
| Tofacitinib 30-15-10 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 18 (n=18,14,12) | 104.42 mg/dL | Standard Deviation 39.3 |
| Tofacitinib 30-15-10 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 24 (n=17,14,12) | 114.00 mg/dL | Standard Deviation 38.82 |
| Tofacitinib 30-15-10 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 30 (n=14,14,10) | 115.50 mg/dL | Standard Deviation 33.45 |
| Tofacitinib 30-15-10 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 42 (n=15,13,9) | 102.11 mg/dL | Standard Deviation 24.94 |
| Tofacitinib 30-15-10 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 48 (n=15,14,10) | 99.70 mg/dL | Standard Deviation 34.56 |
| Tofacitinib 30-15-10 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 54 (n=14,13,10) | 96.50 mg/dL | Standard Deviation 41.04 |
| Tofacitinib 30-15-10 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 60 (n=13,13,10) | 98.60 mg/dL | Standard Deviation 44.67 |
| Tofacitinib 30-15-10 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 66 (n=12,13,10) | 91.90 mg/dL | Standard Deviation 33.14 |
| Tofacitinib 30-15-10 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 72 (n=9,12,8) | 114.25 mg/dL | Standard Deviation 46.57 |
| Tofacitinib 30-15-10 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 78 (n=0,12,8) | 111.13 mg/dL | Standard Deviation 41.46 |
| Tofacitinib 30-15-10 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 90 (n=0,12,7) | 99.00 mg/dL | Standard Deviation 23.93 |
| Tofacitinib 30-15-10 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 96 (n=0,11,6) | 99.83 mg/dL | Standard Deviation 30.3 |
| Tofacitinib 30-15-10 mg BID | Low-Density Lipoprotein (LDL) Levels by Visit | Month 36 (n=15,14,9) | 112.00 mg/dL | Standard Deviation 27.83 |
Secondary
Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire
HCRU assessed healthcare usage during previous 3 months for direct or indirect medical cost domains. Any number of events including visits to doctor or other healthcare professionals (HCP), non-medical practitioner, hospital ER treatment, hospitalizations, number of surgeries, diagnostic tests, and devices/aids used were reported.
Time frame: Months 12, 18, and 24
Population: Safety population; n=number of participants in Safety Population per visit with non-missing value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Previous Hospitalizations: Month 18 (n=3,1,1) | 1.3 events | Standard Deviation 0.6 |
| Tacrolimus | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Other Test/Procedures: Month 18 (n=4,3,0) | 2.5 events | Standard Deviation 1.7 |
| Tacrolimus | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Emergency Room Visits: Month 12 (n=1,1,2) | 1.0 events | — |
| Tacrolimus | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Doctor/HCP Visits: Month 18 (n=10,9,6) | 7.2 events | Standard Deviation 9 |
| Tacrolimus | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Emergency Room Visits: Month 18 (n=3,3,1) | 1.3 events | Standard Deviation 0.6 |
| Tacrolimus | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Emergency Room Visits: Month 24 (n=4,2,2) | 1.0 events | Standard Deviation 0 |
| Tacrolimus | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Doctor/HCP Visits: Month 24 (n=12,11,9) | 5.1 events | Standard Deviation 4.2 |
| Tacrolimus | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Other Test/Procedures: Month 12 (n=1,4,4) | 1.0 events | — |
| Tacrolimus | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Other Test/Procedures: Month 24 (n=4,3,4) | 3.8 events | Standard Deviation 2.8 |
| Tacrolimus | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Doctor/HCP Visits: Month 12 (n=9,10,4) | 3.1 events | Standard Deviation 3.1 |
| Tacrolimus | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Previous Hospitalizations: Month 12 (n=1,1,2) | 2.0 events | — |
| Tacrolimus | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Previous Hospitalizations: Month 24 (n=3,3,1) | 1.0 events | Standard Deviation 0 |
| Tofacitinib 15-10-5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Other Test/Procedures: Month 24 (n=4,3,4) | 1.3 events | Standard Deviation 0.6 |
| Tofacitinib 15-10-5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Previous Hospitalizations: Month 24 (n=3,3,1) | 1.0 events | Standard Deviation 0 |
| Tofacitinib 15-10-5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Doctor/HCP Visits: Month 24 (n=12,11,9) | 2.5 events | Standard Deviation 2 |
| Tofacitinib 15-10-5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Other Test/Procedures: Month 12 (n=1,4,4) | 2.0 events | Standard Deviation 1.4 |
| Tofacitinib 15-10-5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Emergency Room Visits: Month 12 (n=1,1,2) | 1.0 events | — |
| Tofacitinib 15-10-5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Other Test/Procedures: Month 18 (n=4,3,0) | 2.0 events | Standard Deviation 1.7 |
| Tofacitinib 15-10-5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Previous Hospitalizations: Month 12 (n=1,1,2) | 1.0 events | — |
| Tofacitinib 15-10-5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Emergency Room Visits: Month 18 (n=3,3,1) | 1.0 events | Standard Deviation 0 |
| Tofacitinib 15-10-5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Doctor/HCP Visits: Month 18 (n=10,9,6) | 6.4 events | Standard Deviation 7.5 |
| Tofacitinib 15-10-5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Doctor/HCP Visits: Month 12 (n=9,10,4) | 2.7 events | Standard Deviation 2.5 |
| Tofacitinib 15-10-5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Emergency Room Visits: Month 24 (n=4,2,2) | 1.0 events | Standard Deviation 0 |
| Tofacitinib 15-10-5 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Previous Hospitalizations: Month 18 (n=3,1,1) | 1.0 events | — |
| Tofacitinib 30-15-10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Emergency Room Visits: Month 24 (n=4,2,2) | 1.0 events | Standard Deviation 0 |
| Tofacitinib 30-15-10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Other Test/Procedures: Month 12 (n=1,4,4) | 2.3 events | Standard Deviation 1.9 |
| Tofacitinib 30-15-10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Previous Hospitalizations: Month 18 (n=3,1,1) | 2.0 events | — |
| Tofacitinib 30-15-10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Doctor/HCP Visits: Month 12 (n=9,10,4) | 6.3 events | Standard Deviation 3.9 |
| Tofacitinib 30-15-10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Doctor/HCP Visits: Month 18 (n=10,9,6) | 5.8 events | Standard Deviation 2.7 |
| Tofacitinib 30-15-10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Other Test/Procedures: Month 18 (n=4,3,0) | NA events | — |
| Tofacitinib 30-15-10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Other Test/Procedures: Month 24 (n=4,3,4) | 2.8 events | Standard Deviation 2.2 |
| Tofacitinib 30-15-10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Previous Hospitalizations: Month 12 (n=1,1,2) | 1.0 events | Standard Deviation 0 |
| Tofacitinib 30-15-10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Previous Hospitalizations: Month 24 (n=3,3,1) | 1.0 events | — |
| Tofacitinib 30-15-10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Emergency Room Visits: Month 12 (n=1,1,2) | 1.0 events | Standard Deviation 0 |
| Tofacitinib 30-15-10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Emergency Room Visits: Month 18 (n=3,3,1) | 2.0 events | — |
| Tofacitinib 30-15-10 mg BID | Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Health Care Resource Utilization (HCRU) Questionnaire | Doctor/HCP Visits: Month 24 (n=12,11,9) | 5.0 events | Standard Deviation 6.3 |
Secondary
Percentage of Participants Requiring Anti-Hypertensive Medication by Visit
Time frame: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 66 (n=13,14,10) | 76.9 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 36 (n=15,14,10) | 73.3 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 15 (n=18,14,12) | 83.3 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 60 (n=13,14,10) | 69.2 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 42 (n=15,14,10) | 73.3 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 9 (n=18,14,13) | 83.3 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 54 (n=14,14,10) | 71.4 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 48 (n=15,14,10) | 73.3 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 84 (n=0,13,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 18 (n=18,14,12) | 83.3 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 96 (n=0,11,7) | NA percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 78 (n=0,13,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 24 (n=17,14,12) | 82.4 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 12 (n=18,14,13) | 83.3 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 72 (n=9,14,9) | 77.8 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 30 (n=15,14,11) | 73.3 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 90 (n=0,12,8) | NA percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 60 (n=13,14,10) | 71.4 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 9 (n=18,14,13) | 85.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 15 (n=18,14,12) | 85.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 18 (n=18,14,12) | 78.6 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 24 (n=17,14,12) | 85.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 30 (n=15,14,11) | 71.4 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 36 (n=15,14,10) | 71.4 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 42 (n=15,14,10) | 71.4 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 48 (n=15,14,10) | 71.4 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 54 (n=14,14,10) | 71.4 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 12 (n=18,14,13) | 85.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 66 (n=13,14,10) | 71.4 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 72 (n=9,14,9) | 71.4 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 78 (n=0,13,8) | 69.2 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 84 (n=0,13,8) | 69.2 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 90 (n=0,12,8) | 66.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 96 (n=0,11,7) | 72.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 12 (n=18,14,13) | 92.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 66 (n=13,14,10) | 90.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 24 (n=17,14,12) | 91.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 96 (n=0,11,7) | 71.4 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 72 (n=9,14,9) | 88.9 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 18 (n=18,14,12) | 91.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 90 (n=0,12,8) | 75.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 78 (n=0,13,8) | 87.5 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 15 (n=18,14,12) | 91.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 48 (n=15,14,10) | 90.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 42 (n=15,14,10) | 90.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 9 (n=18,14,13) | 92.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 54 (n=14,14,10) | 90.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 36 (n=15,14,10) | 90.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 84 (n=0,13,8) | 75.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 60 (n=13,14,10) | 90.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Anti-Hypertensive Medication by Visit | Month 30 (n=15,14,11) | 81.8 percentage of participants |
Secondary
Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit
Time frame: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 12 (n=18,14,12) | 5.6 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 15 (n=18,14,12) | 5.6 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 78 (n=0,13,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 9 (n=18,14,13) | 5.6 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 18 (n=18,14,12) | 11.1 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 24 (n=17,14,12) | 11.8 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 30 (n=15,14,11) | 13.3 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 36 (n=15,14,10) | 13.3 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 42 (n=15,14,10) | 13.3 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 48 (n=15,14,10) | 13.3 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 54 (n=14,14,10) | 14.3 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 60 (n=13,14,10) | 15.4 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 66 (n=13,14,10) | 15.4 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 72 (n=9,14,8) | 11.1 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 84 (n=0,13,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 90 (n=0,12,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 96 (n=0,11,6) | NA percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 24 (n=17,14,12) | 42.9 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 30 (n=15,14,11) | 42.9 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 72 (n=9,14,8) | 42.9 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 36 (n=15,14,10) | 42.9 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 42 (n=15,14,10) | 42.9 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 84 (n=0,13,8) | 38.5 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 48 (n=15,14,10) | 42.9 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 54 (n=14,14,10) | 42.9 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 96 (n=0,11,6) | 36.4 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 60 (n=13,14,10) | 42.9 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 15 (n=18,14,12) | 42.9 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 78 (n=0,13,8) | 38.5 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 90 (n=0,12,8) | 33.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 9 (n=18,14,13) | 35.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 12 (n=18,14,12) | 35.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 66 (n=13,14,10) | 42.9 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 18 (n=18,14,12) | 42.9 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 78 (n=0,13,8) | 25.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 24 (n=17,14,12) | 33.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 90 (n=0,12,8) | 25.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 12 (n=18,14,12) | 33.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 30 (n=15,14,11) | 27.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 66 (n=13,14,10) | 30.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 18 (n=18,14,12) | 33.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 36 (n=15,14,10) | 30.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 96 (n=0,11,6) | 16.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 15 (n=18,14,12) | 33.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 42 (n=15,14,10) | 30.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 72 (n=9,14,8) | 25.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 60 (n=13,14,10) | 30.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 48 (n=15,14,10) | 30.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 84 (n=0,13,8) | 25.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 9 (n=18,14,13) | 30.8 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Diabetes Agents (Oral Hypoglycemic Agents, Anti-Diabetic Agents, or Insulin) by Visit | Month 54 (n=14,14,10) | 30.0 percentage of participants |
Secondary
Percentage of Participants Requiring Lipid-Lowering Agents by Visit
Time frame: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 66 (n=13,14,10) | 46.2 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 18 (n=18,14,12) | 44.4 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 24 (n=17,14,12) | 47.1 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 60 (n=13,14,10) | 38.5 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 42 (n=15,14,10) | 46.7 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 84 (n=0,13,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 54 (n=14,14,10) | 42.9 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 48 (n=15,14,10) | 46.7 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 36 (n=15,14,11) | 46.7 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 9 (n=18,14,13) | 38.9 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 96 (n=0,12,6) | NA percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 78 (n=0,13,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 12 (n=18,14,13) | 44.4 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 90 (n=0,12,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 72 (n=9,14,9) | 44.4 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 15 (n=18,14,12) | 44.4 percentage of participants |
| Tacrolimus | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 30 (n=15,14,11) | 46.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 30 (n=15,14,11) | 71.4 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 24 (n=17,14,12) | 71.4 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 18 (n=18,14,12) | 71.4 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 9 (n=18,14,13) | 64.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 12 (n=18,14,13) | 64.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 15 (n=18,14,12) | 71.4 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 36 (n=15,14,11) | 71.4 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 42 (n=15,14,10) | 64.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 48 (n=15,14,10) | 64.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 54 (n=14,14,10) | 64.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 60 (n=13,14,10) | 64.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 66 (n=13,14,10) | 64.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 72 (n=9,14,9) | 64.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 78 (n=0,13,8) | 61.5 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 84 (n=0,13,8) | 61.5 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 90 (n=0,12,8) | 58.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 96 (n=0,12,6) | 58.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 24 (n=17,14,12) | 58.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 66 (n=13,14,10) | 80.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 12 (n=18,14,13) | 53.8 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 96 (n=0,12,6) | 100.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 72 (n=9,14,9) | 88.9 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 9 (n=18,14,13) | 53.8 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 90 (n=0,12,8) | 87.5 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 78 (n=0,13,8) | 87.5 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 30 (n=15,14,11) | 63.6 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 48 (n=15,14,10) | 90.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 42 (n=15,14,10) | 90.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 18 (n=18,14,12) | 41.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 54 (n=14,14,10) | 70.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 36 (n=15,14,11) | 72.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 84 (n=0,13,8) | 87.5 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 60 (n=13,14,10) | 80.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants Requiring Lipid-Lowering Agents by Visit | Month 15 (n=18,14,12) | 50.0 percentage of participants |
Secondary
Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
Cutoff categories for BKV DNA were 0-199 and ≥200 copies/PCR. Per protocol, BKV DNA PCR was performed on tofacitinib-treated participants only.
Time frame: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 48 (n=9,6) | 100.0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 36 (n=5,4) | 100.0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 54 (n=13,10) | 100.0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 24 (n=2,1) | 100.0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 60 (n=13,7) | 100.0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 48 (n=9,6) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 66 (n=13,8) | 100.0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 12 (n=13,10) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 72 (n=10,7) | 100.0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 54 (n=13,10) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 78 (n=9,7) | 100.0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 15 (n=13,12) | 100.0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 84 (n=10,7) | 100.0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 60 (n=13,7) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 90 (n=9,4) | 100.0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 15 (n=13,12) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 96 (n=9,3) | 100.0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 66 (n=13,8) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Follow-up (n=3,2) | 100.0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 30 (n=0,1) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 9 (n=14,12) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 72 (n=10,7) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Follow-up (n=3,2) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 30 (n=0,1) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 18 (n=7,8) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 42 (n=11,7) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 12 (n=13,10) | 100.0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 78 (n=9,7) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 18 (n=7,8) | 100.0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 84 (n=10,7) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 24 (n=2,1) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 90 (n=9,4) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 42 (n=11,7) | 100.0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 96 (n=9,3) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 36 (n=5,4) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 9 (n=14,12) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Follow-up (n=3,2) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 15 (n=13,12) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 24 (n=2,1) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 30 (n=0,1) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 36 (n=5,4) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 12 (n=13,10) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 15 (n=13,12) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 18 (n=7,8) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 36 (n=5,4) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 42 (n=11,7) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 48 (n=9,6) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 54 (n=13,10) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 60 (n=13,7) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 66 (n=13,8) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 9 (n=14,12) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 12 (n=13,10) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 18 (n=7,8) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 42 (n=11,7) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 48 (n=9,6) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 54 (n=13,10) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 60 (n=13,7) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 66 (n=13,8) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 72 (n=10,7) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 78 (n=9,7) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 84 (n=10,7) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 90 (n=9,4) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Month 96 (n=9,3) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0-199: Follow-up (n=3,2) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 9 (n=14,12) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 24 (n=2,1) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 30 (n=0,1) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 72 (n=10,7) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 78 (n=9,7) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 84 (n=10,7) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 90 (n=9,4) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With BKV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | ≥200: Month 96 (n=9,3) | 0 percentage of participants |
Secondary
Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit
EBV DNA PCR categories included 0, 1-50, 51-100, 101-1000, and \>1000 copies/PCR.
Time frame: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 and Follow-Up (Month 98)
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 96 (n=0,9,6) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Follow-up (n=2,4,4) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 78 (n=0,12,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 90 (n=0,12,7) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 9 (n=17,14,12) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 96 (n=0,9,6) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 84 (n=0,12,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 12 (n=17,14,12) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 42 (n=14,12,9) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 78 (n=0,12,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 15 (n=17,14,12) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 60 (n=13,13,10) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 72 (n=9,12,8) | 88.9 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 30 (n=13,14,10) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 54 (n=14,14,10) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 66 (n=10,13,9) | 80.0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 36 (n=15,14,8) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Follow-up (n=2,4,4) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 60 (n=13,13,10) | 76.9 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 42 (n=14,12,9) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 84 (n=0,12,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 54 (n=14,14,10) | 57.1 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 48 (n=15,9,6) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 66 (n=10,13,9) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 42 (n=14,12,9) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 72 (n=9,12,8) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 48 (n=15,9,6) | 93.3 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 42 (n=14,12,9) | 92.9 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 72 (n=9,12,8) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 60 (n=13,13,10) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 36 (n=15,14,8) | 86.7 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 30 (n=13,14,10) | 84.6 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 84 (n=0,12,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 78 (n=0,12,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 48 (n=15,9,6) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 24 (n=15,13,12) | 100.0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 96 (n=0,9,6) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 90 (n=0,12,7) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 9 (n=17,14,12) | 88.2 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 9 (n=17,14,12) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 18 (n=17,13,12) | 88.2 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 12 (n=17,14,12) | 94.1 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 24 (n=15,13,12) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 15 (n=17,14,12) | 88.2 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 18 (n=17,13,12) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Follow-up (n=2,4,4) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 24 (n=15,13,12) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 9 (n=17,14,12) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 36 (n=15,14,8) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 96 (n=0,9,6) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 12 (n=17,14,12) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 12 (n=17,14,12) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 48 (n=15,9,6) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 66 (n=10,13,9) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 90 (n=0,12,7) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 54 (n=14,14,10) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 30 (n=13,14,10) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 72 (n=9,12,8) | 11.1 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 66 (n=10,13,9) | 20.0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 78 (n=0,12,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 60 (n=13,13,10) | 23.1 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 84 (n=0,12,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 15 (n=17,14,12) | 5.9 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 54 (n=14,14,10) | 42.9 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 48 (n=15,9,6) | 6.7 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 18 (n=17,13,12) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 84 (n=0,12,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 42 (n=14,12,9) | 7.1 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 24 (n=15,13,12) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 24 (n=15,13,12) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 36 (n=15,14,8) | 13.3 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 54 (n=14,14,10) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 30 (n=13,14,10) | 15.4 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 60 (n=13,13,10) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 66 (n=10,13,9) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 18 (n=17,13,12) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 78 (n=0,12,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 30 (n=13,14,10) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 18 (n=17,13,12) | 11.8 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 90 (n=0,12,7) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 12 (n=17,14,12) | 5.9 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Follow-up (n=2,4,4) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 72 (n=9,12,8) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 9 (n=17,14,12) | 11.8 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 15 (n=17,14,12) | 0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Follow-up (n=2,4,4) | 100.0 percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 90 (n=0,12,7) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 96 (n=0,9,6) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 36 (n=15,14,8) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 48 (n=15,9,6) | 11.1 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 24 (n=15,13,12) | 30.8 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 72 (n=9,12,8) | 50.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 78 (n=0,12,8) | 58.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 84 (n=0,12,8) | 50.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 96 (n=0,9,6) | 66.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 9 (n=17,14,12) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 12 (n=17,14,12) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 15 (n=17,14,12) | 7.1 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 30 (n=13,14,10) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 36 (n=15,14,8) | 7.1 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 42 (n=14,12,9) | 8.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 54 (n=14,14,10) | 7.1 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 66 (n=10,13,9) | 15.4 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 90 (n=0,12,7) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Follow-up (n=2,4,4) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 9 (n=17,14,12) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 12 (n=17,14,12) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 48 (n=15,9,6) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 54 (n=14,14,10) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 90 (n=0,12,7) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 18 (n=17,13,12) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 24 (n=15,13,12) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 66 (n=10,13,9) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 78 (n=0,12,8) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Follow-up (n=2,4,4) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 84 (n=0,12,8) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 96 (n=0,9,6) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Follow-up (n=2,4,4) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 9 (n=17,14,12) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 12 (n=17,14,12) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 15 (n=17,14,12) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 30 (n=13,14,10) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 36 (n=15,14,8) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 42 (n=14,12,9) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 48 (n=15,9,6) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 54 (n=14,14,10) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 60 (n=13,13,10) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 72 (n=9,12,8) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 84 (n=0,12,8) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 90 (n=0,12,7) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 96 (n=0,9,6) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 9 (n=17,14,12) | 71.4 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 12 (n=17,14,12) | 64.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 15 (n=17,14,12) | 57.1 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 18 (n=17,13,12) | 53.8 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 24 (n=15,13,12) | 61.5 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 30 (n=13,14,10) | 42.9 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 36 (n=15,14,8) | 57.1 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 42 (n=14,12,9) | 33.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 48 (n=15,9,6) | 66.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 54 (n=14,14,10) | 50.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 60 (n=13,13,10) | 61.5 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 66 (n=10,13,9) | 38.5 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 72 (n=9,12,8) | 41.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 78 (n=0,12,8) | 41.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 84 (n=0,12,8) | 50.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 90 (n=0,12,7) | 58.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 96 (n=0,9,6) | 33.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Follow-up (n=2,4,4) | 50.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 9 (n=17,14,12) | 28.6 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 12 (n=17,14,12) | 35.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 18 (n=17,13,12) | 30.8 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 30 (n=13,14,10) | 50.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 36 (n=15,14,8) | 35.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 42 (n=14,12,9) | 58.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 54 (n=14,14,10) | 42.9 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 60 (n=13,13,10) | 30.8 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 66 (n=10,13,9) | 46.2 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 90 (n=0,12,7) | 41.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Follow-up (n=2,4,4) | 50.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 18 (n=17,13,12) | 7.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 24 (n=15,13,12) | 7.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 48 (n=15,9,6) | 22.2 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 60 (n=13,13,10) | 7.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 72 (n=9,12,8) | 8.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 78 (n=0,12,8) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 84 (n=0,12,8) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 96 (n=0,9,6) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 15 (n=17,14,12) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 18 (n=17,13,12) | 7.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 24 (n=15,13,12) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 30 (n=13,14,10) | 7.1 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 36 (n=15,14,8) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 42 (n=14,12,9) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 60 (n=13,13,10) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 66 (n=10,13,9) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 72 (n=9,12,8) | 0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 78 (n=0,12,8) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 84 (n=0,12,8) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 72 (n=9,12,8) | 50.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Follow-up (n=2,4,4) | 75.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Follow-up (n=2,4,4) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Follow-up (n=2,4,4) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 9 (n=17,14,12) | 66.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 96 (n=0,9,6) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 12 (n=17,14,12) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 12 (n=17,14,12) | 58.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 84 (n=0,12,8) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 30 (n=13,14,10) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 24 (n=15,13,12) | 58.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 54 (n=14,14,10) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 42 (n=14,12,9) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 30 (n=13,14,10) | 60.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 48 (n=15,9,6) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 15 (n=17,14,12) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 36 (n=15,14,8) | 62.5 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 18 (n=17,13,12) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 24 (n=15,13,12) | 8.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 42 (n=14,12,9) | 66.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 15 (n=17,14,12) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 18 (n=17,13,12) | 41.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 48 (n=15,9,6) | 83.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 90 (n=0,12,7) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 96 (n=0,9,6) | 50.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 54 (n=14,14,10) | 70.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 78 (n=0,12,8) | 12.5 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 18 (n=17,13,12) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 60 (n=13,13,10) | 80.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 72 (n=9,12,8) | 12.5 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 15 (n=17,14,12) | 8.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 66 (n=10,13,9) | 55.6 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 54 (n=14,14,10) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 84 (n=0,12,8) | 75.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 48 (n=15,9,6) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 66 (n=10,13,9) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 90 (n=0,12,7) | 42.9 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 9 (n=17,14,12) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 24 (n=15,13,12) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 96 (n=0,9,6) | 16.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 12 (n=17,14,12) | 8.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 18 (n=17,13,12) | 16.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 90 (n=0,12,7) | 14.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 12 (n=17,14,12) | 33.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 60 (n=13,13,10) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 15 (n=17,14,12) | 41.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 9 (n=17,14,12) | 33.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 42 (n=14,12,9) | 11.1 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 18 (n=17,13,12) | 41.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 90 (n=0,12,7) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 84 (n=0,12,8) | 12.5 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 24 (n=15,13,12) | 33.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 78 (n=0,12,8) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 30 (n=13,14,10) | 10.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 30 (n=13,14,10) | 30.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 72 (n=9,12,8) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 48 (n=15,9,6) | 16.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 36 (n=15,14,8) | 25.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 66 (n=10,13,9) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 72 (n=9,12,8) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 42 (n=14,12,9) | 22.2 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 60 (n=13,13,10) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 9 (n=17,14,12) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 48 (n=15,9,6) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 42 (n=14,12,9) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 60 (n=13,13,10) | 10.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 54 (n=14,14,10) | 30.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 36 (n=15,14,8) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 66 (n=10,13,9) | 44.4 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 60 (n=13,13,10) | 10.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 30 (n=13,14,10) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Month 78 (n=0,12,8) | 62.5 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 66 (n=10,13,9) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 24 (n=15,13,12) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 36 (n=15,14,8) | 12.5 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 72 (n=9,12,8) | 37.5 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 12 (n=17,14,12) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 78 (n=0,12,8) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 78 (n=0,12,8) | 25.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | >1000: Month 9 (n=17,14,12) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 54 (n=14,14,10) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 84 (n=0,12,8) | 12.5 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Follow-up (n=2,4,4) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 1-50: Follow-up (n=2,4,4) | 25.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 90 (n=0,12,7) | 42.9 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 101-1000: Month 96 (n=0,9,6) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 51-100: Month 36 (n=15,14,8) | 0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With EBV DNA Determined Using PCR by Specific Cutoff Categories (in Number of Copies/PCR) and Visit | 0: Month 96 (n=0,9,6) | 33.3 percentage of participants |
Secondary
Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit
Time frame: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 12 (n=16,14,12) | 93.8 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 66 (n=12,13,10) | 83.3 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 36 (n=15,14,9) | 93.3 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 9 (n=18,12,11) | 94.4 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 60 (n=13,13,10) | 76.9 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 42 (n=15,13,9) | 93.3 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 96 (n=0,11,6) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 15 (n=16,14,11) | 100.0 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 54 (n=14,13,10) | 71.4 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 48 (n=15,14,10) | 93.3 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 90 (n=0,12,7) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 18 (n=18,14,12) | 94.4 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 84 (n=0,12,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 78 (n=0,12,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 24 (n=17,14,12) | 94.1 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Follow-Up (n=6,12,8) | 100.0 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 72 (n=9,12,8) | 88.9 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 30 (n=14,14,10) | 78.6 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 18 (n=18,14,12) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 9 (n=18,12,11) | 75.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 12 (n=16,14,12) | 85.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 15 (n=16,14,11) | 92.9 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 24 (n=17,14,12) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 30 (n=14,14,10) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 36 (n=15,14,9) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 42 (n=15,13,9) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 48 (n=15,14,10) | 92.9 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 54 (n=14,13,10) | 92.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 60 (n=13,13,10) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 66 (n=12,13,10) | 92.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 72 (n=9,12,8) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 78 (n=0,12,8) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 84 (n=0,12,8) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 90 (n=0,12,7) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 96 (n=0,11,6) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Follow-Up (n=6,12,8) | 91.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 24 (n=17,14,12) | 91.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 12 (n=16,14,12) | 83.3 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 72 (n=9,12,8) | 75.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 18 (n=18,14,12) | 91.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Follow-Up (n=6,12,8) | 62.5 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 78 (n=0,12,8) | 87.5 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 42 (n=15,13,9) | 100.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 96 (n=0,11,6) | 100.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 84 (n=0,12,8) | 87.5 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 48 (n=15,14,10) | 90.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 15 (n=16,14,11) | 100.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 54 (n=14,13,10) | 90.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 36 (n=15,14,9) | 100.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 9 (n=18,12,11) | 90.9 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 60 (n=13,13,10) | 90.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 30 (n=14,14,10) | 100.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 90 (n=0,12,7) | 100.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Serum LDL Cholesterol to Serum HDL Cholesterol <3.5 by Visit | Month 66 (n=12,13,10) | 90.0 percentage of participants |
Secondary
Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit
Time frame: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tacrolimus | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 66 (n=12,14,10) | 83.3 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 15 (n=16,14,12) | 93.8 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 18 (n=18,14,12) | 88.9 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 24 (n=17,14,12) | 88.2 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 12 (n=16,14,12) | 87.5 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 90 (n=0,12,7) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 9 (n=18,14,12) | 94.4 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 30 (n=14,14,10) | 78.6 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 36 (n=15,14,9) | 86.7 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 42 (n=15,14,9) | 86.7 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 48 (n=15,14,10) | 86.7 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 54 (n=14,14,10) | 78.6 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 60 (n=13,13,10) | 69.2 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 72 (n=9,12,8) | 88.9 percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 78 (n=0,12,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 84 (n=0,12,8) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 96 (n=0,11,6) | NA percentage of participants |
| Tacrolimus | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Follow-Up (n=6,12,8) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 90 (n=0,12,7) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 24 (n=17,14,12) | 85.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 9 (n=18,14,12) | 71.4 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 30 (n=14,14,10) | 92.9 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 78 (n=0,12,8) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 36 (n=15,14,9) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 42 (n=15,14,9) | 78.6 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 48 (n=15,14,10) | 92.9 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 84 (n=0,12,8) | 91.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 12 (n=16,14,12) | 85.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 54 (n=14,14,10) | 85.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 15 (n=16,14,12) | 92.9 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 18 (n=18,14,12) | 92.9 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Follow-Up (n=6,12,8) | 91.7 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 60 (n=13,13,10) | 92.3 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 96 (n=0,11,6) | 100.0 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 66 (n=12,14,10) | 92.9 percentage of participants |
| Tofacitinib 15-10-5 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 72 (n=9,12,8) | 100.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 18 (n=18,14,12) | 75.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 90 (n=0,12,7) | 100.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 72 (n=9,12,8) | 75.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 12 (n=16,14,12) | 75.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 9 (n=18,14,12) | 66.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 24 (n=17,14,12) | 66.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 96 (n=0,11,6) | 100.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 66 (n=12,14,10) | 90.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 30 (n=14,14,10) | 70.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 60 (n=13,13,10) | 80.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 15 (n=16,14,12) | 66.7 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 36 (n=15,14,9) | 100.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 78 (n=0,12,8) | 87.5 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 54 (n=14,14,10) | 90.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 42 (n=15,14,9) | 100.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Follow-Up (n=6,12,8) | 50.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 84 (n=0,12,8) | 50.0 percentage of participants |
| Tofacitinib 30-15-10 mg BID | Percentage of Participants With Ratio of Total Serum Cholesterol to Serum HDL Cholesterol <5 by Visit | Month 48 (n=15,14,10) | 80.0 percentage of participants |
Secondary
Ratio of Fasting Serum Proinsulin (Pmol/L) to Insulin (Pmol/L) by Visit
Measured only in participants who were non-diabetic prior to kidney transplantation and who did not require treatment with oral hypoglycemic agents, anti-diabetic agents, and/or insulin prior to the time of measurement.
Time frame: Months 12 and 24
Population: Safety population; n=number of participants eligible for OGTT and had data (non-missing) at that particular visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | Ratio of Fasting Serum Proinsulin (Pmol/L) to Insulin (Pmol/L) by Visit | Month 12 (n=5,3,3) | 0.15 ratio of serum proinsulin to insulin | Standard Deviation 0.07 |
| Tacrolimus | Ratio of Fasting Serum Proinsulin (Pmol/L) to Insulin (Pmol/L) by Visit | Month 24 (n=3,4,2) | 0.64 ratio of serum proinsulin to insulin | Standard Deviation 0.42 |
| Tofacitinib 15-10-5 mg BID | Ratio of Fasting Serum Proinsulin (Pmol/L) to Insulin (Pmol/L) by Visit | Month 12 (n=5,3,3) | 0.32 ratio of serum proinsulin to insulin | Standard Deviation 0.04 |
| Tofacitinib 15-10-5 mg BID | Ratio of Fasting Serum Proinsulin (Pmol/L) to Insulin (Pmol/L) by Visit | Month 24 (n=3,4,2) | 0.30 ratio of serum proinsulin to insulin | Standard Deviation 0.2 |
| Tofacitinib 30-15-10 mg BID | Ratio of Fasting Serum Proinsulin (Pmol/L) to Insulin (Pmol/L) by Visit | Month 12 (n=5,3,3) | 0.40 ratio of serum proinsulin to insulin | Standard Deviation 0.31 |
| Tofacitinib 30-15-10 mg BID | Ratio of Fasting Serum Proinsulin (Pmol/L) to Insulin (Pmol/L) by Visit | Month 24 (n=3,4,2) | 0.22 ratio of serum proinsulin to insulin | Standard Deviation 0.04 |
Secondary
Ratio of Serum LDL Level to HDL Level by Visit
Time frame: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | Ratio of Serum LDL Level to HDL Level by Visit | Month 84 (n=0,12,8) | NA ratio | — |
| Tacrolimus | Ratio of Serum LDL Level to HDL Level by Visit | Month 66 (n=12,13,10) | 2.34 ratio | Standard Deviation 0.91 |
| Tacrolimus | Ratio of Serum LDL Level to HDL Level by Visit | Month 72 (n=9,12,8) | 2.32 ratio | Standard Deviation 1 |
| Tacrolimus | Ratio of Serum LDL Level to HDL Level by Visit | Month 78 (n=0,12,8) | NA ratio | — |
| Tacrolimus | Ratio of Serum LDL Level to HDL Level by Visit | Month 90 (n=0,12,7) | NA ratio | — |
| Tacrolimus | Ratio of Serum LDL Level to HDL Level by Visit | Month 96 (n=0,11,6) | NA ratio | — |
| Tacrolimus | Ratio of Serum LDL Level to HDL Level by Visit | Month 30 (n=14,14,10) | 2.09 ratio | Standard Deviation 0.99 |
| Tacrolimus | Ratio of Serum LDL Level to HDL Level by Visit | Follow-up (n=6,12,8) | 2.09 ratio | Standard Deviation 1.05 |
| Tacrolimus | Ratio of Serum LDL Level to HDL Level by Visit | Month 18 (n=18,14,12) | 1.98 ratio | Standard Deviation 0.86 |
| Tacrolimus | Ratio of Serum LDL Level to HDL Level by Visit | Month 9 (n=18,12,11) | 2.09 ratio | Standard Deviation 0.84 |
| Tacrolimus | Ratio of Serum LDL Level to HDL Level by Visit | Month 12 (n=16,14,12) | 2.14 ratio | Standard Deviation 0.71 |
| Tacrolimus | Ratio of Serum LDL Level to HDL Level by Visit | Month 54 (n=14,13,10) | 2.48 ratio | Standard Deviation 1.08 |
| Tacrolimus | Ratio of Serum LDL Level to HDL Level by Visit | Month 15 (n=16,14,11) | 1.97 ratio | Standard Deviation 0.62 |
| Tacrolimus | Ratio of Serum LDL Level to HDL Level by Visit | Month 36 (n=15,14,9) | 1.93 ratio | Standard Deviation 0.92 |
| Tacrolimus | Ratio of Serum LDL Level to HDL Level by Visit | Month 24 (n=17,14,12) | 2.04 ratio | Standard Deviation 0.94 |
| Tacrolimus | Ratio of Serum LDL Level to HDL Level by Visit | Month 42 (n=15,13,9) | 2.06 ratio | Standard Deviation 0.87 |
| Tacrolimus | Ratio of Serum LDL Level to HDL Level by Visit | Month 48 (n=15,14,10) | 2.27 ratio | Standard Deviation 0.85 |
| Tacrolimus | Ratio of Serum LDL Level to HDL Level by Visit | Month 60 (n=13,13,10) | 2.45 ratio | Standard Deviation 0.99 |
| Tofacitinib 15-10-5 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 18 (n=18,14,12) | 1.74 ratio | Standard Deviation 0.8 |
| Tofacitinib 15-10-5 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 60 (n=13,13,10) | 1.86 ratio | Standard Deviation 0.67 |
| Tofacitinib 15-10-5 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 66 (n=12,13,10) | 1.96 ratio | Standard Deviation 0.85 |
| Tofacitinib 15-10-5 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 84 (n=0,12,8) | 1.80 ratio | Standard Deviation 0.83 |
| Tofacitinib 15-10-5 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 9 (n=18,12,11) | 2.42 ratio | Standard Deviation 1.25 |
| Tofacitinib 15-10-5 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 72 (n=9,12,8) | 1.66 ratio | Standard Deviation 0.5 |
| Tofacitinib 15-10-5 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 54 (n=14,13,10) | 1.92 ratio | Standard Deviation 0.81 |
| Tofacitinib 15-10-5 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 30 (n=14,14,10) | 1.76 ratio | Standard Deviation 0.69 |
| Tofacitinib 15-10-5 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 78 (n=0,12,8) | 1.72 ratio | Standard Deviation 0.77 |
| Tofacitinib 15-10-5 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 42 (n=15,13,9) | 1.85 ratio | Standard Deviation 0.81 |
| Tofacitinib 15-10-5 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 90 (n=0,12,7) | 1.74 ratio | Standard Deviation 0.74 |
| Tofacitinib 15-10-5 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 15 (n=16,14,11) | 2.07 ratio | Standard Deviation 0.81 |
| Tofacitinib 15-10-5 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 12 (n=16,14,12) | 2.24 ratio | Standard Deviation 0.98 |
| Tofacitinib 15-10-5 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 96 (n=0,11,6) | 1.56 ratio | Standard Deviation 0.66 |
| Tofacitinib 15-10-5 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 24 (n=17,14,12) | 1.78 ratio | Standard Deviation 0.69 |
| Tofacitinib 15-10-5 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 36 (n=15,14,9) | 1.75 ratio | Standard Deviation 0.64 |
| Tofacitinib 15-10-5 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Follow-up (n=6,12,8) | 1.91 ratio | Standard Deviation 0.82 |
| Tofacitinib 15-10-5 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 48 (n=15,14,10) | 1.99 ratio | Standard Deviation 0.73 |
| Tofacitinib 30-15-10 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Follow-up (n=6,12,8) | 3.03 ratio | Standard Deviation 1.15 |
| Tofacitinib 30-15-10 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 48 (n=15,14,10) | 2.07 ratio | Standard Deviation 0.8 |
| Tofacitinib 30-15-10 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 54 (n=14,13,10) | 1.92 ratio | Standard Deviation 1.02 |
| Tofacitinib 30-15-10 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 24 (n=17,14,12) | 2.25 ratio | Standard Deviation 0.98 |
| Tofacitinib 30-15-10 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 30 (n=14,14,10) | 2.36 ratio | Standard Deviation 0.78 |
| Tofacitinib 30-15-10 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 84 (n=0,12,8) | 2.58 ratio | Standard Deviation 0.69 |
| Tofacitinib 30-15-10 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 15 (n=16,14,11) | 2.11 ratio | Standard Deviation 0.74 |
| Tofacitinib 30-15-10 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 9 (n=18,12,11) | 2.17 ratio | Standard Deviation 0.82 |
| Tofacitinib 30-15-10 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 12 (n=16,14,12) | 2.31 ratio | Standard Deviation 0.99 |
| Tofacitinib 30-15-10 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 18 (n=18,14,12) | 2.10 ratio | Standard Deviation 0.93 |
| Tofacitinib 30-15-10 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 36 (n=15,14,9) | 2.03 ratio | Standard Deviation 0.49 |
| Tofacitinib 30-15-10 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 42 (n=15,13,9) | 1.82 ratio | Standard Deviation 0.44 |
| Tofacitinib 30-15-10 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 60 (n=13,13,10) | 1.92 ratio | Standard Deviation 0.98 |
| Tofacitinib 30-15-10 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 66 (n=12,13,10) | 1.88 ratio | Standard Deviation 0.83 |
| Tofacitinib 30-15-10 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 72 (n=9,12,8) | 2.46 ratio | Standard Deviation 1.04 |
| Tofacitinib 30-15-10 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 78 (n=0,12,8) | 2.30 ratio | Standard Deviation 0.8 |
| Tofacitinib 30-15-10 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 90 (n=0,12,7) | 2.04 ratio | Standard Deviation 0.5 |
| Tofacitinib 30-15-10 mg BID | Ratio of Serum LDL Level to HDL Level by Visit | Month 96 (n=0,11,6) | 1.98 ratio | Standard Deviation 0.69 |
Secondary
Ratio of Total Serum Cholesterol Level to HDL Level by Visit
Time frame: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 9 (n=18,14,12) | 3.62 ratio | Standard Deviation 1.05 |
| Tacrolimus | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 12 (n=16,14,12) | 3.72 ratio | Standard Deviation 0.94 |
| Tacrolimus | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 96 (n=0,11,6) | NA ratio | — |
| Tacrolimus | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 15 (n=16,14,12) | 3.48 ratio | Standard Deviation 0.78 |
| Tacrolimus | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 18 (n=18,14,12) | 3.50 ratio | Standard Deviation 1.01 |
| Tacrolimus | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 24 (n=17,14,12) | 3.69 ratio | Standard Deviation 1.28 |
| Tacrolimus | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 30 (n=14,14,10) | 3.70 ratio | Standard Deviation 1.3 |
| Tacrolimus | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 36 (n=15,14,9) | 3.54 ratio | Standard Deviation 1.23 |
| Tacrolimus | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 42 (n=15,14,9) | 3.63 ratio | Standard Deviation 1 |
| Tacrolimus | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 48 (n=15,14,10) | 3.95 ratio | Standard Deviation 1.04 |
| Tacrolimus | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 54 (n=14,14,10) | 4.17 ratio | Standard Deviation 1.22 |
| Tacrolimus | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 60 (n=13,13,10) | 4.12 ratio | Standard Deviation 1.18 |
| Tacrolimus | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 66 (n=12,14,10) | 3.99 ratio | Standard Deviation 1 |
| Tacrolimus | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 72 (n=9,12,8) | 3.97 ratio | Standard Deviation 1.08 |
| Tacrolimus | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 78 (n=0,12,8) | NA ratio | — |
| Tacrolimus | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 84 (n=0,12,8) | NA ratio | — |
| Tacrolimus | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 90 (n=0,12,7) | NA ratio | — |
| Tacrolimus | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Follow-Up (n=6,12,8) | 3.57 ratio | Standard Deviation 1.06 |
| Tofacitinib 15-10-5 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Follow-Up (n=6,12,8) | 3.45 ratio | Standard Deviation 1.07 |
| Tofacitinib 15-10-5 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 9 (n=18,14,12) | 4.09 ratio | Standard Deviation 1.47 |
| Tofacitinib 15-10-5 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 48 (n=15,14,10) | 3.59 ratio | Standard Deviation 1.09 |
| Tofacitinib 15-10-5 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 66 (n=12,14,10) | 3.51 ratio | Standard Deviation 1.08 |
| Tofacitinib 15-10-5 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 12 (n=16,14,12) | 3.92 ratio | Standard Deviation 1.4 |
| Tofacitinib 15-10-5 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 78 (n=0,12,8) | 3.06 ratio | Standard Deviation 0.96 |
| Tofacitinib 15-10-5 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 90 (n=0,12,7) | 3.14 ratio | Standard Deviation 0.89 |
| Tofacitinib 15-10-5 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 84 (n=0,12,8) | 3.22 ratio | Standard Deviation 0.99 |
| Tofacitinib 15-10-5 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 96 (n=0,11,6) | 2.97 ratio | Standard Deviation 0.92 |
| Tofacitinib 15-10-5 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 54 (n=14,14,10) | 3.52 ratio | Standard Deviation 1.14 |
| Tofacitinib 15-10-5 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 15 (n=16,14,12) | 3.66 ratio | Standard Deviation 1.04 |
| Tofacitinib 15-10-5 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 42 (n=15,14,9) | 3.85 ratio | Standard Deviation 1.82 |
| Tofacitinib 15-10-5 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 72 (n=9,12,8) | 3.05 ratio | Standard Deviation 0.62 |
| Tofacitinib 15-10-5 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 18 (n=18,14,12) | 3.32 ratio | Standard Deviation 1.03 |
| Tofacitinib 15-10-5 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 36 (n=15,14,9) | 3.35 ratio | Standard Deviation 0.89 |
| Tofacitinib 15-10-5 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 60 (n=13,13,10) | 3.32 ratio | Standard Deviation 0.87 |
| Tofacitinib 15-10-5 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 24 (n=17,14,12) | 3.35 ratio | Standard Deviation 1.06 |
| Tofacitinib 15-10-5 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 30 (n=14,14,10) | 3.30 ratio | Standard Deviation 0.99 |
| Tofacitinib 30-15-10 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 24 (n=17,14,12) | 3.97 ratio | Standard Deviation 1.43 |
| Tofacitinib 30-15-10 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 30 (n=14,14,10) | 4.03 ratio | Standard Deviation 0.89 |
| Tofacitinib 30-15-10 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 36 (n=15,14,9) | 3.68 ratio | Standard Deviation 0.61 |
| Tofacitinib 30-15-10 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 78 (n=0,12,8) | 4.06 ratio | Standard Deviation 0.89 |
| Tofacitinib 30-15-10 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 42 (n=15,14,9) | 3.35 ratio | Standard Deviation 0.5 |
| Tofacitinib 30-15-10 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Follow-Up (n=6,12,8) | 4.95 ratio | Standard Deviation 1.27 |
| Tofacitinib 30-15-10 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 48 (n=15,14,10) | 3.76 ratio | Standard Deviation 1.2 |
| Tofacitinib 30-15-10 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 54 (n=14,14,10) | 3.64 ratio | Standard Deviation 1.23 |
| Tofacitinib 30-15-10 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 84 (n=0,12,8) | 4.50 ratio | Standard Deviation 0.96 |
| Tofacitinib 30-15-10 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 60 (n=13,13,10) | 3.59 ratio | Standard Deviation 1.2 |
| Tofacitinib 30-15-10 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 9 (n=18,14,12) | 4.08 ratio | Standard Deviation 1.34 |
| Tofacitinib 30-15-10 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 12 (n=16,14,12) | 4.03 ratio | Standard Deviation 1.34 |
| Tofacitinib 30-15-10 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 66 (n=12,14,10) | 3.50 ratio | Standard Deviation 0.93 |
| Tofacitinib 30-15-10 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 90 (n=0,12,7) | 3.91 ratio | Standard Deviation 0.74 |
| Tofacitinib 30-15-10 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 15 (n=16,14,12) | 4.08 ratio | Standard Deviation 1.33 |
| Tofacitinib 30-15-10 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 18 (n=18,14,12) | 3.88 ratio | Standard Deviation 1.29 |
| Tofacitinib 30-15-10 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 72 (n=9,12,8) | 4.30 ratio | Standard Deviation 1.31 |
| Tofacitinib 30-15-10 mg BID | Ratio of Total Serum Cholesterol Level to HDL Level by Visit | Month 96 (n=0,11,6) | 3.72 ratio | Standard Deviation 0.69 |
Secondary
Reciprocal of Serum Creatinine
Time frame: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | Reciprocal of Serum Creatinine | Follow-Up (n=6,12,8) | 0.61 dL/mg | Standard Deviation 0.27 |
| Tacrolimus | Reciprocal of Serum Creatinine | Month 72 (n=9,13,8) | 0.94 dL/mg | Standard Deviation 0.24 |
| Tacrolimus | Reciprocal of Serum Creatinine | Month 30 (n=14,14,10) | 0.95 dL/mg | Standard Deviation 0.29 |
| Tacrolimus | Reciprocal of Serum Creatinine | Month 96 (n=0,11,6) | NA dL/mg | — |
| Tacrolimus | Reciprocal of Serum Creatinine | Month 42 (n=15,14,9) | 0.92 dL/mg | Standard Deviation 0.25 |
| Tacrolimus | Reciprocal of Serum Creatinine | Month 12 (n=16,14,12) | 0.78 dL/mg | Standard Deviation 0.17 |
| Tacrolimus | Reciprocal of Serum Creatinine | Month 66 (n=12,14,10) | 1.05 dL/mg | Standard Deviation 0.42 |
| Tacrolimus | Reciprocal of Serum Creatinine | Month 48 (n=15,14,10) | 0.91 dL/mg | Standard Deviation 0.27 |
| Tacrolimus | Reciprocal of Serum Creatinine | Month 36 (n=15,14,9) | 0.96 dL/mg | Standard Deviation 0.38 |
| Tacrolimus | Reciprocal of Serum Creatinine | Month 60 (n=13,13,10) | 0.94 dL/mg | Standard Deviation 0.29 |
| Tacrolimus | Reciprocal of Serum Creatinine | Month 54 (n=14,14,10) | 0.91 dL/mg | Standard Deviation 0.33 |
| Tacrolimus | Reciprocal of Serum Creatinine | Month 90 (n=0,12,7) | NA dL/mg | — |
| Tacrolimus | Reciprocal of Serum Creatinine | Month 15 (n=16,14,12) | 0.85 dL/mg | Standard Deviation 0.19 |
| Tacrolimus | Reciprocal of Serum Creatinine | Month 18 (n=18,14,12) | 0.89 dL/mg | Standard Deviation 0.2 |
| Tacrolimus | Reciprocal of Serum Creatinine | Month 84 (n=0,12,8) | NA dL/mg | — |
| Tacrolimus | Reciprocal of Serum Creatinine | Month 9 (n=18,14,12) | 0.83 dL/mg | Standard Deviation 0.17 |
| Tacrolimus | Reciprocal of Serum Creatinine | Month 78 (n=0,13,8) | NA dL/mg | — |
| Tacrolimus | Reciprocal of Serum Creatinine | Month 24 (n=17,14,12) | 0.92 dL/mg | Standard Deviation 0.22 |
| Tofacitinib 15-10-5 mg BID | Reciprocal of Serum Creatinine | Month 78 (n=0,13,8) | 0.95 dL/mg | Standard Deviation 0.21 |
| Tofacitinib 15-10-5 mg BID | Reciprocal of Serum Creatinine | Month 36 (n=15,14,9) | 0.96 dL/mg | Standard Deviation 0.2 |
| Tofacitinib 15-10-5 mg BID | Reciprocal of Serum Creatinine | Follow-Up (n=6,12,8) | 0.91 dL/mg | Standard Deviation 0.23 |
| Tofacitinib 15-10-5 mg BID | Reciprocal of Serum Creatinine | Month 9 (n=18,14,12) | 0.88 dL/mg | Standard Deviation 0.22 |
| Tofacitinib 15-10-5 mg BID | Reciprocal of Serum Creatinine | Month 12 (n=16,14,12) | 0.88 dL/mg | Standard Deviation 0.22 |
| Tofacitinib 15-10-5 mg BID | Reciprocal of Serum Creatinine | Month 15 (n=16,14,12) | 0.91 dL/mg | Standard Deviation 0.17 |
| Tofacitinib 15-10-5 mg BID | Reciprocal of Serum Creatinine | Month 18 (n=18,14,12) | 0.90 dL/mg | Standard Deviation 0.18 |
| Tofacitinib 15-10-5 mg BID | Reciprocal of Serum Creatinine | Month 24 (n=17,14,12) | 0.93 dL/mg | Standard Deviation 0.16 |
| Tofacitinib 15-10-5 mg BID | Reciprocal of Serum Creatinine | Month 30 (n=14,14,10) | 0.96 dL/mg | Standard Deviation 0.14 |
| Tofacitinib 15-10-5 mg BID | Reciprocal of Serum Creatinine | Month 42 (n=15,14,9) | 0.97 dL/mg | Standard Deviation 0.24 |
| Tofacitinib 15-10-5 mg BID | Reciprocal of Serum Creatinine | Month 48 (n=15,14,10) | 0.98 dL/mg | Standard Deviation 0.23 |
| Tofacitinib 15-10-5 mg BID | Reciprocal of Serum Creatinine | Month 54 (n=14,14,10) | 0.96 dL/mg | Standard Deviation 0.24 |
| Tofacitinib 15-10-5 mg BID | Reciprocal of Serum Creatinine | Month 60 (n=13,13,10) | 0.97 dL/mg | Standard Deviation 0.26 |
| Tofacitinib 15-10-5 mg BID | Reciprocal of Serum Creatinine | Month 66 (n=12,14,10) | 0.95 dL/mg | Standard Deviation 0.26 |
| Tofacitinib 15-10-5 mg BID | Reciprocal of Serum Creatinine | Month 72 (n=9,13,8) | 0.95 dL/mg | Standard Deviation 0.2 |
| Tofacitinib 15-10-5 mg BID | Reciprocal of Serum Creatinine | Month 84 (n=0,12,8) | 0.94 dL/mg | Standard Deviation 0.2 |
| Tofacitinib 15-10-5 mg BID | Reciprocal of Serum Creatinine | Month 90 (n=0,12,7) | 0.91 dL/mg | Standard Deviation 0.23 |
| Tofacitinib 15-10-5 mg BID | Reciprocal of Serum Creatinine | Month 96 (n=0,11,6) | 0.90 dL/mg | Standard Deviation 0.2 |
| Tofacitinib 30-15-10 mg BID | Reciprocal of Serum Creatinine | Month 66 (n=12,14,10) | 0.84 dL/mg | Standard Deviation 0.17 |
| Tofacitinib 30-15-10 mg BID | Reciprocal of Serum Creatinine | Month 24 (n=17,14,12) | 0.83 dL/mg | Standard Deviation 0.15 |
| Tofacitinib 30-15-10 mg BID | Reciprocal of Serum Creatinine | Follow-Up (n=6,12,8) | 0.80 dL/mg | Standard Deviation 0.28 |
| Tofacitinib 30-15-10 mg BID | Reciprocal of Serum Creatinine | Month 72 (n=9,13,8) | 0.79 dL/mg | Standard Deviation 0.12 |
| Tofacitinib 30-15-10 mg BID | Reciprocal of Serum Creatinine | Month 18 (n=18,14,12) | 0.81 dL/mg | Standard Deviation 0.18 |
| Tofacitinib 30-15-10 mg BID | Reciprocal of Serum Creatinine | Month 30 (n=14,14,10) | 0.83 dL/mg | Standard Deviation 0.18 |
| Tofacitinib 30-15-10 mg BID | Reciprocal of Serum Creatinine | Month 78 (n=0,13,8) | 0.87 dL/mg | Standard Deviation 0.1 |
| Tofacitinib 30-15-10 mg BID | Reciprocal of Serum Creatinine | Month 15 (n=16,14,12) | 0.82 dL/mg | Standard Deviation 0.2 |
| Tofacitinib 30-15-10 mg BID | Reciprocal of Serum Creatinine | Month 96 (n=0,11,6) | 0.92 dL/mg | Standard Deviation 0.12 |
| Tofacitinib 30-15-10 mg BID | Reciprocal of Serum Creatinine | Month 84 (n=0,12,8) | 0.88 dL/mg | Standard Deviation 0.12 |
| Tofacitinib 30-15-10 mg BID | Reciprocal of Serum Creatinine | Month 12 (n=16,14,12) | 0.80 dL/mg | Standard Deviation 0.21 |
| Tofacitinib 30-15-10 mg BID | Reciprocal of Serum Creatinine | Month 36 (n=15,14,9) | 0.78 dL/mg | Standard Deviation 0.14 |
| Tofacitinib 30-15-10 mg BID | Reciprocal of Serum Creatinine | Month 54 (n=14,14,10) | 0.81 dL/mg | Standard Deviation 0.09 |
| Tofacitinib 30-15-10 mg BID | Reciprocal of Serum Creatinine | Month 48 (n=15,14,10) | 0.84 dL/mg | Standard Deviation 0.08 |
| Tofacitinib 30-15-10 mg BID | Reciprocal of Serum Creatinine | Month 90 (n=0,12,7) | 0.88 dL/mg | Standard Deviation 0.14 |
| Tofacitinib 30-15-10 mg BID | Reciprocal of Serum Creatinine | Month 60 (n=13,13,10) | 0.87 dL/mg | Standard Deviation 0.1 |
| Tofacitinib 30-15-10 mg BID | Reciprocal of Serum Creatinine | Month 42 (n=15,14,9) | 0.87 dL/mg | Standard Deviation 0.09 |
| Tofacitinib 30-15-10 mg BID | Reciprocal of Serum Creatinine | Month 9 (n=18,14,12) | 0.83 dL/mg | Standard Deviation 0.2 |
Secondary
Serum Triglyceride Levels by Visit
Time frame: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | Serum Triglyceride Levels by Visit | Month 9 (n=18,14,12) | 129.44 mg/dL | Standard Deviation 53.45 |
| Tacrolimus | Serum Triglyceride Levels by Visit | Month 66 (n=12,14,10) | 143.42 mg/dL | Standard Deviation 54.7 |
| Tacrolimus | Serum Triglyceride Levels by Visit | Month 36 (n=15,14,9) | 142.00 mg/dL | Standard Deviation 68.44 |
| Tacrolimus | Serum Triglyceride Levels by Visit | Month 90 (n=0,12,7) | NA mg/dL | — |
| Tacrolimus | Serum Triglyceride Levels by Visit | Month 42 (n=15,14,9) | 136.60 mg/dL | Standard Deviation 52.91 |
| Tacrolimus | Serum Triglyceride Levels by Visit | Month 15 (n=16,14,12) | 123.56 mg/dL | Standard Deviation 52.9 |
| Tacrolimus | Serum Triglyceride Levels by Visit | Month 60 (n=13,13,10) | 139.38 mg/dL | Standard Deviation 71.94 |
| Tacrolimus | Serum Triglyceride Levels by Visit | Month 48 (n=15,14,10) | 144.67 mg/dL | Standard Deviation 70.99 |
| Tacrolimus | Serum Triglyceride Levels by Visit | Follow-Up (n=6,12,8) | 130.67 mg/dL | Standard Deviation 63.87 |
| Tacrolimus | Serum Triglyceride Levels by Visit | Month 54 (n=14,14,10) | 150.14 mg/dL | Standard Deviation 47.64 |
| Tacrolimus | Serum Triglyceride Levels by Visit | Month 84 (n=0,12,8) | NA mg/dL | — |
| Tacrolimus | Serum Triglyceride Levels by Visit | Month 18 (n=18,14,12) | 123.44 mg/dL | Standard Deviation 53.83 |
| Tacrolimus | Serum Triglyceride Levels by Visit | Month 96 (n=0,11,6) | NA mg/dL | — |
| Tacrolimus | Serum Triglyceride Levels by Visit | Month 78 (n=0,12,8) | NA mg/dL | — |
| Tacrolimus | Serum Triglyceride Levels by Visit | Month 24 (n=17,14,12) | 149.71 mg/dL | Standard Deviation 86.56 |
| Tacrolimus | Serum Triglyceride Levels by Visit | Month 12 (n=16,14,12) | 129.19 mg/dL | Standard Deviation 49.86 |
| Tacrolimus | Serum Triglyceride Levels by Visit | Month 72 (n=9,12,8) | 138.33 mg/dL | Standard Deviation 59.14 |
| Tacrolimus | Serum Triglyceride Levels by Visit | Month 30 (n=14,14,10) | 131.07 mg/dL | Standard Deviation 52.76 |
| Tofacitinib 15-10-5 mg BID | Serum Triglyceride Levels by Visit | Month 18 (n=18,14,12) | 153.79 mg/dL | Standard Deviation 79.29 |
| Tofacitinib 15-10-5 mg BID | Serum Triglyceride Levels by Visit | Month 9 (n=18,14,12) | 205.07 mg/dL | Standard Deviation 139.91 |
| Tofacitinib 15-10-5 mg BID | Serum Triglyceride Levels by Visit | Month 12 (n=16,14,12) | 181.86 mg/dL | Standard Deviation 107.49 |
| Tofacitinib 15-10-5 mg BID | Serum Triglyceride Levels by Visit | Month 15 (n=16,14,12) | 158.93 mg/dL | Standard Deviation 84.58 |
| Tofacitinib 15-10-5 mg BID | Serum Triglyceride Levels by Visit | Follow-Up (n=6,12,8) | 134.50 mg/dL | Standard Deviation 73.14 |
| Tofacitinib 15-10-5 mg BID | Serum Triglyceride Levels by Visit | Month 24 (n=17,14,12) | 146.50 mg/dL | Standard Deviation 106.28 |
| Tofacitinib 15-10-5 mg BID | Serum Triglyceride Levels by Visit | Month 30 (n=14,14,10) | 147.71 mg/dL | Standard Deviation 84.28 |
| Tofacitinib 15-10-5 mg BID | Serum Triglyceride Levels by Visit | Month 36 (n=15,14,9) | 147.14 mg/dL | Standard Deviation 93.13 |
| Tofacitinib 15-10-5 mg BID | Serum Triglyceride Levels by Visit | Month 42 (n=15,14,9) | 195.71 mg/dL | Standard Deviation 156.42 |
| Tofacitinib 15-10-5 mg BID | Serum Triglyceride Levels by Visit | Month 48 (n=15,14,10) | 155.07 mg/dL | Standard Deviation 91.61 |
| Tofacitinib 15-10-5 mg BID | Serum Triglyceride Levels by Visit | Month 54 (n=14,14,10) | 158.43 mg/dL | Standard Deviation 115.94 |
| Tofacitinib 15-10-5 mg BID | Serum Triglyceride Levels by Visit | Month 60 (n=13,13,10) | 125.23 mg/dL | Standard Deviation 46.55 |
| Tofacitinib 15-10-5 mg BID | Serum Triglyceride Levels by Visit | Month 66 (n=12,14,10) | 140.00 mg/dL | Standard Deviation 117.56 |
| Tofacitinib 15-10-5 mg BID | Serum Triglyceride Levels by Visit | Month 72 (n=9,12,8) | 118.33 mg/dL | Standard Deviation 83.47 |
| Tofacitinib 15-10-5 mg BID | Serum Triglyceride Levels by Visit | Month 78 (n=0,12,8) | 104.42 mg/dL | Standard Deviation 58.22 |
| Tofacitinib 15-10-5 mg BID | Serum Triglyceride Levels by Visit | Month 84 (n=0,12,8) | 127.17 mg/dL | Standard Deviation 66.01 |
| Tofacitinib 15-10-5 mg BID | Serum Triglyceride Levels by Visit | Month 90 (n=0,12,7) | 113.75 mg/dL | Standard Deviation 57.79 |
| Tofacitinib 15-10-5 mg BID | Serum Triglyceride Levels by Visit | Month 96 (n=0,11,6) | 119.64 mg/dL | Standard Deviation 76.86 |
| Tofacitinib 30-15-10 mg BID | Serum Triglyceride Levels by Visit | Month 66 (n=12,14,10) | 145.30 mg/dL | Standard Deviation 75.77 |
| Tofacitinib 30-15-10 mg BID | Serum Triglyceride Levels by Visit | Month 24 (n=17,14,12) | 161.33 mg/dL | Standard Deviation 83.95 |
| Tofacitinib 30-15-10 mg BID | Serum Triglyceride Levels by Visit | Month 9 (n=18,14,12) | 194.00 mg/dL | Standard Deviation 128.6 |
| Tofacitinib 30-15-10 mg BID | Serum Triglyceride Levels by Visit | Month 72 (n=9,12,8) | 188.00 mg/dL | Standard Deviation 72.59 |
| Tofacitinib 30-15-10 mg BID | Serum Triglyceride Levels by Visit | Month 18 (n=18,14,12) | 173.08 mg/dL | Standard Deviation 101.81 |
| Tofacitinib 30-15-10 mg BID | Serum Triglyceride Levels by Visit | Follow-Up (n=6,12,8) | 191.88 mg/dL | Standard Deviation 83.21 |
| Tofacitinib 30-15-10 mg BID | Serum Triglyceride Levels by Visit | Month 78 (n=0,12,8) | 172.38 mg/dL | Standard Deviation 53.73 |
| Tofacitinib 30-15-10 mg BID | Serum Triglyceride Levels by Visit | Month 15 (n=16,14,12) | 200.50 mg/dL | Standard Deviation 122.75 |
| Tofacitinib 30-15-10 mg BID | Serum Triglyceride Levels by Visit | Month 96 (n=0,11,6) | 180.17 mg/dL | Standard Deviation 93.92 |
| Tofacitinib 30-15-10 mg BID | Serum Triglyceride Levels by Visit | Month 84 (n=0,12,8) | 199.75 mg/dL | Standard Deviation 84.79 |
| Tofacitinib 30-15-10 mg BID | Serum Triglyceride Levels by Visit | Month 48 (n=15,14,10) | 150.70 mg/dL | Standard Deviation 106.82 |
| Tofacitinib 30-15-10 mg BID | Serum Triglyceride Levels by Visit | Month 12 (n=16,14,12) | 173.00 mg/dL | Standard Deviation 99.25 |
| Tofacitinib 30-15-10 mg BID | Serum Triglyceride Levels by Visit | Month 54 (n=14,14,10) | 170.90 mg/dL | Standard Deviation 83.72 |
| Tofacitinib 30-15-10 mg BID | Serum Triglyceride Levels by Visit | Month 42 (n=15,14,9) | 141.22 mg/dL | Standard Deviation 63.76 |
| Tofacitinib 30-15-10 mg BID | Serum Triglyceride Levels by Visit | Month 36 (n=15,14,9) | 169.11 mg/dL | Standard Deviation 79.39 |
| Tofacitinib 30-15-10 mg BID | Serum Triglyceride Levels by Visit | Month 60 (n=13,13,10) | 161.10 mg/dL | Standard Deviation 93.01 |
| Tofacitinib 30-15-10 mg BID | Serum Triglyceride Levels by Visit | Month 30 (n=14,14,10) | 162.30 mg/dL | Standard Deviation 55.08 |
| Tofacitinib 30-15-10 mg BID | Serum Triglyceride Levels by Visit | Month 90 (n=0,12,7) | 206.29 mg/dL | Standard Deviation 83.17 |
Secondary
SF-36 v2 Subscale Scores by Visit
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as PCS and MCS. Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Time frame: Months 12, 18, and 24
Population: Safety population; n=number of participants in Safety Population per visit with non-missing value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | Bodily Pain: Month 24 (n=16,13,12) | 53.02 scores on a scale | Standard Deviation 9.2 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | Mental Health: Month 24 (n=16,13,12) | 51.31 scores on a scale | Standard Deviation 8.58 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | Social Function: Month 18 (n=15,12,10) | 49.59 scores on a scale | Standard Deviation 9.85 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | General Health: Month 12 (n=12,13,9) | 57.18 scores on a scale | Standard Deviation 6.12 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | Phys Func: Month 24 (n=16,13,12) | 50.84 scores on a scale | Standard Deviation 9.44 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | Social Function: Month 12 (n=13,13,9) | 48.96 scores on a scale | Standard Deviation 8.37 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | General Health: Month 18 (n=15,12,10) | 52.54 scores on a scale | Standard Deviation 10.64 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | Mental Health: Month 18 (n=15,12,10) | 49.21 scores on a scale | Standard Deviation 11.37 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | Vitality: Month 24 (n=16,13,12) | 54.14 scores on a scale | Standard Deviation 10.88 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | General Health: Month 24 (n=16,13,12) | 49.54 scores on a scale | Standard Deviation 10.37 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | Physical: Month 12 (n=13,13,9) | 49.65 scores on a scale | Standard Deviation 11.3 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | Vitality: Month 18 (n=15,12,10) | 53.55 scores on a scale | Standard Deviation 10.11 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | Vitality: Month 12 (n=13,13,9) | 59.78 scores on a scale | Standard Deviation 5.67 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | Phys Func: Month 12 (n=13,13,9) | 53.49 scores on a scale | Standard Deviation 8.32 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | Mental Health: Month 12 (n=13,13,9) | 54.05 scores on a scale | Standard Deviation 8.04 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | Physical: Month 18 (n=15,12,10) | 52.01 scores on a scale | Standard Deviation 8.19 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | Social Function: Month 24 (n=16,13,12) | 51.36 scores on a scale | Standard Deviation 7.72 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | Emotional: Month 24 (n=16,13,12) | 47.63 scores on a scale | Standard Deviation 14.49 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | Physical: Month 24 (n=16,13,12) | 48.12 scores on a scale | Standard Deviation 14.6 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | TR Scale Score: Month 18 (n=15,12,10) | 1.53 scores on a scale | Standard Deviation 0.74 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | Emotional: Month 18 (n=15,12,10) | 51.64 scores on a scale | Standard Deviation 8.87 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | Bodily Pain: Month 12 (n=13,13,9) | 53.19 scores on a scale | Standard Deviation 13.05 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | Phys Func: Month 18 (n=15,12,10) | 53.16 scores on a scale | Standard Deviation 7.68 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | TR Scale Score: Month 12 (n=13,13,9) | 1.23 scores on a scale | Standard Deviation 0.83 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | Bodily Pain: Month 18 (n=15,12,10) | 53.53 scores on a scale | Standard Deviation 9.59 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | TR Scale Score: Month 24 (n=16,13,12) | 2.00 scores on a scale | Standard Deviation 0.97 |
| Tacrolimus | SF-36 v2 Subscale Scores by Visit | Emotional: Month 12 (n=13,13,9) | 49.27 scores on a scale | Standard Deviation 13.51 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | Emotional: Month 18 (n=15,12,10) | 50.63 scores on a scale | Standard Deviation 10.12 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | Phys Func: Month 12 (n=13,13,9) | 47.82 scores on a scale | Standard Deviation 14.75 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | Phys Func: Month 18 (n=15,12,10) | 50.29 scores on a scale | Standard Deviation 11.22 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | Phys Func: Month 24 (n=16,13,12) | 52.70 scores on a scale | Standard Deviation 8.47 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | Physical: Month 12 (n=13,13,9) | 51.85 scores on a scale | Standard Deviation 10.67 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | Physical: Month 18 (n=15,12,10) | 50.26 scores on a scale | Standard Deviation 8.89 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | Physical: Month 24 (n=16,13,12) | 53.69 scores on a scale | Standard Deviation 6.69 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | Bodily Pain: Month 12 (n=13,13,9) | 54.25 scores on a scale | Standard Deviation 7.34 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | Bodily Pain: Month 18 (n=15,12,10) | 54.32 scores on a scale | Standard Deviation 11.78 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | Bodily Pain: Month 24 (n=16,13,12) | 50.57 scores on a scale | Standard Deviation 12.55 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | General Health: Month 12 (n=12,13,9) | 52.96 scores on a scale | Standard Deviation 8.5 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | General Health: Month 18 (n=15,12,10) | 50.10 scores on a scale | Standard Deviation 8.89 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | General Health: Month 24 (n=16,13,12) | 54.33 scores on a scale | Standard Deviation 8.23 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | Vitality: Month 12 (n=13,13,9) | 55.64 scores on a scale | Standard Deviation 13.28 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | Vitality: Month 18 (n=15,12,10) | 57.44 scores on a scale | Standard Deviation 11.69 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | Vitality: Month 24 (n=16,13,12) | 59.55 scores on a scale | Standard Deviation 7.19 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | Social Function: Month 12 (n=13,13,9) | 46.48 scores on a scale | Standard Deviation 13.14 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | Social Function: Month 18 (n=15,12,10) | 50.58 scores on a scale | Standard Deviation 10.11 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | Social Function: Month 24 (n=16,13,12) | 52.27 scores on a scale | Standard Deviation 7 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | Emotional: Month 12 (n=13,13,9) | 49.56 scores on a scale | Standard Deviation 10.54 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | Emotional: Month 24 (n=16,13,12) | 52.18 scores on a scale | Standard Deviation 7.16 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | Mental Health: Month 12 (n=13,13,9) | 51.71 scores on a scale | Standard Deviation 9.67 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | Mental Health: Month 18 (n=15,12,10) | 54.66 scores on a scale | Standard Deviation 9.87 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | Mental Health: Month 24 (n=16,13,12) | 56.19 scores on a scale | Standard Deviation 6.45 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | TR Scale Score: Month 12 (n=13,13,9) | 1.23 scores on a scale | Standard Deviation 0.83 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | TR Scale Score: Month 18 (n=15,12,10) | 1.67 scores on a scale | Standard Deviation 0.78 |
| Tofacitinib 15-10-5 mg BID | SF-36 v2 Subscale Scores by Visit | TR Scale Score: Month 24 (n=16,13,12) | 1.62 scores on a scale | Standard Deviation 0.77 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | Social Function: Month 24 (n=16,13,12) | 51.03 scores on a scale | Standard Deviation 9.17 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | Bodily Pain: Month 18 (n=15,12,10) | 52.64 scores on a scale | Standard Deviation 10.01 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | Mental Health: Month 18 (n=15,12,10) | 49.02 scores on a scale | Standard Deviation 11.37 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | Bodily Pain: Month 12 (n=13,13,9) | 50.70 scores on a scale | Standard Deviation 11.18 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | Emotional: Month 12 (n=13,13,9) | 48.53 scores on a scale | Standard Deviation 10.61 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | Physical: Month 24 (n=16,13,12) | 51.45 scores on a scale | Standard Deviation 6.42 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | Social Function: Month 18 (n=15,12,10) | 50.49 scores on a scale | Standard Deviation 12.53 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | Emotional: Month 18 (n=15,12,10) | 48.49 scores on a scale | Standard Deviation 12.42 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | Physical: Month 18 (n=15,12,10) | 46.12 scores on a scale | Standard Deviation 11.37 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | TR Scale Score: Month 12 (n=13,13,9) | 1.33 scores on a scale | Standard Deviation 1 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | Emotional: Month 24 (n=16,13,12) | 52.52 scores on a scale | Standard Deviation 4.52 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | Physical: Month 12 (n=13,13,9) | 42.57 scores on a scale | Standard Deviation 13.2 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | Phys Func: Month 12 (n=13,13,9) | 47.56 scores on a scale | Standard Deviation 10.97 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | Mental Health: Month 12 (n=13,13,9) | 52.35 scores on a scale | Standard Deviation 9.08 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | Vitality: Month 12 (n=13,13,9) | 58.61 scores on a scale | Standard Deviation 11.86 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | General Health: Month 24 (n=16,13,12) | 48.14 scores on a scale | Standard Deviation 6.2 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | Phys Func: Month 24 (n=16,13,12) | 47.39 scores on a scale | Standard Deviation 9.28 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | Vitality: Month 18 (n=15,12,10) | 53.75 scores on a scale | Standard Deviation 10.58 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | General Health: Month 18 (n=15,12,10) | 46.67 scores on a scale | Standard Deviation 10.08 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | TR Scale Score: Month 24 (n=16,13,12) | 2.33 scores on a scale | Standard Deviation 0.98 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | Vitality: Month 24 (n=16,13,12) | 50.96 scores on a scale | Standard Deviation 9.75 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | General Health: Month 12 (n=12,13,9) | 47.86 scores on a scale | Standard Deviation 8.52 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | Phys Func: Month 18 (n=15,12,10) | 44.42 scores on a scale | Standard Deviation 11.12 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | Social Function: Month 12 (n=13,13,9) | 50.43 scores on a scale | Standard Deviation 9.1 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | Bodily Pain: Month 24 (n=16,13,12) | 51.51 scores on a scale | Standard Deviation 8.78 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | TR Scale Score: Month 18 (n=15,12,10) | 1.70 scores on a scale | Standard Deviation 1.06 |
| Tofacitinib 30-15-10 mg BID | SF-36 v2 Subscale Scores by Visit | Mental Health: Month 24 (n=16,13,12) | 50.50 scores on a scale | Standard Deviation 9.84 |
Secondary
Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale
The SF-36 is a general health status questionnaire that assesses 8 domains of functional health and well being: Physical Functioning, 36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects can also be summarized as physical and mental component scores (PCS and MCS). Total of 11 variables were analyzed (8 subscales, 2 composite subscales and Question 2 how would you rate your health in general now? (range 1= better, 5= worst). The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Time frame: Months 12, 18, and 24
Population: Safety population; n=number of participants in Safety Population per visit with non-missing value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale | PCS: Month 12 (n=12,13,9) | 54.33 score on a scale | Standard Deviation 7.83 |
| Tacrolimus | Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale | PCS: Month 18 (n=15,12,10) | 53.76 score on a scale | Standard Deviation 8.18 |
| Tacrolimus | Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale | PCS: Month 24 (n=16,13,12) | 50.82 score on a scale | Standard Deviation 9.33 |
| Tacrolimus | Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale | MCS: Month 12 (n=12,13,9) | 53.39 score on a scale | Standard Deviation 7.93 |
| Tacrolimus | Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale | MCS: Month 18 (n=15,12,10) | 49.70 score on a scale | Standard Deviation 10.59 |
| Tacrolimus | Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale | MCS: Month 24 (n=16,13,12) | 50.70 score on a scale | Standard Deviation 9.4 |
| Tofacitinib 15-10-5 mg BID | Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale | MCS: Month 24 (n=16,13,12) | 55.61 score on a scale | Standard Deviation 6 |
| Tofacitinib 15-10-5 mg BID | Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale | PCS: Month 12 (n=12,13,9) | 51.71 score on a scale | Standard Deviation 10.22 |
| Tofacitinib 15-10-5 mg BID | Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale | MCS: Month 12 (n=12,13,9) | 50.83 score on a scale | Standard Deviation 11.12 |
| Tofacitinib 15-10-5 mg BID | Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale | MCS: Month 18 (n=15,12,10) | 53.92 score on a scale | Standard Deviation 10.61 |
| Tofacitinib 15-10-5 mg BID | Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale | PCS: Month 18 (n=15,12,10) | 50.67 score on a scale | Standard Deviation 10.48 |
| Tofacitinib 15-10-5 mg BID | Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale | PCS: Month 24 (n=16,13,12) | 52.17 score on a scale | Standard Deviation 8.06 |
| Tofacitinib 30-15-10 mg BID | Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale | PCS: Month 18 (n=15,12,10) | 46.89 score on a scale | Standard Deviation 9.61 |
| Tofacitinib 30-15-10 mg BID | Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale | PCS: Month 24 (n=16,13,12) | 48.85 score on a scale | Standard Deviation 7.4 |
| Tofacitinib 30-15-10 mg BID | Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale | MCS: Month 24 (n=16,13,12) | 52.14 score on a scale | Standard Deviation 8.89 |
| Tofacitinib 30-15-10 mg BID | Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale | MCS: Month 12 (n=12,13,9) | 54.08 score on a scale | Standard Deviation 10.32 |
| Tofacitinib 30-15-10 mg BID | Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale | PCS: Month 12 (n=12,13,9) | 46.05 score on a scale | Standard Deviation 8.7 |
| Tofacitinib 30-15-10 mg BID | Short-Form 36 Version 2 (SF-36 v2) Mental Component Summary (MCS) and Physical Component Summary (PCS) Scores by Visit and Scale | MCS: Month 18 (n=15,12,10) | 51.44 score on a scale | Standard Deviation 12.21 |
Secondary
Tofacitinib Concentrations in Plasma (ng/mL) by Visit
Time frame: Months 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-up (Month 98)
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 24, predose (n=14,12) | 15.43 ng/mL | Standard Deviation 11.14 |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 48, 0.5 hours postdose (n=1,1) | 1.00 ng/mL | — |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 12, 1 hour postdose (n=1,0) | 51.50 ng/mL | — |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 48, 1 hour postdose (n=1,0) | 56.60 ng/mL | — |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 24, 0.5 hours postdose (n=5,2) | 28.02 ng/mL | Standard Deviation 4.44 |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 54, predose (n=14,10) | 15.99 ng/mL | Standard Deviation 14.97 |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 9, 0.5 hours postdose (n=0,1) | NA ng/mL | — |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 60, predose (n=11,10) | 10.69 ng/mL | Standard Deviation 9.62 |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 24, 1 hour postdose (n=6,3) | 40.88 ng/mL | Standard Deviation 9.28 |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 60, 0.5 hours postdose (n=1,0) | 41.10 ng/mL | — |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 18, predose (n=12,10) | 13.77 ng/mL | Standard Deviation 10.6 |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 66, predose (n=11,10) | 14.64 ng/mL | Standard Deviation 15.04 |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 9, predose (n=13,11) | 40.97 ng/mL | Standard Deviation 46.65 |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 66, 0.5 hours postdose (n=1,2) | 27.70 ng/mL | — |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 30, 0.5 hours postdose (n=5,2) | 51.44 ng/mL | Standard Deviation 26.39 |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 66, 1 hour postdose (n=1,1) | 18.90 ng/mL | — |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 18, 0.5 hours postdose (n=0,1) | NA ng/mL | — |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 30, 1 hour postdose (n=5,2) | 57.78 ng/mL | Standard Deviation 10.9 |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 78, predose (n=10,8) | 4.13 ng/mL | Standard Deviation 3 |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 12, predose (n=13,12) | 14.75 ng/mL | Standard Deviation 10.44 |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 84, predose (n=11,5) | 21.46 ng/mL | Standard Deviation 37.92 |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 36, predose (n=14,8) | 6.73 ng/mL | Standard Deviation 4.49 |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 90, predose (n=10,5) | 6.91 ng/mL | Standard Deviation 7.88 |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 18, 1 hour postdose (n=0,1) | NA ng/mL | — |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 90, 0.5 hours postdose (n=0,1) | NA ng/mL | — |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 42, predose (n=14, 8) | 19.70 ng/mL | Standard Deviation 29.98 |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 96, predose (n=10,6) | 21.07 ng/mL | Standard Deviation 39.16 |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 72, predose (n=9,7) | 10.07 ng/mL | Standard Deviation 14.63 |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Follow-up, predose (n=1,1) | 16.00 ng/mL | — |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 48, predose (n=12,9) | 9.71 ng/mL | Standard Deviation 6.51 |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Follow-up, 0.5 hours postdose (n=2,4) | 2.57 ng/mL | Standard Deviation 2.23 |
| Tacrolimus | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 30, predose (n=14,9) | 6.53 ng/mL | Standard Deviation 5.37 |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Follow-up, 0.5 hours postdose (n=2,4) | 5.39 ng/mL | Standard Deviation 5.28 |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 9, predose (n=13,11) | 12.38 ng/mL | Standard Deviation 7.6 |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 9, 0.5 hours postdose (n=0,1) | 24.00 ng/mL | — |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 12, predose (n=13,12) | 32.86 ng/mL | Standard Deviation 46.5 |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 12, 1 hour postdose (n=1,0) | NA ng/mL | — |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 18, predose (n=12,10) | 7.84 ng/mL | Standard Deviation 7.37 |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 18, 0.5 hours postdose (n=0,1) | 86.30 ng/mL | — |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 18, 1 hour postdose (n=0,1) | 80.70 ng/mL | — |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 24, predose (n=14,12) | 28.15 ng/mL | Standard Deviation 45.77 |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 24, 0.5 hours postdose (n=5,2) | 96.30 ng/mL | Standard Deviation 32.1 |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 24, 1 hour postdose (n=6,3) | 72.33 ng/mL | Standard Deviation 35.8 |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 30, predose (n=14,9) | 16.18 ng/mL | Standard Deviation 19.46 |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 30, 0.5 hours postdose (n=5,2) | 54.95 ng/mL | Standard Deviation 16.05 |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 30, 1 hour postdose (n=5,2) | 98.45 ng/mL | Standard Deviation 30.48 |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 36, predose (n=14,8) | 13.28 ng/mL | Standard Deviation 9.88 |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 42, predose (n=14, 8) | 22.01 ng/mL | Standard Deviation 13.71 |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 48, predose (n=12,9) | 15.54 ng/mL | Standard Deviation 7.33 |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 48, 0.5 hours postdose (n=1,1) | 55.70 ng/mL | — |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 48, 1 hour postdose (n=1,0) | NA ng/mL | — |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 54, predose (n=14,10) | 24.74 ng/mL | Standard Deviation 41.68 |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 60, predose (n=11,10) | 15.03 ng/mL | Standard Deviation 10.78 |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 60, 0.5 hours postdose (n=1,0) | NA ng/mL | — |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 66, predose (n=11,10) | 22.78 ng/mL | Standard Deviation 18.11 |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 66, 0.5 hours postdose (n=1,2) | 29.75 ng/mL | Standard Deviation 18.17 |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 66, 1 hour postdose (n=1,1) | 29.10 ng/mL | — |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 72, predose (n=9,7) | 20.43 ng/mL | Standard Deviation 20.53 |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 78, predose (n=10,8) | 18.94 ng/mL | Standard Deviation 18.48 |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 84, predose (n=11,5) | 11.93 ng/mL | Standard Deviation 6.59 |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 90, predose (n=10,5) | 13.28 ng/mL | Standard Deviation 9.78 |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 90, 0.5 hours postdose (n=0,1) | 17.70 ng/mL | — |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Month 96, predose (n=10,6) | 31.97 ng/mL | Standard Deviation 24.39 |
| Tofacitinib 15-10-5 mg BID | Tofacitinib Concentrations in Plasma (ng/mL) by Visit | Follow-up, predose (n=1,1) | 1.00 ng/mL | — |
Secondary
Total Cholesterol Levels by Visit
Time frame: Months 9, 12, 15, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, and Follow-Up (Month 98)
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | Total Cholesterol Levels by Visit | Month 9 (n=18,14,12) | 187.94 mg/dL | Standard Deviation 44.81 |
| Tacrolimus | Total Cholesterol Levels by Visit | Month 66 (n=12,14,10) | 188.25 mg/dL | Standard Deviation 46.65 |
| Tacrolimus | Total Cholesterol Levels by Visit | Month 36 (n=15,14,9) | 175.80 mg/dL | Standard Deviation 42.49 |
| Tacrolimus | Total Cholesterol Levels by Visit | Month 96 (n=0,11,6) | NA mg/dL | — |
| Tacrolimus | Total Cholesterol Levels by Visit | Month 60 (n=13,13,10) | 178.77 mg/dL | Standard Deviation 50.2 |
| Tacrolimus | Total Cholesterol Levels by Visit | Month 42 (n=15,14,9) | 179.87 mg/dL | Standard Deviation 40.82 |
| Tacrolimus | Total Cholesterol Levels by Visit | Month 15 (n=16,14,12) | 171.06 mg/dL | Standard Deviation 40.13 |
| Tacrolimus | Total Cholesterol Levels by Visit | Month 54 (n=14,14,10) | 184.86 mg/dL | Standard Deviation 43.06 |
| Tacrolimus | Total Cholesterol Levels by Visit | Month 48 (n=15,14,10) | 188.87 mg/dL | Standard Deviation 64.11 |
| Tacrolimus | Total Cholesterol Levels by Visit | Follow-Up (n=6,12,8) | 191.83 mg/dL | Standard Deviation 41.84 |
| Tacrolimus | Total Cholesterol Levels by Visit | Month 90 (n=0,12,7) | NA mg/dL | — |
| Tacrolimus | Total Cholesterol Levels by Visit | Month 18 (n=18,14,12) | 173.28 mg/dL | Standard Deviation 41.76 |
| Tacrolimus | Total Cholesterol Levels by Visit | Month 84 (n=0,12,8) | NA mg/dL | — |
| Tacrolimus | Total Cholesterol Levels by Visit | Month 78 (n=0,13,8) | NA mg/dL | — |
| Tacrolimus | Total Cholesterol Levels by Visit | Month 24 (n=17,14,12) | 185.53 mg/dL | Standard Deviation 62.85 |
| Tacrolimus | Total Cholesterol Levels by Visit | Month 12 (n=16,14,12) | 180.31 mg/dL | Standard Deviation 46.99 |
| Tacrolimus | Total Cholesterol Levels by Visit | Month 72 (n=9,12,8) | 177.22 mg/dL | Standard Deviation 43.21 |
| Tacrolimus | Total Cholesterol Levels by Visit | Month 30 (n=14,14,10) | 175.43 mg/dL | Standard Deviation 44.91 |
| Tofacitinib 15-10-5 mg BID | Total Cholesterol Levels by Visit | Month 18 (n=18,14,12) | 185.21 mg/dL | Standard Deviation 45.99 |
| Tofacitinib 15-10-5 mg BID | Total Cholesterol Levels by Visit | Month 78 (n=0,13,8) | 191.85 mg/dL | Standard Deviation 41.96 |
| Tofacitinib 15-10-5 mg BID | Total Cholesterol Levels by Visit | Month 9 (n=18,14,12) | 233.71 mg/dL | Standard Deviation 71.97 |
| Tofacitinib 15-10-5 mg BID | Total Cholesterol Levels by Visit | Month 12 (n=16,14,12) | 228.57 mg/dL | Standard Deviation 64.34 |
| Tofacitinib 15-10-5 mg BID | Total Cholesterol Levels by Visit | Month 15 (n=16,14,12) | 208.79 mg/dL | Standard Deviation 50.9 |
| Tofacitinib 15-10-5 mg BID | Total Cholesterol Levels by Visit | Month 24 (n=17,14,12) | 188.64 mg/dL | Standard Deviation 40.29 |
| Tofacitinib 15-10-5 mg BID | Total Cholesterol Levels by Visit | Month 30 (n=14,14,10) | 185.71 mg/dL | Standard Deviation 37.82 |
| Tofacitinib 15-10-5 mg BID | Total Cholesterol Levels by Visit | Month 36 (n=15,14,9) | 174.86 mg/dL | Standard Deviation 34.82 |
| Tofacitinib 15-10-5 mg BID | Total Cholesterol Levels by Visit | Month 42 (n=15,14,9) | 206.29 mg/dL | Standard Deviation 78.76 |
| Tofacitinib 15-10-5 mg BID | Total Cholesterol Levels by Visit | Month 48 (n=15,14,10) | 195.79 mg/dL | Standard Deviation 45.97 |
| Tofacitinib 15-10-5 mg BID | Total Cholesterol Levels by Visit | Month 54 (n=14,14,10) | 201.79 mg/dL | Standard Deviation 51.39 |
| Tofacitinib 15-10-5 mg BID | Total Cholesterol Levels by Visit | Month 60 (n=13,13,10) | 184.23 mg/dL | Standard Deviation 34.67 |
| Tofacitinib 15-10-5 mg BID | Total Cholesterol Levels by Visit | Month 66 (n=12,14,10) | 185.64 mg/dL | Standard Deviation 46.46 |
| Tofacitinib 15-10-5 mg BID | Total Cholesterol Levels by Visit | Month 72 (n=9,12,8) | 186.42 mg/dL | Standard Deviation 44.88 |
| Tofacitinib 15-10-5 mg BID | Total Cholesterol Levels by Visit | Month 84 (n=0,12,8) | 192.42 mg/dL | Standard Deviation 42.02 |
| Tofacitinib 15-10-5 mg BID | Total Cholesterol Levels by Visit | Month 90 (n=0,12,7) | 185.92 mg/dL | Standard Deviation 51.46 |
| Tofacitinib 15-10-5 mg BID | Total Cholesterol Levels by Visit | Month 96 (n=0,11,6) | 183.27 mg/dL | Standard Deviation 38.74 |
| Tofacitinib 15-10-5 mg BID | Total Cholesterol Levels by Visit | Follow-Up (n=6,12,8) | 185.58 mg/dL | Standard Deviation 56.08 |
| Tofacitinib 30-15-10 mg BID | Total Cholesterol Levels by Visit | Month 66 (n=12,14,10) | 172.20 mg/dL | Standard Deviation 36.33 |
| Tofacitinib 30-15-10 mg BID | Total Cholesterol Levels by Visit | Month 24 (n=17,14,12) | 201.58 mg/dL | Standard Deviation 47.21 |
| Tofacitinib 30-15-10 mg BID | Total Cholesterol Levels by Visit | Follow-Up (n=6,12,8) | 213.13 mg/dL | Standard Deviation 40.7 |
| Tofacitinib 30-15-10 mg BID | Total Cholesterol Levels by Visit | Month 72 (n=9,12,8) | 200.25 mg/dL | Standard Deviation 57.28 |
| Tofacitinib 30-15-10 mg BID | Total Cholesterol Levels by Visit | Month 18 (n=18,14,12) | 192.00 mg/dL | Standard Deviation 42.14 |
| Tofacitinib 30-15-10 mg BID | Total Cholesterol Levels by Visit | Month 78 (n=0,13,8) | 195.00 mg/dL | Standard Deviation 48.57 |
| Tofacitinib 30-15-10 mg BID | Total Cholesterol Levels by Visit | Month 48 (n=15,14,10) | 180.10 mg/dL | Standard Deviation 38.08 |
| Tofacitinib 30-15-10 mg BID | Total Cholesterol Levels by Visit | Month 96 (n=0,11,6) | 188.00 mg/dL | Standard Deviation 18.89 |
| Tofacitinib 30-15-10 mg BID | Total Cholesterol Levels by Visit | Month 84 (n=0,12,8) | 204.00 mg/dL | Standard Deviation 36.43 |
| Tofacitinib 30-15-10 mg BID | Total Cholesterol Levels by Visit | Month 15 (n=16,14,12) | 198.58 mg/dL | Standard Deviation 30.8 |
| Tofacitinib 30-15-10 mg BID | Total Cholesterol Levels by Visit | Month 42 (n=15,14,9) | 187.67 mg/dL | Standard Deviation 22.57 |
| Tofacitinib 30-15-10 mg BID | Total Cholesterol Levels by Visit | Month 9 (n=18,14,12) | 198.58 mg/dL | Standard Deviation 40.95 |
| Tofacitinib 30-15-10 mg BID | Total Cholesterol Levels by Visit | Month 54 (n=14,14,10) | 183.70 mg/dL | Standard Deviation 42.5 |
| Tofacitinib 30-15-10 mg BID | Total Cholesterol Levels by Visit | Month 36 (n=15,14,9) | 202.22 mg/dL | Standard Deviation 31.25 |
| Tofacitinib 30-15-10 mg BID | Total Cholesterol Levels by Visit | Month 90 (n=0,12,7) | 189.86 mg/dL | Standard Deviation 30.62 |
| Tofacitinib 30-15-10 mg BID | Total Cholesterol Levels by Visit | Month 60 (n=13,13,10) | 189.10 mg/dL | Standard Deviation 56.48 |
| Tofacitinib 30-15-10 mg BID | Total Cholesterol Levels by Visit | Month 30 (n=14,14,10) | 198.30 mg/dL | Standard Deviation 36.42 |
| Tofacitinib 30-15-10 mg BID | Total Cholesterol Levels by Visit | Month 12 (n=16,14,12) | 210.08 mg/dL | Standard Deviation 44.32 |
Secondary
Trough Levels of Tacrolimus (ng/mL) by Visit
Time frame: Months 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, and 72 and Follow-up (Month 98)
Population: Safety population; n=number of participants assessed for the specified parameter at a given visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tacrolimus | Trough Levels of Tacrolimus (ng/mL) by Visit | Month 48 (n=15) | 8.07 ng/mL | Standard Deviation 2.96 |
| Tacrolimus | Trough Levels of Tacrolimus (ng/mL) by Visit | Month 54 (n=1) | 10.00 ng/mL | — |
| Tacrolimus | Trough Levels of Tacrolimus (ng/mL) by Visit | Month 36 (n=15) | 6.87 ng/mL | Standard Deviation 2.26 |
| Tacrolimus | Trough Levels of Tacrolimus (ng/mL) by Visit | Month 42 (n=13) | 7.08 ng/mL | Standard Deviation 1.85 |
| Tacrolimus | Trough Levels of Tacrolimus (ng/mL) by Visit | Month 9 (n=16) | 7.00 ng/mL | Standard Deviation 1.55 |
| Tacrolimus | Trough Levels of Tacrolimus (ng/mL) by Visit | Month 12 (n=10) | 9.50 ng/mL | Standard Deviation 5.08 |
| Tacrolimus | Trough Levels of Tacrolimus (ng/mL) by Visit | Month 18 (n=17) | 8.00 ng/mL | Standard Deviation 2.81 |
| Tacrolimus | Trough Levels of Tacrolimus (ng/mL) by Visit | Month 24 (n=9) | 8.78 ng/mL | Standard Deviation 3.93 |
| Tacrolimus | Trough Levels of Tacrolimus (ng/mL) by Visit | Month 30 (n=12) | 6.17 ng/mL | Standard Deviation 2.55 |
| Tacrolimus | Trough Levels of Tacrolimus (ng/mL) by Visit | Month 60 (n=12) | 6.58 ng/mL | Standard Deviation 3.78 |
| Tacrolimus | Trough Levels of Tacrolimus (ng/mL) by Visit | Month 72 (n=8) | 7.13 ng/mL | Standard Deviation 1.64 |
| Tacrolimus | Trough Levels of Tacrolimus (ng/mL) by Visit | Follow-up (n=1) | 8.00 ng/mL | — |